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

You asked the Plan to cover Auryxia. 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 Auryxia 210 mg. The drug is requested to treat secondary hyperparathyroidism and hyperphosphatemiarelated to chronic kidney disease not on dialysis, which are off-label (non-FDA approved) uses. TheMedicare-approved compendia do not contain any citations to support the use of the requested drug, asprescribed, for treatment of the noted conditions. Therefore, the requested drug is not being prescribed for amedically accepted indication as defined by Medicare law. As such, an exceptions request based onmedical necessity cannot be considered because the requested drug, as prescribed, does not meet thedefinition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage underMedicare Part D for the noted conditions.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 Auryxia 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 Auryxia.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 Xiidra. The Plan did not grant this request. We received this case to conduct anindependent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Xiidra. The drug is requested to treat dry eye syndrome. 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 Xiidra.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Vesicare 10 mg. 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 Vesicare 10 mg. The drug is requested to treat urge incontinence. Upon reconsideration, you state thatthe enrollee tried and failed treatment with Trospium. You have indicated why all alternatives required bythe Plan would likely not be as effective as the requested drug for the enrollee, and/or would likely causeadverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria ismedically necessary. Our Physician Reviewer's opinion 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 Vesicare 10 mg.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Gralise ER. 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 Gralise ER 600 mg. The drug is requested to treat idiopathic progressive neuropathy and chronic pain syndrome related to car accidents and neck surgery, 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 Gralise ER 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 Gralise ER.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 Ofev 150 mg capsule. The Plan did not grant this request. We received thiscase to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Ofev 150 mg capsule. The drug is requested to treat interstitial lung disease/idiopathic pulmonaryfibrosis. For coverage under the prescription drug benefit, Medicare requires that the drug prescribed beused for a medically accepted indication. On March 20, 2020 you sent additional information and medicalrecords addressing the diagnosis and the Plan's coverage criteria. Our Physician Reviewer found that theMedicare-approved resources do contain citations to support the use of the requested drug for treatment ofthe noted condition. Therefore, the requested drug is being prescribed for a medically accepted indication.The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that priorauthorization criteria are met.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 reviewedthis file and determined that there are citations in the Medicare approved compendia that support the use ofOfev 150 mg capsule for the diagnosed condition. As a result, Ofev 150 mg capsule is being prescribed fora medically accepted indication as defined by Medicare law.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 aremet. Therefore, our decision is the Plan is required to cover Ofev 150 mg capsule.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ondansetron HCL. 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 Ondansetron HCL. The drug is requested to treat nausea and vomiting related to peritoneal dialysis forend stage renal disease, which is an off-label (non-FDA approved) use. The Medicare-approved compendiado not contain any citations to support the use of the requested drug, as prescribed, for treatment of thenoted condition. Therefore, the requested drug is not being prescribed for a medically accepted indicationas defined by Medicare law. As such, an exceptions request based on medical necessity cannot beconsidered because the requested drug, as prescribed, does not meet the definition of a Medicare Part Ddrug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the notedcondition.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 Ondansetron HCL 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 forOndansetron HCL.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 Auryxia. 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 Auryxia.Auryxia is requested for treatment of disorder of phosphorus metabolism and anemia in this enrollee with chronic kidney disease (CKD), stage IV, who is not on dialysis. For the diagnosis of anemia, Auryxia is excluded from coverage under Medicare Part D because it is being used as a prescription vitamin/mineral. The diagnosis of disorder of phosphorus metabolism in this enrollee with CKD not on dialysis is an off-label (non-FDA approved) use for the requested drug. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the disorder of phosphorus related to CKD in patients not on dialysis. In summary, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law for the diagnosis of disorder of phosphorus metabolism related to CKD in an enrollee not on dialysis, and the requested drug is excluded from coverage for the diagnosis of anemia related to CKD.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 Auryxia 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 Auryxia. 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 Promethazine HCL. 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 Promethazine HCL 12.5 mg.The drug is requested to treat chronic nausea, which is an off-label (non-FDA approved) use. TheMedicare-approved compendia do not contain any citations to support the use of the requested drug, asprescribed, for treatment of the noted condition. Therefore, the requested drug is not being prescribed for amedically accepted indication as defined by Medicare law. As such, an exceptions request based onmedical necessity cannot be considered because the requested drug, as prescribed, does not meet thedefinition 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 Promethazine HCL 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, 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 forPromethazine HCL.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 Zolpidem ER. 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 ER. The drug is requested to treat insomnia. The prescriber stated that you have tried andfailed Trazodone. The prescriber has not indicated why all alternatives required by the Plan would likelynot be as effective for you as the requested drug; and/or would likely cause adverse reaction(s) or otherharm to you. Therefore, an exception to the Plan's coverage criteria is not supported. Our PhysicianReviewer'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 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 Zolpidem ER.
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 Lidocaine 5% patch. 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 Lidocaine 5% patch. The drug is requested to treat acute low back pain without sciatica and musclespasm, which are off-label (non-FDA approved) uses. The Medicare-approved compendia do not containany 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 byMedicare law. As such, an exceptions request based on medical necessity cannot be considered because therequested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, therequested 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 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 Lidocaine 5% patch 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, 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 forLidocaine 5% patch.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: Favorable

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 Xeljanz XR ER 24-hour 11 mg. 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 XR ER 24-hour 11 mg. Xeljanz XR ER 24-hour 11 mg is requested for ongoing treatment of moderate to severe rheumatoid arthritis. The prescriber states that Xeljanz was started in 2019, and that the treatment has been effective. Per HPMS (Health Plan Management System - CMS's official database for Plan formularies), the Plan's coverage rules for the enrollee's diagnosis apply to new starts only. The enrollee is already taking the requested drug; the requested drug is not a new start. Therefore, the Plan's coverage rules for this drug to not apply. Our Physician Reviewer's opinion is that Medicare Part D criteria for coverage of the requested drug have been 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 Xeljanz XR ER 24-hour 11 mg.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Fentanyl. 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 Fentanyl 100 mcg/hr every 72 hours. Fentanyl 100 mcg/hr every 72 hours is requested for ongoingtreatment of chronic non cancer pain. It is noted that the enrollee is also being treated with Oxycodoneimmediate release, 15 mg every 8 hours as needed. The plan has coverage criteria when daily morphineequivalent (MME) limit exceeds 200 mg daily; in this instance, the plan requires physician documentationof the MME required. the plan has indicated that based on the dose/quantity of Fentanyl patch requested,and the recent fill of Oxycodone 15 mg, #122 per 28 days (4 per day), that the enrollee's MME is 330 mg.Additional information was requested from the prescriber who states that over the course of the treatment,the enrollee has been weaned significantly, and that an MME of 330 mg is the lowest dose she can tolerateto manage her pain. The prescriber has indicated that the MME required is the same as calculated by theplan based on Oxycodone filled. Our Physician Reviewer's opinion is that prior authorization criteria aremet.Of note. the prescriber states that the enrollee is treated with Oxycodone IR 15 mg every 8 hours as needed,but states that the 30 day supply is #180 per 30 days which equals #6 per day; however based on theprescribing instructions, the maximum quantity would be 15 mg, #4 per day which results in the stated totaldaily MME of 330 mg.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 aremet. Therefore, our decision is the Plan is required to cover Fentanyl.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Cinacalcet HCL. 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 Cinacalcet HCL 30 mg tablet. The drug is requested to treat hypercalcemia, in a renal transplantrecipient with persistent hyperparathyroidism (NOT on dialysis). This enrollee is a 66 year old femalestatus post (s/p) renal transplant on 9/13/2019 for end-stage renal disease (ESRD) secondary tohypertension. This patient had a previous kidney transplant on 1/25/2016 which failed due to graftthrombosis. For coverage under the prescription drug benefit, Medicare requires that the drug prescribed beused for a medically accepted indication. Our Physician Reviewer found that the Medicare-approvedresources do contain citations to support the use of the requested drug for treatment of the noted condition.The following citation in DrugDex, a Medicare approved compendium, supports the use of the requesteddrug for the enrollee's condition: Cinacalcet treatment significantly decreased the mean corrected totalserum calcium to less than 10.2 mg/dL in 78.9% of patients compared with 3.5% with placebo in a 26-week, randomized study of renal transplant recipients with hypercalcemia and persistenthyperparathyroidism. Therefore, the requested drug is being prescribed for a medically acceptedindication. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that priorauthorization 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 aremet. Therefore, our decision is the Plan is required to cover Cinacalcet HCL.