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

You asked the Plan to cover Mesalamine 4 gm/60 ml kit. 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 Mesalamine 4 gram/60 mL enema. The drug is requested to treat non-specific ulcerative colitis. 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.On 05/06/2020 and 05/12/2020 the prescriber sent additional information and medical records addressing the diagnosis and the Plan's coverage criteria. 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 Mesalamine 4 gm/60 ml kit for the diagnosed condition. As a result, Mesalamine 4 gm/60 ml kit 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 Mesalamine 4 gm/60 ml kit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Hizentra. 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 Hizentra 4 gram per 20 ml. The drug is requested to treat chronic lymphocytic leukemia with low immunoglobulins and recurrent infection. The enrollee does not satisfy the Plan's coverage criteria. You have not sufficiently addressed the Plan's coverage criteria and/or 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. 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 Hizentra.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ipratropium Bromide 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 Part A or Part B of Medicare for that individual. Medicare Part B may pay for supplies necessary for the effective use of durable medical equipment, including drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic benefit of the durable medical equipment. Medicare Part B local policy states that a small volume nebulizer and related compressor are covered when medically necessary to administer Ipratropium Bromide Solution for the management of obstructive pulmonary disease. In this case, the record shows that Ipratropium Bromide Solution is administered through a nebulizer in the home for a diagnosis of J45.909 Unspecified asthma, uncomplicated and J44.9 Chronic obstructive pulmonary disease, unspecified. There is no indication that it is not administered through a small volume nebulizer. It appears that this medication is eligible for coverage under Part B rather than Part D. Drugs which are eligible for coverage under Part B are excluded from Part D coverage by Medicare law. Therefore, it is our decision that the Part D Plan is not required to cover Ipratropium Bromide Solution.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: Unfavorable

You asked the Plan to cover Xeljanz XR, 11 mg tablet. The Plan did not grant this request. We receivedthis case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Xeljanz XR, 11mg tablet.The drug is requested to treat Reiter's disease, multiple sites, which is an off-label (non-FDA approved)use. The prescriber attested that the requested drug was for the treatment of Reiter's disease. The prescriberprovided medical records from date of service 4/10/2020 to support this diagnosis. These office notesdocument that the enrollee's current symptoms may be related to osteoarthritis rather than related toReiter's syndrome or psoriatic arthritis. The enrollee's most recent x-rays were most consistent withosteoarthritis. Osteoarthritis would not respond to a biologic. In the request for reconsideration dated5/12/2020, the prescriber changed the diagnosis to psoriatic arthritis. Relevant medical records wererequested but not provided to support the diagnosis of psoriatic arthritis.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 XR, 11 mg tablet for the diagnosed condition. As aresult, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. Assuch, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions requestbased on medical necessity cannot be considered because this drug, as prescribed, does not meet thedefinition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to providecoverage for Xeljanz XR, 11 mg tablet.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 Ciprofloxacin-Mometasone-Sodium Chloride Compound . The Plan did notgrant this request. We received this case to conduct an independent review.Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. Wedetermined that Ciprofloxacin-Mometasone-Sodium Chloride Compound is not FDA approved for bothsafety and effectiveness by checking FDA sources. Therefore, the Plan is not required to coverCiprofloxacin-Mometasone-Sodium Chloride Compound.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 Xyosted. 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 Xyosted 75 mg/0.5 mL subcutaneous solution. The drug is requested to treat unspecified testicularhypofunction, which is an off-label (non-FDA approved) use. The Medicare-approved compendia do notcontain any citations to support the use of the requested drug, as prescribed, for treatment of the notedcondition. Therefore, the requested drug is not being prescribed for a medically accepted indication asdefined by Medicare law. As such, an exceptions request based on medical necessity cannot be consideredbecause 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 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 Xyosted 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 Xyosted.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 Spiriva Respimat Aerosol Sol 2.5 mcg/act. 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 Spiriva Respimat Aerosol Sol 2.5 mcg/act.The drug is requested to treat Chronic obstructive pulmonary disease. 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 Spiriva Respimat Aerosol Sol 2.5 mcg/act.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Uribel. The Plan did not grant this request. We received this case to conduct anindependent review.Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. Wedetermined that Uribel is not FDA approved for both safety and effectiveness by checking FDA sources.Therefore, the Plan is not required to cover Uribel.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 Budesonide . The Plan did not grant this request. We received this case to conduct an independent review.We sent the case file to a Physician Reviewer. We asked this doctor to determine whether the Plan was correct in denying the request for Budesonide. Our Physician Reviewer noted that Budesonide was requested for an enrollee with a diagnosis of J32.2 Chronic ethmoidal sinusitis. We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Budesonide 0.5 mg/2mL. The drug is requested to treat J32.2 Chronic ethmoidal sinusitis, 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.Medicare law specifically excludes coverage for any drug for which payment would be available under Part A or Part B of Medicare for that individual. Medicare Part B may pay for supplies necessary for the effective use of durable medical equipment, including drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic benefit of the durable medical equipment. Medicare Part B local policy states that a small volume nebulizer and related compressor are covered when medically necessary to administer Budesonide for the management of obstructive pulmonary disease.In this case, the record shows that Budesonide is administered for a diagnosis of J32.2 Chronic ethmoidal sinusitis. Medicare Part B does not provide coverage for Budesonide for this diagnosis. Thus, Budesonide would not be eligible for Part B coverage in this case.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Invega Sustenna 234 mg/1.5 per 21 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 Invega Sustenna 234 mg/1.5 per 21 days (156mg/ml). The drug is requested to treat schizoaffectivedisorder. The Plan limits the amount of Invega Sustenna 156mg/ml to 1.5 ml per 28 days.The product label, available at drugs@fda, states: The maximum monthly dose for the treatment ofSchizoaffective disorder is 234 mg per month. Therefore, an exception to the Plan's coverage criteria is notsupported. Our Physician Reviewer's opinion is that quantity limit exception criteria are not met.Medicare rules allow a Part D Plan to manage its formulary by covering a limited quantity of certain drugs.A Plan must grant an exception if it determines that the requested dosage is medically reasonable andnecessary, consistent with the prescriber's statement. Based on a review of the available documentation,our Physician Reviewer's opinion is that an exception to the quantity limit criteria is not met. Therefore, thePlan is not required to cover the requested quantity of Invega Sustenna 234 mg/1.5 per 21 days.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Cinacalcet 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 Cinacalcet HCL 30 mg. The drug is requested to treat secondary hyperparathyroidism in an enrolleewith chronic kidney disease receiving dialysis at home. 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 aremet. Therefore, our decision is the Plan is required to cover Cinacalcet HCL.Note, the Plan had denied coverage of Cinacalcet HCL stating it was covered under Medicare Part B -ESRD, however we requested additional information from you and found that the enrollee Cinacalcet HCLwill be receiving Cinacalcet HCL by dialysis in their home, therefore we had our Physician Reviewerreview Cinacalcet HCL for coverage under Medicare Part D.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Androderm. 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 Androderm 4 mg/24hour patch. The drug is requested to treat unspecified testicular hypofunction, 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 Androderm 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 Androderm. 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 QVAR redihaler. 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 QVAR redihaler. The drug is requested to treat J45.50 - moderate persistent asthma. 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 QVAR redihaler.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Verzenio. 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 Verzenio. Verzenio is requested to treat breast cancer.The enrollee is an 82-year-old woman with metastatic breast cancer involving lymph nodes. Her tumor is hormone receptor positive and HER2 negative by FISH. She has been treated with Letrozole and Palbociclib with disease progression in 2019. She has been treated with Fulvestrant, Taxol, Adriamycin, and Cytoxan. Radiation is being considered. The prescriber requests Verzenio to be given with Fulvestrant to treat her.Per the FDA website, Verzenio is in combination with Fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.She had progressive disease on Palbociclib which is exclusion criterion on the Plan's prior authorization.This exclusion is supported by the NCCN compendium: for Abemaciclib (Verzenio) as second-line therapy or beyond in combination with Fulvestrant (preferred regimen) if CDK4/6 inhibitor not previously used.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 Verzenio.