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

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified timeframe.If the Plan does not make a timely decision, this is considered a denial. The Plan forwarded this case to usas required by Medicare rules because it did not make a timely decision.You asked the Plan to provide a tiering exception for Prolensa. The Plan did not grant this request. Wereceived 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. Prolensa is a Tier 3 brand drug.The lower cost-sharing tier(s) only contain(s) generic alternative drugs. Therefore, our decision is the Planis not required to provide a tiering exception for Prolensa.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide reimbursement for Bicalutamide purchased on March 5 and June 24, 2020,from the pharmacy. The Plan did not grant this request. We received this case to conduct an independentreview.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 Bicalutamide waspurchased on March 5 and June 24, 2020, from the pharmacy. During the deductible stage, the Planrequires that the enrollee pay the full cost of Tier 3, Tier 4, and Tier 5 drugs purchased in 2020 before thePlan would pay a share of the cost. Bicalutamide is on the Plan's 2020 formulary and is classified as a Tier3 drug. The Plan provided documentation showing that this claim was covered by the Plan at the time ofpurchase, 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 Bicalutamide purchased onMarch 5 and June 24, 2020, from the pharmacy.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Buprenorphine 5 mcg/hr Patch. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Buprenorphine 5 mcg/hour Patch.The drug is requested to treat chronic back pain, fibromyalgia and cervicalgia. The prescriber has not indicated why all alternatives required by the Plan would likely not be as effective for the enrollee as the requested drug; and/or would likely cause adverse reaction(s) or other harm to the enrollee. A request for medical records was sent to the prescriber as a report of prior trial and failure of fentanyl Patch, morphine ER tablet and Xtampza ER capsule was added at the reconsideration level with no supporting records. Despite the request, no records were provided to document the prior trial and failure of the formulary alternatives. Therefore, an exception to the Plan's coverage criteria is not 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 requested drug is medically necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that formulary exception criteria are not met. Therefore, the Plan is not required to cover Buprenorphine 5 mcg/hr Patch.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Dutasteride. 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 Dutasteride 0.5 mg. The drug is requested to treat prostate cancer, 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 Dutasteride 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 Dutasteride.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 Carisoprodol. The Plan did not grant this request. We received this case toconduct an independent review.We asked a Physician Reviewer to determine whether the Plan was correct in denying the request forCarisoprodol which is subject to prior approval. Our Physician Reviewer needed additional informationfrom the prescriber to make this determination. The prescriber was asked to address whether the drugsoffered by the Plan for the treatment of your condition would: (1) not be as effective as the requested drug;and/or (2) have adverse effects. The requested information was not received. Based on a review of theavailable documentation, neither prior authorization criteria nor prior authorization exception criteria aremet.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 Carisoprodol.
Appeal type: Prescription Drug
Decision: Unfavorable

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified timeframe.If the Plan does not make a timely decision, this is considered a denial. The Plan forwarded this case to usas required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Lanthanum Carbonate. 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 Lanthanum Carbonate. The drug is requested to treat hyperphosphatemia. You have not indicated whyall alternatives required by the Plan (including Sevelamer Carbonate and Auryxia) would likely not be aseffective for the enrollee as the requested drug; and/or would likely cause adverse reaction(s) or other harmto the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. Our PhysicianReviewer'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 Lanthanum Carbonate.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Victoza 18 mg/3 mL, 9 per 28 days. 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 Victoza 18 mg/3 mL 9/28.The drug is requested to treat obesity. For coverage under the prescription drug benefit, Medicare requiresthat the drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that theMedicare-approved resources do contain citations to support the use of the requested drug for treatment ofthe noted condition. Therefore, the requested drug is being prescribed for a medically accepted indication.The following citation in AHFS-DI, a Medicare approved compendium, supports the use of the requesteddrug for the enrollee's condition:Liraglutide is used as an adjunct to caloric restriction and increased physical activity for the long-termmanagement of body weight in patients who are obese (pretreatment body mass index [BMI] of 30 kg/m2or greater) or, in the presence of an underlying weight-related comorbid condition (e.g., hypertension, type2 diabetes mellitus, dyslipidemia), those who are overweight (pretreatment BMI of 27 kg/m2 or greater).Drugs prescribed to treat weight gain (promote weight loss) are excluded from coverage under MedicarePart D. Therefore the requested drug is excluded from coverage.Medicare law excludes certain drugs from Part D coverage. Victoza 18 mg/3 mL, 9 per 28 days is one ofthose excluded drugs because it is a drug used for anorexia, weight loss or weight gain. The recordsubmitted by the Plan does not indicate that they provide supplemental coverage for Victoza 18 mg/3 mL, 9per 28 days. Therefore, the Plan is not required to cover Victoza 18 mg/3 mL, 9 per 28 days.This decision does not address the medical necessity or appropriateness of the requested drug. It onlyestablishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Rocklatan 0.2/0.005%. The Plan did not grant thisrequest. We received this case to conduct an independent review.Medicare law and Plan rules do not allow tiering exceptions for non-formulary drugs being coveredthrough a formulary exception. The documentation in the record shows that Rocklatan 0.2/0.005% iscurrently being covered for the enrollee through a formulary exception. Therefore, our decision is the Planis not required to provide a tiering exception for Rocklatan 0.2/0.005%.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Amitiza, 24 mcg capsule. 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 Amitiza, 24 mcg capsule.The drug is requested to treat opioid-induced constipation, in an enrollee with chronic pain syndrome. Theprescriber clarified the drugs tried in the request for reconsideration dated 6/29/2020. The prescriber statesthe enrollee has tried and failed the following medications: Metamucil, Fibercon, Dulcolax, Senokot, Milkof Magnesia, and Miralax. The enrollee does not satisfy the Plan's coverage criteria. The prescriber has notsufficiently addressed the Plan's coverage criteria and/or has not indicated why all alternatives required bythe Plan 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. Our Physician's opinion is that neither prior authorizationnor 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 Amitiza, 24 mcg capsule.
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 mixed connective tissue disease/systemic involvementunspecified connective tissue, which is an off-label (non-FDA approved) use. The Medicare-approvedcompendia do not contain any citations to support the use of the requested drug, as prescribed, for treatmentof the noted condition. Additional medical information was requested by the Part D QIC. You were askedto address the diagnosis and formulary alternatives. The prescriber statement was returned. Youdocumented a diagnosis of discoid lupus. However, the progress notes submitted do not support a diagnosisof discoid lupus. 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 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 Pregabalin. 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 Pregabalin 100 mg capsule. The drug is requested to treat low back pain, osteoarthritis of multiple jointsand chronic pain syndrome, which are off-label (non-FDA approved) uses. Medical records were provided.The Medicare-approved compendia do not contain any citations to support the use of the requested drug, asprescribed, for treatment of the noted conditions. 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 conditions.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 Pregabalin 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 Pregabalin.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 Tukysa. 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 Tukysa. The drug is requested to treat metastatic colon cancer, which is an off-label (non-FDAapproved) use.The enrollee is a 54 year old man with metastatic colon cancer involving liver and stomach. He has beentreated with over ten lines of treatment. He now has HER2 positive colon and stomach cancer. You requestTukysa to be given with Trastuzumab to treat him. A journal article, an abstract and a press release weresubmitted in support of the request. The journal article related to preclinical laboratory results and theabstract was a preliminary report of an ongoing clinical trial. Therefore the requested use is investigational.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 Tukysa 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 Tukysa.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 Aranesp. 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 Aranesp 200 mcg/0.4 ml syr. The drug is requested to treat Anemia in an enrollee with Myelodysplastic syndrome. In the Reconsideration appeal the prescriber provided office notes. The notes state, As per IPSET criteria, since JAK2 negative, Risk assessment intermediate. The following citation in DrugDex, a Medicare approved compendium, supports the use of the requested drug for the enrollee's condition: In a randomized study in patients with low to intermediate-1 risk myelodyplastic syndromes given an initial darbepoetin alfa dose of 240 mcg had the highest major erythroid response rate of 33.3% in the initial 16 week period, with responses of 17.6% with 60 mg and 16.7% with the 120 gm-dose. A major or minor erythroid response occurred in 66.7% receiving the 240 mcg-initial dose, 64.7% with the 60 mcg-dose, and 44.4% in the 120 mcg- dose group. 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.You have not indicated why all alternatives required by the Plan would likely not be as effective for the enrollee as the requested drug; and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not 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 requested drug is medically necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that formulary exception criteria are not met. Therefore, the Plan is not required to cover Aranesp.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Buprenorphine patch. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Buprenorphine 15 mcg patch. The drug is requested to treat chronic pain. You have not indicated why all alternatives required by the Plan would likely not be as effective for the enrollee as the requested drug; and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not 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 requested drug is medically necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that formulary exception criteria are not met. Therefore, the Plan is not required to cover Buprenorphine patch.