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

You asked the Plan to cover IPN Compound (Travasol, Dianeal). 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 Intraperitoneal nutrition/IPN Compound - Travasol/Dianeal Solution. IPN Compound -Travasol/Dianeal Solution is requested to treat malnutrition/weight loss in this enrollee with end stage renaldisease who is on home peritoneal dialysis. You have specifically stated that the IPN will be administeredduring dialysis. As the IPN will be administered with the dialysate, IPN is eligible for coverage underMedicare Part B. Based on the documentation provided, our Physician Reviewer's opinion is that therequested drug is not eligible for Part D coverage.Medicare law requires that all drugs and biologicals used in the treatment of ESRD or AKI be included inthe ESRD PPS payment bundle, regardless of the reason why the drug is being prescribed and regardless ofwhether or not the drug is furnished by a dialysis facility. Drugs that are always considered ESRD andAKI-related include access management drugs, anemia management drugs, anti-infectives to treat siteaccess infection, bone and mineral metabolism drugs and cellular management drugs.In this case, IPN Compound (Travasol, Dianeal) is being prescribed to an enrollee who has ESRD or AKIand is on dialysis. IPN Compound (Travasol, Dianeal) is a class of medication which is always consideredESRD or AKI-related for purposes of the Part B ESRD payment bundle. Thus, the requested drug iseligible for coverage under the Part B ESRD payment bundle, regardless of the reason why the drug isbeing prescribed and regardless of whether or not the drug is being furnished by a dialysis facility. Drugswhich are eligible for Part B coverage are excluded from Part D coverage by Medicare law. Therefore, ourdecision is the Part D Plan is not required to cover IPN Compound (Travasol, Dianeal).This decision does not concern the medical necessity or appropriateness of the requested drug. It onlyestablishes if payment can be made under the Medicare Part D benefit.You may wish to submit this request to the Part B carrier.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Xifaxan. 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 colitis with small intestinal bacterial overgrowth, 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 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. 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

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 usas required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Vigamox. The Plan did not grant this request. We received this case to conductan independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Vigamox 0.5% opth drops. Vigamox 0.5% opth drops is requested to treat an unknown diagnosis. Theprescriber was asked to state the enrollee's diagnosis, because there was no prescriber statement of theenrollee's diagnosis in the case file. The prescriber was also asked to address medical necessity for therequested drug. A response from the prescriber was not received. Therefore, based on the current record,there is insufficient documentation that the requested medication is being prescribed for a medicallyaccepted indication as defined by Medicare law. In addition, an exceptions request based on medicalnecessity cannot be considered because it cannot be confirmed that the drug meets the definition of aMedicare Part D drug.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 Vigamox 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 Vigamox.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 Estradiol 0.025 mg/24 hr patch. The Plan did notgrant 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 Estradiol 0.025 mg/24 hr patch.The drug is requested for hormone replacement therapy for menopausal symptoms. Estradiol 0.025 mg/24hr patch is a generic drug on tier 3 of the Plan's formulary. There are no available lower tier generic drugsof the same type on the Plan's formulary to treat the enrollee's condition. Therefore, the drug is not eligiblefor 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 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 Estradiol 0.025 mg/24hr patch.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Prolia 60 mg/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 Prolia 60 mg/mL.The drug is requested to treat postmenopausal osteoporosis. The prescriber documented that the enrollee will be taking Evista (Raloxifene) in combination with the requested drug. 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 Prolia 60 mg/mL.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Ingrezza. The Plan did not grant this request. We received this case to conductan independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Ingrezza 40 mg. Ingrezza 40 mg is requested for ongoing treatment of tardive dyskinesia affecting thetongue and jaw resulting in difficulty speaking and eating. The prescriber states that the enrollee has failedmaximum doses of Austedo, and has been stable on a regimen of the requested drug plus Clonazepam plusBotox. Botox has been held during the pandemic; the prescriber states that symptoms have beensatisfactorily controlled with the oral medications. The plan has indicated that Tetrabenazine is on theirformulary. The prescriber has specifically addressed the plan's alternative, and has provided a sufficientlystrong statement as to why ongoing treatment with the noted regimen is the best option for this enrollee.The prescriber has indicated why all alternatives required by the Plan would likely not be as effective as therequested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee.Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer'sopinion is that formulary exception criteria are 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 met. Therefore,the Plan is required to cover Ingrezza.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Repatha SureClick 140 mg/mL. 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 Repatha SureClick 140 mg/mL solution.The drug is requested to treat hyperlipidemia/atherosclerotic cardiovascular disease. The prescriber has notindicated why all alternatives required by the Plan (Praluent) would likely not be as effective for theenrollee 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 opinionis 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 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 Repatha SureClick 140 mg/mL.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Duavee. 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 Duavee 0.45-20 mg. The drug is requested to treat symptoms of menopause including vasomotor symptoms in an individual with history of breast cancer. The presence of history of breast cancer is a labeled contraindication to the use of the requested medication. 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 Duavee.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Acthar Gel. 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 Acthar Gel 400 unit/5 ml. The drug is requested to treat Stage IV Sarcoidosis. 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 Acthar Gel
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Mometasone Compound. The Plan did not grant this request. We received thiscase to conduct an independent review.Medicare Part D does not cover drugs that are not FDA approved. A representative of the pharmacy statedthat bulk powder was used or would be used when compounding the prescription for MometasoneCompound. Bulk powders used in pharmacy compounding are not reviewed and approved for safety andefficacy by the FDA. Therefore, the Plan is not required to cover Mometasone Compound.This decision does not address the medical necessity or appropriateness of the requested drug. It onlyestablishes 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 Vimpat. 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 a tiering exception for Vimpat 200 mg tablet.The drug is requested to treat G40.31 Generalized idiopathic epilepsy and epileptic syndromes, intractable.Vimpat 200 mg tablet is a brand drug on tier 4 of the Plan's formulary. There are no available lower tierbrand drugs of the same type on the Plan's formulary to treat the enrollee's condition. Therefore, the drug isnot eligible for a tiering exception. Our Physician Reviewer's opinion is that tiering exception criteria arenot 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 Vimpat.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Trulicity. 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 a tiering exception for Trulicity. The drug is requested to treat type 2 diabetes mellitus. The drug is onTier 3 of the Plan's formulary. There are no available lower tier biologic drugs on the Plan's formulary totreat the enrollee's condition. Therefore, the drug is not eligible for a tiering exception. Our PhysicianReviewer'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 Trulicity
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Trulicity and Humalog Kwikpen. The Plan did not grant this request. We received this case to conduct an independent review.Med Humalog Kwik Penicare rules do not require the Part D plan to grant a tiering exception for a brand or biologic drug of the same type if the lower tier(s) on the formulary only contain(s) generic alternative drugs. Trulicity and Humalog Kwikpen is a Tier 3 biologic drug. The lower cost-sharing tier(s) only contain(s) generic alternative drugs. Therefore, our decision is the Plan is not required to provide a tiering exception for Trulicity and Humalog Kwikpen.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Arnuity Ellipta. The Plan did not grant this request.We received this case to conduct an independent review.Medicare rules do not require the Part D plan to grant a tiering exception for a brand or biologic drug of thesame type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) ifthe lower tier(s) on the formulary only contain(s) generic alternative drugs. Arnuity Ellipta is a Tier 3 branddrug. The lower cost-sharing tier(s) only contain(s) generic alternative drugs. Therefore, our decision is thePlan is not required to provide a tiering exception for Arnuity Ellipta.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Xeljanz. 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 Xeljanz 5 mg tablet. The drug is requested to treat Giant cell arteritis with renal artery stenosis, 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 Xeljanz 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 Xeljanz. 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 Mycophenolate Mofetil. 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 Mycophenolate Mofetil.Mycophenolate Mofetil is requested for ongoing prevention of lung transplant rejection, 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 Mycophenolate Mofetil 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 Mycophenolate Mofetil. 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.