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

You asked the Plan to cover Cyclosporine modified 50 mg capsule. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law specifically excludes coverage for any drug under the Part D program for which payment would be available under Parts A or B of Medicare for that individual. Coverage is available under Medicare Part B for prescription drugs used in immunosuppressive therapy furnished to a beneficiary who has received an organ transplant, provided the transplant was paid for by Medicare Part A. The case record indicates that Cyclosporine is needed for a Kidney transplant performed September 14, 1989. In this case, we requested additional information from the Part D Plan. We requested the evidence the Plan used to determine that the transplant was paid for by Medicare. We received a response from the Part D Plan, however there is insufficient information to show that the transplant was paid for by Medicare. Based on the available information we are unable to verify that coverage for the requested drug would be available for coverage under Medicare Part B. Therefore, it appears that Cyclosporine may be eligible for Part D coverage. We asked our Physician Reviewer to determine if other 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 Cyclosporine modified 50 mg capsule.The drug is requested to treat kidney transplant rejection prophylaxis. For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of the requested drug for treatment of the noted condition. Therefore, the requested drug is being prescribed for a medically accepted indication. The enrollee satisfies the Plan's coverage criteria. No evidence was received to indicate that the transplant was paid for by Medicare, therefore the drug is eligible for Part D coverage. 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 Cyclosporine.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover HP Acthar gel. 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 Acthar 80 unit/ml gel.The drug is requested to treat focal segmental glomerulosclerosis. The prescriber has not indicated why allalternatives required by the Plan (including dexamethasone, cyclophosphamide and Leukeran) would likelynot be as effective for the enrollee as the requested drug; and/or would likely cause adverse reaction(s) orother harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. OurPhysician Reviewer's opinion is that formulary exception criteria are not met.A Plan must grant an exception for a drug that is not on its formulary if it determines that the requesteddrug is medically necessary, consistent with the prescriber's statement. Based on a review of the availabledocumentation, our Physician Reviewer's opinion is that formulary exception criteria are not met.Therefore, the Plan is not required to cover HP Acthar gel.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Restasis 0.05% eye emulsion, 120 units per 30 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 request for Restasis 0.05% eye emulsion, 120 units per 30 days. The drug is requested to treat keratoconjunctivitis sicca, not specified as Sjogren's, bilateral. The Plan limits the amount of the drug to 60 units per 30 days. Based on the CMS memo of April 21, 2020 with regard to the COVID-19 public health emergency, Part D sponsors must permit enrollees to obtain the total days supply prescribed for a covered Part D drug (as defined in 42 CFR 423.100) up to a 90-day supply in one fill (or one refill) if requested by the enrollee, Prior Authorization or Step Therapy requirements have been satisfied and no safety edits otherwise limit the quantity or days supply. Therefore, an exception to the Plan's coverage criteria is medically necessary.Our Physician Reviewer's opinion is that quantity limit exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by covering a limited quantity of certain drugs. A Plan must grant an exception if it determines that the requested dosage is medically reasonable and 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 the quantity limit criteria is met. Therefore, the Plan is required to cover the requested quantity of Restasis 0.05% eye emulsion, 120 units per 30 days.
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 5 gm/50 ml.Gammagard 5 gm/50 ml is requested for ongoing treatment of Opsoclonus-myoclonus syndrome (OMS),which is an off-label (non-FDA approved) use. The prescriber states that the enrollee condition hasimproved on the requested drug with marked functional improvement of gait, tremors and myoclonus;however the Medicare-approved compendia do not contain any citations to support the use of the requesteddrug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is not beingprescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions requestbased on medical necessity cannot be considered because the requested drug, as prescribed, does not meetthe definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage underMedicare 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 Gammagard for the diagnosed condition. As a result, the drugis not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannotbe covered 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 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 provide a tiering exception for Potassium Citrate ER 10 meq. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for a tiering exception for Potassium Citrate ER 10 meq. Potassium Citrate ER 10 meq is prescribed for use for an enrollee with nephrolithiasis and chronic kidney disease. Potassium Citrate ER 10 meq is on Tier 3 of the Plan's formulary. There are no similar available lower tier drugs on the Plan's formulary to treat your condition. Therefore, the drug is not eligible for a tiering exception. Our Physician Reviewer's opinion is that tiering exception criteria are not met.Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in a lower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug is being used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met because there are no lower cost-sharing tiered drugs of the same type for treating the enrollee's condition. Therefore, our decision is the Plan is not required to provide a tiering exception for Potassium Citrate ER 10 meq.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cresemba. 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 Cresemba 186 mg capsule.Cresemba 186 mg capsule is requested for use as antifungal prophylaxis in this enrollee with chronicneutropenia related to high grade myelodysplastic syndrome/early acute myeloid leukemia who will bereceiving chemotherapy, which is an off-label (non-FDA approved) use. The prescriber states that theenrollee is not a candidate for the usual drugs used for antifungal prophylaxis because of potential seriousdrug interactions with the enrollee's psychotropic medication; however the Medicare-approved compendiado not contain any citations to support the use of the requested drug, as prescribed, for antifungalprophylaxis. Therefore, the requested drug is not being prescribed for a medically accepted indication asdefined by Medicare law. As such, an exceptions request based on medical necessity cannot be consideredbecause 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 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 Cresemba 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 Cresemba.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide reimbursement for Tizanidine purchased on January 22, February 17, andMarch 9, 2020, from the pharmacy. The Plan did not grant this request. We received this case to conduct anindependent review. You also requested we consider Tizanidine purchased on March 27 and April 7, 2020.Please note that the Plan has indicated that they have only issued a denial for Tizanidine purchased onJanuary 22, 2020. However, Medicare rules require a Part D Plan to issue a coverage decision or aredetermination decision within the specified timeframes. If the Plan does not make a timely decision, thisis considered a denial. In these circumstances, the Plan is required to forward the coverage request or theredetermination request to the Part D QIC. The case record indicates requests for reimbursement forTizanidine purchased on February 17 and March 9, 2020, were submitted to the Plan. The Plan did notproperly process these requests to move the case forward to the next appeal level. Therefore, the applicabletime frames have been exceeded, and the Part D QIC has jurisdiction to process these requests.Medicare rules allow a Part D Plan to apply coinsurance and copayments to covered drugs. If an enrolleepays the full cost of a prescription, the enrollee may submit a request for reimbursement with proof ofpayment to ask the Plan to pay its share of the cost. The Plan required a $10 copayment amount for up to a31-day supply of a Tier 1 drug purchased from a standard retail pharmacy in 2020. A request forreimbursement was submitted to the Plan. In this case, the case record contains documentation showing thatthis claim was covered by the Plan at the time of purchase. The record shows that Tizanidine waspurchased for an amount that is less than or equal to the required copayment amount.The case record indicates that the Plan provided coverage in accordance with the Part D contract.Therefore, our decision is the Plan is not required to provide reimbursement for Tizanidine purchased onJanuary 22, February 17, and March 9, 2020, from the pharmacy.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ipratropium Albuterol neb sol. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law specifically excludes coverage for any drug for which payment would be available under Part A or Part B of Medicare for that individual. Medicare Part B may pay for supplies necessary for the effective use of durable medical equipment, including drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic benefit of the durable medical equipment. Medicare Part B local policy states that a small volume nebulizer and related compressor are covered when medically necessary to administer Ipratropium Albuterol neb sol for the management of obstructive pulmonary disease. In this case, the record shows that Ipratropium Albuterol neb sol is administered through a nebulizer in the home for a diagnosis of COPD. There is no indication that it is not administered through a small volume nebulizer. It appears that this medication is eligible for coverage under Part B rather than Part D. Drugs which are eligible for coverage under Part B are excluded from Part D coverage by Medicare law. Therefore, it is our decision that the Part D Plan is not required to cover Ipratropium Albuterol neb sol.This decision does not concern the medical necessity or appropriateness of the requested drug. It only establishes 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 Fondaparinux. 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. Fondaparinux 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 Fondaparinux.
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 the Shingrix vaccine purchased January 20, 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 the Shingrix vaccine was purchased on January 20, 2020. During the deductible stage, the Plan requires that the enrollee pay the full cost of Tier 3, Tier 4 and Tier 5 drugs purchased in 2020 before the Plan would pay a share of the cost. The Shingrix vaccine is on the Plan's 2020 formulary and was classified as a Tier 3 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 the Shingrix vaccine purchased January 20, 2020.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Diclofenac Sodium. 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 Diclofenac Sodium 1% gel. Diclofenac Sodium 1% gel is requested for treatment of left hip pain due to trochanteric bursitis, 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 Diclofenac Sodium 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 Diclofenac Sodium. 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 Vivotif EC. The Plan did not grant this request. We received this case toconduct an independent review.CMS publishes a list of participating brand name drug manufacturers that have signed the MedicareCoverage Gap discount agreement. Vivotif EC is a brand name drug, and its manufacturer is not on this list.Therefore, the Part D Plan is not required to cover Vivotif EC.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cinacalcet. 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 is being prescribed to an enrollee who has ESRD or AKI and is on dialysis.Cinacalcet is a class of medication which is always considered ESRD or AKI-related for purposes of thePart 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.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: Favorable

You asked the Plan to cover Amphetamine-Dextroamphetamine ER 30 mg capsule, 4 capsules daily. ThePlan 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 Amphetamine-Dextroamphetamine ER 30 mg capsule, 4 capsules daily. Amphetamine-Dextroamphetamine ER 30 mg capsule, 4 capsules daily, is requested for ongoing treatment of narcolepsy.The Plan denied coverage of the requested drug because they concluded that narcolepsy is not a medicallyaccepted indication for the use of Amphetamine-Dextroamphetamine ER 30 mg. For coverage under theprescription drug benefit, Medicare requires that the drug prescribed be used for a medically acceptedindication. Our Physician Reviewer found that the Medicare-approved resources do contain citations tosupport the use of the requested drug for treatment of the noted condition. Drugdex has a link from theirmonograph on the requested drug to their DRUG CONSULTS monograph titled Narcolepsy and Cataplexy- Drug Therapy; which cites the American Academy of Sleep Medicine Consensus Practice Parameters forthe Treatment of Narcolepsy and other Hypersomnias of Central Origin (Sleep. 2007 Dec 1; 30(12): 1705-1711.) which state, Based on evidence and/or long history of use in the therapy of narcolepsy, committeeconsensus was that modafinil, amphetamine, methamphetamine, dextroamphetamine, and methylphenidateare reasonable options for the therapy of hypersomnia of central origin. In the noted consensus statement,it is stated that Combinations of long- and short-acting forms of stimulants may be indicated and effectivefor some patients. Therefore, the requested drug is being prescribed for a medically accepted indication.The Plan limits the amount of the drug to 60 capsules per 30 days. The prescriber has indicated that thenumber of doses of the requested drug allowed by the Plan has been ineffective in treating your condition.Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer'sopinion is that quantity limit exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by covering a limited quantity of certain drugs.A Plan must grant an exception if it determines that the requested dosage is medically reasonable andnecessary, consistent with the prescriber's statement. Based on a review of the available documentation,our Physician Reviewer's opinion is that an exception to the quantity limit criteria is met. Therefore, thePlan is required to cover the requested quantity of Amphetamine-Dextroamphetamine ER 30 mg capsule.