Persius/hicric huggingface dataset:
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 us as required by Medicare rules because it did not make a timely decision.You asked the Plan to provide reimbursement for Metoprolol Succinate ER 50 mg, Buspirone HCL 10 mg, Amlodipine Besylate 2.5 mg, Pantoprazole DR 40 mg, Ventolin HFA 90 mcg, Lorazepam 1 mg, Tizanidine HCL 4 mg, Citalopram HBR 40 mg, Clonidine HCL 0.1 mg, Chantix 0.5 mg and Prednisone 10 mg. The Plan did not grant this request. We received this case to conduct an independent review.Medicare rules state that an individual that meets requirements under Medicare's low income subsidy (LIS) rules is entitled to a reduction or elimination in the premium, a reduction or elimination in the annual deductible, a reduction in cost-sharing for all covered Part D drugs below the out-of-pocket limit, and a reduction or elimination in cost-sharing for covered Part D drugs above the out-of-pocket limit. The extent of reduction in these benefits depends on an individual's income and resources. According to enrollment records from CMS, you were determined to be entitled to an LIS, copay level 1. For copay level 1, an enrollee is required to pay $3.60 for generic or preferred multi-source drugs and $8.95 for any other drugs with no deductible.In this case, you purchased Metoprolol Succinate ER 50 mg, Buspirone HCL 10 mg, Amlodipine Besylate 2.5 mg, Pantoprazole DR 40 mg, Ventolin HFA 90 mcg and Clonidine HCL 0.1 mg, Lorazepam 1 mg, Tizanidine HCL 4 mg, Citalopram HBR 40 mg, Chantix 0.5 mg and Prednisone 10 mg. The receipts provided show that each of these purchases were for more than the LIS copayment that you were entitled. The Plan did not provide any documentation that these claims have been processed and reimbursement provided. The Plan also did not provide any reason why these claims should not be paid at this time.The case record indicates that the Plan did not provide coverage in accordance with the Part D Plan contract and with the LIS benefit to which you were entitled. Therefore, our decision is the Plan is required to process and provide reimbursement for Metoprolol Succinate ER 50 mg, Buspirone HCL 10 mg, Amlodipine Besylate 2.5 mg, Pantoprazole DR 40 mg, Ventolin HFA 90 mcg, Lorazepam 1 mg, Tizanidine HCL 4 mg, Citalopram HBR 40 mg, Clonidine HCL 0.1 mg, Chantix 0.5 mg and Prednisone 10 mg.Please note that if the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The health plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will notify you in writing that the case is being reviewed again and the outcome of the reopening.
Appeal type: Prescription Drug
Decision: 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 us as required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Advair Diskus 500-50 mcg. 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 Advair Diskis 500-50 mcg. The drug is requested to treat moderate persistent asthma. You state that the enrollee failed treatment with Advair HFA, Symbicort, and Fluticasone-Salmeterol (AirDuo and Wixela). You have indicated why all alternatives required by the Plan would likely not be as effective as the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that formulary exception criteria are 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 met. Therefore, the Plan is required to cover Advair Diskus 500-50 mcg.Please note that if the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The health plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will notify you in writing that the case is being reviewed again and the outcome of the reopening.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Daurismo, 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 Daurismo 100 mg; 30/30.The drug is requested to treat relapsed acute myelogenous leukemia (AML), which is an off-label (non-FDA approved) use. The enrollee is a 64 year old man with AML. He has been treated with Cytarabine and Daunorubicin and with Venetoclax. He is in his third relapse with white blood counts over 20,000. The prescriber states he needs a cytoreducing agent and cannot stand Daunorubicin and Cytarabine again. The prescriber requests Daurismo to treat him.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 Daurismo, 100 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 Daurismo, 100 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 Zerbaxa 1.5 gm. 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 Zerbaxa 1.5 gm.The drug is requested to treat diabetic foot ulcer and right foot osteomyelitis, 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 Zerbaxa 1.5 gm 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 Zerbaxa 1.5 gm. 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 Venclexta. The Plan did not grant this request. We received this case to conduct an independent review.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 needed additional information from you to determine whether the enrollee is using Venclexta for an FDA-approved use, or a use listed in the Medicare-approved compendia. The requested information was not received. As a result, we could not confirm that the drug is being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit. An exceptions request based on medical necessity cannot be considered because it cannot be confirmed that the drug meets the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Venclexta. 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: 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 us as required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Repatha SureClick, 140 mg/mL. 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 Repatha SureClick, 140 mg/mL. Repatha SureClick, 140 mg/mL is requested for ongoing treatment of hypercholesterolemia without clinical atherosclerotic cardiovascular disease (ASCVD), in an enrollee with statin intolerance. You do not satisfy the Plan's coverage criteria. The prescriber has indicated why all alternatives required by the Plan would likely not be as effective as the requested drug for you, and/or would likely cause adverse reaction(s) or other harm to you. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that prior authorization exception criteria are met.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for a tiering exception for Repatha SureClick, 140 mg/mL. The drug is requested to treat your condition. The drug is a brand on Tier 3 of the Plan's formulary. There are no available lower tier brand drugs on the Plan's formulary to treat your 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 your condition. Therefore, our decision is the Plan is not required to provide a tiering exception for Repatha SureClick,140 mg/mL.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Vyvanse, 70 mg capsule. 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 Vyvanse, 70 mg capsule.The drug is requested to treat fatigue related to renal cell carcinoma and chemotherapy, 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 Vyvanse, 70 mg capsule 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 Vyvanse, 70 mg capsule. 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 Prevymis. 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 Prevymis 480 mg tablet. The drug is requested for prophylaxis of cytomegaloviral disease in a patient with a lung transplant and pancytopenia, 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 Prevymis 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 Prevymis.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 Gilotrif. 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 Gilotrif 40 mg; 30/30. The drug is requested to treat the enrollee's condition, which is an off-label (non-FDA approved) use. The enrollee is a 68 year old man with metastatic adenocarcinoma of the lung, a type of non-small cell lung cancer (NSCLC.) It involved pleura, nodes and bone. His tumor has a sensitizing EGFR mutation and he was treated with Tarceva. He was then found to have a T790M mutation and switched to Tagrisso. Recent scans showed progression of the cancer. The option of chemotherapy was discussed and the enrollee refused. The prescriber requests Gilotrif to be given as monotherapy with plans to add Vectibix later. An article for 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 Gilotrif 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 Gilotrif. 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: Partially Favorable

You asked the Plan to provide reimbursement for Azithromycin 250 mg and Robitussin DM received while aboard a cruise ship. The Plan did not grant this request. We received this case to conduct an independent review.AzithromycinThe Plan covers prescriptions filled at an out-of-network pharmacy only in certain limited circumstances. In this case, you were on a cruise. During the cruise you required medical attention. The documentation provided shows you were docked at a United States Port. You visited the medical center aboard the cruise ship and received the medication. Therefore, you received the medication while docked in the United States. Additionally, the prescriber listed on the medical center documentation has an active National Prescriber Identifier (NPI) number. Azithromycin 250 mg is a valid, Part D eligible drug and proof of payment has been provided for Azithromycin 250 mg. Additionally, Medicare rules state that when a Plan sponsor could acquire missing information, such as the National Drug Code (NDC) number, by contacting the enrollee's pharmacist, physician, or other prescriber, it should do so instead of relying on the enrollee to provide the information. If there is any additional information required, the Plan may utilize the remainder of the 30-day payment period after approval is granted to obtain missing information in order to determine the amount of reimbursement to be provided. Thus, the Plans reimbursement rules as stated in the Evidence of Coverage have been met, and the Plan should obtain missing NDC information in order to process reimbursement.The Plan's out-of-network coverage rules were followed. Therefore, our decision is the Plan is required to provide coverage and reimbursement for Azithromycin 250 mg received while aboard a cruise ship.Robitussin DMMedicare Part D does not cover non-prescription drugs. We checked FDA approved sources for the drug's classification or determined from other available resources that the drug is a non-prescription or OTC drug. Therefore, Robitussin DM received  is not eligible for Part D coverage, and the Plan is not required to cover or provide reimbursement for it under the Part D benefit.This decision does not address the medical necessity or appropriateness of the requested drug. It only establishes that payment cannot be made under the Medicare Part D benefit.