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 Oxycodone HCl 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 Oxycodone HCl ER. The drug is requested to treat pain in an enrollee with diffuse large B-cell lymphoma. 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 Oxycodone HCl ER.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Oxycontin ER. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Oxycontin ER. The drug is requested to treat chronic pain syndrome. 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. You sent additional information and medical records detailing a trial and failure of the formulary alternativeXtampza ER. However, there is no documentation of trail and failure of at least one other formulary alternative (fentanyl patch, hydrocodone extended-release capsule, methadone tablet, morphine sulfate extended-release tablet, Nucynta extended-release tablet or tramadol extended-release tablet) as required by the health plan. Therefore, an exception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is that formulary exception criteria are not met.A Plan must grant an exception for a drug that is not on its formulary if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that formulary exception criteria are not met. Therefore, the Plan is not required to cover Oxycontin ER.
Appeal type: Prescription Drug
Decision: 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 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. The drug is requested to treat anemia in chronic kidney disease. You have not indicated why all alternatives required by the Plan (Retacrit) 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 Procrit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Trelegy Ellipta. 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 Trelegy Ellipta.Trelegy Ellipta is requested for treatment of the enrollee's condition. You have indicated that the enrollee has failed Anoro Ellipta and Spiriva, and that the requested drug is felt to be the best option for the enrollee. Although it is stated that the enrollee failed Anoro Ellipta, the medical records state that Anoro Ellipta was discontinued by you because you did not feel it was needed based on the enrollee's FEV1 of 109% of predicted at the time. There is insufficient documentation that the enrollee has chronic obstructive pulmonary disease; however 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 Trelegy Ellipta.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Freestyle Libre 14 Day Sensor. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover devices. Freestyle Libre 14 Day Sensor 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 Freestyle Libre 14 Day Sensor. 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.Please contact the Plan for more information regarding coverage of Freestyle Libre 14 Day Sensor under the Part B benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Tadalafil 20 mg. The Plan did not grant this request. We received this case to conduct an independent review.If a Plan maintains a specialty tier, the Plan may design its exception process so that drugs placed in the specialty tier are not eligible for a tiering exception. Tadalafil 20 mg is in the specialty tier. The record indicates the Plan has chosen to exclude the specialty tier from the tiering exception process. Therefore, the Plan is not required to provide a tiering exception for Tadalafil 20 mg.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Rybelsus. 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 Rybelsus 7 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 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 Rybelsus.
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 Depo-Testosterone. 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 Depo-Testosterone 200 mg/ml solution.The drug is requested to treat the enrollee's condition. The prescriber has not indicated why all alternatives required by the Plan (Testosterone Cypionate, Androderm, Testosterone) 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 Depo-Testosterone.Therefore, since the Plan is not required to cover Depo-Testosterone, the subsequent requests for reimbursement have not been reviewed.
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 pulmonary obstructive disease, unspecified and J43.9 Emphysema, 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 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 Hydroxyzine HCL. 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 Hydroxyzine HCL. The drug is requested to treat anxiety. You do 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 (buspirone) would likely not be as effective for you as the requested drug, and/or would likely cause adverse reaction(s) or other harm to you. The prescriber sent additional information and medical records addressing the diagnosis and coverage criteria including detailed information on your prior issues with hyponatremia related to selective serotonin reuptake inhibitor use. The remaining required safer formulary alternative buspirone, however remains unaddressed. Hyponatremia is not reported as a side effect of buspirone. 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 Hydroxyzine HCL.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Dextroamphetamine/Amphetamine 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 Dextroamphetamine/Amphetamine ER 30 mg. Dextroamphetamine/Amphetamine ER 30 mg is requested for ongoing treatment of attention deficit disorder, combined type. The plan's redetermination denial letters states that Atomoxetine capsule is on their formulary. The prescriber has indicated that the enrollee is stable on the requested drug, a change in therapy will put the patient at risk for a decrease in compliance, decrease in efficacy, and increase in certain side effects, and that a change in therapy is not medically appropriate for this enrollee. Medical records were submitted which support the prescriber's statement. The enrollee has a complicated medical and psychiatric history, he is stable on a multidrug combination that includes numerous psychotropic drugs. 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 not met. Therefore, the Plan is not required to cover Dextroamphetamine/Amphetamine ER.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 Nurtec (Rimegepant). The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Nurtec (Rimegepant). The drug is requested to treat acute migraines. You have not indicated why one additional formulary abortive alternative for migraines required by the Plan (Zolmitriptan, Naratriptan, Frovatriptan, or Celecoxib) would likely not be as effective for the enrollee as the requested drug; and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is that formulary exception criteria are not met.A Plan must grant an exception for a drug that is not on its formulary if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that formulary exception criteria are not met. Therefore, the Plan is not required to cover Nurtec (Rimegepant).
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Rituxan 100 mg/10mL. 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 Rituxan, 1000 mg.The drug is requested to treat nephrotic syndrome due to membranous glomerulonephritis. For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of the requested drug for treatment of the noted condition. The following citation in DrugDex, a Medicare approved compendium, supports the use of the requested drug for the enrollee's condition:Rituximab was non-inferior to cyclosporine for a composite of complete or partial remission (60% vs 20%) at 24 months in the randomized MENTOR trial in patients with apparent primary membranous nephropathy (N=130); rituximab met criteria for superiority.Therefore, the requested drug is being prescribed for a medically accepted indication.Additional medical information was requested by the Part D QIC. The prescribing physician was asked to address the formulary alternatives. 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 Rituxan, 100 mg/10 mL.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Xeljanz XR 11 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 Part D Plan was correct in denying the request for Xeljanz XR 11 mg. The drug is requested to treat psoriatic arthritis. Additional medical information was requested by the Part D QIC. You were asked to address the Plan's prior authorization criteria. The request is for continuation of therapy. You attest that the enrollee continues to benefit from the requested medication. 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 Xeljanz XR 11 mg.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 Cresemba, 186 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 Cresemba, 186 mg capsules; 60/30.The drug is requested to treat prophylaxis against fungal infection, which is an off-label (non-FDA approved) use. The enrollee is a 59 year old woman with acute myelogenous leukemia (AML) being treated with chemotherapy. She has been persistently neutropenic. Cultures have been negative for fungal infection. She has been on empiric Cefepime, Vancomycin and Acyclovir. Cresemba has been started in hospital. The prescriber requests Cresemba to continue to treat her. The prescriber states she is at high risk for invasive fungal infections. The prescriber states she cannot receive Posaconazole, Voriconazole or Fluconazole due to prolonged QTc interval of over 500. Medical literature was provided and reviewed. The drug is not being used as leukemia directed therapy. Therefore this review was done using the non-cancer CMS rules for 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. 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 Cresemba, 186 mg capsule 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 Cresemba, 186 mg capsule.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.