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

You asked the Plan to cover Nucynta ER, 150 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 Nucynta ER, 150 mg tablet, 60/30.The drug is requested to treat chronic pain. 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 Nucynta ER, 150 mg tablet.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Eplerenone, 50 mg tablet, 30 per 30 days. 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 Eplerenone, 50 mg.Eplerenone, 50 mg is requested for treatment of congestive heart failure associated with ischemic cardiomyopathy. It is noted that the enrollee had a systolic ejection fraction of 25% which improved to 30 - 35% more recently. The enrollee had been treated with an aggressive medication regimen which included Furosemide, oral nitrates, Lisinopril, Metoprolol, and Spironolactone, but developed severe painful gynecomastia on Spironolactone; therefore the prescriber has requested Eplerenone, 50 mg in place of Spironolactone. It is noted that the enrollee has already been started on the requested drug, and the prescriber has indicated that ongoing treatment with Eplerenone is medically necessary. The Plan's denial letter states that Amiloride is on their formulary. Amiloride is a potassium sparing diuretic; however unlike Spironolactone and Eplerenone, Amiloride Is Not an aldosterone receptor antagonist. As such, Amiloride is not an appropriate substitution for Spironolactone, and would not be as effective as Spironolactone or Eplerenone for treatment of systolic heart failure in this complex patient. 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 Eplerenone, 50 mg tablet, 30 per 30 days.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ipratropium Albuterol. 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 J44.9 chronic obstructive pulmonary disease, unspecified. 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

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 Zolpidem Tartrate ER, 12.5 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 Zolpidem Tartrate ER, 12.5 mg tablet, which is not on the Plan's formulary. 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 would: (1) not be as effective as the requested non-formulary drug; and/or (2) have adverse effects. The requested information was not received. Based on a review of the available documentation, 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 Zolpidem Tartrate ER, 12.5 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Mirena 20 mcg/24 hrs IUD. 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 Mirena IUD (intrauterine device).Mirena IUD is requested for treatment of heavy, abnormal uterine bleeding - ICD code N93.9, 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 Mirena 20 mcg/24 hrs IUD 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 Mirena 20 mcg/24 hrs IUD. 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 a tiering exception for Potassium Citrate 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 a tiering exception for Potassium Citrate ER 10 mEq for the 2021 plan year. Potassium Citrate ER 10 mEq is prescribed to treat your condition. Potassium Citrate ER 10 mEq is on Tier 3 of the Plan's 2021 formulary. Potassium Citrate ER 5 mEq is on Tier 2 of the Plan's 2021 formulary. The prescriber does not state why all available lower tier alternatives on the Plan's formulary to treat your condition (1) would not be as effective for you as the requested drug and/or (2) would have adverse effects on you. 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 Potassium Citrate ER.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Enbrel Mini 50 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 Enbrel Mini 50 mg/ml. Enbrel Mini 50 mg/ml is requested for treatment of seropositive rheumatoid arthritis. You have indicated that the enrollee has tried and failed many drugs including, but not limited to, Methotrexate, Humira, Simponi, Actemra, Kevzara, and most recently Orencia. You have indicated why all alternatives required by the Plan would likely not be as effective as the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that formulary exception criteria are 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 Enbrel Mini 50 mg/ml.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Leflunomide. 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 Leflunomide.Leflunomide is requested for ongoing treatment of your condition. Leflunomide is on Tier 3 of the Plan's formulary. There are no available lower tier drugs on the Plan's formulary to treat your condition. Therefore, the drug is not eligible for a tiering exception. Our Physician Reviewer's opinion is that tiering exception criteria are not met.Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in a lower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug is being used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met because there are no lower cost-sharing tiered drugs of the same type for treating your condition. Therefore, for the 2021 Plan year, our decision is the Plan is not required to provide a tiering exception for Leflunomide.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Letairis. 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 Letairis. The drug is requested to treat pulmonary arterial hypertension. The enrollee does not satisfy the Plan's coverage criteria. You have not sufficiently addressed the Plan's coverage criteria (no trial/failure/intolerance of Ambrisentan or Bosentan) 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 Letairis.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Revlimid. 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 Revlimid. The drug is requested to treat multiple myeloma as monotherapy, which is an off-label (non-FDA approved) use.The enrollee is a 77-year-old man with multiple myeloma who is also being treated for a dermatologic condition. Bone marrow testing showed a plasma cell clone with a 1q duplication and monosomies 13 and 14. The report states this is considered high risk. Serum IgG levels was elevated to 2,995 (normal to 1600). MRI of spine did not identify any bone lesions. The prescriber requests Revlimid to treat him. The original request did not have the diagnosis of multiple myeloma. In response to inquiry the prescriber corrected the diagnosis and stated the drug would not be given in combination with other drugs.Revlimid is FDA approved and compendium supported for use in combination with Dexamethasone. Therefore, the requested use as monotherapy is not a medically accepted 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. 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 Revlimid 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 Revlimid. 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

You asked the Plan to cover Theophylline 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 Theophylline 300 mg Extended Release Tablet, 45 per 30 days. Theophylline 300 mg Extended Release Tablet, 45 per 30 days, is requested for ongoing treatment of asthma. You have indicated that the enrollee has been stable on a multidrug regimen which includes the requested drug. There are no applicable utilization management criteria identified for coverage of Theophylline 300 mg Extended Release Tablet. Our Physician Reviewer's opinion is that Medicare Part D criteria for coverage of the requested drug have been met. Please Note: The Plan reviewed the case for Theo-24 ER 300 mg capsule and issued an unfavorable decision for a non-formulary exception. However, the prescriber clearly provided medical records at the appeal level to the Plan indicating that the requested drug is Theophylline 300 mg Extended Release Tablet. As such, this medical review is for coverage of the requested drug Theophylline 300 mg Extended Release Tablet.Medicare rules allow a Part D Plan to manage its formulary by requiring prior authorization, step therapy or quantity limits. Theophylline ER is on the Plan's formulary and is not subject to any of these restrictions. Therefore, our decision is the Plan is required to cover Theophylline ER.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Synvisc One. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover devices. Synvisc One 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 Synvisc One. 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.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Veltassa. 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 Veltassa. The drug is requested to treat hyperkalemia. 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 Veltassa.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Topamax. 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 Topamax 100mg. Topamax 100mg is requested for ongoing treatment of chronic, diffuse multifocal pain related to fibromyalgia and an inflammatory arthritis/mixed connective tissue disease, 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 Topamax 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 Topamax. 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.