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

You asked the Plan to cover Dupixent 300 mg/2 mL. 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 Dupixent 300 mg/ 2 mL.The drug is requested to treat bullous pemphigoid, 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 Dupixent 300 mg/2 mL 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 Dupixent 300 mg/2 mL.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Eplerenone. 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 Eplerenone 25 mg tablet. The drug is requested to treat the enrollee's condition.The drug is a GENERIC drug on Tier 4 of the Plan's formulary. The prescriber does not state why allavailable lower tier 1 mineralocorticoid-receptor antagonist alternatives on the Plan's formulary to treat theenrollee's condition (Spironolactone) (1) would not be as effective for the enrollee as the requested drugand/or (2) would have adverse effects for the enrollee. Therefore, an exception to these criteria is notsupported. 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 thehigher cost-sharing tiered drug for treatment of the enrollee's condition is medically necessary consistentwith the prescriber's statement. Our Physician Reviewer's opinion is that tiering exception criteria are notmet. Therefore, our decision is the Plan is not required to provide a tiering exception for Eplerenone.
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 provide reimbursement for Shingrix purchased on February 21, 2020, from thepharmacy. The Plan did not grant this request. We received this case to conduct an independent review.Medicare rules allow a Part D Plan to apply coinsurance and copayments to covered drugs. If an enrolleepays the full cost of a prescription, the enrollee may submit a request for reimbursement with proof ofpayment to ask the Plan to pay its share of the cost. The Plan requires a $47 copayment for up to a 30-daysupply of a Tier 3 drug purchased from a standard retail pharmacy in 2020. A request for reimbursementwas submitted to the Plan. In this case, the Plan provided documentation showing that this claim wascovered by the Plan at the time of purchase. The record shows that Shingrix was purchased for an amountthat is less than or equal to the required copayment amount.The case record indicates that the Plan provided coverage in accordance with the Part D contract.Therefore, our decision is the Plan is not required to provide reimbursement for Shingrix purchased onFebruary 21, 2020, from the pharmacy.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Rytary 48.75 mg per 195 mg ER 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 Plan was correct in denying the request forRytary (Carbidopa/ Levodopa) 48.75 mg per 195 mg ER capsule. Rytary (Carbidopa/Levodopa) 48.75 mgper 195 mg ER capsule is requested to treat Parkinson's disease. Additional medical information wasrequested by the Part D QIC. You were asked to address Step Therapy coverage criteria. Your letter wasreturned. You documented that Carbidopa/ Levodopa IR tablets were tried and failed. You have indicatedwhy all alternatives required by the Plan would likely not be as effective as the requested drug for theenrollee, and/or would likely cause adverse reactions or other harm to the enrollee. Therefore, an exceptionto the Plan's coverage criteria is medically necessary.Our Physician Reviewer's opinion is that step therapy exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring step therapy for certain drugs. APlan must grant an exception to step therapy rules if it determines that the requested drug is medicallynecessary, consistent with the prescriber's statement. Based on a review of the available documentation,our Physician Reviewer's opinion is that an exception to step therapy criteria is met. Therefore, the Plan isrequired to cover Rytary 48.75 mg per 195 mg ER capsule.
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 Polyethylene Glycol and Acetaminophen received February 6, 2020 while inthe hospital. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover non-prescription drugs. We checked FDA approved sources for the drug'sclassification or determined from other available resources that the drug is a non-prescription or OTC drug.Therefore, Polyethylene Glycol and Acetaminophen is not eligible for Part D coverage, and the Plan is notrequired to cover it under the Part D benefit.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 provide additional reimbursement for Prednisone 20 mg tablet purchased April 17, 2020 from the pharmacy. The Plan did not grant this request. We received this case to conduct an independent review.Medicare rules allow a Part D Plan to apply coinsurance and copayments to covered drugs. If you pay the full cost of a prescription drug out-of-pocket or if you find you have paid more than you expected to pay under the Plan's coverage rules, you can ask the Plan to pay you back. When submitting a request for reimbursement, the Plan requires that you submit your receipt documenting the payment you have made along with your reimbursement request. Pursuant to guidelines issued by the Centers for Medicare and Medicare Services (CMS), as of February 1, 2014, the Plan has enacted a policy in which an enrollee is responsible for the difference between the cash price paid and the Plan's contracted negotiated rate for a drug for any purchases made at an in-network pharmacy that are not submitted online electronically through the pharmacy.In this case, the Plan approved coverage for Prednisone 20 mg tablet purchased on April 17, 2020 from the pharmacy. The Plan calculated reimbursement by using their contracted negotiated rate as the total cost for the drug and subtracting the requirement copayment amount. Thus, the Plan charged the enrollee the difference between the cash price paid and the Plan's contracted negotiated rate for this drug. The Plan is permitted to calculate reimbursement this way for in-network pharmacy purchases not run online electronically per Medicare rules.The case record indicates that the Plan provided coverage and calculated reimbursement in accordance with Medicare law and rules. Therefore, our decision is the Plan is not required to provide additional reimbursement for Prednisone purchased on April 17, 2020 from the pharmacy.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Xifaxan. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Xifaxan 550 mg tab. The drug is requested to treat small intestine bacterial overgrowth in an enrollee with systemic sclerosis with impaired small bowel transit and fibrosis of the small bowel, which is an off-label (non-FDA approved) use. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia that support the use of Xifaxan for the diagnosed condition. As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Xifaxan. This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Azathioprine. 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 Azathioprine 50 mg. The drug is requested to treat sarcoidosis of the lung and lymph nodes, which is anoff-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 Azathioprine for the diagnosed condition. As a result, the drugis not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannotbe covered 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 Azathioprine.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 Tacrolimus 0.1% Ointment. 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 Tacrolimus 0.1%. The drug is requested to treat lichen simplex chronicus, which is an off-label (non-FDA approved) use. The Medicare-approved compendia do not contain any citations to support the use ofthe requested drug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is notbeing prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptionsrequest based on medical necessity cannot be considered because the requested drug, as prescribed, doesnot meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverageunder 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 Tacrolimus 0.1% 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 Tacrolimus 0.1% Ointment.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 Renal-Vite. The Plan did not grant this request. We received this case to conduct an independent review.A written request for Reconsideration must be filed within 60 days from the date of the Plan's Redetermination Letter. This request was not filed within the required 60-day time limit. However, the case record reflects there is good cause for the late filing. Therefore the Reconsideration request is being processed.Medicare Part D does not cover non-prescription drugs. We checked FDA approved sources for the drug's classification or determined from other available resources that the drug is a non-prescription or OTC drug. Therefore, Renal-Vite is not eligible for Part D coverage, and the Plan is not required to cover it under the Part D benefit. This decision does not address the medical necessity or appropriateness of the requested drug. It only establishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lidocaine patch. 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 Lidocaine 5% patch. The drug is requested to treat unspecified osteoarthritis, unspecified site, chronicpain, unspecified facet joint pain, status post spinal fusion, and fibromyalgia, which are off-label (non-FDAapproved) uses. The Medicare-approved compendia do not contain any citations to support the use of therequested drug, as prescribed, for treatment of the noted conditions. Therefore, the requested drug is notbeing prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptionsrequest based on medical necessity cannot be considered because the requested drug, as prescribed, doesnot meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverageunder 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 patch 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 forLidocaine 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

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 provide reimbursement for Shingrix Vaccine purchased on June 3, 2019 andNovember 29, 2019 from the pharmacy. The Plan did not grant this request. We received this case toconduct an independent review.Medicare rules allow a Part D Plan to apply coinsurance and copayments to covered drugs. If an enrolleepays the full cost of a prescription, the enrollee may submit a request for reimbursement with proof ofpayment to ask the Plan to pay its share of the cost. The Plan required a $15 for up to a 30 day supply of aTier 3 drug purchased from a preferred retail in 2019. A request for reimbursement was submitted to thePlan. In this case, the Plan provided documentation showing that this claim was covered by the Plan at thetime of purchase. The record shows that Shingrix Vaccine was purchased for an amount that is less than orequal to the required copayment amount.The case record indicates that the Plan provided coverage in accordance with the Part D contract.Therefore, our decision is the Plan is not required to provide reimbursement for Shingrix Vaccinepurchased on June 3, 2019 and November 29, 2019 from the pharmacy.
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 provide reimbursement for the Shingrix vaccine received December 28, 2019 andFebruary 28, 2020. The Plan did not grant this request. We received this case to conduct an independentreview.Medicare rules allow a Part D Plan to apply coinsurance and copayments to covered drugs. If an enrolleepays the full cost of a prescription, the enrollee may submit a request for reimbursement with proof ofpayment to ask the Plan to pay its share of the cost. The Plan required a $30 copayment amount for up to a30 day supply of a Tier 3 drug purchased in 2019 and 2020 from a preferred retail pharmacy. The Shingrixvaccine was on the Plan's 2019 and 2020 formulary and was classified as a Tier 3 drug. A request forreimbursement was submitted to the Plan. In this case, the Plan provided documentation showing that theseclaims were covered by the Plan at the time of purchase. The record shows that the Shingrix vaccinereceived December 28, 2019 and February 28, 2020 was purchased for an amount that is less than or equalto the required copayment amount.The case record indicates that the Plan provided coverage in accordance with the Part D contract.Therefore, our decision is the Plan is not required to provide reimbursement for the Shingrix vaccinereceived December 28, 2019 and February 28, 2020.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Sildenafil 100 mg. The Plan did not grant this request. We received this case toconduct an independent review.Medicare law excludes certain drugs from Part D coverage. Sildenafil is one of those excluded drugsbecause it is a drug used to treat sexual or erectile dysfunction or sexual or erectile dysfunction drug used totreat a condition other than sexual or erectile dysfunction for which the drug has not been approved by theFDA. Social Security Act, Sections 1860D-2(e) (2) (A), 1927(d) (2) and 1927(d) (4) (C). The recordsubmitted by the Plan does not indicate that they provide supplemental coverage for Sildenafil. Therefore,the Plan is not required to cover Sildenafil.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.