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

You asked the Plan to cover Diclofenac Gel 3%. 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 Diclofenac Gel 3%. The drug is requested to treat M05.79, Rheumatoid arthritis with rheumatoid factorof multiple sites without organ or systems involvement and M15.0, Primary generalized osteoarthritis,which are off-label (non-FDA approved) uses. The Medicare-approved compendia do not contain anycitations to support the use of the requested drug, as prescribed, for treatment of the noted conditions.Therefore, the requested drug is not being prescribed for a medically accepted indication as defined byMedicare law. As such, an exceptions request based on medical necessity cannot be considered because therequested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, therequested drug is not eligible for coverage under 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 Diclofenac Gel 3% 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 forDiclofenac Gel 3%.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 additional reimbursement for the Boostrix vaccine received September 16,2019. 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 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 the Boostrix vaccine received September 16, 2019.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Vascepa. 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 Vascepa. The drug is requested to treat the enrollee's condition. The drug is a brand drug on Tier 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 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 Vascepa.You also asked the Plan to provide a tiering exception for Xarelto and Multaq. The Plan did not grant this request.Medicare rules do not require the Part D plan to grant a tiering exception for a brand or biologic drug of thesame type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) ifthe lower tier(s) on the formulary only contain(s) generic alternative drugs. Xarelto and Multaq is a Tier 3 brand drug.The lower cost-sharing tier(s) only contain(s) generic alternative drugs. Therefore, our decision is the Planis not required to provide a tiering exception for Xarelto and Multaq.
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 11, 2019. ThePlan 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. In this case,documentation in the record shows that the enrollee was in the deductible stage when the Shingrix vaccinewas received on December 11, 2019 from the pharmacy. During the deductible stage, the Plan requires thatthe enrollee pay the full cost of Tier 3, Tier 4 and Tier 5 drugs purchased in 2019 before the Plan would paya share of the cost. The Shingrix vaccine was on the Plan's 2019 formulary and was classified as a Tier 3drug. The Plan provided documentation showing that this claim was covered by the Plan at the time ofpurchase, and that the full cost of the purchase in dispute was applied to the required deductible amount.Additionally, according to the pharmacy receipt provided only the cost of the vaccine was charged. Thereceipt does not indicate any administration fee was charged.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 the Shingrix vaccinereceived December 11, 2019.
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 conductan independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Xifaxan 550 mg tab. The drug is requested to treat chronic diarrhea in an enrollee with a history ofpouchitis, ulcerative colitis, status post proctocolectomy with ileal pouch, which is an off-label (non-FDAapproved) use. Medical records from date of service 5/20/2020 were provided which support thesediagnoses. The Medicare-approved compendia do not contain any citations to support the use of therequested 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 Xifaxan 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 Xifaxan.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 reimbursement for Polyethylene Glycol 3350 purchased March 13, 2020 andMarch 26, 2020. The Plan did not grant this request. We received this case to conduct an independentreview.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 3350 purchased March 13, 2020 and March 26, 2020 is not eligible for PartD coverage, and the Plan is not required 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.
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 First-Omeprazole. 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's classification or determined from other available resources that the drug is a non-prescription or OTC drug. Therefore, First-Omeprazole 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

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 March 4, 2020. The Plandid 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. In this case,documentation in the record shows that the enrollee was in the deductible stage when the Shingrix vaccinewas received on March 4, 2020. During the deductible stage, the Plan requires that the enrollee pay the fullcost of Tier 3, Tier 4 and Tier 5 drugs purchased in 2020 before the Plan would pay a share of the cost. TheShingrix vaccine is on the Plan's 2020 formulary and was classified as a Tier 3 drug. The Plan provideddocumentation showing that this claim was covered by the Plan at the time of purchase, and that the fullcost of the purchase 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 the Shingrix vaccinereceived March 4, 2020.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Mycophenolate Mofetil. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Mycophenolate Mofetil. Mycophenolate Mofetil is requested for ongoing treatment of polmyositis, which is an off-label (non-FDA approved) use. You indicated that Mycophenolate Mofetil has been effective, and that a change in therapy will put the enrollee at risk for relapse of her disease and worsening disability; however the Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia that support the use of Mycophenolate Mofetil for the diagnosed condition. As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Mycophenolate Mofetil. 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 provide a tiering exception for Livalo. 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 Livalo.Livalo is requested for treatment of the enrollee's condition. Livalo is a brand drug on Tier 3 of the Plan's formulary. There are no available lower tier brand statin 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 Livalo.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Smoflipid Emulsion. 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 Smoflipid Emulsion 20%. The drug is requested to treat K91.2, Postsurgical malabsorption, notelsewhere classified. The prescriber was asked questions from Local Coverage Article: PARENTERALNutrition - Policy Article (A52515), to see if the enrollee would qualify under Part B. Based on theinformation provided, the drug would be eligible for coverage under Part D for the enrollee's condition. OurPhysician Reviewer's opinion is that the requested drug is not eligible for Part B coverage in this case.You were also asked about the formulary alternatives. You stated that they would consider switching to oneof the formulary alternatives. You have not indicated why all alternatives required by the Plan would likelynot be as effective for the enrollee as the requested drug; and/or would likely cause adverse reaction(s) orother harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. 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 Smoflipid Emulsion.Please note that the Plan denied coverage stating Smoflipid Emulsion would be covered under MedicarePart B. Upon review of the rules as stated above it was determined that Smoflipid Emulsion would not beeligible for coverage under Medicare Part B. We therefore, had our Physician Reviewer review coverage ofSmoflipid Emulsion under Medicare Part D rules.
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 Testosterone 1.62% Gel Pump purchased April 21, 2020.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. In this case,documentation in the record shows that the enrollee was in the deductible stage when Testosterone 1.62%Gel Pump was purchased on April 21, 2020. During the deductible stage, the Plan requires that the enrolleepay the full cost of Tier 3, Tier 4 and Tier 5 drugs purchased in 2020 before the Plan would pay a share ofthe cost. Testosterone 1.62% Gel Pump was on the Plan's 2020 formulary and was classified as a Tier 4drug. The Plan provided documentation showing that this claim was covered by the Plan at the time ofpurchase, and that the full cost of the purchase 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 Testosterone 1.62% GelPump purchased April 21, 2020.
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 received June 28, 2019 and June 29, 2019. ThePlan 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, Aspirin received June 28, 2019 and June 29, 2019 is not eligible for Part D coverage, and thePlan is not required 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.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Xpovio. 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 Xpovio 100 mg. The drug is requested to treat Multiple myeloma. The Plan requires the following:The member has received at least four prior therapies AND the member's disease is refractory to at leasttwo proteasome inhibitors (e.g. bortezomib, carfilzomib), at least two immunomodulatory agents (e.g.lenalidomide, pomalidomide) and an anti-CD38 monoclonal antibody (e.g. daratumumab) AND Themember will be using Xpovio (selinexor) in combination with dexamethasone.The enrollee does not satisfy the Plan's coverage criteria. You have not sufficiently addressed the Plan'scoverage criteria and/or have not indicated why all alternatives required by the Plan would likely not be aseffective for the enrollee as the requested drug, and/or would likely cause adverse reaction(s) or other harmto the enrollee. Our Physician's opinion is that neither prior authorization nor prior authorization exceptioncriteria 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 Xpovio.
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 March 7, 2020. The Plandid 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 required a $47 copayment for up to a 30 daysupply of a Tier 3 drug purchased in 2020 from a standard retail pharmacy. The Shingrix vaccine is on thePlan's 2020 formulary and was classified as a Tier 3 drug. A request for reimbursement was submitted tothe Plan. In this case, the Plan provided documentation showing that this claim was covered by the Plan atthe time of purchase. The record shows that the Shingrix vaccine received March 7, was purchased for anamount that 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 the Shingrix vaccinereceived March 7, 2020.