Persius/hicric huggingface dataset:
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 Tretinoin 0.025% cream. 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 Tretinoin 0.025% topical cream.The drug is requested to treat acne vulgaris. Additional medical information was requested by the Part DQIC. The prescribing physician was asked to address the enrollee's diagnosis and prior authorizationcoverage criteria. The prescriber statement was returned. The prescriber has not documented that theenrollee had a failure of a one month trial of each of the following: combination formulary agent containingtopical erythromycin and benzoyl peroxide; combination formulary agent containing topical clindamycinand benzoyl peroxide. The enrollee does not satisfy the Plan's coverage criteria. The prescriber has notsufficiently addressed the Plan's coverage criteria and/or has not indicated why all alternatives required bythe Plan 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. Our Physician's opinion is that neither prior authorizationnor prior authorization exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. APlan must grant an exception to prior approval rules if it determines that the requested drug is medicallynecessary, consistent with the prescriber's statement. Based on the available documentation, our PhysicianReviewer's opinion is that an exception to prior approval criteria is not met. Therefore, the Plan is notrequired to cover Tretinoin 0.025% cream.
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 Fluticasone-Salmeterol. 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 Fluticasone-Salmeterol.Fluticasone-Salmeterol is requested for treatment of the enrollee's condition. You were asked to provide the diagnosis being treated with the requested drug, and to address the formulary alternatives; however no additional information was received from you. 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. 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 Fluticasone-Salmeterol.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Humira 40 mg/0.4 ml syringe. 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 Humira 40 mg/0.4 ml syringe. The drug is requested to treat H20.9 - uveitis in an enrollee withsarcoidosis. You clarified the diagnosis in the request for reconsideration. Medical records from date ofservice May 11, 2020 were provided which support these diagnoses. For coverage under the prescriptiondrug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. OurPhysician Reviewer found that the Medicare-approved resources do contain citations to support the use ofthe requested drug for treatment of the noted condition. Therefore, the requested drug is being prescribedfor a medically accepted indication. The enrollee satisfies the Plan's coverage criteria. Our PhysicianReviewer's opinion is that prior authorization 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 ofHumira 40 mg/0.4 ml syringe for the diagnosed condition. As a result, Humira 40 mg/0.4 ml syringe isbeing prescribed for a 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 Humira 40 mg/0.4 ml syringe.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Hydroxyzine. 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 tiering exception request for Hydroxyzine. Our Physician Reviewer needed additional information from the prescriber to make this determination. The prescriber was asked to address whether the lower cost-sharing tiered drug(s) offered by the Plan to treat your condition would: (1) be less effective than the requested non-preferred 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 tiering exception criteria are not met.Medicare rules require a Plan to grant an exception to its tiering structure whenever it determines that the higher cost-sharing tiered drug for treatment of the enrollee's condition is medically necessary consistent with the prescriber's statement. Our Physician Reviewer's opinion is that tiering exception criteria are not met. Therefore, our decision is the Plan is not required to provide a tiering exception for Hydroxyzine.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Vraylar. 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 Vraylar 1.5 mg capsule.The drug is requested to treat the enrollee's condition. The drug is a brand drug on tier 4 of the Plan'sformulary. There are no available lower tier brand drugs on the Plan's formulary to treat the enrollee'scondition. Therefore, the drug is not eligible for a tiering exception. Our Physician Reviewer's opinion isthat 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 Vraylar.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Oxycodone HCL 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 Oxycodone HCL ER. The drug is requested to treat chronic pain. Additional medical information was requested by the Part D QIC. You were asked to address the formulary alternatives. Fentanyl patch is available on the Plan's formulary and was not addressed. In addition, requested supporting chart notes were not submitted. 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. 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 Oxycodone HCL ER.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Sildenafil Citrate 20 mg. The Plan did not grant this request. We received thiscase to conduct an independent review.Medicare law excludes certain drugs from Part D coverage. Sildenafil Citrate 20 mg is one of thoseexcluded drugs because it is a drug being used to treat sexual or erectile dysfunction. The record submittedby the Plan does not indicate that they provide supplemental coverage for Sildenafil Citrate 20 mg.Therefore, the Plan is not required to cover Sildenafil Citrate 20 mg.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% 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.Lidocaine 5% Patch is requested for treatment of chronic low back pain in this enrollee who has complexregional pain syndrome, which are off-label (non-FDA approved) uses. The Medicare-approved compendiado not contain any citations to support the use of the requested drug, as prescribed, for treatment of thenoted conditions. 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 notedconditions.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 conditions. 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 these conditions. 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: Unfavorable

You asked the Plan to cover Cyclobenzaprine 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 Cyclobenzaprine HCL 10 mg tablet. The drug is requested for ongoing treatment of chronic back pain/degenerative disc disease, 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 Cyclobenzaprine 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 Cyclobenzaprine 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: Unfavorable

You asked the Plan to cover Tadalafinil. 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 Tadalafinil 5 mg tablet. The drug is requested to treat primary pulmonary hypertension, which is an offlabel(non-FDA approved) use. The Medicare-approved compendia do not contain any citations to supportthe use of the requested drug, as prescribed, for treatment of the noted condition. Therefore, the requesteddrug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, anexceptions 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 Tadalafinil 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 Tadalafinil.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Otezla. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Otezla 10-20-30mg tablet.The drug is requested to treat lichen planus, which is an off-label (non-FDA approved) use. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia that support the use of Otezla for the diagnosed condition. As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Otezla. This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lyrica, 300 mg capsule. 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 Lyrica, 300 mg capsule.The drug is requested to treat neuropathic leg pain. DRUGDEX cites results from the following reference in the FDA USE section Neuropathic pain - spinal cord injury: Finnerup NB, Attal N, Haroutounian S, et al: Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol 2015; 14(2):162-173 which concluded that the requested drug is one of several drugs proposed as first line treatment of neuropathic pain in general. It is noted that the enrollee's condition is included in the patient population of studies cited. Therefore, this drug is being prescribed for a medically accepted indication. For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of the requested drug for treatment of the noted condition. Therefore, the requested drug is being prescribed for a medically accepted indication.Also note that in the Reconsideration appeal relevant medical records were requested. No medical records were provided. The prescriber 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. 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 Lyrica, 300 mg capsule.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Mexiletine HCL 200 mg capsule. 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 Mexiletine HCL 200 mg. The drug is requested to treat ventricular tachycardia and ventricular fibrillation. Upon reconsideration, the prescribing physician has submitted additional information including statement and chart notes. You are prescribed both Amiodarone and Mexiletine. Chart notes indicate that you have a prolonged QT interval. The prescriber states that you have life threatening arrhythmia and that no other alternatives are appropriate for you. The prescriber has indicated why all alternatives required by the Plan would likely not be as effective as the requested drug for you, and/or would likely cause adverse reaction(s) or other harm to you. Therefore, an exception to the Plan's coverage criteria is medically 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 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 met. Therefore, the Plan is required to cover Mexiletine HCL 200 mg capsule.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Zolpidem. 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 Zolpidem.Zolpidem is requested to treat insomnia. For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of the requested drug for treatment of the noted condition. Therefore, the requested drug is being prescribed for a medically accepted indication. You do 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 you as the requested drug, and/or would likely cause adverse reaction(s) or other harm to you. 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 Zolpidem.