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

You asked the Plan to cover Mycophenolate Mofetil. 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 Mycophenolate Mofetil 500 mg.The drug is requested to treat dermatomyositis with advanced interstitial lung disease, which is an off-label(non-FDA approved) use. The Medicare-approved compendia do not contain any citations to support theuse of the requested drug, as prescribed, for treatment of the noted condition. Therefore, the requested drugis not being prescribed for a medically accepted indication as defined by Medicare law. As such, anexceptions 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 Mycophenolate Mofetil for the diagnosed condition. As aresult, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. Assuch, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions requestbased on medical necessity cannot be considered because this drug, as prescribed, does not meet thedefinition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to providecoverage for Mycophenolate Mofetil.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 Humira CF 40 mg/0.4 mL pen. 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 Humira 40 mg/0.4 mL pen.The drug is requested to treat sarcoidosis, which is an off-label (non-FDA approved) use. The Medicareapprovedcompendia do not contain any citations to support the use of the requested drug, as prescribed, fortreatment of the noted condition. Therefore, the requested drug is not being prescribed for a medicallyaccepted indication as defined by Medicare law. As such, an exceptions request based on medical necessitycannot be considered because the requested drug, as prescribed, does not meet the definition of a MedicarePart D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the notedcondition.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 Humira CF 40 mg/0.4 mL pen for the diagnosed condition. Asa 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 requestbased on medical necessity cannot be considered because this drug, as prescribed, does not meet thedefinition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to providecoverage for Humira CF 40 mg/0.4 mL pen.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 Otezla. 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 Otezla 28 day starter pack. The drug is requested to treat Psoriatic arthritis. The enrollee does not satisfythe Plan's coverage criteria. The Plan requires the enrollee to have had prior therapy, contraindication, orintolerance with two of the following: Humira, Enbrel or Cosentyx. The prescriber has not sufficientlyaddressed the Plan's coverage criteria and/or has not indicated why all alternatives required by the Planwould likely not be as effective for the enrollee as the requested drug, and/or would likely cause adversereaction(s) or other harm to the enrollee. Our Physician's opinion is that neither prior authorization nor priorauthorization 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 Otezla.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Mycophenolate Mofetil. 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 Mycophenolate Mofetil 500mg. The drug is requested to treat Renal transplant rejection. The enrolleesatisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteriaare met.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 Part A.The case record indicates that Mycophenolate Mofetil is needed for a kidney transplant performedSeptember 7, 2011. In this case, we sent a request for additional information to the Part D Plan. Werequested the evidence that the Plan used to determine that Medicare paid for the transplant performedSeptember 7, 2011. The Plan responded to our request, however the Plan failed to provide claims data thatsupports that Medicare paid for the transplant in question. Based on the available information we cannotverify that coverage would be available for the requested drug under Medicare Part B. Therefore we askedour Physician Reviewer to determine if other Medicare Part D coverage criteria are met.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ipratropium Albuterol. The Plan did not grant this request. We received thiscase to conduct 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 Ipratropium Albuterol for the management of obstructive pulmonary disease.In this case, the record shows that Ipratropium Albuterol is administered through a nebulizer in the homefor a diagnosis of chronic obstructive pulmonary disease. There is no indication that it is not administeredthrough a small volume nebulizer. It appears that this medication is eligible for coverage under Part Brather than Part D. Drugs which are eligible for coverage under Part B are excluded from Part D coverageby Medicare law. Therefore, it is our decision that the Part D Plan is not required to cover IpratropiumAlbuterol.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 Oxcarbazepine, 600 mg tablet. 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 a tiering exception for Oxcarbazepine, 600 mg.Oxcarbazepine, 600 mg is requested to treat the enrollee's condition. The requested drug is on tier 3 of thePlan's formulary. There are no similar lower tier drugs 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 Oxcarbazepine, 600 mgtablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Adderall XR, 20 mg capsule. 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 Adderall XR, 20 mg.Adderall XR, 20 mg capsule, 60 per 30 days, is requested for treatment of major depressive disorder,recurrent episode, mild, which is an off-label (non-FDA approved) use. The Medicare-approved compendiado not contain any citations to support the use of the requested drug, as prescribed, for treatment of thenoted condition. Therefore, the requested drug is not being prescribed for a medically accepted indicationas defined by Medicare law. As such, an exceptions request based on medical necessity cannot beconsidered because the requested drug, as prescribed, does not meet the definition of a Medicare Part Ddrug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the notedcondition.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 Adderall XR, 20 mg capsule for the diagnosed condition. As aresult, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. Assuch, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions requestbased on medical necessity cannot be considered because this drug, as prescribed, does not meet thedefinition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to providecoverage for Adderall XR, 20 mg capsule.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 Hizentra. 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 Hizentra 10 gm/50 ml sol.The drug is requested to treat Myelin oligodendrocyte glycoprotein (MOG) antibody disease, which is anoff-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 Hizentra 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 Hizentra.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 Albuterol Sulfate Nebulizer Solution. The Plan did not grant this request. Wereceived this case to conduct 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 Albuterol Sulfate Nebulizer Solution for the management of obstructive pulmonarydisease.In this case, the record shows that Albuterol Sulfate Nebulizer Solution is administered through a nebulizerin the home for a diagnosis of J41.0 Simple chronic bronchitis and J42.0 Unspecified chronic bronchitis.There is no indication that it is not administered through a small volume nebulizer. It appears that thismedication is eligible for coverage under Part B rather than Part D. Drugs which are eligible for coverageunder Part B are excluded from Part D coverage by Medicare law. Therefore, it is our decision that the PartD Plan is not required to cover Albuterol Sulfate Nebulizer Solution.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

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 and provide reimbursement for Standard PPP Alprostadil/Phentolamine/Papaverine Compound purchased May 8, 2020 at a compounding pharmacy. 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 Standard PPP Alprostadil/Phentolamine/Papaverine Compound purchased May 8, 2020 at a compound pharmacy. 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 or provide reimbursement for Standard PPP Alprostadil/Phentolamine/Papaverine Compound purchased May 8, 2020 at a compounding pharmacy. 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.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Acitretin, 25 mg capsule. 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 Acitretin 25 mg.Acitretin, 25 mg is requested to treat the enrollee's condition. The requested drug is on tier 4 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 Acitretin, 25 mgcapsule.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Xifaxan, 550 mg tablet 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 Xifaxan, 550 mg tablet.The drug is requested to treat irritable bowel disease with diarrhea in this 35 year old with Crohn's diseasestatus post J-pouch. Additional medical information was requested by the Part D QIC. The prescribingphysician was asked to address the enrollee's diagnosis and prior authorization coverage criteria.The prescriber statement was returned. The prescriber documented that this is the ONLY medication thathelps decrease his hospitalizations for dehydration from diarrhea. In addition, the following citation inDrugDex, a Medicare approved compendium, supports the use of the requested drug for the enrollee'sdiagnosis of Crohn's disease: Remission of moderately active Crohn disease was significant at 12 weekswith an 800-mg twice-daily dose, but the 400- and 1200-mg doses only trended toward significance(proportion achieving remission: 400 mg, 54%; 800 mg, 62%; 1200 mg, 47%; placebo, 43%).The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that priorauthorization 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 Xifaxan, 550 mg tablet as prescribed.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Motegrity, 2 mg tablet. The Plan did not grant this request. We received thiscase to conduct an independent review.We asked a Physician Reviewer to determine whether the Plan was correct in denying the request forMotegrity, 2 mg tablet, which is not on the Plan's formulary. Our Physician Reviewer needed additionalinformation from the prescriber to make this determination. The prescriber was asked to address whetherthe drugs offered by the Plan would: (1) not be as effective as the requested non-formulary drug; and/or (2)have adverse effects. The requested information was not received. Based on a review of the availabledocumentation, 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 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 Motegrity, 2 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cinacalcet HCL. The Plan did not grant this request. We received this case toconduct an independent review.Medicare law requires that all drugs and biologicals used in the treatment of ESRD or AKI be included inthe ESRD PPS payment bundle, regardless of the reason why the drug is being prescribed and regardless ofwhether or not the drug is furnished by a dialysis facility. Drugs that are always considered ESRD andAKI-related include access management drugs, anemia management drugs, anti-infectives to treat siteaccess infection, bone and mineral metabolism drugs and cellular management drugs.In this case, Cinacalcet HCL is being prescribed to an enrollee who has ESRD or AKI and is on dialysis.Cinacalcet HCL is a class of medication which is always considered ESRD or AKI-related for purposes ofthe Part B ESRD payment bundle. Thus, the requested drug is eligible for coverage under the Part B ESRDpayment bundle, regardless of the reason why the drug is being prescribed and regardless of whether or notthe drug is being furnished by a dialysis facility. Drugs which are eligible for Part B coverage are excludedfrom Part D coverage by Medicare law. Therefore, our decision is the Part D Plan is not required to coverCinacalcet HCL.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 cover One Touch Ultra Test Strips. The Plan did not grant this request. We receivedthis case to conduct an independent review.Medicare rules state that the definition of a Part D drug includes medical supplies directly associated withthe injection of insulin. Test strips, lancets and needle disposal systems are not considered medical suppliesdirectly associated with the delivery of insulin for purposes of coverage under Part D. You asked the Part DPlan to provide coverage for test strips. Diabetic test strips are a medical supply that is specificallyexcluded from Part D coverage by Medicare law. Therefore, our decision is the Part D Plan is not requiredto cover One Touch Ultra Test Strips.This decision does not concern the medical necessity or appropriateness of the requested item. It onlyestablishes if payment can be made under the Medicare Part D benefit.