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

You asked the Plan to cover Zileuton ER 600 mg tablet. 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 Zileuton ER 600 mg tablet. The drug is requested to treat severe persistent asthma, uncomplicated. OnApril 13, 2020 you sent additional information indicating trial and failure of the formulary alternativeZafirlukast - the enrollee developed side effect of headache with lack of improvement in asthma symptoms.You have indicated why all alternatives required by the Plan would likely not be as effective as therequested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee.Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer'sopinion 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 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 met. Therefore,the Plan is required to cover Zileuton ER 600 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Nadolol. 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 Nadolol 20 mg tablet. The drug is requested to treat Postural Orthostatic Tachycardia Syndrome, whichis an off-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 Nadolol 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 Nadolol.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: Favorable

You asked the Plan to cover Ozempic 0.25/0.5 mg, 1 pen per 21 days. 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 Ozempic .5 mg weekly. Ozempic .5 mg weekly is requested for ongoing treatment of type 2 diabetesmellitus. You have indicated that the enrollee is stable on the requested dose/quantity of Ozempic. The Planlimits the amount of the requested drug to 1.5 ml per 28 days. The Plan processed the request for Ozempic0.25/0.5 mg/1.5 ml, 1 pen per 21 days, however each Ozempic 0.25/0.5 mg pen contains 2 mg of activedrug/1.5 ml (1.34 mg/ml). As such, each prefilled Ozempic 2mg/1.5 ml pen injector would yield 4 doses of.5 mg. Consequently, the request is for Ozempic 0.25/0.5 mg/1.5 ml, 1.5 ml every 28 days. In summary, therequested quantity is within the number of doses/quantity allowed by the Plan. Our Physician Reviewer'sopinion is that quantity limit criteria are met.Of note, per the FDA label:How supplied: OZEMPIC injection is supplied as a clear, colorless solution that contains 2 mg ofsemaglutide in a 1.5 mL (1.34 mg/mL) pre-filled, disposable, single-patient-use pen injector in thefollowing packaging configurations:Carton of 1 Pen (NDC 0169-4132-12) - pen delivers doses of 0.25 mg or 0.5 mg per injection.Medicare rules allow a Part D Plan to manage its formulary by covering a limited quantity of certain drugs.Based on a review of the available documentation, our Physician Reviewer's opinion is that the doserequested is within the allowed quantity limit. Therefore, the Plan is required to cover the requestedquantity of Ozempic 0.25/0.5 mg, 1 pen per 21 days.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Azathioprine. 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 Azathioprine 50 mg.The drug is requested to treat idiopathic orbital pseudotumor, 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 Azathioprine 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 Azathioprine. 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 Uribel. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. We determined that Uribel is not FDA approved for both safety and effectiveness by checking FDA sources. Therefore, the Plan is not required to cover Uribel. 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 Solifenacin. 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 Solifenacin.Solifenacin is requested for treatment of urinary incontinence. The Plan has indicated in their denial letter that Toviaz tablet extended release and Oxybutynin are on their formulary. Your office has provided documentation that the enrollee has had adverse side effects to Oxybutynin and Myrbetriq; your office states that the enrollee cannot afford Toviaz. 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 Solifenacin.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Apriso ER. 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 Apriso ER 0.375 gm.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 of the same type on the Plan's formulary to treatthe enrollee's condition. Therefore, the drug is not eligible for a tiering exception. Our Physician Reviewer'sopinion 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 Apriso ER.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Enteragam. The Plan did not grant this request. We received this case toconduct an independent review.Medicare Part D does not cover medical foods. Enteragam is a medical food. Therefore, Enteragam is noteligible 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 product. 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 reimbursement for Vivotif DR received February 23, 2019. The Plan did not grant this request. We received this case to conduct an independent review.CMS publishes a list of participating brand name drug manufacturers that have signed the Medicare Coverage Gap discount agreement. Vivotif DR received February 23, 2019 is a brand name drug, and its manufacturer is not on this list. Therefore, the Part D Plan is not required to cover or provide reimbursement for Vivotif DR received February 23, 2019.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Lidocaine 5% Patch as prescribed. 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 Lidocaine 5% Patch.The drug is requested for ongoing treatment of diabetic neuropathy in a patient with insulin dependent type2 diabetes mellitus. Additional medical information was requested by the Part D QIC. The prescribingphysician was asked to address the diagnosis and prior authorization coverage criteria. The prescriberstatement was returned. The prescriber documented an additional diagnosis of type 2 diabetes mellitus withdiabetic polyneuropathy (ICD-10 E11.42), in this patient with back, hip, and knee pain. For coverage underthe prescription drug benefit, Medicare requires that the drug prescribed be used for a medically acceptedindication. Our Physician Reviewer found that the Medicare-approved resources (DrugDex) do containcitations to support the use of the requested drug for treatment of the noted condition. Per DrugDex,5% lidocaine patches were well tolerated and reduced pain in patients with diabetic neuropathy.Therefore, the requested drug is being prescribed for a medically accepted indication.The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that priorauthorization 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 ofLidocaine 5% Patch as prescribed for the diagnosed condition. As a result, Lidocaine 5% Patch asprescribed is being 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 Lidocaine 5% Patch as prescribed.
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 provide a tiering exception for Cyclobenzaprine ER. The Plan did not grant this request. We received this case to conduct an independent review.If a Plan maintains a specialty tier, the Plan may design its exception process so that drugs placed in the specialty tier are not eligible for a tiering exception. Cyclobenzaprine ER is in the specialty tier. The record indicates the Plan has chosen to exclude the specialty tier from the tiering exception process. Therefore, the Plan is not required to provide a tiering exception for Cyclobenzaprine ER.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Promethazine-Codeine Syrup. The Plan did not grant this request. We receivedthis case to conduct an independent review.Medicare law excludes certain drugs from Part D coverage. Promethazine-Codeine Syrup is one of thoseexcluded drugs because it is a drug used for the symptomatic relief of coughs and colds. The recordsubmitted by the Plan does not indicate that they provide supplemental coverage for Promethazine-CodeineSyrup. Therefore, the Plan is not required to cover Promethazine-Codeine Syrup.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 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. The drug is requested to treat Multiple sclerosis and steroid responsive encephalopathy, which are off-label (non-FDA approved) uses. The Medicare-approved compendia do not contain any citations 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 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 conditions.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

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 provide reimbursement for Bisoprolol-Hydrochlorothiazide 5-6.25 mg purchased February 13, 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 Bisoprolol-Hydrochlorothiazide 5-6.25 mg was purchased on February 13, 2020. During the deductible stage, the Plan requires that the enrollee pay the full cost of drugs purchased in 2020 before the Plan would pay a share of the cost. Bisoprolol-Hydrochlorothiazide 5-6.25 mg was on the Plan's 2020 formulary and was classified as a Tier 1 drug. The Plan provided documentation showing that this claim was covered by the Plan at the time of purchase, 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 Bisoprolol-Hydrochlorothiazide 5-6.25 mg purchased February 13, 2020.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Oxycodone HCL Compound. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover drugs that are not FDA approved. A representative of the pharmacy stated that bulk powder was used or would be used when compounding the prescription for Oxycodone HCL Compound. Bulk powders used in pharmacy compounding are not reviewed and approved for safety and efficacy by the FDA. Therefore, the Plan is not required to cover Oxycodone HCL Compound. This decision does not address the medical necessity or appropriateness of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit. Since the Part D Plan cannot provide coverage, the subsequent request for reimbursement has not been reviewed at this time.
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 Humalog KwikPen U-100. 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 Humalog KwikPen U-100. Humalog KwikPen U-100 is requested to treat an unknown diagnosis. The prescriber was asked to state the enrollee's diagnosis, because there was no prescriber statement of the enrollee's diagnosis in the case file. The prescriber was also asked to address medical necessity for the requested drug. A response from the prescriber was not received. Therefore, based on the current record, there is insufficient documentation that the requested medication is being prescribed for a medically accepted indication as defined by Medicare law. Additionally, the prescriber has not indicated that the enrollee has tried all alternatives required by the Plan, or why the Plan's required step therapy drugs would likely not be as effective for the enrollee as the requested drug, and/or would likely cause adverse reactions or other harm to the enrollee. Our Physician Reviewer's opinion is that neither step therapy nor step therapy exception criteria are met.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 Humalog KwikPen U-100 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 Humalog KwikPen U-100. 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.Please note: the request for a tiering exception (lower copayment) for Humalog KwikPen U-100 was not reviewed. We cannot consider a tiering exception for a drug for which the Part D Plan is unable to provide coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Betahistine Compound. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. We determined that Betahistine Compound is not FDA approved for both safety and effectiveness by checking FDA sources. Therefore, the Plan is not required to cover Betahistine Compound. 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.Please note: the request for a tiering exception (lower copayment) for Betahistine Compound was not reviewed. We cannot consider a tiering exception for a drug for which the Part D Plan is unable to provide coverage.