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

You asked the Plan to cover Heparin Sodium. 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, Heparin Sodium is being prescribed to an enrollee who has ESRD or AKI and is on dialysis. Heparin Sodium 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 ESRD payment bundle, regardless of the reason why the drug is being prescribed and regardless of whether or not the drug is being furnished by a dialysis facility. Drugs which are eligible for Part B coverage are excluded from Part D coverage by Medicare law. Therefore, our decision is the Part D Plan is not required to coverHeparin Sodium.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.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ingrezza. 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 Ingrezza 40 mg capsule. The drug is requested to treat Tardive Dyskinesia. The prescriber has 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 Ingrezza.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Retacrit. The Plan did not grant this request. We received this case to conduct an independent review.CMS publishes a list of participating brand name drug manufacturers that have signed the Medicare Coverage Gap discount agreement. Retacrit (NDC 59353-010-10) is a brand name drug, and its manufacturer is not on this list. Therefore, the Part D Plan is not required to cover Retacrit
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Prednisone. The Plan did not grant this request. We received this case toconduct an independent review.The case record indicates that Prednisone is needed for a kidney transplant performed July 8, 2009. In thiscase, we sent a request for additional information to the Part D Plan. We requested the evidence that thePlan used to determine that Medicare paid for the transplant performed July 8, 2009. The Plan responded toour request, however the Plan failed to provide claims data that supports that Medicare paid for thetransplant in question. Based on the available information we cannot verify that coverage would beavailable for the requested drug under Medicare Part B. Therefore we asked our Physician Reviewer todetermine 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 Prednisone 5 mg. The drug is requested for the prophylaxis of renal transplant rejection. There is noevidence that Medicare paid for the transplant, and therefore is not part B eligible. The enrollee satisfies thePlan'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 aremet. Therefore, our decision is the Plan is required to cover Prednisone.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Sumatriptan. 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 Sumatriptan 100 mg tablet 180 tablets/90 days. The drug is requested to treat acute Migraines. The Planlimits the amount of Sumatriptan 100 mg tablet to 9 tablets per 30 days. The product label, available atdrugs@fda, states: The maximum daily dose is 200 mg in a 24-hour period. The safety of treating anaverage of more than 4 headaches in a 30-day period has not been established. As such the requestedquantity is also a safety issue. The prescriber has not indicated that the number of doses of the requesteddrug allowed by the plan would likely be ineffective in treating the enrollee's condition and/or would likelycause harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. OurPhysician Reviewer's opinion is that quantity limit exception criteria are not 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 not met. Therefore, thePlan is not required to cover the requested quantity of Sumatriptan.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Oxycontin ER. 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 Oxycontin ER. The drug is requested to treat multiple myeloma/cancer-related pain status postprophylactic fixation left proximal femur with an intramedullary cephalo-medullary device. You have notindicated why all alternatives required by the Plan (Morphine Sulfate ER) would likely not be as effectivefor the enrollee as the requested drug; and/or would likely cause adverse reaction(s) or other harm to theenrollee. Therefore, an exception to the Plan's coverage criteria is not supported. Our Physician Reviewer'sopinion 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 Oxycontin ER.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Testosterone 1.62% Gel Pump. 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 Testosterone 1.62% Gel Pump. The drug is requested to treat late-onset (age related)hypogonadism/testicular hypofunction and erectile dysfunction, which are off-label (non-FDA approved)uses. The Medicare-approved compendia do not contain any citations to support the use of the requesteddrug, as prescribed, for treatment of the noted conditions. 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 Testosterone 1.62% Gel Pump 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 Testosterone 1.62% Gel Pump.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Favorable

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 Rosuvastatin 5 mg tablet, Diltiazem ER 240 mg capsule, and Metformin HCL 500 mg tablet purchased from the pharmacy on April 1, 2020, April 8, 2020, May 6, 2020 and May 7, 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. If you pay the full cost of a prescription drug out-of-pocket you can ask the Plan to pay you back. When submitting a request for reimbursement, the Plan requires that you submit your receipt documenting the payment you have made along with your reimbursement request. In this case, you submitted a request for reimbursement to the Plan for Rosuvastatin 5 mg tablet, Diltiazem ER 240 mg capsule, and Metformin HCL 500 mg tablet purchased April 1, 2020, April 8, 2020, May 6, 2020 and May 7, 2020 at the pharmacy. The case record includes include proof of payment. Medicare rules allow a Part D Plan to manage its formulary by requiring prior authorization, step therapy or quantity limits. These drugs are on the Plan's formulary and are not subject to any of these restrictions. Therefore, our decision is the Plan is required to cover and provide any applicable reimbursement for Rosuvastatin 5 mg tablet, Diltiazem ER 240 mg capsule, and Metformin HCL 500 mg tablet purchased April 1, 2020, April 8, 2020, May 6, 2020 and May 7, 2020 at the pharmacy.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Cinacalcet HCL. 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 Cinacalet HCL 30 mg. The drug is requested to treat hypercalcemia in a renal transplant recipient with persistent hyperparathyroidism. Medical records were provided. Laboratory results from March 5, 2020 documented a serum calcium of 10.6 (ref range 8.4-10.2 mg/dL) and PTH 276 (ref range 23-97 pg/mL). 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 Cinacalcet HCL.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Repatha SureClick. 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 Repatha SureClick 140 mg/ml syringe. The drug is requested to treat theenrollee's condition. The prescriber was asked questions to address the Plan's coverage/exception criteria. Aresponse from the prescriber was not received. Repatha SureClick is a biologic on tier 3 of the Plan'sformulary. There are no available lower tier biologic drugs of the same type on the Plan's formulary to treatthe enrollee's condition. Therefore, the drug is not eligible for a tiering exception. Our Physician Reviewer'sopinion is that tiering exception criteria are not met.Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of thesame type in a lower cost-sharing tier approved for treating the same condition that the higher cost-sharingtiered drug is being used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are notmet because there are no lower cost-sharing tiered drugs of the same type for treating the enrollee'scondition. Therefore, our decision is the Plan is not required to provide a tiering exception for RepathaSureClick.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Plaquenil. 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 Plaquenil. The drug is requested to treat CREST syndrome (calcinosis cutis, Raynaud phenomenon,esophageal dysmotility, sclerodactyly, and telangiectasia), 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, asprescribed, for treatment of the noted condition. 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 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 Plaquenil 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 Plaquenil.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 Octreotide. 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 Octreotide. The drug is requested to treat menorrhagia, which is an off-label (non-FDA approved) use. You clarified the diagnosis in the request for reconsideration dated July 8, 2020. Relevant medical records were not provided. 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 Octreotide 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 Octreotide. 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 provide a tiering exception for Prolia. 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 Prolia. The drug is requested to treat M81.0 Age-related osteoporosis withoutcurrent pathological fracture. Prolia is a biologic drug on Tier 4 of the Plan's formulary. There are noavailable lower tier biologic drugs of the same type 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 tieringexception 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 Prolia.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cyclobenzaprine. 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 Cyclobenzaprine 10 mg tablet.The drug is requested to treat chronic back pain and muscle spasm, which is an off-label (non-FDAapproved) use. The Medicare-approved compendia do not contain any citations to support the use of therequested drug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is notbeing prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptionsrequest based on medical necessity cannot be considered because the requested drug, as prescribed, doesnot meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverageunder 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 Cyclobenzaprine for the diagnosed condition. As a result, thedrug 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 forCyclobenzaprine.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 Levalbuterol 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 Levalbuterol nebulizer solution for the management of obstructive pulmonarydisease.In this case, the record shows that Levalbuterol nebulizer solution is administered through a nebulizer in thehome for a diagnosis of chronic obstructive pulmonary disease (COPD). There is no indication that it is notadministered through a small volume nebulizer. It appears that this medication is eligible for coverageunder Part B rather than Part D. Drugs which are eligible for coverage under Part B are excluded from PartD coverage by Medicare law. Therefore, it is our decision that the Part D Plan is not required to coverLevalbuterol 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

You asked the Plan to cover MuGard. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover devices. MuGard has been classified by the FDA as a device, not as a drug. Therefore, our decision is the Part D Plan is not required to cover MuGard. This decision does not address the medical necessity or appropriateness of the requested item. It only establishes that payment cannot be made under the Medicare Part D benefit.