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

You asked the Plan to cover Kineret. 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 Kineret.Kineret is requested for treatment of hidradenitis suppurativa, which is an off-label (non-FDA approved) use. You have indicated that the enrollee has extensive disease, she has failed conventional therapies, and that the requested drug has been effective for the enrollee's condition in clinical trials; however, 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 Kineret 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 Kineret. 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 Nurtec 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 Nurtec ODT. The drug is requested for the treatment of acute migraine headaches. You have not indicated why all alternatives required by the Plan (Naratriptan and Prochlorperazine) 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 Nurtec ODT.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Prolia. 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. The drug is requested to treat the enrollee's condition. A request for prescriber statement was sent and not returned. 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 Prolia.
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 Everolimus 5 mg purchased August 21, 2020. The Plan did not grant this request. We received this case to conduct an independent review.In this case, the records show that when Everolimus 5 mg was purchased August 21, 2020, the claim straddled the deductible stage, the initial coverage stage and the coverage gap stage of the Part D benefit. An enrollee is responsible for the full cost of covered drugs until the deductible amount $365 is satisfied. The initial coverage phase and the coverage gap stages of coverage required a 25% coinsurance amount for this drug and day supply purchased.The Plan documentation shows that the total approved cost of the drug was $10,519.49. There was $238.55 remaining in the deductible phase of coverage. This amount is subtracted from the total cost of the drug. This left a remaining total drug cost owed of $10,280.94. $3,592.46 was the amount that was subject to the initial coverage stage 25% coinsurance amount. 25% of the initial coverage limit balance is $898.12. The remaining amount ($6,688.48) was also subject to the coverage gap 25% coinsurance amount. 25% of the coverage gap balance is $1,672.12. The total of the three figures owed during each benefit phase (deductible and initial coverage) is $2,808.79. Your total cost at the time of purchase was $525.97. The record shows that the enrollee was charged an amount that is less than or equal to the required copayment for each phase the claim was processed in. The cost of Everolimus 5 mg purchased August 21, was applied to your yearly true out-of-pocket (TrOOP) costs.The case record indicates that the Plan provided coverage in accordance with the Part D Plan contract. Therefore, the Plan is not required to provide additional payment and/or reimbursement for Everolimus 5 mg purchased August 21, 2020.Please note: the Plan provided documentation that the claim may have been re-processed which resulted in an increase in cost to you. The Plan also provided documentation that After adjusting a claim, CMS requires that we make an attempt to collect the balance due; however, if the member cannot or is not willing to pay the amount requested, we will consider this matter resolved and will not cancel the plan or contact the member about it again.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Nexletol. 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 Nexletol. The drug is requested to treat mixed hyperlipidemia, coronary artery disease (CAD), without clinical atherosclerotic cardiovascular disease (ASCVD), in a patient with hypertension and an intolerance to statin therapy. You have not indicated why all alternatives required by the Plan (Praluent) 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 Nexletol.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Trelstar. The Plan did not grant this request. We received this case to conduct an independent review.CMS publishes a list of participating brand name drug manufacturers that have signed the Medicare Coverage Gap discount agreement. Trelstar is a brand name drug, and its manufacturer is not on this list. Therefore, the Part D Plan is not required to cover Trelstar.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Xolair. 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 Xolair 150mg. The drug is requested to treat Xolair 150 mg. 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 Xolair.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ipratropium Albuterol. 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 Albuterol for the management of obstructive pulmonary disease.In this case, the record shows that Ipratropium Albuterol 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 Ipratropium Albuterol. 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 Cialis. 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 Cialis.Cialis is requested for treatment of benign prostatic hypertrophy (BPH) and erectile dysfunction (ED). The treatment of erectile dysfunction is not a covered benefit under Medicare Part D. Sexual/erectile dysfunction drugs prescribed to treat sexual/erectile dysfunction or other conditions for which the drug is not FDA approved, are excluded from coverage under Medicare Part D. There are other drugs on the Plan's formulary to treat BPH. You have not indicated why the formulary alternatives required by the Plan (Alfuzosin ER tablet, Tamsulosin capsule, Terazosin capsule and Dutasteride capsule, or Finasteride 5 mg tablet) 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 Cialis.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Amitiza, 24 mcg capsule for the 2021 Plan benefit year. 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 Amitiza, 24 mcg.The drug is requested to treat the enrollee's condition. A request for prescriber statement and medical records was sent. The returned statement did not provide a sufficient medical rationale why the Plan's formulary alternatives were not appropriate for the enrollee. 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 Amitiza, 24 mcg capsule for the 2021 Plan benefit year.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Hydroxychloroquine Sulfate. 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 Hydroxychloroquine Sulfate. The drug is requested to treat pancreatic cancer, which is an off-label (non-FDA approved) use.The enrollee is a 55 year old woman with metastatic pancreatic cancer involving peritoneum, liver and possibly lung. She has been treated with 5FU, Irinotecan, Leucovorin, Oxaliplatin, Gemcitabine, Abraxane, Capecitabine, VMD-928 and radiation. She has progressive cancer on her most recent scans. You request Hydroxychloroquine Sulfate to be given with Trametinib to treat her. You state her treatment options are limited and she has a good performance status. Journal articles were submitted in support of the request and were reviewed. There is an ongoing clinical trial, NCT03825289. The requested combination is investigational.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 Hydroxychloroquine Sulfate 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 Hydroxychloroquine Sulfate. 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 Auryxia. 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 Auryxia.Auryxia is requested for treatment of the enrollee's condition. It has been noted that the enrollee has chronic renal insufficiency, secondary hyperparathyoridism with hyperphosphatemia, and anemia. For the diagnosis of anemia associated with chronic kidney disease, Auryxia is excluded from coverage under Medicare Part D because it is being used as a prescription vitamin/mineral. There is conflicting information in the case file as to whether the enrollee is on dialysis. If the enrollee is not on dialysis, the diagnosis of hyperphosphatemia associated with chronic kidney disease is an off-label (non-FDA approved) use for the requested drug. Additionally, the Plan's coverage criteria require a trial of calcium acetate before they will approve the requested drug. You state that the enrollee has a low PTH (parathyroid hormone level); therefore calcium would further suppress the enrollee's parathyroid hormone level. However, the enrollee's diagnosis is secondary hyperparathyroidism; therefore the low PTH level mentioned is inconsistent with the stated diagnosis.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 Auryxia.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Oxycontin ER. 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 Oxycontin ER. The drug is requested to treat chronic low back pain. The prescriber has not indicated why all alternatives required by the Plan (Xtampza) would likely not be as effective for you as the requested drug; and/or would likely cause adverse reaction(s) or other harm to you. 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 Oxycontin ER.
Appeal type: Prescription Drug
Decision: Favorable

We previously issued a favorable reconsideration decision, finding that the Plan was required to provide coverage of Repatha. Our Physician Reviewer determined that an exception to the Plan's prior authorization criteria was warranted. The Plan then requested a reopening on the basis that there was an error in our first review. Specifically, the Plan stated that prior authorization criteria is not met. We reopened this case to address the Plan's argument.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Repatha 140 mg/mL syringe. Repatha 140 mg/mL syringe is requested to treat hyperlipidemia in an enrollee with atherosclerotic cardiovascular disease. The enrollee does not satisfy the Plan's coverage criteria. However, the prescriber has 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.The Plan has requested a reopening disagreeing with the favorable finding of an exception to the prior authorization criteria. The Plan is correct that the enrollee did not satisfy the prior authorization criteria for reauthorization as only a current LDL was included and therefore it is not possible to determine improvement. Therefore, the reviewer properly performed an exception analysis under Medicare law which requires consideration of all other formulary drugs. The original decision is affirmed.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 met. Therefore, our decision is the Plan is required to cover Repatha.This decision affirms our previous favorable decision.