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

You asked the Plan to cover Xiaflex. 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 Xiaflex. The drug is requested to treat Dupuytren's contracture. We requested additional information from the prescribing physician and information was returned. However, the enrollee does not satisfy the Plan's coverage criteria. The provided medical records do not document that the enrollee has a contracture of a metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint of at least 20 degrees. 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 Xiaflex.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Imbruvica. 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 Imbrivica. The drug is requested to treat prolymphocytic B cell leukemia (B-PLL), which is an off-label (non-FDA approved) use.You are 71 year old man with B-PLL. You were started on Venetoclax and Obinotuzumab. The prescriber requests Imbruvica to be added to those two drugs to treat you. Journal articles relating to chronic lymphocytic leukemia were submitted in support of the request. These do not reflect your clinical situation. The NCCN Guidelines Version 2.2021 Chronic Lymphocytic Leukemai/Small Lymphocytic Lymphoma page CSLL-1 footnote a specifically states cases diagnosed with B-PLL are excluded from the guideline.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 Imbruvica 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 Imbruvica. 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 reimbursement for Estradiol 0.05 mg/24 hr Patch. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law states that Part D sponsors are required to coordinate with other providers of prescription drug coverage with respect to the payment of premiums and coverage, as well as coverage supplementing the benefits available under Part D. Which insurance company provides benefits first will depend on the situation. The Plan denied the request for reimbursement for Estradiol 0.05 mg/24 hr Patch purchased on the basis that the Explanation of Benefits from your primary insurance, who already covered their portion of these claims. The Explanation of Benefits from your primary insurance was not provided. Therefore, it is our decision the Plan is not required to provide reimbursement for Estradiol 0.05 mg/24 hr Patch.You may wish to contact your primary insurance and request the Explanation of Benefits and submit it to the Part D Plan directly.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Frovatriptan Succinate. 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 Plan was correct in denying the request for Frovatriptan Succinate 2.5 mg tablet. Frovatriptan Succinate 2.5 mg tablet is requested to treat migraine headaches. The prescriber has not indicated that the enrollee has tried 1 additional Step 1 alternative required by the Plan (Rizatriptan or Naratriptan), or why the Plan's required step therapy drugs would likely not be as effective for the enrollee as the requested drug, and/or would likely cause adverse reactions or other harm to the enrollee. Our Physician Reviewer's opinion is that neither step therapy or step therapy exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring step therapy for certain drugs. A Plan must grant an exception 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 an exception to step therapy criteria is not met. Therefore, the Plan is not required to cover Frovatriptan Succinate.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Procrit. 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 Procrit 10000 unit/ml. Procrit 10000 unit/ml is requested for ongoing treatment of anemia of unstated/uncertain cause, which is an off-label (non-FDA approved) use. The prescriber has indicated that the enrollee has responded to the requested treatment; however Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of anemia of uncertain cause. 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 Procrit 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 Procrit. 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 Freestyle Libre 14-day sensor. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover devices. Freestyle Libre 14-day sensor has been classified by the FDA as a device, not as a drug. Therefore, our decision is the Part D Plan is not required to cover Freestyle Libre 14-day sensor. This decision does not address the medical necessity or appropriateness of the requested item. It only establishes that payment cannot be made under the Medicare Part D benefit.Please contact the Plan for more information regarding coverage of Freestyle Libre 14-day sensor under the Part B benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified timeframe. If the Plan does not make a timely decision, this is considered a denial. The Plan forwarded this case to us as required by Medicare rules because it did not make a timely decision.You asked the Plan to provide reimbursement for Mucinex DM, Vitamin D3, Bacillus Clausii probiotic, Omeprazole 40 mg, Symbicort 160-4.5 mcg, Lamotrigine 500 mg, Acetylcysteine 600 mg, Tramadol 325 mg, Monurol 500 mg and Enoxaparin 40 mg purchased while outside the United States. The Plan did not grant this request. We received this case to conduct an independent review.Mucinex DM, Vitamin D3, Bacillus Clausii probiotic, Omeprazole 40 mg, Symbicort 160-4.5 mcg, Lamotrigine 500 mg, Acetylcysteine 600 mg, Tramadol 325 mg, Monurol 500 mg and Enoxaparin 40 mg purchased are not covered by Medicare because they were purchased outside the United States. Therefore, our decision is that the Part D Plan is not required to pay for Mucinex DM, Vitamin D3, Bacillus Clausii probiotic, Omeprazole 40 mg, Symbicort 160-4.5 mcg, Lamotrigine 500 mg, Acetylcysteine 600 mg, Tramadol 325 mg, Monurol 500 mg and Enoxaparin 40 mg purchased while outside the United States.This decision does not concern the medical appropriateness of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Humalog 200 unit/mL Kwikpen. 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 Humalog 200 unit/mL Kwikpen. Humalog 200 unit/mL Kwikpen, 70 units, 3 times daily with meals, up to 200 units daily, is requested to treat poorly controlled type II diabetes mellitus. It is noted that HbA1c is greater than 14, and that the enrollee has failed U100 and U500 insulin. The prescriber has clarified that the requested drug will not be used in a V-go device in contrast to what was initially stated. The prescriber's statement and associated documentation indicate 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 metA 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 Humalog 200 unit/mL Kwikpen.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 Dupixent. 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 Dupixent 200 mg/1.14 ml solution. The drug is requested to treat chronic obstructive pulmonary disease, moderate persistent asthma, unspecified (no documentation of eosinophilic phenotype or oral corticosteroid dependence) and shortness of breath, which are off-label (non-FDA approved) uses. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted conditions. 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 conditions.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 Dupixent 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 Dupixent. 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: 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 Shingrix vaccine provided at your doctor's office. The Plan did not grant this request. We received this case to conduct an independent review.The Plan covers prescriptions filled at an out-of-network pharmacy only in certain limited circumstances. In this case, the Shingrix vaccine was administered at your doctor's office. Proof of payment was provided. The Plan's out-of-network coverage rules were followed. Therefore, our decision is the Plan is required to provide coverage for Shingrix vaccine.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 Venclexta 100 mg tablet. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Venetoclax 100 mg tablet. The drug is requested to treat myelodysplastic syndrome (MDS). The enrollee is a 78 year old man with MDS with very high risk IPSS-R score. He has been treated with Azacitidine. His blood counts at diagnosis were: white blood count 2,000, platelets 72,000, hemoglobin 12.2. White blood count 2,480, hemoglobin 9.8 and platelets 93,000. You request Venclexta to be added to the Azacitidine to treat him.Per DrugDex, Venclexta has orphan drug designation: Treatment of myelodysplastic syndromes. Per CMS this is considered a medically accepted indication. 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 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 Venclexta 100 mg tablet for the diagnosed condition. As a result, Venclexta 100 mg tablet 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 Venclexta 100 mg tablet.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 Vyvanse. 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 20 mg. The drug is requested to treat primary hypersomnia, 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 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. 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 Sandostatin LAR Depot. 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 Sandostatin LAR Depot 20mg Kit. The drug is requested to treat gastrointestinal (GI) bleed due to vascular ectasia of proximal jejunum in a patient with advanced heart failure s/p left-ventricular assist device (LVAD) on long-term anticoagulation therapy, 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 Sandostatin LAR Depot 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 Sandostatin LAR Depot. 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.