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

You asked the Plan to cover Colestipol HCL. 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 Colestipol HCL. The drug is requested to treat chronic diarrhea, 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 Colestipol HCL 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 forColestipol HCL.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.Please note: the request for a tiering exception (lower copayment) for Colestipol HCL was not reviewed.We cannot consider a tiering exception for a drug for which the Part D Plan is unable to provide coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Livalo. The Plan did not grant this request. We received this case to conductan independent review.We asked our Physician Reviewer to determine whether the Plan was correct in denying the request forLivalo.Livalo is requested for ongoing treatment of hyperlipidemia. Per the Plan's notes, you initially indicatedthat the enrollee had not trialed any of the Plan's alternatives, but you did note that the enrollee has beentaking the requested medication since October 9, 2015. At the time of the request for reconsideration, youstate that the enrollee had myalgias to Pravastatin and Atorvastatin. Medical records submitted with therequest for reconsideration include a note from a patient encounter on February 25, 2020 which states thatthe enrollee has failed Pravastatin and Atorvastatin because of myalgias; however the progress notesubmitted is subsequent to the Plan's initial denial of Livalo on January 31, 2020. There were no medicalrecords submitted which actually document when Pravastatin and Atorvastatin were prescribed, and norecords documenting the side effects at the time they occurred. You have not provided sufficientdocumentation that the enrollee has tried all alternatives required by the Plan, or why the Plan's requiredstep therapy drugs would likely not be as effective for the enrollee as the requested drug, and/or wouldlikely cause adverse reactions or other harm to the enrollee. Our Physician Reviewer's opinion is thatneither step therapy or step therapy exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring step therapy for certain drugs. APlan must grant an exception if it determines that the requested drug is medically necessary, consistent withthe prescriber's statement. Based on a review of the available documentation, our Physician Reviewer'sopinion is that an exception to step therapy criteria is not met. Therefore, the Plan is not required to coverLivalo.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Actonel, 150 mg tablet. 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 Actonel, 150 mg tablet.Actonel, 150 mg is requested to treat the enrollee's condition. The requested 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 requested 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 Actonel, 150 mg tablet.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Tecfidera 240 mg. 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 Tecfidera 240mg. Tecfidera 240mg is requested for ongoing treatment of progressive relapsing multiple sclerosis/MS. Although the initial diagnosis being treated with Tecfidera 240mg was stated to be primary progressive multiple sclerosis, you have indicated that the enrollee has had a relapsing course; and therefore amended the diagnosis as noted. Medical records were submitted which clearly document that the enrollee has had an aggressive progressive clinical course, with episodic flares/relapses requiring episodic treatment with intravenous Solumedrol. 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 Tecfidera 240 mg.Please note that if the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The health plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will notify you in writing that the case is being reviewed again and the outcome of the reopening.
Appeal type: Prescription Drug
Decision: Unfavorable

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

You asked the Plan to cover Pilocarpine HCL. 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 a tiering exception for Pilocarpine HCL 5mg. The drug is requested to treat Sjogren's syndrome - severedry mouth. Pilocarpine HCL 5mg is a generic drug on Tier 4 of the Plan's formulary. There are no availablelower tier generic drugs of the same type 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.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 Pilocarpine HCL 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 forPilocarpine HCL.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

We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Northera.Northera is requested for treatment of symptomatic neurogenic orthostatic hypotension NOT due to primary autonomic failure (Parkinson's disease, multiple system atrophy, or pure autonomic failure), dopamine beta-hydroxylase deficiency, or non-diabetic autonomic neuropathy, 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. There was no peer-reviewed, clinically relevant, medical literature from an approved journal submitted to support this appeal. 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. For Part D drugs used in an anticancer chemotherapeutic regimen, 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 or peer-reviewed medical literature in CMS-approved journals or publications. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia and there was no peer-reviewed literature from an approved journal submitted to support the use of Northera 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 Northera. 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 Rocklatan. The Plan did not grant this request. 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 the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) if the lower tier(s) on the formulary only contain(s) generic alternative drugs. Rocklatan is a Tier 3 brand drug. The lower cost-sharing tier(s) only contain(s) generic alternative drugs. Therefore, our decision is the Plan is not required to provide a tiering exception for Rocklatan.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ondansetron. 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 Ondansetron 8 mg.The drug is requested to treat nausea and vomiting due to autonomic dysfunction, which is an off-label(non-FDA approved) use. The Medicare-approved compendia do not contain any citations to support theuse of the requested drug, as prescribed, for treatment of the noted condition. Therefore, the requested drugis not being prescribed for a medically accepted indication as defined by Medicare law. As such, anexceptions request based on medical necessity cannot be considered because the requested drug, asprescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is noteligible for coverage under Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Ondansetron 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 Ondansetron.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 Wixela. 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 Wixela. The drug is requested to treat chronic obstructive pulmonary disease. Wixela is a generic drug on Tier 3 of the Plan's formulary. There are no available lower tier generic drugs of the same type 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 (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 Wixela.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Xifaxan 550mg tablet. 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 Xifaxan 550mg tablet. The drug is requested to treat hepatic encephalopathy prophylaxis. For coverageunder the prescription drug benefit, Medicare requires that the drug prescribed be used for a medicallyaccepted indication. On March 16, 2020 the prescriber sent additional information and medical recordsaddressing the diagnosis and the Plan's coverage criteria. Our Physician Reviewer found that the Medicareapprovedresources do contain citations to support the use of the requested drug for treatment of the notedcondition. Therefore, the requested drug is being prescribed for a medically accepted indication. Theenrollee satisfies the Plan's coverage criteria.Our Physician Reviewer's opinion 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 ofXifaxan 550mg tablet for the diagnosed condition. As a result, Xifaxan 550mg tablet is being prescribed fora 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 Xifaxan 550mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Dupixent. 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 Dupixent 300 mg/2 mL.The drug is requested to treat Atopic dermatitis. The provided office notes state that the enrollee did tryProtopic (Tacrolimus), Methotrexate, Vanicream and Triamcimolone. The prescriber has not indicated whyall 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 thePlan'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 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 Dupixent.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ipratropium-Albuterol nebulizer solution. 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 PartA or Part B of Medicare for that individual. Medicare Part B may pay for supplies necessary for theeffective use of durable medical equipment, including drugs and biologicals which must be put directly intothe equipment in order to achieve the therapeutic benefit of the durable medical equipment. Medicare PartB local policy states that a small volume nebulizer and related compressor are covered when medicallynecessary to administer Ipratropium-Albuterol nebulizer solution for the management of obstructivepulmonary disease.We requested additional medical information to determine if criteria for Medicare Part D have been met.We requested the enrollee's diagnosis and ICD-10 code for which Ipratropium-Albuterol nebulizer solutionhas been prescribed, and confirmation of where this drug is being administered. A response to our requestwas not received in the timeframe required for review of this case. There is insufficient information toshow that this drug is not eligible for Medicare Part B coverage. As a result, the record does not establishthat Ipratropium-Albuterol nebulizer solution is a Part D drug in this case. Therefore, it is our decision thatthe Part D Plan is not required to cover Ipratropium-Albuterol nebulizer solution.This decision does not concern the medical necessity or appropriateness of the requested drug. It onlyestablishes if payment can be made under the Medicare Part D benefit.You may wish to submit this request to the Medicare Part B carrier.
Appeal type: Prescription Drug
Decision: Unfavorable

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified timeframe. If the Plan does not make a timely decision, this is considered a denial. The Plan forwarded this case to us as required by Medicare rules because it did not make a timely decision.You asked the Plan to provide a tiering exception for Diovan. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law and Plan rules do not allow tiering exceptions for non-formulary drugs being covered through a formulary exception. The documentation in the record shows that Diovan is currently being covered for the enrollee through a formulary exception. Therefore, our decision is the Plan is not required to provide a tiering exception for Diovan.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to provide reimbursement for Oxycodone HCL 5 mg received May 24, 2019 and May25, 2019. The Plan did not grant this request. We received this case to conduct an independent review.The Plan covers prescriptions filled at an out-of-network pharmacy only in certain limited circumstances.In this case, you were a patient at the hospital. You received several self-administered drugs during thisstay. You requested reimbursement from the Part D Plan. The request includes proof of payment and anitemized statement from the hospital. The Plan denied the request on the basis that the National Drug Code(NDC) provided is an invalid NDC. It is noted, that the Plan reviewed the request for Oxycodone HCL 5mg capsule. However, the itemized statement shows you were given Oxycodone HCL 5 mg tablet (NDC00904-6444-61). The NDC provided is a valid, Part D eligible NDC, of a re-packaged product. Medicarerules that it is reasonable and acceptable for a hospital to provide drugs from repackaged products. ThePlan's out-of-network coverage rules were followed. Therefore, our decision is the Plan is required toprovide reimbursement for Oxycodone HCL 5 mg received May 24, 2019 and May 25, 2019.