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

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified timeframe. If the Plan does not make a timely decision, this is considered a denial. The Plan forwarded this case to us as required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Lidocaine 5% Patch. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Lidocaine 5% Patch. The drug is requested to treat chronic pain, unspecified osteoarthritis, cervical spondylosis, and lumbosacral spondylosis. You were asked to clarify the enrollee's diagnoses, as medical records had not been submitted. You were also asked prior authorization coverage criteria. A response from you was not received. Therefore, based on the current record, there is insufficient documentation that the requested medication is being prescribed for a medically accepted indication as defined by Medicare law. In addition, prior authorization exception criteria are not 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 no citations in the Medicare approved compendia that support the use of Lidocaine 5% Patch for the diagnosed conditions. 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 these conditions. 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 Lidocaine 5% Patch. 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 Hydroxychloroquine. 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 Hydroxychloroquine. The drug is requested to treat systemic lupus erythematosus (SLE). The drug is a generic on Tier 3 of the Plan's formulary. There are no available similar lower tier drugs on the Plan's formulary to specifically 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 Hydroxychloroquine.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Vemlidy. 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 Vemlidy 25 mg tablet. The drug is requested to treat hepatitis B. The prescriber indicated in the case file and the appeal request that the formulary alternatives lamivudine and adefovir are not appropriate due to the enrollee's stage IV chronic kidney disease; Drugdex/Micromedex and The American Hospital Formulary Service Drug Information both indicate the formulary alternatives are safe to use in chronic kidney disease with proper dose adjustment. Thus the prescriber has not indicated why all alternatives required by the Plan would likely not be as effective for the enrollee as the requested drug; and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is that formulary exception criteria are not met.A Plan must grant an exception for a drug that is not on its formulary if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that formulary exception criteria are not met. Therefore, the Plan is not required to cover Vemlidy.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Zejula. 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 Zejula. The drug is requested to treat the enrollee's condition, which is an off-label (non-FDA approved) use.The enrollee is a 66 year old woman with a history of Stage I breast cancer. She was diagnosed with primary glioblastoma of the spinal cord, also called primary diffuse leptomeningeal gliomatosis, in the submitted office records. She has been treated with surgery, radiation, Temozolomide, Olaparib, and Bevacizumab. Her tumor has a BRCA1 mutation suggesting possible response to Niraparib. You request Niraparib (Zejula) to treat her. You state it crosses the blood brain barrier better than Olaparib. Medical literature was submitted in support of the request and was reviewed.A letter states the enrollee has metastatic breast cancer. The submitted office notes do not mention metastatic breast cancer. The drug is not FDA approved or compendium supported for metastatic breast cancer or for glioblastoma/primary diffuse leptomeningeal gliomatosis.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 Zejula 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 Zejula. 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 Januvia, Flovent HFA and Lantus SoloStar. The Plan did not grant this request. We received this case to conduct an independent review.Januvia and Flovent HFA: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. Januvia and Flovent HFA are Tier 3 brand drugs. 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 Januvia and Flovent HFA.Lantus SoloStar:A Part D Plan may establish tiered cost-sharing for drugs on its formulary of the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug). Lantus Solostar is classified as a Tier 6 drug (Select Care Drugs) on the Plan's formulary. Tier 6 drugs are not eligible for a tiering exception because they are already classified as the lowest cost share tier on the Plan's formulary. Therefore, our decision is the Part D Plan is not required to provide a tiering exception for Lantus Solostar.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Xarelto. 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. Xarelto 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 Xarelto for the 2021 Plan year.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Colesevelam. 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 Colesevelam 625 mg tablet. The drug is requested to treat collagenous colitis, 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 Colesevelam 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 Colesevelam. 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.We are dismissing the request for Budesonide. You requested an appeal of the Plan's unfavorable determination for coverage of Budesonide. Medicare rules do not allow us to review this case until you have completed all levels of appeal with the Plan.Medicare rules set forth the steps you must take when appealing a Part D plan's denial of coverage. If you do not agree with a coverage decision from the Plan, you must request that the Plan review this decision, and the Plan must issue a Coverage Determination. If you do not agree with the Plan's Coverage Determination, the next step is for you to request a Redetermination appeal from the Plan. The request for a Redetermination asks the Plan to reconsider the initial Coverage Determination. Both levels of appeal with the Plan must be completed before you can appeal to us. You may request a Reconsideration appeal with us after the Plan issues an unfavorable Redetermination for Budesonide.
Appeal type: Prescription Drug
Decision: Unfavorable

We previously issued an unfavorable reconsideration decision, finding that the Plan was not required to provide coverage of Levalbuterol HCL Solution. We had requested additional information that was not received in time. After we issued our decision, we received new information. We reopened this appeal to conduct a second 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 Levalbuterol HCL Solution for the management of obstructive pulmonary disease.In this case, the record shows that Levalbuterol HCL Solution is administered through a nebulizer in the home for a diagnosis of Chronic Obstructive Pulmonary Disease. 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 Levalbuterol HCL 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.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ondansetron ODT. 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 Ondansetron ODT. The drug is requested to treat nausea related to intrahepatic bile duct carcinoma (with no documentation of emetogenic chemotherapy or radiation treatment), 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 Ondansetron ODT 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 Ondansetron ODT. 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 Butalbital-Acetaminophen-Caffeine. 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 Butalbital-Acetaminophen-Caffeine. The drug is requested to treat headache due to occipital neuralgia, 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. Upon reconsideration, the prescribing physician submitted a diagnosis of migraine; however, chart notes do not support the change in diagnosis. 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 Butalbital-Acetaminophen-Caffeine 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 Butalbital-Acetaminophen-Caffeine. 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 Ondansetron HCL. 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 Ondansetron HCL 4 mg tablet. The drug is requested to treat gastroparesis and unspecified drug induced nausea, which is an off-label (non-FDA approved) use. A request for medical records was sent to the prescriber as the diagnosis of drug induced nausea was added at the reconsideration level with no supporting records. Unfortunately, the provided medical records did not support that the chronic nausea was drug induced; in addition, nothing in the medical record indicated which medication(s) were related to the nausea. Also Drugdex only indicates that ondansetron is medically accepted for use in nausea related to acetaminophen overdose, acetylcysteine use, opioid use or theophylline use - none of these scenarios appear to apply to this enrollee. 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 Ondansetron HCL 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 Ondansetron HCL.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.