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

You asked the Plan to provide a tiering exception for Lumigan and Combigan. The Plan did not grant thisrequest. We received this case to conduct an independent review.Medicare rules do not require the Part D plan to grant a tiering exception for a brand or biologic drug of thesame type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) ifthe lower tier(s) on the formulary only contain(s) generic alternative drugs. Lumigan and Combigan areTier 3 brand drugs. The lower cost-sharing tier(s) only contain(s) generic alternative drugs. Therefore, ourdecision is the Plan is not required to provide a tiering exception for Lumigan and Combigan.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Gattex 5 mg kit as prescribed. 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 Gattex, 5 mg.The drug is requested to treat short bowel syndrome secondary to Crohn's disease and multiple small bowelresections. The prescriber clarified the medical history in a letter dated 7/6/2020. The enrollee has beencurrently receiving therapy with the requested medication. The prescriber confirms that the enrollee'srequirement for parenteral support has decreased from baseline while on therapy with the requestedmedication. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is thatprior 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 Gattex 5 mg kit as prescribed.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Armodafinil. 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 Armodafinil 150 mg tab. The drug is requested to treat fatigue in an enrollee with multiple sclerosis,which is an off-label (non-FDA approved) use. 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 Armodafinil 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 Armodafinil.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 Mycophenolic Acid DR and Tacrolimus. 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 Mycophenolic Acid DR and Tacrolimus. Mycophenolic Acid DR and Tacrolimus are requested for ongoing use for treatment of interstitial lung disease associated with anti-synthetase syndrome, which is an off-label (non-FDA approved) use. The prescriber has discussed the enrollee's clinical course, and has cited medical literature to support the noted request; however the Medicare-approved compendia do not contain any citations to support the use of the requested drugs, 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 drugs, as prescribed, do not meet the definition of a Medicare Part D drug. Therefore, the requested drugs are 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 Mycophenolic Acid DR and Tacrolimus 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 Mycophenolic Acid DR and Tacrolimus. 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: Favorable

You asked the Plan to cover Armodafinil 150 mg tablet. 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 Armodafinil 150 mg tablet. The drug is requested to treat obstructive sleep apnea with excessivedaytime sleepiness. You sent additional information and medical records on July 8, 2020 addressing thediagnosis and coverage criteria. A report of a sleep study from May 12, 2006 was provided documentingobstructive sleep apnea along with details of excessive sleepiness and a follow-up office visit of February4, 2020. 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 Armodafinil 150 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Jardiance. 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 Jardiance. The drug is requested to treat diabetes. The drug is a brand drug onTier 3 of the Plan's formulary. There are no available lower tier drugs on the Plan's formulary to treat yourcondition. 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 your condition. Therefore, ourdecision is the Plan is not required to provide a tiering exception for Jardiance.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Mekinist. 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 Mekinist. The drug is requested to treat endometrial cancer, which is an off-label (non-FDA approved)use.The enrollee is a 66 year old woman with metastatic endometrial cancer involving the omentum and liverarea. She has been treated with Carboplatin, Paclitaxel, Temsirolimus and Letrozole. CT scan onJune 29, 2020 showed modest increased size of omental nodularity, increasing cystic mass adjacent to theliver and no ascites. Foundation One testing identified an NRAS mutation suggesting possible response toMekinist. You request Mekinist to treat her. Journal articles relating to other cancer types were submitted insupport of the requests and were reviewed.The Medicare-approved compendia do not contain any citations to support the use of the requested drug, asprescribed, for treatment of the noted condition. There was no peer-reviewed, clinically relevant, medicalliterature from an approved journal submitted to support this appeal. 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. For Part D drugs used in an anticancer chemotherapeutic regimen, a medically acceptedindication means a use that is approved by the FDA or a use that is supported by one or more citations inMedicare approved compendia or peer-reviewed medical literature in CMS-approved journals orpublications.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia and there was no peer-reviewed literature from an approved journal submitted tosupport the use of Mekinist for the diagnosed condition. As a result, the drug is not being prescribed for amedically accepted indication as defined by Medicare law. As such, it cannot be covered under theMedicare Part D benefit for this condition. An exceptions request based on medical necessity cannot beconsidered 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 Mekinist.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 usas required by Medicare rules because it did not make a timely decision.You asked the Plan to provide reimbursement for the TDVAX vaccine and its administration fee receivedJanuary 24, 2020. The Plan did not grant this request. We received this case to conduct an independentreview.The Plan covers prescriptions filled at an out-of-network pharmacy only in certain limited circumstances.In this case, you received the TDVAX vaccine from your prescriber's office. You requested reimbursementfrom the Part D Plan. The Plan did not process the request. A representative from Maximus Federal verifiedwith the prescriber's office that the vaccine and its administration fee have been paid for in full and theTDVAX vaccine (13533-131-00) was administered as a preventative/routine vaccine not as a result ofinjury or exposure. The TDVAX vaccine is on Tier 3 of the Plan's 2020 Formulary. The Plan's out-ofnetworkcoverage rules were followed. Therefore, our decision is the Plan is required to provide coverageand reimbursement for the TDVAX Vaccine and its administration fee received January 24, 2020.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Alclometasone Dipro 0.05% cream. 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 Alclometasone Dipro 0.05% topical cream.The drug is requested to treat the enrollee's condition. Additional medical information was requested by thePart D QIC. The prescribing physician was asked to address additional formulary alternatives tried andfailed. The prescriber statement was not returned. The prescriber has not indicated why all alternativesrequired by the Plan (Fluticasone Propionate topical cream and Hydrocortisone topical cream) 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 Alclometasone Dipro 0.05% cream.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Neupro. 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 Neupro 6 mg (24 hr) transdermal patch. The drug is requested to treat the enrollee's condition. The drug is a brand drug on tier 4 of the Plan's formulary. There are no available lower tier brand drugs on the Plan'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 the same type 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 Neupro.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Repatha SureClick. The Plan did not grant this request. We received this caseto conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Repatha SureClick 140 mg/ml.The drug is requested to treat hyperlipidemia in a patient with atherosclerotic cardiovascular disease(ASCVD), and statin intolerance. The prescriber has not indicated why all alternatives required by the Plan(Praluent) would likely not be as effective for the enrollee as the requested drug; and/or would likely causeadverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria isnot supported. 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 Repatha SureClick.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Budesonide 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 Budesonide for the management of obstructive pulmonary disease.In this case, the record shows that Budesonide is administered through a nebulizer in the home for adiagnosis of ICD-10 J47.1 (Bronchiectasis with (acute) exacerbation). 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 coverBudesonide 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.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Testosterone 50 mg/5 gm gel. 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 Testosterone 50 mg/5 gm gel.The drug is requested to treat male hypogonadism. The enrollee does not satisfy the Plan's coveragecriteria. The prescriber has not sufficiently addressed the Plan's coverage criteria and/or has not indicatedwhy all alternatives required by the Plan 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 Testosterone 50 mg/5 gm gel.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Corlanor. 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 Corlanor.Corlanor is requested for treatment of inappropriate sinus tachycardia, which is an off-label (non-FDA approved) use. You have discussed the enrollee's clinical course, and have submitted medical literature to support the noted request; however 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 Corlanor 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 Corlanor. 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: Favorable

You asked the Plan to cover Posaconazole DR 100 mg tablet. 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 Posaconazole DR 100 mg tablet. The drug is requested as Prophylaxis against Invasive candidiasis in aseverely immunocompromised patient. In the Reconsideration appeal dated July 7, 2020, you clarified thediagnosis. You also stated that the enrollee had a recent bone marrow transplant to treat acute myeloidleukemia and was extremely immunocompromised. For coverage under the prescription drug benefit,Medicare requires that the drug prescribed be used for a medically accepted indication. Our PhysicianReviewer found that the Medicare-approved resources do contain citations to support the use of therequested drug for treatment of the noted condition. Therefore, the requested drug is being prescribed for amedically accepted indication. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer'sopinion is that prior authorization criteria are met.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 reviewedthis file and determined that there are citations in the Medicare approved compendia that support the use ofPosaconazole DR 100 mg tablet for the diagnosed condition. As a result, Posaconazole DR 100 mg tablet isbeing prescribed for a medically accepted indication as defined by Medicare law.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 Posaconazole DR 100 mg tablet.