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

You asked the Plan to cover Stelara. 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 Stelara 90 mg/ml syringe. The drug is requested to treat Crohn's Disease. 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Plan (Humira) would likely not be as effective for the enrollee as the requested drug (the Medicare approved compendia do not cite fatty liver as a contraindication for Humira), and/or would likely cause adverse reaction(s) or other harm to the enrollee.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 Stelara.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Lumigan 0.01%. 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 Lumigan 0.01% ophthalmic drops. The drug is requested to treat the enrollee's condition. The drug is a brand drug on Tier 3 of the Plan's formulary. For the 2020 Plan year, eligibility for a tiering exception requires the presence of at least one similar lower tier brand drug on the Plan's formulary to treat the enrollee's condition. There are no similar brand drugs on the lower tiers of the Plan's formulary. Therefore the requested 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 Lumigan 0.01%.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Diclofenac 1% 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 Diclofenac 1% gel. The drug is requested to treat knee pain in a patient with unspecified osteoarthritis, 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 Diclofenac 1% gel 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 Diclofenac 1% gel. 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 Lidocaine 5% Patch. The Plan did not grant this request. We received this caseto conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Lidocaine 5% Patch. The drug is requested to treat acute hip and back pain after fall, which is an offlabel(non-FDA approved) use. The Medicare-approved compendia do not contain any citations to supportthe use of the requested drug, as prescribed, for treatment of the noted condition. Therefore, the requesteddrug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, anexceptions request based on medical necessity cannot be considered because the requested drug, asprescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is noteligible 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 acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Lidocaine 5% Patch 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, itcannot be covered under the Medicare Part D benefit for this condition. An exceptions request based onmedical necessity cannot be considered because this drug, as prescribed, does not meet the definition of aMedicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage forLidocaine 5% Patch.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Creon DR for the 2019 coverage 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 Creon DR. The drug is requested to treat exocrine pancreatic insufficiency and pancreatitis. The drug is on tier 3 of the Plan's 2019 formulary. There are no available lower tier drugs on the Plan's 2019 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 Creon DR.
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 30 mg tablet.The drug is requested to treat psoriasis vulgaris. 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 (any two of the following preferred agents: Humira, Stelara, Cosentyx, Enbrel, Skyrizi) would likely not be as effective for this specific enrollee as the requested drug, and/or would likely cause adverse reaction(s) or other harm to this specific enrollee. Additionally, no medical records were submitted to support this request. 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 Otezla.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Praluent. The Plan did not grant this request. We received this case to conductan independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Praluent. The drug is requested to treat hyperlipidemia. Upon redetermination request, the prescriberhas not provided a sufficient medical rationale why the formulary alternative Repatha is not appropriate forthe enrollee. The prescriber has not indicated why all alternatives required by the Plan would likely not beas effective for the enrollee as the requested drug; and/or would likely cause adverse reaction(s) or otherharm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. Our PhysicianReviewer'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 requesteddrug is medically necessary, consistent with the prescriber's statement. Based on a review of the availabledocumentation, our Physician Reviewer's opinion is that formulary exception criteria are not met.Therefore, the Plan is not required to cover Praluent.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Gabapentin, 300 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 Gabapentin, 300 mg capsule.The drug is requested to treat insomnia, 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 Gabapentin, 300 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 Gabapentin, 300 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.
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 reimbursement for Cough Syrup, Diclofenac Potassium 50 mg and Rimantadine HCL 100 mg purchased January 3, 2018 while in Costa Rica. The Plan did not grant this request. We received this case to conduct an independent review.Cough Syrup, Diclofenac Potassium 50 mg and Rimantadine HCL 100 mg purchased January 3, 2018 while in Costa Rica are not covered by Medicare because they were purchased outside the United States. Therefore, our decision is that the Part D Plan is not required to pay for Cough Syrup, Diclofenac Potassium 50 mg and Rimantadine HCL 100 mg purchased January 3, 2018 while in Costa Rica. This decision does not concern the medical appropriateness 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 Tremfya. 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 Tremfya. The drug is requested to treat moderate to severe plaque psoriasis. 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 Tremfya.
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. The drug is requested to treat anemia in an enrollee with chronic kidney disease. The enrollee does not satisfy the Plan's coverage criteria. The Plan requires an inadequate response to Retacrit therapy for at least two consecutive months with appropriate dose adjustment. 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 Procrit.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Metolazone. 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 Metolazone 5 mg 45/90. The drug is requested to treat congestive heart failure. Upon reconsideration, you submitted a sufficiently strong statement as to why the formulary alternatives are inappropriate for the enrollee. 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 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 Metolazone.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 Melphalan. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law defines those drugs that are eligible to be covered under the prescription drug benefit. Medicare law specifically excludes coverage for any drug for which payment would be available under Parts A or B of Medicare for that individual. Medicare Part B coverage includes oral anti-cancer drugs that are prescribed as anti-cancer chemotherapeutic agents providing they have the same active ingredients and are used for the same indications as anti-cancer chemotherapeutic agents which would be covered if they were not self-administered and they were furnished incident to a physician's service as drugs and biologicals. This coverage includes FDA approved prodrugs used as anti-cancer drugs. The oral anti-cancer drug must be used for the same anti-cancer chemotherapeutic indications, including unlabeled or off-label uses, as the non-self-administrable form of the drug.A claim denied for the reason that the diagnosis does not fall in the covered diagnosis section of the Policy Article, titled ICD-10 Codes that are Covered, will receive a statutory denial as non-covered, but may be covered at appeal if used for a medically accepted indication, as defined by Medicare law for oral anti-cancer chemotherapeutic agents. In this case the record shows that Melphalan is being prescribed for a diagnosis of ICD-10 C94.6 (Myelodysplastic disease, not classified). Medicare Part B provides coverage for oral anti-cancer drugs when used as anti-cancer chemotherapeutic agents. It appears Melphalan may be eligible for coverage under Medicare Part B for the diagnosis provided in this case. Drugs which are eligible for Part B coverage are excluded from Part D coverage by Medicare law. Therefore, our decision is that the Part D Plan is not required to cover Melphalan. This decision does not concern the medical necessity or appropriateness of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.Please contact the Plan for more information regarding coverage of Melphalan under the Part B benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Betahistine. The Plan did not grant this request. We received this case toconduct an independent review.Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. Wedetermined that Betahistine is not FDA approved for both safety and effectiveness by checking FDAsources. Therefore, the Plan is not required to cover Betahistine.This decision does not address the medical necessity or appropriateness of the requested drug. It onlyestablishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Multaq for the 2019 coverage 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 Multaq. The drug is requested to treat atrial fibrillation. The drug is on tier 3 of the Plan's 2019 formulary. There are no available lower tier brand drugs on the Plan's 2019 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 Multaq.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover K-Phos No 2. The Plan did not grant this request. We received this case toconduct an independent review.Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. Wedetermined that K-Phos No 2 is not FDA approved for both safety and effectiveness by checking FDAsources. Therefore, the Plan is not required to cover K-Phos No 2.This decision does not address the medical necessity or appropriateness of the requested drug. It onlyestablishes that payment cannot be made under the Medicare Part D benefit.