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

You asked the Plan to cover Hydromet Syrup. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law excludes certain drugs from Part D coverage. Hydromet Sryup is one of those excluded drugs because it is a drug used for the symptomatic relief of coughs and colds. The record submitted by the Plan does not indicate that they provide supplemental coverage for Hydromet Sryup. Therefore, the Plan is not required to cover Hydromet Sryup. 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.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Buprenorphine HCL, 8 mg tablet. The Plan did not grant this request. We received this case to conduct an independent review.We asked a Physician Reviewer to determine whether the Plan was correct in denying the request for Buprenorphine HCL, 8 mg tablet which is subject to prior approval. Our Physician Reviewer needed additional information from the prescriber to make this determination. The prescriber was asked to address whether the drugs offered by the Plan for the treatment of the enrollee's condition would: (1) not be as effective as the requested drug; and/or (2) have adverse effects. The requested information was not received. Based on a review of the available documentation, neither prior authorization criteria 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 Buprenorphine HCL, 8 mg tablet.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Invega Trinza 819 mg syringe. 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 Invega Trinza 819 mg/2.625 ml syringe every 11 weeks. Invega Trinza 819 mg/2.625 ml syringe every 11 weeks is requested for ongoing treatment of schizoaffective order. The Plan limits the amount of the drug to 2.625 ml every 90 days. You have explained that the enrollee had breakthrough symptoms on the dosing allowed by the Plan's quantity limit, and that the requested dosing of Invega Trinza 819 mg/2.625 ml syringe every 11 weeks has controlled the enrollee's condition. You have indicated that the number of doses of the requested drug allowed by the Plan has been ineffective in treating the enrollee's condition. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that quantity limit exception criteria are met. Of note, although the information provided to the Plan included documentation that the enrollee experienced breakthrough symptoms necessitating a change in dosing frequency to the requested dose/frequency, the Plan issued a denial stating that a statement is required from the prescriber that the requested dose is approved by the Food and Drug Administration or there is medical literature that finds it safe and effective. Medicare guidelines DO NOT require that a requested dose is FDA approved or documented to be effective in the medical literature. Medically accepted indication for Medicare Part D refers to the diagnosis being treated not the dose being prescribed.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 and 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 the quantity limit criteria is met. Therefore, the Plan is required to cover the requested quantity of Invega Trinza 819 mg syringe.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 Lidocaine 5% Patch. The Plan did not grant this request. We received this caseto conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Lidocaine 5% Patch. The drug is requested to treat meralgia paresthetica and idiopathic progressivepolyneuropathy, which are off-label (non-FDA approved) uses. The Medicare-approved compendia do notcontain any citations to support the use of the requested drug, as prescribed, for treatment of the notedconditions. Upon reconsideration, the prescribing physician submitted an additional diagnosis ofosteoarthritis. Additional medical information was requested by the Part D QIC. The prescribing physicianwas asked to address the Plan's prior authorization criteria and to submit medical records supporting thechange in diagnosis. The requested medical records were not submitted. Therefore, the requested drug isnot being prescribed for a medically accepted indication as defined by Medicare law. As such, anexceptions request based on medical necessity cannot be considered because the requested drug, asprescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is noteligible 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 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 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, itcannot be covered under the Medicare Part D benefit for these conditions. An exceptions request based onmedical necessity cannot be considered because this drug, as prescribed, does not meet the definition of aMedicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage forLidocaine 5% Patch.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Prolia 60 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 Prolia 60 mg/mL.The drug is requested to treat postmenopausal osteoporosis. 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 Prolia 60 mg/mL.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Rydapt. 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 Rydapt. The drug is requested to treat chronic myelomonocytic leukemia with FLT3 mutation, 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. You have submitted references in support of the use of this drug; however, the clinical characteristics of the enrollee and the cancer as well as the planned treatment are not adequately represented in the published evidence. 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 Rydapt 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 Rydapt.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 Tagrisso. 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 Tagrisso 80 mg. The drug is requested to treat non-small cell lung cancer (NSCLC). The enrollee is a 68 year old woman with metastatic NSCLC. She was diagnosed with stage IIIA lung cancer in 2019 and treated with chemo-radiation. The chemotherapy included Cisplatin, Alimta and Carboplatin. The tumor has an EGFR exon 21 L858R mutation. The test was done by Integrated Oncology EGFR snapshot which is not an FDA approved test. The patient had cough and hemoptysis and was found to have recurrence in the lung. The prescriber requests Tagrisso to treat her.This treatment is first line treatment for metastatic NSCLC as her chemotherapy was given as part of treatment with curative intent for stage IIIA disease. However, the EGFR test is not an FDA approved test. In response to inquiry the prescriber states and FDA approved test, Foundation One CDx is pending. 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 PhysicianReviewer's opinion is that an exception to prior approval criteria is not met. Therefore, the Plan is not required to cover Tagrisso.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Repatha SureClick 140 mg/mL. The Plan did not grant this request. Wereceived 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 Repatha 140 mg/mL.The drug is requested to treat hyperlipidemia and coronary artery disease with stents. The enrollee does notsatisfy the Plan's coverage criteria. The prescriber has not sufficiently addressed the Plan's coverage criteriaand/or has not indicated why all alternatives required by the Plan would likely not be as effective for theenrollee as the requested drug, and/or would likely cause adverse reaction(s) or other harm to the enrollee.Our Physician's opinion is that neither prior authorization nor prior authorization exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. APlan must grant an exception to prior approval rules if it determines that the requested drug is medicallynecessary, consistent with the prescriber's statement. Based on the available documentation, our PhysicianReviewer's opinion is that an exception to prior approval criteria is not met. Therefore, the Plan is notrequired to cover Repatha SureClick 140 mg/mL.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Hydromorphone-Bupivacaine-Clonidine-Baclofen Compound. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover drugs that are not FDA approved. A representative of the pharmacy stated that bulk powder was used or would be used when compounding the prescription for Hydromorphone-Bupivacaine-Clonidine-Baclofen Compound. Bulk powders used in pharmacy compounding are not reviewed and approved for safety and efficacy by the FDA. Therefore, the Plan is not required to cover Hydromorphone-Bupivacaine-Clonidine-Baclofen Compound. This decision does not address 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

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 a tiering exception for Lorazepam. 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 Lorazepam. The drug is requested to treat generalized anxiety disorder in an enrollee with major depressive disorder. Lorazepam is a generic drug on Tier 2 of the Plan's formulary. There are no available lower tier generic drugs of the same type on the Plan's formulary to 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 Lorazepam.
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 Benztropine 1 mg. 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 Benztropine 1 mg.Benztropine 1 mg is requested for ongoing treatment of extrapyramidal symptoms related to antipsychotic medication in this enrollee with schizoaffective disorder. The medical records indicate that the enrollee has a long history of psychiatric illness requiring multiple hospitalizations and medication adjustments. You state that the enrollee is currently stable on a multi-drug regimen that includes Benztropine 1 mg, and that any change in medication could result in a setback for the enrollee. You have provided a sufficiently strong statement as to why ongoing treatment with Benztropine 1 mg is the best and most appropriate option for this enrollee. The enrollee does not satisfy the Plan's coverage criteria. 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 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 medicallynecessary, 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 met. Therefore, our decision is the Plan is required to cover Benztropine 1 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

You asked the Plan to cover Prednisone 5 mg tablet. The Plan did not grant this request. We received thiscase to conduct an independent review.Medicare law specifically excludes coverage for any drug under the Part D program for which paymentwould be available under Parts A or B of Medicare for that individual. Coverage is available underMedicare Part B for prescription drugs used in immunosuppressive therapy furnished to a beneficiary whohas received an organ transplant, provided the transplant was paid for by Medicare Part A.The case record indicates that Prednisone is needed for a Kidney transplant. Inthis case, we requested additional information from the Part D Plan. We requested the evidence the Planused to determine that the transplant was paid for by Medicare. We received a response from the Part DPlan, however there is insufficient information to show that the transplant was paid for by Medicare. Basedon the available information we are unable to verify that coverage for the requested drug would beavailable for coverage under Medicare Part B. Therefore, it appears that Prednisone may be eligible for PartD coverage. We asked our Physician Reviewer to determine if other Part D coverage criteria are met.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Prednisone 5 mg.The drug is requested to treat kidney transplant. There is no evidence that Medicare paid for the enrollee'stransplant; therefore, the requested drug is not eligible for coverage under Part B. The enrollee satisfies thePlan'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 Prednisone.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 inwriting that the case is being reviewed again and the outcome of the reopening.