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

You asked the Plan to cover Concerta ER, 18 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 Concerta ER, 18 mg tablet.The drug is requested to treat attention deficit hyperactivity disorder (ADHD). The prescriber has not indicated why all alternatives required by the Plan (Atomoxetine capsule, Dexmethylphenidate tablet, Dextroamphetamine tablet, Dextroamphetamine/Amphetamine tablet, and Methylphenidate 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 Concerta ER, 18 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ofev, 150 mg 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 Ofev, 150 mg.The drug is requested to treat pulmonary fibrosis. 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 Ofev, 150 mg capsule.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Aspirin-Dipyridamole 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 Aspirin-Dipyridamole ER. The drug is requested to treat stroke. The drug is on Tier 4 of the Plan's formulary. There are no available lower tier drugs 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 Aspirin-Dipyridamole ER.
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 Lasix for Plan years 2020 and 2021. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law and Plan rules do not allow tiering exceptions for non-formulary drugs being covered through a formulary exception. The documentation in the record shows that Lasix is currently being covered for the enrollee through a formulary exception. Therefore, our decision is the Plan is not required to provide a tiering exception for Lasix for Plan years 2020 and 2021.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Potassium Chloride 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 Chloride ER. The drug is requested to treat hypokalemia. The drug is a generic drug on Tier 2 of the Plan's formulary. There are no available lower tier drugs 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 Potassium Chloride ER.
Appeal type: Prescription Drug
Decision: Unfavorable

We previously issued an unfavorable reconsideration decision, finding that the Plan was not required to provide coverage of Mektovi. Our Physician Reviewer determined that the requested drug is not being prescribed to treat a medically accepted indication. After we issued our decision, we received new information. We reopened this appeal to conduct a second review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Mektovi 15 mg tablet. Mektovi is requested to treat melanoma without a BRAF V600 mutation, nor a NRAS mutation, which is an off-label (non-FDA approved) use. Upon the reopening request, the prescriber submitted additional information. The enrollee is a 56-year-old man with metastatic melanoma involving bone and soft tissue. He has been treated with surgery, radiation, and Nivolumab. Next generation sequencing identified a BRAF mutation of unknown significance and an NF1 mutation suggesting possible response to Mektovi. The prescriber has requested Mektovi to treat him.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 Mektovi 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 Mektovi. 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.This decision affirms our previous unfavorable decision.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Eplerenone, 25 mg tablet 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 a tiering exception for Eplerenone, 25 mg tablet.The drug is requested to treat the enrollee's condition. The drug is a Generic drug on Tier 4 of the Plan's formulary. The prescriber does not state why all available lower tier potassium-sparing alternatives on the Plan's formulary 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 Eplerenone, 25 mg tablet for the 2021 Plan benefit year.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Octreotide, 100 mcg/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 Octreotide, 100 mcg/ml injection solution.The drug is requested to treat chylous ascites, 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 Octreotide, 100 mcg/mL 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 Octreotide, 100 mcg/mL.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 Ipratropium Albuterol 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 Ipratropium Albuterol Solution for the management of obstructive pulmonary disease.In this case, the record shows that Ipratropium Albuterol Solution is administered through a nebulizer in the home for a diagnosis of J44.9 chronic obstructive pulmonary disease and J44.1 chronic obstructive pulmonary disease with (acute) exacerbation. 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 Solution. 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 Vardenafil HCL. 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. Vardenafil HCL is one of those excluded drugs because it is a sexual or erectile dysfunction drug used to treat a condition other than sexual or erectile dysfunction for which the drug has not been approved by the FDA. The record submitted by the Plan does not indicate that they provide supplemental coverage for Vardenafil HCL. Therefore, the Plan is not required to cover Vardenafil HCL. 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 Norvasc, 5 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 Norvasc, 5 mg tablet.The drug is requested to treat hypertension. The prescriber has not indicated why all alternatives required by the Plan (Nifedipine ER tablet, Felodipine ER tablet, and Isradipine capsule) 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 Norvasc, 5 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Saphris. 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 Saphris. The drug is requested to treat, major depressive disorder, irritability, behavioral disturbances and overanxious situations, 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 Saphris 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, it cannot be covered under the Medicare Part D benefit for these conditions. 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 Saphris. 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 Otezla. 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 Otezla. The drug is requested to treat pustulosis palmaris et plantaris, 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 Otezla 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 Otezla. 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 Fleet Bisacodyl 10 mg enema. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover non-prescription drugs. We checked FDA approved sources for the drug's classification or determined from other available resources that the drug is a non-prescription or OTC drug. Therefore, Fleet Bisacodyl 10 mg enema is not eligible for Part D coverage, and the Plan is not required to cover it under the Part D benefit. 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 Trulicity 3 mg/0.5 ml pen, 45 ml 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 Trulicity 3 mg/0.5 ml pen, 45 ml per 30 days. The drug is requested to treat Type 2 diabetes mellitus. The Plan limits the amount of Trulicity 3 mg/0.5 ml pen to 2 mls (4 pens) per 28 days. Medical records from date of service November 9, 2020 were provided which documented that the prescriber is prescribing Trulicity 3 mg once a week. However, the submitted request is for 45 mls per 30 days. The prescriber has not indicated that the number of doses of the requested drug allowed by the Plan would likely be ineffective in treating your condition and/or would likely cause harm to you. Therefore, an exception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is that quantity limit exception criteria are not met.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 not met. Therefore, the Plan is not required to cover the requested quantity of Trulicity 3 mg/0.5 ml pen, 45 ml per 30 days.