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 Linezolid 600 mg, #180 per 90 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 Linezolid 600 mg tablet, 180 tablets / 90 days.The drug is requested to treat osteomyelitis. The enrollee does not satisfy the Plan's coverage criteria. Prior authorization limits treatment to 14 days with a maximum of 28 days for the treatment of VRE. Treatment is requested for 90 days. 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 Reviewer'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 Linezolid.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Procrit. 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 Procrit 10,000 units/mL solution.The drug is requested to treat anemia, to reduce the need for allogeneic red blood transfusion in a patient scheduled to undergo elective, noncardiac, nonvascular surgery. 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 Reviewer'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 Procrit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lyrica, 100 mg capsule, 90 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 Lyrica, 100 mg capsule.The drug is requested to treat degenerative disc disease, spinal stenosis, and distal symmetric sensory neuropathy, 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 Lyrica, 100 mg capsule, 90 per 30 days 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 Lyrica, 100 mg capsule, 90 per 30 days. 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 Tadalafil 5 mg tablet, 2 tablets per day. 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 Tadalafil 5 mg tablet, 2 tablets per day. The drug is requested to treat benign prostatic hyperplasia, which is an off-label (non-FDA approved) use at this dosage. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed (10 mg per day), 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 Tadalafil 5 mg tablet, 2 tablets per day, 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 Tadalafil 5 mg tablet, 2 tablets per day. 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 Xarelto. 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 Xarelto 20 mg tablet. The drug is requested to treat the enrollee's condition. The drug is a brand drug on Tier 3 of the Plan's formulary. There are no available lower tier brand 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 Xarelto.
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 Metformin ER. The Plan did not grant this request. We received this case to conduct an independent review.The Plan provided documentation that coverage (as a formulary exception) was approved by the Plan. Therefore, we are dismissing the request for coverage for Metformin ER 500 mg. You should contact the Plan for more information regarding how and when coverage for Metformin ER will be provided.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 Metformin ER 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 Metformin ER.Please note: the documentation in the file provided by the Plan indicates you are concerned that a recent purchase of Metformin ER should have had a copayment of $0 as a Tier 1 medication. It is noted that the National Drug Code (NDC) reviewed and approved as a formulary exception for Metformin ER is 16714-938-01. Because this NDC is not on the formulary but approved as a formulary exception it will be covered at the Tier 4 copayment amount. The NDC that is on the formulary as a Tier 1 medication is 62756-142-02. In order to receive the Tier 1 copayment amount for Metformin ER 500 mg tablet, you may wish to discuss with the pharmacy and ensure NDC 62756-142-02 is being used. You may also wish to discuss this with the Plan.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Venclexta. 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 Venetoclax 100 mg; 30/30. The drug is requested to treat newly diagnosed acute myelogenous leukemia (AML). The enrollee is a 51-year-old man with diabetes and a kidney mass and with newly diagnosed AML. He was previously diagnosed with myelodysplastic syndrome. Repeat bone marrow shows AML. On 4/2/20, the enrollee's creatinine clearance was >60, liver tests (albumin, bilirubin, ALT, AST, and alkaline phosphatase were all normal. He has no history of cardiac or pulmonary disorder and his performance status is ECOG 1. The prescriber requests Venclexta to be given with Decitabine to treat him.The prescriber states he is eligible for intensive induction chemotherapy. The plan will be to proceed to transplant after achieving remission. The prescriber states he is at high risk for complications due to his diabetes. and less intense therapy is preferred. She also states the enrollee suffers from anxiety and has a strong preference for shorter inpatient state. The office note of 4/3/20 states he is opposed to inpatient chemotherapy induction.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 Venclexta.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Ozempic. 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 Ozempic 0.25mg dose pen 3/90. The drug is requested to treat diabetes mellitus. The drug is on tier 3 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 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 Ozempic.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lynparza. 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 Lynparza. The drug is requested to treat esophageal cancer, which is an off-label (non-FDA approved) use.The enrollee is a 66-year-old man with esophageal cancer with local residual disease. He has been treated with radiation, Carboplatin/Taxol, 5FU, Leucovorin, Oxaliplatin, Capecitabine, Pembrolizumab and stenting. The prescriber notes there is a BRCA inversion defect. Next generation sequencing showed CDK6 amplification suggesting possible response to Lynparza. The prescriber requests Lynparza 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. This reviewer did a PubMed search and found no supporting citations. 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 Lynparza 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 Lynparza. 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 Jardiance. The Plan did not grant this request. We received this case to conduct an independent review.Medicare rules do not require the Part D plan to grant a tiering exception for a brand or biologic drug of the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) if the lower tier(s) on the formulary only contain(s) generic alternative drugs. Jardiance is a Tier 3 brand drug. The lower cost-sharing tier(s) only contain(s) generic alternative drugs. Therefore, our decision is the Plan is not required to provide a tiering exception for Jardiance.We also received your letter asking for an appeal of the Plan's unfavorable determination for Mesalamine. We are dismissing this case. Medicare rules do not allow us to review this case until you have completed the appeal process with the Plan. You may request a Reconsideration appeal with us after the Plan issues an unfavorable Redetermination. You may wish to submit this request to the Plan at this time.
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 other intervertebral disc displacement, lumbosacral region. 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 (Xtampza ER) 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 Oxycontin ER.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cosentyx. 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 Cosentyx. The drug is requested to treat plaque psoriasis. 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 Cosentyx.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Testosterone 10 mg/act (2%) gel. 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 Testosterone 10 mg/act (2%) gel. The drug is requested to treat the enrollee's condition. A request for prescriber statement and medical records was sent. The statement was returned without medical records and did not provide a sufficient medical rationale why the Plan's formulary alternatives are 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 Testosterone 10 mg/act (2%) gel.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Duloxetine HCL DR. 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 Duloxetine HCL DR. The drug is requested to treat peripheral neuropathy, unspecified, 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 Duloxetine HCL DR 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 Duloxetine HCL DR. 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.