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

You asked the Plan to cover Venclexta, 100 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 Venclexta, 100 mg tablet; 120/30.Venclexta is requested to treat CLL (chronic lymphocytic leukemia). The enrollee is a 67 year old man with relapsed CLL. He has been treated with Bendamustine, Rituximab and Prednisone. He now has painful enlarging lymph nodes and splenomegaly causing organ dysfunction with inferior vena cava compression. He was started on Prednisone. The prescriber requests Venclexta to be given with Gazyva to treat him. The office note of 4/27/20 states the option of oral Ibrutinib or Acalabrutinib were discussed. The prescriber states due to advanced age and disease status he cannot tolerate IV treatments.Per the FDA website, Venclexta is s indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of the requested drug for treatment of the noted condition. Therefore, the requested drug is being prescribed for a medically accepted indication.The enrollee does not satisfy the Plan's coverage criteria. The prescriber has not sufficiently addressed the Plan's coverage criteria and/or 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. Our Physician's opinion is that 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. A Plan must grant an exception to prior approval rules if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on the available documentation, our Physician Reviewer's opinion is that an exception to prior approval criteria is not met. Therefore, the Plan is not required to cover Venclexta, 100 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Xeljanz. 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 Xeljanz. The drug is requested to treat Crohn's disease, 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 Xeljanz for the diagnosed condition. As a result, the drug is notbeing 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 Xeljanz.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 Tussionex. The Plan did not grant this request. We received this case toconduct an independent review.Medicare law excludes certain drugs from Part D coverage. Tussionex is one of those excluded drugsbecause it is a drug used for the symptomatic relief of coughs and colds. The record submitted by the Plandoes not indicate that they provide supplemental coverage for Tussionex. Therefore, the Plan is notrequired to cover Tussionex.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 cover Xeljanz, 5 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 Xeljanz, 5 mg tablet.The drug is requested to treat alopecia areata, which is an off-label (non-FDA approved) use. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia that support the use of Xeljanz, 5 mg tablet 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 Xeljanz, 5 mg tablet. This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Mycophenolate Mofetil. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law specifically excludes coverage for any drug under the Part D program for which payment would be available under Parts A or B of Medicare for that individual. Coverage is available under Medicare Part B for prescription drugs used in immunosuppressive therapy furnished to a beneficiary who has received an organ transplant, provided that Medicare Part A paid for the transplant in question. The case record indicates that Mycophenolate Mofetil is needed for a Kidney transplant performed September 5, 2010. According to the case record, the transplant in question was paid for by Medicare Part A. Thus, the transplant is considered a Medicare covered transplant and Mycophenolate Mofetil is eligible for coverage under Medicare Part B. Drugs which are eligible for Part B coverage are excluded from Part D coverage by Medicare law. Therefore, our decision is that Part D Plan is not required to cover Mycophenolate Mofetil. This decision does not concern the medical necessity or appropriateness of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.You may wish to submit this request to the Medicare Part B carrier.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Zejula, 100 mg capsule as prescribed. 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 Zejula, 100 mg.The drug is requested to treat recurrent primary peritoneal cancer as maintenance. The enrollee is a 72 yearold woman with recurrent primary peritoneal cancer. She was diagnosed in 2018 and treated withneoadjuvant Carboplatin/Taxol followed by surgery followed by completion of 6 cycles of chemotherapy.She had progression with CA125 rising to 330. She was started on Carboplatin/Gemzar and Bevacizumab.Her CA125 dropped to 13. She has not tolerated the treatment well and developed an abdominal abscess.She will not complete the last 2 planned cycles.The prescriber requests Zejula as maintenance therapy. Per the FDA website, Zejula is indicated for themaintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primaryperitoneal cancer who are in a complete or partial response to platinum based chemotherapy. The enrolleehas recurrent primary peritoneal cancer that has responded to Carboplatin, a Platinum based chemotherapywith marked decline in CA125. The stated use is maintenance therapy. Therefore the requested use is amedically accepted treatment that meets the plans prior authorization criteria. For coverage under theprescription drug benefit, Medicare requires that the drug prescribed be used for a medically acceptedindication. Our Physician Reviewer found that the Medicare-approved resources do contain citations tosupport the use of the requested drug for treatment of the noted condition. Therefore, the requested drug isbeing prescribed for a medically accepted indication.The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that priorauthorization 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 ofZejula, 100 mg capsule as prescribed for the diagnosed condition. As a result, Zejula, 100 mg capsule asprescribed is being 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 Zejula, 100 mg capsule as prescribed.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lenvima. 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 Lenvima (20 mg daily dose) cap therapeutic pack 2 x 10 mg; 1 per 28 days. The drug is requested to treat adrenocortical cancer, which is an off-label (non-FDA approved) use. The enrollee is a 66 year old woman with metastatic adrenocortical cancer involving liver, perinephric soft tissue, and lung and sternum lesions on imaging. She has been treated with surgery, Cisplatin/Etoposide, Nivolumab/Ipilumumab, Cabozantinib, and was started on Pembrolizumab. The prescriber requests Lenvima to be given with Pembrolizumab to treat her.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 Lenvima 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 Lenvima. 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

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 Lidocaine 5% Patch. 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 Lidocaine 5% Patch. The drug is requested to treat the enrollee's condition. Thedrug is a generic drug on tier 3 of the Plan's formulary. There are no available lower tier drugs on the Plan'sformulary to treat the enrollee's condition. Therefore, the drug is not eligible for a tiering exception. OurPhysician 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 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 Lidocaine 5% Patch.
Appeal type: Prescription Drug
Decision: Partially 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 cover and provide reimbursement for Atropine 0.01 mg/1 mg, Enoxaparin 10 mg/40mg, Aspirin 81 mg chew tab, Aspirin 5 gm, Ciprofloxacin 500 mg, Losartan 50 mg, Tramadol 50 mg,Amlodipine 5 mg, Indapamide 2.5 mg, Famotidine 20 mg, Pantoprazole 40 mg, Isosorbide Mono 30 mg,Citalopram 20 mg and Insulin Lispro (Humalog) all received while you were a patient at the hospital onJune 28, 2019 through June 29, 2019. The Plan did not grant this request. We received this case to conductan independent review.Atropine 0.1 mg/1 mg and Enoxaparin 10 mg/40 mg:Medicare rules require a Part D Plan to issue a coverage decision or a redetermination decision within thespecified timeframes. If the Plan does not make a timely decision, this is considered a denial. In thesecircumstances, the Plan is required to forward the coverage request or the redetermination request to thePart D QIC. The case record indicates a request was submitted to the Plan. The Plan did not properlyprocess this request to move the case forward to the next appeal level. Therefore, the applicable timeframes have been exceeded, and the Part D QIC has jurisdiction to process this case.The Plan covers prescriptions filled at an out-of-network pharmacy only in certain limited circumstances.The records shows you were a patient at the hospital on June 28, 2019 through June 29, 2019 and youreceived Atropine and Enoxaparin, self-administered drugs. You submitted a request for reimbursement tothe Part D Plan. The Plan's out-of-network coverage rules were followed. Therefore our decision is thePlan is required to provide applicable reimbursement for Atropine 0.1 mg/1 mg and Enoxaparin 10 mg/40mg received while you were a patient at the hospital on June 28, 2019 through June 29, 2019.Aspirin 81 mg chew tab and Aspirin 5 gm:Medicare Part D does not cover non-prescription drugs. We checked FDA approved sources for the drug'sclassification or determined from other available resources that the drugs are non-prescription or OTCdrugs. Therefore, Aspirin 81 mg chew tab and Aspirin 5 gm, received while you were a patient at thehospital on June 28, 2019 through June 29, 2019 are not eligible for Part D coverage, and the Plan is notrequired to cover them under the Part D benefit.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: Favorable

You asked the Plan to cover Promacta, 50 mg tablet, 30 per 30 days. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Promacta, 50 mg tablet.The drug is requested to treat chronic or persistent immune thrombocytopenia. For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of the requested drug for treatment of the noted condition. Therefore, the requested drug is being prescribed for a medically accepted indication.The prescriber sent a letter dated 6/17/2020 clarifying the medical history. The prescriber states the enrollee had an inadequate response to corticosteroids. Laboratory reports were provided which documented that the enrollee has had platelet counts less than 30,000 per microliter. The enrollee 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 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 citations in the Medicare approved compendia that support the use of Promacta, 50 mg tablet, 30 per 30 days for the diagnosed condition. As a result, Promacta, 50 mg tablet, 30 per 30 days is being 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 are met. Therefore, our decision is the Plan is required to cover Promacta, 50 mg tablet, 30 per 30 days.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Febuxostat. 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 Febuxostat 40 mg.The drug is requested to treat gout. For coverage under the prescription drug benefit, Medicare requires thatthe 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 prescriber has not indicated why all alternatives required by the Plan 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'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 Febuxostat.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Oxycodone HCL ER. 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 Oxycodone HCL ER 20 mg. The drug is requested to treat chronic severe cancer pain. You have 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. In addition to Fentanyl patch, Tramadol ER and Morphine ER,Xtampza is available on the formulary. The following strength capsules are available: 9 mg, 13.5 mg, 18mg, 27 mg and 36 mg.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 Oxycodone HCL ER.