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

You asked the Plan to cover Flector Patch. 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 Flector Patch. The drug is requested to treat post-herpetic neuralgia, 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 Flector Patch 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 Flector Patch.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 cover Imbruvica. 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 Imbruvica 560 mg; 28/28. The drug is requested to treat marginal zone lymphoma.The enrollee is a 59 year old woman with marginal zone lymphoma involving breast mass, cervical, chest,abdominal and pelvic lymph nodes as well as subcutaneous nodules and intramuscular foci with a possiblelung site. She has been treated with radiation, Rituximab, Cytoxan, Vincristine, Adriamycin, Prednisone,Bexxar RIT, Bendamustine, Lenalidomide, Gemcitabine, Oxaliplatin and Obinutuzumab. She hasrecurrent/progressive lymphoma with updated biopsy showing marginal zone lymphoma. The prescriberrequests Imbruvica to treat her.Per the FDA website, Imbruvica is indicated for the treatment of adult patients with marginal zonelymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-basedtherapy. The enrollee has been treated with Rituximab, Bexxar RIT and Obinutuzumab which are all anti-CD20 agents. She has multiple sites of lymphoma. The prescriber recommends she be treated. Therefore, inthe opinion of this reviewer she meets the medically accepted use and the plan's prior authorization criteria.For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for amedically accepted indication. Our Physician Reviewer found that the Medicare-approved resources docontain 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 satisfies the Plan'scoverage 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
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cabometyx. 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 Cabometyx. The drug is requested to treat intermediate grade neuroendocrine cancer of the lung, whichis an off-label (non-FDA approved) use.The enrollee is a 69 year old man with metastatic intermediate grade neuroendocrine cancer of the lunginvolving lung, bones, epidural mass and liver. He has been treated with radiation, Capecitabine,Temozolomide, Carboplatin, and Etoposide. His tumor is SSTR2A-CXCR4 negative. You state he hasprogression in the liver on CT scan of June 22, 2020. He is unlikely to tolerate further chemotherapy. Yourequest Cabometyx to treat him. A 2017 abstract was submitted in support of the request. The conclusionwas that further evaluation is warranted. Abstracts cannot be used to determine medically accepted use.This reviewer did not find any supportive citations in a PubMed search.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 Cabometyx for the diagnosed condition. As a result, the drug is not being prescribed fora medically 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 Cabometyx.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 Calcitriol. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law requires that all drugs and biologicals used in the treatment of ESRD or AKI be included in the ESRD PPS payment bundle, regardless of the reason why the drug is being prescribed and regardless of whether or not the drug is furnished by a dialysis facility. Drugs that are always considered ESRD and AKI-related include access management drugs, anemia management drugs, anti-infectives to treat site access infection, bone and mineral metabolism drugs and cellular management drugs.In this case, Medicare records document that Calcitriol is being prescribed to an enrollee who is not on dialysis. Thus, in this case the requested drug is not eligible for coverage under the Part B ESRD payment bundle. We therefore asked our Physician Reviewer to determine if Part D coverage criteria have been met.Our Physician Reviewer thoroughly reviewed the case record to determine whether the Part D Plan was correct in denying the request for Calcitriol 0.25 mcg.The drug is requested for the prevention of bone loss in a patient status post kidney transplant (7/3/2020), no longer receiving dialysis, 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 Calcitriol 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 Calcitriol. 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 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. The enrollee does notsatisfy the Plan's coverage criteria. The prescriber has not sufficiently addressed the Plan's coverage criteriaand/or has not indicated why all alternatives required by the Plan would likely not be as effective for theenrollee 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. 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 Repatha SureClick.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lynparza. 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 Lynparza. The drug is requested to treat small cell lung cancer, which is an off-label (non-FDA approved) use.The enrollee is a 67 year old woman with stage IV small cell lung cancer involving pleura, liver and epidural space. She has been treated with Carboplatin, Etoposide, Atezolizumab, Irinotecan, and Gemcitabine. It is expected she will have radiation to the epidural metastases. You request Lynparza to be given with Temozolomide to treat her. The office note indicates Lurbinectedin is an alternative FDA approved treatment but is not available in the pharmacy. An article from a non-CMS approved journal was submitted in support of the request.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 Lynparza 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 Lynparza. 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 Oxcarbazepine 300 mg, 270 per 90 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 requestfor Oxcarbazepine 300 mg. The drug is requested to treat diabetic neuropathy, which is an off-label (non-FDA approved) use. The Medicare-approved compendia do not contain any citations to support the use ofthe requested 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 Oxcarbazepine 300 mg, 270 per 90 days for the diagnosedcondition. As a result, the drug is not being prescribed for a medically accepted indication as defined byMedicare law. As such, it cannot be covered under the Medicare Part D benefit for this condition. Anexceptions request based on medical necessity cannot be considered because this drug, as prescribed, doesnot meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required toprovide coverage for Oxcarbazepine 300 mg, 270 per 90 days.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

You asked the Plan to cover Zolpidem 10 mg tablet, 30 tablets per 30 days. 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 Zolpidem 10 mg tablet, 30 tablets per 30 days. The drug is requested to treat insomnia. In theReconsideration appeal dated July 8, 2020 you addressed the Prior Authorization criteria. You also statedthat the enrollee has contraindications to both Doxepin and Trazodone. The enrollee satisfies the Plan'scoverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs.Based on the available documentation, our Physician Reviewer's opinion is that prior approval criteria aremet. Therefore, our decision is the Plan is required to cover Zolpidem 10 mg tablet, 30 tablets per 30 days.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Buprenorphine patch. 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 Buprenorphine patch. The drug is requested to treat radiculopathy, lumbar region. 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.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 Buprenorphine patch.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Nulojix 250 mg. 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 Nulojix 250 mg/vial IV solution. The drug is requested for continued prophylaxis of organ rejection inthis Epstein-Barr virus (EBV) seropositive kidney transplant (#2) recipient (6/20/2017), status post 1stfailed kidney transplant in 2006. The requested drug is subject to B versus D prior authorization criteria.The requested drug is not eligible for coverage under Part B rules, as the requested intravenous (IV)infusion will be administered in the enrollee's home. The prescriber has documented that the enrollee isCMV positive, EBV seropositive, received Basiliximab for induction, and concomitant MycophenolateMofetil and corticosteroids. The prescriber stated that Tacrolimus had been tried for the prevention of renaltransplant rejection. Our Physician Reviewer's opinion is that prior authorization criteria are met. Theenrollee satisfies the Plan's coverage criteria.Medicare law specifically excludes coverage for any drug under the Part D program for which paymentwould be available under Parts A or B of Medicare for that individual. Coverage is available underMedicare Part B for prescription drugs used in immunosuppressive therapy furnished to a beneficiary whohas received an organ transplant, provided that Medicare Part A paid for the transplant in question. In thiscase, Nulojix is requested for home infusion. Medicare Part B will not cover Nulojix (Belatacept) for homeinfusion. Therefore, this request is not eligible for coverage under Medicare Part B and we sent the requestto our physician reviewer to review for coverage under Medicare Part D.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 Nulojix.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Toujeo Max SoloStar. 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 Toujeo Max SoloStar. The drug is requested to treat Type 2 diabetes mellitus. The prescriber stated thatthe enrollee has tried and failed Basaglar, Levemir and Humulin N. 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 exceptioncriteria 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 Toujeo Max SoloStar.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Lynparza. 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 Lynparza 100 mg. The drug is requested to treat small cell lung cancer. The enrollee is a 69 year oldwoman with metastatic small cell lung cancer. She has had lung transplant which contraindicatesimmunotherapy and other cytotoxic chemotherapy. The prescriber requests Lynparza to be given withTemozolomide to treat her. Small cell lung cancer is universally fatal if untreated. The use of thiscombination of drugs is supported in a non-CMS journal, Farago et al, Combination Olaparib andTemozolomide in Relapsed Small-Cell Lung Cancer, Cancer Discovery. 2019 Oct; 9(10):1372-1387. Inthis phase I/II trial, 50 patients with relapsed small cell lung cancer were treated with Olaparib andTemozolomide. The overall response rate was 41.7% with a median progression free survival of 4.2 monthsand median overall survival of 8.5 months. The enrollee cannot be treated with standard chemotherapy orimmunotherapy drugs. She has no other treatment options. In this case, the enrollee has a malignancywhich is fatal and has few therapeutic options. Given the clinical situation, the proposed treatment ismedically reasonable and necessary; thus qualifying as a medically accepted indication as defined byMedicare.The enrollee does not satisfy the Plan's coverage criteria. The prescriber states why all alternatives requiredby the Plan are likely to be ineffective or cause an unacceptable side effect for the enrollee. Therefore, anexception to these criteria is medically necessary. Our Physician Reviewer's opinion is that priorauthorization exception 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 Lynparza.