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

You asked the Plan to cover Entresto, 24-26 mg tablet. 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 Entresto (Sacubitril/Valsartan) 24 mg/26 mg tablet.The drug is requested to treat chronic heart failure (HF)/cardiomyopathy with a reduced ejection fraction (EF) of 30-40%. The prescriber documented that the requested drug will be used with an ACE inhibitor/ACE inhibitor containing product, or an ARB/ARB containing product. The enrollee does not satisfy the Plan's coverage criteria. The prescriber has not sufficiently addressed the Plan's coverage criteria and/or has 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. Our Physician's opinion 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. 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 Entresto, 24-26 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Myfortic. The Plan did not grant this request. We received this case to conductan independent review.Medicare law specifically excludes coverage for any drug under the Part D program for which paymentwould be available under Parts A or B of Medicare for that individual. Coverage is available underMedicare Part B for prescription drugs used in immunosuppressive therapy furnished to a beneficiary whohas received an organ transplant, provided the transplant was paid for by Medicare.The case record indicates that Myfortic is needed for a Kidney transplant performed December 7, 2017.According to the case record, it was determined that Medicare Part A paid for the transplant in question.Specifically, your provider answered that Medicare Part A paid for the transplant in question. Thus, thetransplant is considered a Medicare covered transplant and Myfortic is eligible for coverage underMedicare Part B. Drugs which are eligible for Part B coverage are excluded from Part D coverage byMedicare law.Additionally, drugs eligible to be covered under Parts A and/or B are considered available (and excludedfrom Part D) even if a beneficiary chooses not to pay premiums or if a beneficiary has enrolled in Part Bbut that coverage has not yet taken effect. Medicare records show that the enrollee is entitled to Part Bcoverage at this time, even though the beneficiary may have chosen not to pay premiums and/or coveragemay not have taken effect. Thus, Myfortic is not considered a Part D drug in this case. Therefore, ourdecision is the Part D Plan is not required to cover Myfortic.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.
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 a tiering exception for Tresiba FlexTouch. 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 Tresiba FlexTouch. The drug is requested to treat the enrollee's condition. Thedrug is a brand drug on tier 3 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 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 Tresiba FlexTouch.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Emsam. The Plan did not grant this request. Wereceived 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 thespecialty tier are not eligible for a tiering exception. Emsam is in the specialty tier. The record indicates thePlan has chosen to exclude the specialty tier from the tiering exception process. Therefore, the Plan is notrequired to provide a tiering exception for Emsam.
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 Lotemax. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Plan was correct in denying the request for Lotemax 0.5% ophthalmic suspension.Lotemax 0.5% ophthalmic suspension is requested to treat allergic conjunctivitis. The prescriber has not indicated that the enrollee has tried a Step-1 alternative 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 or step therapy exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring step therapy for certain drugs. A Plan must grant an exception 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 an exception to step therapy criteria is not met. Therefore, the Plan is not required to cover Lotemax.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Vimpat. 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 Vimpat. The drug is requested to treat a seizure disorder. The drug is on Tier 4 ofthe Plan's formulary. There are no available (branded) lower tier drugs on the Plan's formulary to treat theenrollee's condition. Please note, so-called branded generic drugs are considered generic drugs byMedicare. Therefore, the drug is not eligible for a tiering exception. Our Physician Reviewer's opinion isthat 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 Vimpat.
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 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 primary osteoarthritis, unspecified site, 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 Hyoscyamine. 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 Hyoscyamine is not FDA approved for both safety and effectiveness by checking FDAsources. Therefore, the Plan is not required to cover Hyoscyamine.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

You asked the Plan to cover Botox 100 unit/vial. 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 Botox 100 unit/vial.Medicare law specifically excludes coverage for any drug for which payment would be available underParts A or B of Medicare for that individual. Medicare Part B pays for services and supplies incident to theservice of a physician (or other practitioner).In this case, the record reflects that Botox will not be supplied from physician and/or office stock supply,and will not be billed as part of a physician service. As a result, the drug as administered in this case doesnot appear to be eligible for coverage under Medicare Part B. Therefore, we asked our physician reviewer ifcoverage can be made under Medicare Part D.Botox 100 unit/vial is requested to treat spasticity related to spinal cord injury which resulted fromneurodecompressive surgery, and spasticity related to multiple sclerosis. The drug is not eligible forcoverage under Medicare Part B because the prescriber has indicated that the requested drug is billed andshipped from a retail pharmacy on member's behalf to a physicians' office or facility for administration.The prescriber has addressed the plan's formulary alternatives. The prescriber has indicated why allalternatives required by the Plan would likely not be as effective as the requested drug for the enrollee,and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to thePlan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that formularyexception criteria are metA 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 Botox.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Tacrolimus. The Plan did not grant this request. We received this case to conduct an independent review.The case record indicates that Tacrolimus is needed for a kidney transplant performed February 15, 2011. In this case, we sent a request for additional information to the Part D Plan. We requested the evidence that the Plan used to determine that Medicare paid for the transplant performed February 15, 2011. The Plan responded to our request, however the Plan failed to provide claims data that supports that Medicare paid for the transplant in question. Based on the available information we cannot verify that coverage would be available for the requested drug under Medicare Part B. Therefore we asked our Physician Reviewer to determine if other Medicare Part D coverage criteria are met.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Tacrolimus 0.5 mg. Tacrolimus 0.5 mg is requested for ongoing use for prevention of kidney transplant rejection. There is insufficient evidence that Medicare PAID for the transplant, therefore the requested immunosuppressant is not eligible for coverage under Medicare Part B. As such, the requested drug is eligible for coverage under Medicare Part D. The enrollee satisfies the Plan's coverage criteria. Our Physician 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 are met. Therefore, our decision is the Plan is required to cover Tacrolimus.
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 and Cyclosporine. The Plan did not grant this request.We received this case to conduct an independent review.The case record indicates that Mycophenolate Mofetil and Cyclosporine are needed for a kidney transplantperformed December 24, 2002. In this case, we sent a request for additional information to the Part D Plan.We requested the evidence that the Plan used to determine that Medicare paid for the transplant performed.The Plan responded to our request, however the Plan failed to provide claims data that supports thatMedicare paid for the transplant in question. Based on the available information we cannot verify thatcoverage would be available for the requested drug under Medicare Part B. Therefore we asked ourPhysician Reviewer to determine if other Medicare Part D coverage criteria are met.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Mycophenolate Mofetil 250 mg & Cyclosporine 25 mg. Mycophenolate Mofetil 250 mg &Cyclosporine 25 mg are prescribed for prevention of renal transplant rejection. There is insufficientevidence that Medicare PAID for the transplant, therefore the requested immunosuppressants are noteligible for coverage under Medicare Part B. As such, the requested drugs are eligible for coverage underMedicare Part D. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion isthat 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 and Cyclosporine.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Vraylar. 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 Vraylar 1.5 mg capsule. The drug is requested to treat mixed bipolar 1 disorder (ICD-10 F31.60). Theenrollee does not satisfy the Plan's coverage criteria. The prescriber has not sufficiently addressed the Plan'scoverage criteria and/or has not indicated why one additional alternative required by the Plan (Risperidone,Olanzapine, Ziprasidone, or Aripiprazole) would likely not be as effective for the enrollee as the requesteddrug, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Our Physician's opinion isthat 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 Vraylar.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ozempic 2 mg/1.5 mL. The Plan did not grant this request. We received thiscase to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Ozempic 2 mg/1.5 mL.The drug is requested to treat obesity in an enrollee with hypothyroidism and borderline diabetes, which isan off-label (non-FDA approved) use. In a statement dated 6/30/2020, the prescriber attested that theenrollee has the diagnoses of obesity and hypothyroidism and that the enrollee does not have Type 2diabetes mellitus. Medical records from date of service 6/29/2020 documents that the enrollee isborderline diabetic and that her weight is holding steady. In the request for reconsideration, dated7/8/2020, the prescriber changed the diagnosis to Type 2 diabetes mellitus. Relevant medical records wererequested to support the appeal but not provided. The Medicare-approved compendia do not contain anycitations 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 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 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 Ozempic 2 mg/1.5 mL 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, 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 forOzempic 2 mg/1.5 mL.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Testosterone 1.62% Gel PKT. 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 Testosterone 1.62% Gel PKT. The drug is requested to treat low testosterone, decreased libido and fatigue. The enrollee does not satisfy the Plan's coverage criteria. You have not sufficiently addressed the Plan's coverage criteria and/or 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. Our Physician's opinion 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. 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 Testosterone 1.62% Gel PKT.