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

You asked the Plan to provide additional reimbursement for Symbicort (Budesonide-Formoterol Fumarate)received October 7, 2019. The Plan did not grant this request. We received this case to conduct anindependent review.A written request for Reconsideration must be filed within 60 days from the date of the Plan'sRedetermination Letter. This request was not filed within the required 60-day time limit. However, the caserecord reflects there is good cause for the late filing. Therefore the Reconsideration request is beingprocessed.The Part D Plan covers prescriptions filled at an out-of-network pharmacy only in certain limitedcircumstances. The Plan submitted documentation showing that they approved coverage. They calculatedreimbursement based on the total cost of the drug, less your required copayment amount, and less thedifference between what the Plan normally pays for the drug and what the out-of-network pharmacy (i.e.,hospital or provider's office) charged you.The case record indicates that the Plan provided coverage and reimbursement in accordance with the Part DPlan rules for out-of-network reimbursement. Therefore, our decision is the Plan is not required to provideany additional reimbursement for Symbicort (Budesonide-Formoterol Fumarate) received October 7, 2019.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Repatha Sureclick. 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 a tiering exception for Repatha Sureclick.Repatha Sureclick is requested for treatment of the enrollee's condition. Repatha Sureclick is a biologicdrug on Tier 3 of the plan's formulary. There are no available lower tier biologic drugs on the Plan'sformulary to treat the enrollee's condition. Therefore, the requested drug is not eligible for a tieringexception. Our Physician Reviewer's opinion is that 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 Repatha Sureclick.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Mesalamine DR. 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 requestfor a tiering exception for Mesalamine DR. The drug is requested to treat your condition. The drug is ageneric drug on Tier 4 of the Plan's formulary. There are no available lower tier oral drugs on the Plan'sformulary to treat your condition. Therefore, the drug is not eligible for a tiering exception. Our PhysicianReviewer's opinion is that 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 Mesalamine DR.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Fentanyl patch. 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 Fentanyl patch which is subject to prior approval. Our Physician Reviewer needed additional information from the prescriber to make this determination. The prescriber was asked to address whether the drugs offered by the Plan for the treatment of the enrollee's condition would: (1) not be as effective as the requested drug; and/or (2) have adverse effects. The requested information was not received. Based on a review of the available documentation, neither prior authorization criteria nor prior authorization exception criteria are mt.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 Fentanyl patch.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Pradaxa. 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 Pradaxa 150 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. The prescriber does not state why all available lower tier brand alternatives on the Plan'sformulary to treat the enrollee's condition (1) would not be as effective for the enrollee as the requesteddrug and/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 Pradaxa.
Appeal type: Prescription Drug
Decision: Favorable

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified timeframe.If the Plan does not make a timely decision, this is considered a denial. The Plan forwarded this case to usas required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Oxycodone HCL 10 mg tablet. 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 Oxycodone HCL 10 mg tablet. The drug is requested to treat chronic pain syndrome. Documentationsupports a formulary exception has previously been approved. Prior authorization from the Plan indicatesquantities should not exceed a morphine equivalent dose of 200mg per day. Review of the documentationindicates a maximum daily dose of 120mg MED. The enrollee satisfies the Plan's coverage criteria. OurPhysician Reviewer's opinion is that prior authorization criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs.Based on the available documentation, our Physician Reviewer's opinion is that prior approval criteria aremet. Therefore, our decision is the Plan is required to cover Oxycodone HCL 10 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Vitamin K1. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law excludes certain drugs from Part D coverage. Vitamin K1 is one of those excluded drugs because it is a prescription vitamin and mineral product. The record submitted by the Plan does not indicate that they provide supplemental coverage for Vitamin K1. Therefore, the Plan is not required to cover Vitamin K1. 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

A written request for Reconsideration must be filed within 60 days from the date of the Plan'sRedetermination Letter. This request was not filed within the required 60-day time limit. However, the caserecord reflects there is good cause for the late filing. Therefore the Reconsideration request is beingprocessed.You asked the Plan to provide reimbursement for Vitamin K1 received October 7, 2019. The Plan did notgrant this request. We received this case to conduct an independent review.Medicare law excludes certain drugs from Part D coverage. Vitamin K1 is one of those excluded drugsbecause it is a prescription vitamin and mineral product. The record submitted by the Plan does not indicatethat they provide supplemental coverage for Vitamin K1. Therefore, the Plan is not required to providereimbursement for Vitamin K1 received October 7, 2019.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 a tiering exception for Myrbetriq. 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 Myrbetriq 25 mg.Myrbetriq 25 mg is requested for treatment of the enrollee's condition. Myrbetriq 25 mg is a brand drug onTier 4 of the plan's formulary. There are no available lower tier brand drugs on the Plan's formulary to treatthe enrollee's condition. Therefore, the requested drug is not eligible for a tiering exception.Our Physician Reviewer's opinion is that 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 Myrbetriq.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Venclexta. 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 Venclexta.Venclexta is requested to treat chronic lymphocytic leukemia (CLL). The enrollee is a 73 year old manwith CLL. He has been treated with Revlimid. The office note of December 2019 indicates treatmentoptions were considered including the requested combination, Venetoclax with Gazyva versus Ibrutinibversus Acalabrutinib. You request Venetoclax to be given with Gazyva to treat him. An article from Bloodwas submitted in support of the request.Per the FDA website, Venclexta is indicated for the treatment of adult patients with chronic lymphocyticleukemia (CLL) or small lymphocytic lymphoma (SLL). The label does not specify monotherapy orspecific combinations. Therefore in the opinion of this reviewer, the requested combination is a medicallyaccepted use. However, the submitted office note states alternative treatments and does not indicate whythose alternatives would be inferior to the requested regimen.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. Therefore,the requested drug is being prescribed for a medically accepted indication. The enrollee does not satisfy thePlan's coverage criteria. You have not sufficiently addressed the Plan's coverage criteria and/or have notindicated why all alternatives required by the Plan 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. Our Physician'sopinion 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. 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 Venclexta Starter Pack.
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 Aspirin DR 81 mg, Prasugrel HCL 5 mg, MetoprololSuccinate ER 25 mg and Tamsulosin HCL 0.4 mg purchased April 7, 2020. The Plan did not grant thisrequest. We received this case to conduct an independent review.Aspirin DRMedicare 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, Aspirin DR purchased April 7, 2020 is not eligible for Part D coverage, and the Plan is notrequired to cover or provide reimbursement for 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.Prasugrel HCL, Metoprolol Succinate ER and Tamsulosin HCLMedicare rules allow a Part D Plan to apply coinsurance and copayments to covered drugs. In this case,documentation in the record shows that the enrollee was in the deductible stage when Prasugrel HCL 5 mg,Metoprolol Succinate ER 25 mg and Tamsulosin HCL 0.4 mg were purchased on April 7,2020. During thedeductible stage, the Plan requires that the enrollee pays the full cost of Tier 2, Tier 3, Tier 4 and Tier 5drugs before the Plan will pay a share of the cost. Once the enrollee has met the deductible amount of $435,the enrollee moves into the initial coverage stage. If an enrollee pays the full cost of a prescription, theenrollee may submit a request for reimbursement with proof of payment to ask the Plan to pay its share ofthe cost. Prasugrel HCL 5 mg and Tamsulosin HCL 0.4 mg are on the Plan's 2020 formulary and classifiedas Tier 2 drugs. Metoprolol Succinate ER 25 mg is on the Plan's 2020 formulary and classified as a Tier 3drug. The Plan provided documentation showing that these claims were covered by the Plan at the time ofpurchase, and that the full cost of the purchases in dispute was applied to the required deductible amount.The case record indicates that the Plan provided coverage in accordance with the Part D Plan contract.Therefore, our decision is the Plan is not required to provide reimbursement for Aspirin DR 81 mg,Prasugrel HCL 5 mg, Metoprolol Succinate ER 25 mg and Tamsulosin HCL 0.4 mg purchased April 7,2020.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ondansetron HCL. The Plan did not grant this request. We received this caseto conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Ondansetron HCL.Ondansetron HCL is requested for treatment of nausea/vomiting in this elderly patient with aspirationpneumonia, 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.Of note, there was no case file from the Plan available for this medical review.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Ondansetron HCL for the diagnosed condition. As a result, thedrug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, itcannot be covered under the Medicare Part D benefit for this condition. An exceptions request based onmedical necessity cannot be considered because this drug, as prescribed, does not meet the definition of aMedicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage forOndansetron HCL.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tukysa. The Plan did not grant this request. We received this case to conductan independent review.We asked a Physician Reviewer to determine whether the Plan was correct in denying the request forTukysa, which is not on the Plan's formulary. Our Physician Reviewer needed additional information fromthe prescriber to make this determination. The prescriber was asked to address whether the drugs offered bythe 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, ourPhysician 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 Tukysa.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Picaco 0.015% Gel. 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 a tiering exception for Picaco 0.015% Gel.Picaco 0.015% Gel is requested to treat the enrollee's condition. The requested drug is a brand drug onTier 4 of the Plan's formulary. There are no available lower tier brand drugs on the Plan's formulary to treat the enrollee's condition. Therefore, the requested drug is not eligible for a tiering exception. Our Physician Reviewer's opinion is that 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 the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in a lower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug is being used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met because there 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 Picaco 0.015% Gel.
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 fibromyalgia and right ear canal pain, 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 conditions.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Lidocaine 5% Ointment for the diagnosed conditions. 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 these conditions. 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 if paymentcan be made under the Medicare Part D benefit.