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

You asked the Plan to cover Gammagard. 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 Gammagard.Gammagard is requested to treat an unknown diagnosis. The prescriber was asked to state the enrollee'sdiagnosis, because there was no prescriber statement of the enrollee's diagnosis in the case file. Theprescriber was also asked to address medical necessity for the requested drug. A response from theprescriber was not received. Therefore, based on the current record, there is insufficient documentation thatthe requested medication is being prescribed for a medically accepted indication as defined by Medicarelaw. In addition, an exceptions request based on medical necessity cannot be considered because it cannotbe confirmed that the drug meets the definition of a Medicare Part D drug.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 needed additional information from the prescriber to determine whether theenrollee is using Gammagard for an FDA-approved use, or a use listed in the Medicare-approvedcompendia. The requested information was not received. As a result, we could not confirm that the drug isbeing prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot becovered under the Medicare Part D benefit. An exceptions request based on medical necessity cannot beconsidered because it cannot be confirmed that the drug meets the definition of a Medicare Part D drug.Therefore, our decision is that the Plan is not required to provide coverage for Gammagard.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 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 chronic inflammatory demyelinating polyneuritis, 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 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 cover Lidocaine 5% Patch. 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 Lidocaine 5% Patch. The drug is requested to treat pain due to burn of second degree of right axilla, 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 Lidocaine 5% Patch 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 Lidocaine 5% Patch. 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 Loteprednol Etabonate and Fluorometholone. 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 Loteprednol Etabonate 0.5% drop. The drug is requested to treat dry eye syndrome of bilateral lacrimal glands with meibomian gland dysfunction, which is an off-label (non-FDA approved) use. You clarified the medical history in a statement dated July 1, 2020. 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 Loteprednol Etabonate 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 Loteprednol Etabonate.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.Fluorometholone:We are dismissing the request for Fluorometholone. We received your letter asking for an appeal of the Plan's unfavorable determination for Fluorometholone. Medicare rules do not allow us to review this case until you have completed the appeal process with the Plan. You may request a Reconsideration appeal with us after the Plan issues an unfavorable Redetermination. You may wish to submit this request to the Plan 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 usas required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Slow-Mag. The Plan did not grant this request. We received this case toconduct 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, Slow-Mag is not eligible for Part D coverage, and the Plan is not required to cover it under thePart 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: 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 Mycophenolate Mofetil, 500 mg tablet as prescribed. The Plan did not grantthis 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 Mycophenolate Mofetil, 500 mg tablet.Mycophenolate Mofetil, 500 mg is requested for use in this enrollee who is status post bone marrowtransplant. There is insufficient evidence that Medicare Paid for the transplant, therefore the requestedimmunosuppressant is not eligible for coverage under Medicare Part B. As such, the requested drug iseligible for coverage under Medicare Part D. 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 Mycophenolate Mofetil, 500 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Budesonide . The Plan did not grant this request. We received this case toconduct an independent review.Medicare law specifically excludes coverage for any drug for which payment would be available under PartA or Part B of Medicare for that individual. Medicare Part B may pay for supplies necessary for theeffective use of durable medical equipment, including drugs and biologicals which must be put directly intothe equipment in order to achieve the therapeutic benefit of the durable medical equipment. Medicare PartB local policy states that a small volume nebulizer and related compressor are covered when medicallynecessary to administer Budesonide for the management of obstructive pulmonary disease.In this case, the record shows that Budesonide is administered through a nebulizer in the home for adiagnosis of J44.9 Chronic obstructive pulmonary disease and J42 Unspecified chronic bronchitis. There isno indication that it is not administered through a small volume nebulizer. It appears that this medication iseligible for coverage under Part B rather than Part D. Drugs which are eligible for coverage under Part Bare excluded from Part D coverage by Medicare law. Therefore, it is our decision that the Part D Plan is notrequired to cover Budesonide.This decision does not concern the medical necessity or appropriateness of the requested drug. It onlyestablishes if payment can be made under the Medicare Part D benefit.You may wish to submit this request to the Medicare Part B carrier.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Synthroid. 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 Synthroid. Synthroid is requested to treat the enrollee's condition. The requesteddrug is a brand drug on tier 4 of the Plan's formulary. There are no available lower tier brand drugs on thePlan's formulary 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 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 Synthroid.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Modafinil, 200 mg tablet. 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 Modafinil.Modafinil is requested to treat the enrollee's condition. The requested drug is on tier 3 of the Plan'sformulary. There are no similar lower tier drugs available on the Plan's formulary to treat the enrollee'scondition. Therefore, the requested 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 Modafinil, 200 mgtablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Premarin. 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 Premarin. The drug is requested to treat N95.2 - Postmenopausal atrophic vaginitis. You 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. Therefore, anexception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is thatformulary 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 Premarin.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Nature Throid. The Plan did not grant this request. We received this case toconduct an independent review.Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. Wedetermined that Nature Throid is not FDA approved for both safety and effectiveness by checking FDAsources. Therefore, the Plan is not required to cover Nature Throid.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 Naltrexone HCL Powder compound. The Plan did not grant this request. Wereceived this case to conduct an independent review.Medicare Part D does not cover drugs that are not FDA approved. A representative of the pharmacy statedthat bulk powder was used or would be used when compounding the prescription for Naltrexone HCLPowder compound. Bulk powders used in pharmacy compounding are not reviewed and approved forsafety and efficacy by the FDA. Therefore, the Plan is not required to cover Naltrexone HCL Powdercompound.This decision does not address the medical necessity or appropriateness of the requested drug. It onlyestablishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Sildenafil. 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 Sildenafil. The drug is requested to treat pulmonary hypertension in an enrollee with coronary arterydisease, congestive heart failure, tricuspid regurgitation, status post aortic and mitral valve replacement,which is an off-label (non-FDA approved) use. Medical records were provided to support these diagnoses.The Medicare-approved compendia do not contain any citations to support the use of the requested drug, asprescribed, for treatment of the noted conditions. 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 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 Sildenafil for the diagnosed conditions. 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 these conditions. 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 Sildenafil.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 Repatha SureClick. 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 Repatha SureClick. The drug is requested to treat E78.5 - Hyperlipidemia, unspecified in an enrolleewith I25.10 - Atherosclerotic heart disease of native coronary artery without angina pectoris. You 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. Therefore, anexception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is thatformulary 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 Repatha SureClick.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Simbrinza and Vyzulta. The Plan did not grant this request. We received this case to conduct an independent review.Medicare rules do not require the Part D plan to grant a tiering exception for a brand or biologic drug of the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) if the lower tier(s) on the formulary only contain(s) generic alternative drugs. Simbrinza is a Tier 3 brand drug. Vyzulta is a Tier 4 brand drug that has already had a tiering exception approved, allowing coverage at the Tier 3 copayment level. The lower cost-sharing tier(s) only contain(s) generic alternative drugs. Therefore, our decision is the Plan is not required to provide a tiering exception for Simbrinza and Vyzulta.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cosentyx Sensoready. 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 Cosentyx Sensoready. The drug is requested to treat plaque psoriasis. You have not indicated why allalternatives 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 thePlan's coverage criteria is not supported. Our Physician Reviewer's opinion is that formulary exceptioncriteria 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 Cosentyx Sensoready.