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

You asked the Plan to cover Nourianz. 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 Nourianz. The drug is requested to treat off episodes associated with Parkinson's disease. Theprescriber has not indicated why all alternatives required by the Plan (Entacapone tablet, Pramipexoletablet, Ropinirole tablet, and Selegiline capsule) 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. Therefore, anexception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is thatformulary 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 Nourianz.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Motegrity. 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 Motegrity.Motegrity is requested to increase gastric emptying, in this enrollee with a delay in emptying of the distalesophagus which you feel contributes to recurrent aspiration and flares of the enrollee's chronic obstructivelung disease, 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 Motegrity 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 Motegrity.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 Guanfacine 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 Guanfacine HCL 1 mg tab. The drug is requested to treat attention deficit hyperactivity disorder in anadult enrollee with Down's syndrome, anxiety, depression and obsessive compulsive disorder, which is anoff-label (non-FDA approved) use. The prescriber clarified the diagnosis in a letter dated 6/22/2020. 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 Guanfacine 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 forGuanfacine 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 Lidocaine HCL. 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 Lidocaine HCL Urethral/Mucosal 2% prefilled syringe. The drug is requested to treat anal fissure and unspecified hemorrhoids, 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 Lidocaine 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, 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 Lidocaine HCL. 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 Pregabalin 75 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 Pregabalin 75 mg. The drug is requested for ongoing treatment of chronic low back pain with lumbarradiculopathy/lumbar fusion/ post-surgical neuropathic pain. Additional medical information was requestedby the Part D QIC. The prescribing physician was asked to address the enrollee's diagnosis and priorauthorization coverage criteria. The prescriber statement was returned.For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for amedically accepted indication. Our Physician Reviewer found that the Medicare-approved resources docontain citations to support the use of the requested drug for treatment of the noted condition. DrugDex, aMedicare approved compendium, cites results from the following reference in the FDA Use sectionNeuropathic pain - spinal cord injury: Finnerup NB, Attal N, Haroutounian S, et al: Pharmacotherapy forneuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol 2015; 14(2):162-173which concluded that the requested drug is one of several drugs proposed as first line treatment ofneuropathic pain in general. It is noted that the enrollee's condition is included in the patient population ofstudies cited. Therefore, this drug is being prescribed for a medically accepted indication.The prescriber documented that the enrollee had tried and failed Gabapentin (11/4/2014-3/12/2015). Theenrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorizationcriteria 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 ofPregabalin for the diagnosed condition. As a result, Pregabalin is being prescribed for a medically acceptedindication 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 Pregabalin.
Appeal type: Prescription Drug
Decision: Favorable

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 100 mg. Pregabalin 100 mg, is requested for treatment of chronic back pain related tolumbar degenerative disc disease associated with radiculopathy in this enrollee who is status post fusionand laminectomy. The documentation indicates that the enrollee has failed Gabapentin, and has beentreated with various opioids, non-steroidal anti-inflammatory drugs, and muscle relaxants.The plan denied coverage of Pregabalin because they determined that it is not being prescribed for amedically accepted indication. For coverage under the prescription drug benefit, Medicare requires that thedrug prescribed be used for a medically accepted indication. Our Physician Reviewer found that theMedicare-approved resources do contain citations to support the use of the requested drug for treatment ofthe noted condition. DRUGDEX cites results from the following reference in the FDA USE sectionNeuropathic pain - spinal cord injury: Finnerup NB, Attal N, Haroutounian S, et al: Pharmacotherapy forneuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol 2015; 14(2):162-173which concluded that the requested drug is one of several drugs proposed as first line treatment ofneuropathic pain. It is noted that the enrollee's condition is included in the patient population of studiescited. Therefore, this drug is being prescribed for a medically accepted indication. The enrollee does notsatisfy the Plan's coverage criteria. The prescriber has indicated why all alternatives required by the Planwould likely not be as effective as the requested drug for the enrollee, and/or would likely cause adversereaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is medicallynecessary. Our Physician Reviewer's opinion is that 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 met. Therefore, our decision is the Planis required to cover Pregabalin.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Dronabinol. 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 Dronabinol 2.5 mg. The drug is requested to treat anorexia nervosa restricting type, 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 Dronabinol 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 Dronabinol. 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 Gralise. 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. The drug is requested to treat neuralgia & neuritis, unspecified and neuralgia & neuritis, unspecified and neuralgia from shingles. A returned prescriber was reviewed. Medical records as requested were not included for review to support the added diagnosis of a postherpetic neuralgia. For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. Additionally, you have not indicated why all alternatives required by the Plan would likely not be as effective for the enrollee as the requested drug; and/or would likely cause adverse reaction(s) or other harm to the enrollee. Medical records to support previous trials were not submitted as requested. 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 Gralise.
Appeal type: Prescription Drug
Decision: Unfavorable

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified timeframe. If the Plan does not make a timely decision, this is considered a denial. The Plan forwarded this case to us as required by Medicare rules because it did not make a timely decision.You asked the Plan to cover or provide reimbursement for Fentanyl received January 9, 2020 while you were a patient at the hospital. The Plan did not grant this request. We received this case to conduct an independent review.The Part D Plan covers prescriptions filled at an out-of-network pharmacy only in certain limited circumstances. If an enrollee must use an out-of-network pharmacy, the enrollee will generally have to pay the full cost when the prescription is filled. The enrollee may submit a request for reimbursement with proof of payment to ask the Plan to pay its share of the cost. In this case, the record shows that you were a patient at the hospital on January 9, 2020. You received Fentanyl for a medical emergency or urgent care. You submitted a request for reimbursement with a copy of the hospital bill. However, the record does not include proof of payment in full of the self-administered drug portion of the bill or an itemized list of the drugs administered. The Plan's criteria for out-of-network coverage and reimbursement have not been met. Therefore, our decision is the Plan is not required to cover or provide reimbursement for Fentanyl received January 9, 2020 as a patient at the hospital.Please note once you have paid your bill in full you can resubmit your request for review to your Part D Plan.
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. Epidiolex is requested for treatment of drug-resistant focal epilepsy not associated withLennox-Gastaut or Dravet Syndrome, which is an off-label (non-FDA approved) use. The Medicareapprovedcompendia do not contain any citations to support the use of the requested drug, as prescribed, fortreatment of the noted condition. Therefore, the requested drug is not being prescribed for a medicallyaccepted indication as defined by Medicare law. As such, an exceptions request based on medical necessitycannot be considered because the requested drug, as prescribed, does not meet the definition of a MedicarePart D drug. 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 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 Koselugo. 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 Koselugo 10 mg; 180/30. The drug is requested to treat an adult with plexiform neurofibromas, which is an off-label (non-FDA approved) use.The enrollee is a 72 year old woman with neurofibromatosis type 1.She has had multiple neurofibromas resected. The prescriber states they are plexiform neurofibromas. She now has inoperable lesions on the larynx and right neck. The prescriber requests Koselugo to treat her. The prescriber states she likely has had this condition since childhood. The drug is approved and supported for pediatric patients. There is no support for use in adults.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. There was no peer-reviewed, clinically relevant, medical literature from an approved journal submitted to support this appeal. 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. For Part D drugs used in an anticancer chemotherapeutic regimen, 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 or peer-reviewed medical literature in CMS-approved journals or publications.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia and there was no peer-reviewed literature from an approved journal submitted to support the use of Koselugo 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 Koselugo. 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.