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

You asked the Plan to cover Mycophenolate Mofetil, 500 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 Mycophenolate Mofetil, 500 mg.The drug is requested to treat interstitial lung disease of unclear etiology in an enrollee with rheumatoid arthritis, which is an off-label (non-FDA approved) use. Medical records from date of service 5/4/2020 were provided which support these diagnoses. 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, 500 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 Mycophenolate Mofetil, 500 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 Pregabalin, 225 mg capsule, 90 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 Pregabalin, 225 mg.The drug is requested to treat right knee pain related to patellar tendonitis/bursitis, 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 Pregabalin, 225 mg capsule 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 Pregabalin, 225 mg capsule, 90 per 30 days. 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 Testosterone 1.62% gel. 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 Testosterone 1.62% gel. The drug is requested to treat age related late onset male hypogonadism, whichis an off-label (non-FDA approved) use. The Medicare-approved compendia do not contain any citations tosupport the use of the requested drug, as prescribed, for treatment of the noted condition. Additionalmedical information was requested by the Part D QIC. The prescribing physician was asked to address thePlan's prior authorization criteria and to clarify your diagnosis. The prescribing physician states that yourdiagnosis is age related late onset hypogonadism. Therefore, the requested drug is not being prescribed fora medically 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 Testosterone 1.62% gel for the diagnosed condition. As aresult, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. Assuch, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions requestbased 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 Testosterone 1.62% gel.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 conductan independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Auryxia. The drug is requested to treat Iron deficiency anemia in an enrollee who has chronic kidneydisease and is not on dialysis. Prescription vitamins and minerals are excluded from coverage underMedicare Part D drug plans. Therefore the requested drug is excluded from coverage.Medicare law excludes certain drugs from Part D coverage. Auryxia is one of those excluded drugs becauseit is a prescription vitamin and mineral product. The record submitted by the Plan does not indicate thatthey provide supplemental coverage for Auryxia. Therefore, the Plan is not required to cover Auryxia.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 Lidocaine 5% ointment. 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 Lidocaine 5% Ointment. The drug is requested to treat pain in left ankle and joints of left foot, which isan off-label (non-FDA approved) use. The Medicare-approved compendia do not contain any citations tosupport the use of the requested drug, as prescribed, for treatment of the noted condition. Therefore, therequested drug is not being prescribed for a medically accepted indication as defined by Medicare law. Assuch, an exceptions request based on medical necessity cannot be considered because the requested drug, asprescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is noteligible 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 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% ointment for the diagnosed condition. As aresult, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. Assuch, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions requestbased 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 Lidocaine 5% ointment.This decision does not concern the medical necessity of the requested drug. It only establishes i f paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover L-Methylfolate Forte. The Plan did not grant this request. We received thiscase to conduct an independent review.Medicare Part D does not cover medical foods. L-Methylfolate Forte is a medical food. Therefore,L-Methylfolate Forte is not eligible for Part D coverage, and the Plan is not required to cover it under thePart D benefit.This decision does not address the medical necessity or appropriateness of the requested product. 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 Lanthanum, 1000 mg tablet. The Plan did not grant this request. We receivedthis case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Lanthanum, 1000 mg tablet.The drug is requested to treat hyperphosphatemia in an enrollee with end-stage renal disease receivinghemodialysis. Lanthanum, 1000 mg tablet is not on the Plan's formulary. Auryxia is on the Plan'sformulary. Medical records from date of service 6/10/2020 were provided which documented Pendingtrial: Fosrenol, Auryxia, Velphoro. The prescriber has not indicated why all alternatives required by thePlan would likely not be as effective for the enrollee as the requested drug; and/or would likely causeadverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria isnot 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 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 Lanthanum, 1000 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Oxycontin 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 Oxycontin ER 60 mg tablet, morphine mg equivalent (MME) limit. The drug is requested to treatchronic pain. The Plan limits the amount of opioid to 200 morphine mg equivalents unless a statement ismade by the prescriber that a higher morphine mg equivalent (MME) is required to adequately manage theenrollee's pain. The prescriber indicated that the MME required for this enrollee is 205 although based onthe records the enrollee would be receiving 225 MME with Percocet 10/325 mg three times daily andOxycontin ER 60 mg twice daily. The prescriber has not indicated that the number of doses of therequested drug allowed by the plan would likely be ineffective in treating the enrollee's condition and/orwould likely cause harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is notsupported. Our Physician Reviewer's opinion is that MME 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 andnecessary, 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, thePlan is not required to cover the requested quantity of Oxycontin ER.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Humalog 100 units/ml kwikpen as prescribed. The Plan did not grant thisrequest. 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 Humalog 100 units/ml kwikpen.The drug is requested to treat type I diabetes mellitus in a patient with episodes of hypoglycemia due tosickle cell anemia. The prescriber has indicated that due to the enrollee's sickle-cell anemia, monitoring ofblood glucose and dosing of insulin is very difficult. The prescriber has indicated why all alternativesrequired by the Plan would likely not be as effective as the requested drug for the enrollee, and/or wouldlikely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan'scoverage criteria is medically necessary. Our Physician Reviewer's opinion is that formulary exceptioncriteria 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 Humalog 100 units/ml kwikpen as prescribed.
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 Insulin Aspart FlexPen. 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 Insulin Aspart FlexPen 100 unit/mL. Insulin Aspart FlexPen 100 unit/mL is requested for ongoingtreatment of type II diabetes mellitus. The prescriber was asked to address the plan's formulary alternatives;however no additional information was received from the prescriber. The prescriber has not indicated whyall 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 thePlan's coverage criteria is not supported. Our Physician Reviewer's opinion is that formulary exceptioncriteria 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 Insulin Aspart FlexPen.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Epidiolex. 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 Epidiolex 100 mg/ ml.The drug is requested to treat intractable epilepsy/seizures not associated with Lennox-Gastaut or Dravetsyndromes, which is an off-label (non-FDA approved) use. The Medicare-approved compendia do notcontain any citations to support the use of the requested drug, as prescribed, for treatment of the notedcondition. Therefore, the requested drug is not being prescribed for a medically accepted indication asdefined by Medicare law. As such, an exceptions request based on medical necessity cannot be consideredbecause 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 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 Epidiolex 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 Epidiolex.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 Praluent. The Plan did not grant this request. We received this case to conduct an independent review.In this case, you requested coverage for Praluent that was already billed or will be billed at the pharmacy via a patient assistance program (PAP). According to the Plan's Evidence of Coverage (Chapter 5, Section 4.1):When you get a drug through a patient assistance program offered by a drug manufacturerSome members are enrolled in a patient assistance program offered by a drug manufacturer that is outside the plan benefits. If you get any drugs through a program offered by a drug manufacturer, you may pay a copayment to the patient assistance program.&#61623; Save your receipt and send a copy to us so that we can have your out-of-pocket expenses count toward qualifying you for the Catastrophic Coverage Stage.&#61623; Please note: Because you are getting your drug through the patient assistance program and not through the plan's benefits, we will not pay for any share of these drug costs. But sending a copy of the receipt allows us to calculate your out-of-pocket costs correctly and may help you qualify for the Catastrophic Coverage Stage more quickly.When you decided to use a PAP you acknowledged and agreed that the PAP will be treated as the primary payor with respect to medications that you have selected to purchase through the PAP services. Thus, Praluent is not eligible for coverage or reimbursement by Part D. Therefore, it is our decision that the Plan is not required to cover Praluent, while you are enrolled with the PAP.Please note: if you are not using the PAP for prescription drug coverage, the request for Praluent may still be eligible for coverage and/or reimbursement under the Part D Plan.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Diclofenac Sodium 1% gel. The Plan did not grant this request. We receivedthis case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Diclofenac Sodium 1% gel.The drug is requested for the treatment of chronic low back pain due to degenerative discdisease/osteoarthritis, status post (s/p) spine fusion x2, sacroiliac joint pain, trochanteric bursitis of righthip, chronic bilateral knee pain s/p bilateral knee replacements, and neuropathic pain, which are off-label(non-FDA approved) uses. The appeal request noted a diagnosis of knee osteoarthritis, however, this wasnot supported in the medical records, as ICD-10 code M25.561 was documented (right knee pain). 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 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 isOur Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Diclofenac Sodium 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 forDiclofenac Sodium.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 Dupixent. The Plan did not grant this request. We received this case to conduct an independent review.We asked a Physician Reviewer to determine whether the Plan was correct in denying the request for Dupixent, which is not on the Plan's formulary. Our Physician Reviewer needed additional information from you to make this determination. You were asked to address whether the drugs offered by the Plan would: (1) not be as effective as the requested non-formulary drug; and/or (2) have adverse effects. The requested information was not received. Based on a review of the available documentation, 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 Dupixent.