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

You asked the Plan to provide a tiering exception for Vyzulta. The Plan did not grant this request. Wereceived this case to conduct an independent review.Medicare law and Plan rules do not allow tiering exceptions for non-formulary drugs being coveredthrough a formulary exception. The documentation in the record shows that Vyzulta is currently beingcovered for the enrollee through a formulary exception. Therefore, our decision is the Plan is not requiredto provide a tiering exception for Vyzulta.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ramelteon. The Plan did not grant this request. We received this case toconduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Ramelteon. The drug is requested to treat insomnia. You have not indicated why all alternativesrequired by the Plan would likely not be as effective for the enrollee as the requested drug; and/or wouldlikely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan'scoverage criteria is not supported. Our Physician Reviewer's opinion is that formulary exception criteria arenot met.A Plan must grant an exception for a drug that is not on its formulary if it determines that the requesteddrug is medically necessary, consistent with the prescriber's statement. Based on a review of the availabledocumentation, our Physician Reviewer's opinion is that formulary exception criteria are not met.Therefore, the Plan is not required to cover Ramelteon.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Contrave ER and SelRx Shampoo. The Plan did not grant this request. Wereceived this case to conduct an independent review.Contrave ER:Medicare law excludes certain drugs from Part D coverage. Contrave ER is one of those excluded drugsbecause it is a drug used for anorexia, weight loss or weight gain. The record submitted by the Plan doesnot indicate that they provide supplemental coverage for Contrave ER. Therefore, the Plan is not requiredto cover Contrave ER.This decision does not address the medical necessity or appropriateness of the requested drug. It onlyestablishes that payment cannot be made under the Medicare Part D benefit.SelRx Shampoo:Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. Wedetermined that SelRx Shampoo is not FDA approved for both safety and effectiveness by checking FDAsources. Therefore, the Plan is not required to cover SelRx Shampoo.This decision does not address the medical necessity or appropriateness of the requested drug. It onlyestablishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Pregabalin. The Plan did not grant this request. We received this case toconduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Pregabalin 25 mg. The drug is requested to treat bilateral anterior thigh pain in an enrollee status postbilateral total hip arthroplasties, which is an off-label (non-FDA approved) use. Medical records wereprovided. The Medicare-approved compendia do not contain any citations to support the use of therequested drug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is notbeing prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptionsrequest based on medical necessity cannot be considered because the requested drug, as prescribed, doesnot meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverageunder Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Pregabalin for the diagnosed condition. As a result, the drug isnot being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot becovered under the Medicare Part D benefit for this condition. An exceptions request based on medicalnecessity cannot be considered because this drug, as prescribed, does not meet the definition of a MedicarePart D drug. Therefore, our decision is that the Plan is not required to provide coverage for Pregabalin.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Myrbetriq 25 mg tablet and Myrbetriq 50 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 requestfor a tiering exception for Myrbetriq 25 mg tablet and 50 mg tablet.The drug is requested to treat urinary incontinence. Myrbetriq 25 mg and 50 mg tablet is a brand drug ontier 4 of the Plan's formulary. There are no available lower tier brand drugs of the same type on the Plan'sformulary to treat the enrollee's condition. Therefore, the drug is not eligible for a tiering exception. OurPhysician 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 thesame type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in alower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug isbeing used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met becausethere 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 Myrbetriq, 25 mg tabletand Myrbetriq, 50 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Shingrix Vaccine. 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 requestfor a tiering exception for Shingrix Vaccine. The drug is requested to treat your condition. The drug is abrand drug on Tier 3 of the Plan's formulary. There are no available lower tier brand drugs of the same typeon the Plan's formulary to treat your 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 in alower cost-sharing tier approved for treating the same condition that the higher cost-sharing tier drug isbeing used to treat. In this case, the Plan covers vaccines as a Tier 3 item only. There are no lower costsharingtier vaccines available on the Plan's formulary. Because there are no lower cost-sharing tiervaccines, Shingrix Vaccine is not eligible for a tiering exception. Therefore, our decision is the Plan is notrequired to provide a tiering exception for Shingrix Vaccine.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Nurtec. 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 Nurtec. The drug is requested to treat migraine. You have not indicated why all alternatives required by the Plan (Amerge/naratriptan) 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 Nurtec.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Imatinib Mesylate, 400 mg tablet. The Plan did not grant this request. Wereceived this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Imatinib Mesylate, 400 mg tablet.The drug is requested to treat morphea and eosinophilic fasciitis, which is an off-label (non-FDA approved)use. The Medicare-approved compendia do not contain any citations to support the use of the requesteddrug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is not beingprescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions requestbased on medical necessity cannot be considered because the requested drug, as prescribed, does not meetthe definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage underMedicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Imatinib Mesylate, 400 mg tablet for the diagnosed condition.As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicarelaw. As such, it cannot be covered under the Medicare Part D benefit for this condition. An exceptionsrequest based on medical necessity cannot be considered because this drug, as prescribed, does not meet thedefinition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to providecoverage for Imatinib Mesylate, 400 mg tablet.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Xifaxan, 550 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 Xifaxan, 550 mg tablet.The drug is requested to treat unspecified diarrhea, 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 Xifaxan, 550 mg tablet 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 Xifaxan, 550 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: Favorable

You asked the Plan to cover Humira (CF) Pen 40 mg/0.4 ml. 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 Humira (CF) Pen 40 mg/0.4 ml. The drug is requested to treat active ankylosing spondylitis. You sent a statement clarifying the diagnosis. Medical records were provided which support the diagnosis. You state the enrollee has had prior therapy, contraindication, or intolerance with a non-steroidal anti-inflammatory drug. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. Based on the available documentation, our Physician Reviewer's opinion is that prior approval criteria are met. Therefore, our decision is the Plan is required to cover Humira (CF) Pen 40 mg/0.4 ml.Please note that if the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The health plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will notify you in writing that the case is being reviewed again and the outcome of the reopening.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Zolpidem. The Plan did not grant this request. We received this case toconduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Zolpidem 10 mg. The drug is requested to treat insomnia. The enrollee does not satisfy the Plan'scoverage criteria. The prescriber has not sufficiently addressed the Plan's coverage criteria and/or has notindicated why all alternatives required by the Plan would likely not be as effective for the enrollee as therequested drug, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Our Physician'sopinion 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. APlan must grant an exception to prior approval rules if it determines that the requested drug is medicallynecessary, consistent with the prescriber's statement. Based on the available documentation, our PhysicianReviewer's opinion is that an exception to prior approval criteria is not met. Therefore, the Plan is notrequired to cover Zolpidem.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Striverdi Respimat. The Plan did not grant this request. We received this caseto conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Striverdi Respimat 2.5 mcg. The drug is requested to treat asthma, which is an off-label (non-FDAapproved) use. The Medicare-approved compendia do not contain any citations to support the use of therequested drug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is notbeing prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptionsrequest based on medical necessity cannot be considered because the requested drug, as prescribed, doesnot meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverageunder Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Striverdi Respimat for the diagnosed condition. As a result, thedrug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, itcannot be covered under the Medicare Part D benefit for this condition. An exceptions request based onmedical necessity cannot be considered because this drug, as prescribed, does not meet the definition of aMedicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage forStriverdi Respimat.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Otezla. 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 Otezla. The drug is requested to treat ankylosing spondylitis, 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 Otezla 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 Otezla. 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 Eliquis. The Plan did not grant this request. We received this case to conduct an independent review.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 Eliquis.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Testosterone. 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 Testosterone 1.62% Gel Pump. The drug is requested to treat male hypogonadism. 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. 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 Testosterone.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Epidiolex. 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 Epidiolex 100 mg/mL.The drug is requested to treat localization-related epilepsy with complex partial seizures with intractable epilepsy, 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 Epidiolex 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 Epidiolex. 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.