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

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified timeframe. If the Plan does not make a timely decision, this is considered a denial. The Plan forwarded this case to us as required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Parsabiv. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law requires that all drugs and biologicals used in the treatment of ESRD or AKI be included in the ESRD PPS payment bundle, regardless of the reason why the drug is being prescribed and regardless of whether or not the drug is furnished by a dialysis facility. Drugs that are always considered ESRD and AKI-related include access management drugs, anemia management drugs, anti-infectives to treat site access infection, bone and mineral metabolism drugs and cellular management drugs.In this case, Parsabiv is being prescribed to an enrollee who has ESRD or AKI and is on dialysis. Parsabiv is a class of medication which is always considered ESRD or AKI-related for purposes of the Part B ESRD payment bundle. Thus, the requested drug is eligible for coverage under the Part B ESRD payment bundle, regardless of the reason why the drug is being prescribed and regardless of whether or not the drug is being furnished by a dialysis facility. Drugs which are eligible for Part B coverage are excluded from Part D coverage by Medicare law. Therefore, our decision is the Part D Plan is not required to cover Parsabiv. 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.Please contact the Plan for more information regarding coverage of Parsabiv under the Part B benefit.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Cinacalcet. The Plan did not grant this request. We received this case to conduct an independent review.The Plan denied the request for Cinacalcet on the basis it would be covered under Medicare Part B. Upon review of documentation received and the Medicare Database, we determined that the enrollee was no longer on dialysis, therefore Cinacalcet may be covered under Medicare Part D. We sent this to our Physician Reviewer to determine if prior authorization criteria was met for coverage under Medicare Part D.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Cinacalcet 30 mg, 30 per 30 days. The drug is requested to treat Hypercalcemia in a renal transplant recipient with hyperparathyroidism. The enrollee stopped dialysis. You provided a recent, post-transplant PTH level of 508 pg/ml. The enrollee satisfies the Plan'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 are met. Therefore, our decision is the Plan is required to cover Cinacalcet.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 Repatha SureClick 140 mg/ml Auto-injector. 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 Auto-injector. The drug is requested for the treatment of hyperlipidemia and for the prevention of stroke in this patient without clinical atherosclerotic cardiovascular disease (ASCVD), right carotid arrtery stenosis (79%), peripheral arterial occlusive disease, peripheral vascular disease, hypertension. The enrollee satisfies the Plan'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 are met. Therefore, our decision is the Plan is required to cover Repatha SureClick 140 mg/ml Auto-injector.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 Haegarda. 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 Haegarda. The drug is requested for prevention of acquired angioedema which is an off-label (non FDA approved) use. We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Haegarda. The drug is requested to treat acquired angioedema.The enrollee is an 80 year old man with a history of cancers of prostate, melanoma and kidney. He has had angioedema attacks and has required intubation for laryngeal attacks. He has also had two episodes of facial edema requiring hospitalization and experiences debilitating attacks of abdominal pain 1-2 times per month. C1 esterase inhibitor panel showed complement component 4 <2 (normal 10-40), C-1-esterase 8 (normal 21-39), C-1 esterase inhibitor functional 46% (considered intemediate) and complement component 1q level <50 (normal 109-242). The prescriber requests Haegarda for prophylaxis against potentially life threatening attacks. Meanwhile he will be treated with fresh frozen plasma for acute symptoms.Per the FDA website, the drug has orphan drug approval only for use in hereditary angioedema.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 Haegarda 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 Haegarda. 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 Myfortic and Cyclosporine. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law specifically excludes coverage for any drug under the Part D program for which payment would be available under Parts A or B of Medicare for that individual. Coverage is available under Medicare Part B for prescription drugs used in immunosuppressive therapy furnished to a beneficiary who has received an organ transplant, provided the beneficiary receiving the drug was enrolled in Medicare Part A at the time of the organ transplant.The case record indicates that Myfortic and Cyclosporine are needed for a kidney and liver transplant. According to Medicare enrollment records, the enrollee was determined to be entitled to Medicare Part A coverage at the time of the transplant. Thus, the transplant is considered a Medicare covered transplant and Myfortic and Cyclosporine are eligible for coverage under Medicare Part B. Drugs which are eligible for Part B coverage are excluded from Part D coverage by Medicare law.Additionally, drugs eligible to be covered under Parts A and/or B are considered available (and excluded from Part D) even if a beneficiary chooses not to pay premiums or if a beneficiary has enrolled in Part B but that coverage has not yet taken effect. Medicare records show that the enrollee is entitled to Part B coverage at this time, even though the beneficiary may have chosen not to pay premiums and/or coverage may not have taken effect. Thus, Myfortic and Cyclosporine are not considered a Part D drug in this case. Therefore, our decision is the Part D Plan is not required to cover Myfortic and Cyclosporine.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 Plaquenil, 200 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 Plaquenil, 200 mg tablet.The drug is requested to treat undifferentiated connective tissue disease (consisting chiefly of arthralgias and necrotizing granulomatous dermatitis), 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 Plaquenil, 200 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 Plaquenil, 200 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 Acetylcysteine nebulizer solution. 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 Acetylcysteine for persistent thick or tenacious pulmonary secretions.In this case, the record shows that Acetylcysteine is administered through a nebulizer in the home for a diagnosis of bronchiectasis. 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 Acetylcysteine. 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

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 Ibandronate Sodium. 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 Ibandronate Sodium 150 mg tablet. The drug is requested to treat osteoporosis. The prescriber has not indicated why all alternatives required by the Plan (Alendronate tablet, Calcitonin (salmon) nasal spray, Forteo subcutaneous pen injector, and Prolia subcutaneous syringe), 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 Ibandronate Sodium.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Nulojix 250 mg vial. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part B local policy states that immunosuppressive drugs are covered only for the specific labeled indications and approval for marketing by the FDA. The Medicare Part B rules state that parenteral Belatacept (Nulojix) is not proven to be safe when administered in the home setting, and therefore will be denied under Medicare Part B as not medically necessary when provided in that setting. The case record indicates that Nulojix will be administered in the home. Nulojix would therefore not be eligible for coverage under Medicare Part B in this case. Thus, Nulojix may be eligible for coverage under Medicare Part D. We therefore asked our Physician Reviewer to determine if Part D coverage criteria have been met.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Nulojix 250 mg/vial IV solution. The drug is requested for prophylaxis of organ rejection in this Epstein-Barr virus (EBV) seropositive kidney transplant recipient. The requested drug is subject to B versus D prior authorization criteria. The requested drug is not eligible for coverage under Part B rules, as the requested intravenous (IV) infusion will be administered in the enrollee's home. The prescriber documented that the enrollee is EBV seropositive, and stated that the enrollee is receiving Mycophenolate, Tacrolimus, and corticosteroids. 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 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 Nulojix.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. The drug is requested to treat atopic dermatitis. You sent a letter with the request for reconsideration. You state the enrollee has tried and failed or had adverse effects with Triamcinolone 0.1% ointment, Clobetasol 0.05%, Hydroxyzine, Betamethasone 0.05%, Cellcept 500 mg, and Tacrolimus 0.1%. Prednisone 10 mg taper and Kenalog injection were used to control flare. Phototherapy was discontinued due to distance required for treatment. You 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. 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 Dupixent.
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 and provide a tiering exception for Ziprasidone HCL 20 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 Plan was correct in denying the request for Ziprasidone HCL 20 mg. Ziprasidone HCL 20 mg capsule (Step-1 drug) is requested to treat the enrollee's condition. 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 reactions 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 step therapy 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 Ziprasidone HCL 20 mg capsule. The drug is requested to treat unspecified bipolar disorder (ICD-10 F31.9). The drug is a generic drug on Tier 4 of the Plan's formulary. The prescriber does not state why all available lower tier 2 alternatives on the Plan's formulary (Quetiapine) to treat the enrollee's condition (1) would not be as effective for the enrollee as the requested drug and/or (2) would have adverse effects for the enrollee. Therefore, an exception to these criteria is not supported. Our Physician Reviewer's opinion is that tiering exception criteria are not met.Medicare rules require a Plan to grant an exception to its tiering structure whenever it determines that the higher cost-sharing tiered drug for treatment of the enrollee's condition is medically necessary consistent with the prescriber's statement. Our Physician Reviewer's opinion is that tiering exception criteria are not met. Therefore, our decision is the Plan is not required to provide a tiering exception for Ziprasidone HCL 20 mg.
Appeal type: Prescription Drug
Decision: Unfavorable

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified timeframe. If the Plan does not make a timely decision, this is considered a denial. The Plan forwarded this case to us as required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Linzess, 290 mcg 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 Linzess, 290 mcg.The drug is requested to treat irritable bowel syndrome with constipation. Additional medical information was requested by the Part D QIC. The prescribing physician was asked to address the Plan's prior authorization criteria. 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 Linzess, 290 mcg capsule.