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

You asked the Plan to cover Benztropine Mesylate, 1 mg tablet. The Plan did not grant this request. We received this case to conduct an independent review.   We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Benztropine Mesylate, 1 mg tablet.  The drug is requested to treat contracture of muscle and blepharospasm, which are off-label (non-FDA approved) uses. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted conditions. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted conditions.  For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia.   Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia that support the use of Benztropine Mesylate, 1 mg tablet for the diagnosed conditions. As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit for these conditions. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Benztropine Mesylate, 1 mg tablet.  This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tacrolimus and Mycophenolate Mofetil . The Plan did not grant this request. We received this case to conduct an independent review.Medicare law specifically excludes coverage for any drug under the Part D program for which payment would be available under Parts A or B of Medicare for that individual. Coverage is available under Medicare Part B for prescription drugs used in immunosuppressive therapy furnished to a beneficiary who has received an organ transplant, provided the beneficiary receiving the drug was enrolled in Medicare Part A at the time of the organ transplant.The case record indicates that Tacrolimus and Mycophenolate Mofetil are needed for a Kidney transplant. According to Medicare enrollment records, you were determined to be entitled to Medicare Part A coverage at the time of the transplant. Thus, the transplant is considered a Medicare covered transplant and Tacrolimus and Mycophenolate Mofetil are eligible for coverage under Medicare Part B. Drugs which are eligible for Part B coverage are excluded from Part D coverage by Medicare law.Additionally, drugs eligible to be covered under Parts A and/or B are considered available (and excluded from Part D) even if a beneficiary chooses not to pay premiums or if a beneficiary has enrolled in Part B but that coverage has not yet taken effect. Medicare records show that you are entitled to Part B coverage at this time, even though you may have chosen not to pay premiums and/or coverage may not have taken effect. Thus, Tacrolimus and Mycophenolate Mofetil are not considered as Part D drugs in this case. Therefore, our decision is the Part D Plan is not required to cover Tacrolimus and Mycophenolate Mofetil. This decision does not concern the medical necessity or appropriateness of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.You may wish to submit this request to the Medicare Part B carrier.
Appeal type: Prescription Drug
Decision: Unfavorable

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified timeframe. If the Plan does not make a timely decision, this is considered a denial. The Plan forwarded this case to us as required by Medicare rules because it did not make a timely decision.  You asked the Plan to cover Inbrija. The Plan did not grant this request. We received this case to conduct an independent review.   We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Inbrija. Inbrija is requested to treat Parkinson's disease. The prescriber was asked questions to clarify the diagnosis being treated and to provide documentation to support the noted diagnosis. The prescriber was also asked questions to address the Plan's coverage/exception criteria. A response from the prescriber was not received. Therefore, based on the current record, there is insufficient documentation to support an exception to the Plan's coverage criteria.  For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia.   Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia that support the use of Inbrija for the diagnosed condition. As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Inbrija.  A Plan must grant an exception for a drug that is not on its formulary if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that formulary exception criteria are not met. Therefore, the Plan is not required to cover Inbrija.  This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.  Please note: the request for a tiering exception (lower copayment) for Inbrija was not reviewed. We cannot consider a tiering exception for a drug for which the Part D Plan is unable to provide coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Veltassa 8.4 gm packet. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Veltassa 8.4 gm packet.The drug is requested to treat hyperkalemia. The enrollee does not satisfy the Plan's coverage criteria. The prescriber has not sufficiently addressed the Plan's coverage criteria and/or has not indicated why all alternatives required by the Plan would likely not be as effective for the enrollee as the requested drug, and/or would likely cause adverse reaction(s) or other harm to the enrollee. The enrollee has not tried and failed the health Plan's first line agent Lokelma. Although the prescriber states that Lokelma cannot be used for the enrollee due to the risk of edema, this is not a true contraindication. Our Physician's opinion is that neither prior authorization nor prior authorization exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. A Plan must grant an exception to prior approval rules if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on the available documentation, our Physician Reviewer's opinion is that an exception to prior approval criteria is not met. Therefore, the Plan is not required to cover Veltassa 8.4 gm packet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Prevymis. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Prevymis 480 mg. The drug is requested to to prevent cytomegalovirus disease viremia after a solid organ (heart) transplant, which is an off-label (non-FDA approved) use. The following citation in AHFS-DI, a Medicare approved compendium states: Safety and efficacy of letermovir for prophylaxis to prevent CMV infection and disease in solid organ transplant recipients or for preemptive treatment of CMV infection or disease in HSCT or solid organ transplant recipients have not been established. 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. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia that support the use of Prevymis for the diagnosed condition. As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Prevymis. This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ketoconazole, 200 mg tablet. The Plan did not grant this request. We received this case to conduct an independent review.   We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Ketoconazole, 200 mg tablet.  The drug is requested for prevention of recurrent candidiasis related to kidney transplant and stabilization of Prograf levels related to kidney transplant, which are off-label (non-FDA approved) uses. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted conditions. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted conditions.  For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia.   Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia that support the use of Ketoconazole, 200 mg tablet for the diagnosed conditions. As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit for these conditions. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Ketoconazole, 200 mg tablet.  This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Vascepa, 1 gm capsule. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for a tiering exception for Vascepa, 1 gm.The drug is requested to treat the enrollee's condition. The drug is a brand drug on tier 4 of the Plan's formulary. There are no available lower tier drugs of the same type on the Plan's formulary to treat the enrollee's condition. Therefore, the drug is not eligible for a tiering exception. Our Physician Reviewer's opinion is that tiering exception criteria are not met.Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in a lower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug is being used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met because there are no lower cost-sharing tiered drugs of the same type for treating the enrollee's condition. Therefore, our decision is the Plan is not required to provide a tiering exception for Vascepa, 1 gm capsule.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Azathoprine. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law specifically excludes coverage for any drug under the Part D program for which payment would be available under Parts A or B of Medicare for that individual. Coverage is available under Medicare Part B for prescription drugs used in immunosuppressive therapy furnished to a beneficiary who has received an organ transplant, provided the beneficiary receiving the drug was enrolled in Medicare Part A at the time of the organ transplant. The case record indicates that Azathoprine is needed for a kidney transplant. According to Medicare enrollment records, the enrollee was determined to be entitled to Medicare Part A coverage at the time of the transplant. Thus, the transplant is considered a Medicare covered transplant and Azathoprine is eligible for coverage under Medicare Part B. Drugs which are eligible for Part B coverage are excluded from Part D coverage by Medicare law.Additionally, drugs eligible to be covered under Parts A and/or B are considered available (and excluded from Part D) even if a beneficiary chooses not to pay premiums or if a beneficiary has enrolled in Part B but that coverage has not yet taken effect. Medicare records show that the enrollee is entitled to Part B coverage at this time, even though the beneficiary may have chosen not to pay premiums and/or coverage may not have taken effect. Thus, Azathoprine is not considered a Part D drug in this case. Therefore, our decision is the Part D Plan is not required to cover Azathoprine. This decision does not concern the medical necessity or appropriateness of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.You may wish to submit this request to the Medicare Part B carrier.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ubrelvy 100 mg, 30 per 30 days. The Plan did not grant this request. We received this case to conduct an independent review. We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Ubrelvy 100 mg, 30 tablets per 30 days. The drug is requested to treat migraine headache. The Plan limits the amount of Ubrelvy 100 mg tablet to 8 tablets per 30 days. The prescriber has not indicated that the number of doses of the requested drug allowed by the plan would likely be ineffective in treating the enrollee's condition and/or would likely cause harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is that quantity limit exception criteria are not met.Medicare rules allow a Part D Plan to manage its formulary by covering a limited quantity of certain drugs. A Plan must grant an exception if it determines that the requested dosage is medically reasonable and necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that an exception to the quantity limit criteria is not met. Therefore, the Plan is not required to cover the requested quantity of Ubrelvy 100 mg, 30 per 30 days.Please note: the documentation indicates you are requesting 10 tablets per 30 days. Maximus Federal is required to perform reviews that are consistent with the Plan's documentation. The Plan provided documentation shows 30 tablets per 30 days was reviewed, not 10 tablets per 30 days. If you would like to pursue coverage of 10 tablets per 30 days, you may wish to submit that request to the Plan at this time.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Toujeo Solostar. The Plan did not grant this request. We received this case to conduct an independent review.   We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for a tiering exception for Toujeo Solostar 300 units/mL. The drug is requested to treat type 2 diabetes mellitus. The drug is on tier 3 of the Plan's formulary. There are no available lower tier brand drugs on the Plan's formulary to treat the enrollee's condition. Therefore, the drug is not eligible for a tiering exception. Our Physician Reviewer's opinion is that tiering exception criteria are not met.  Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of the same type in a lower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug is being used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met because there are no lower cost-sharing tiered drugs of the same type for treating the enrollee's condition. Therefore, our decision is the Plan is not required to provide a tiering exception for Toujeo Solostar.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Edetate Disodium powder, Benzalkonium Chloride, and sterile water injection. The Plan did not grant this request. We received this case to conduct an independent review.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. If a drug is not used for a medically accepted indication of therapeutic value on the body, it cannot satisfy the definition of a Part D drug. Edetate Disodium powder, Benzalkonium Chloride, and sterile water injection are used as a fillers (inactive)/vehicles/excipients in the reconstitution of the Intron A-Sodium Chloride Compound. Edetate Disodium powder, Benzalkonium Chloride, and sterile water injection use in this instance are not therapeutic. Thus, Edetate Disodium powder, Benzalkonium Chloride, and sterile water injection do not meet the definition of Part D drugs. Therefore, the Plan is not required to cover Edetate Disodium powder, Benzalkonium Chloride, or sterile water injection.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Prevymis. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Prevymis 480 mg. The drug is requested for prevention of cytomegalovirus disease related to lung transplant, which is an off-label (non-FDA approved) use. 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. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia that support the use of Prevymis for the diagnosed condition. As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Prevymis. This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Vyvanse. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Vyvanse. The drug is requested to treat Attention Deficit Hyperactivity Disorder. For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of the requested drug for treatment of the noted condition. Therefore, the requested drug is being prescribed for a medically accepted indication. You stated that the enrollee tried and failed Adderall, Strattera, and Methylphenidate. You have not indicated why all alternatives required by the Plan would likely not be as effective for the enrollee as the requested drug; and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is that formulary exception criteria are not met.A Plan must grant an exception for a drug that is not on its formulary if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that formulary exception criteria are not met. Therefore, the Plan is not required to cover Vyvanse.