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

You asked the Plan to cover Repatha SureClick 140 mg/mL. The Plan did not grant this request. Wereceived this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Repatha SureClick 140 mg/mL.The drug is requested to treat hyperlipidemia in an enrollee with coronary artery disease. RepathaSureClick 140 mg/mL is not on the Plan's formulary. Praluent is on the Plan's formulary. The prescriber hasnot indicated why all alternatives required by the Plan would likely not be as effective for the enrollee asthe 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 thatformulary 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 Repatha SureClick 140 mg/mL.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover SM Nasal Spray. 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, SM Nasal Spray 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 Piqray. 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 Piqray 300 mg daily dose.The drug is requested to treat prostate cancer. The enrollee is a 77 year old man with metastatic prostate cancer involving bones. He has been treated with Bicalutamide, Lupron, Zytiga plus Prednisone, and Erleada. He is opposed to systemic chemotherapy. Guardant360 testing revealed mutations with lack of response to those drugs and to Xtandi. It showed PIK3CA mutation suggesting possible response to Piqray. The prescriber requests Piqray to treat him.The use of Piqray to treat prostate cancer 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. 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 Piqray 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 Piqray. 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 Vascepa. 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 Vascepa 1 gram capsule.The drug is requested to treat hyperlipidemia/hypertriglyceridemia. The drug is on Tier 4 of the Plan's formulary. There are no available (branded) 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 Vascepa.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Xifaxan, 550 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 Xifaxan, 550 mg tablet.The drug is requested to treat short bowel syndrome causing diarrhea and bloating, 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 Xifaxan, 550 mg tablet 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 Xifaxan, 550 mg tablet. 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 Cyclophosphamide. The Plan did not grant this request. We received this caseto 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 underParts A or B of Medicare for that individual. Medicare Part B coverage includes oral anti-cancer drugs thatare prescribed as anti-cancer chemotherapeutic agents providing they have the same active ingredients andare used for the same indications as anti-cancer chemotherapeutic agents which would be covered if theywere not self-administered and they were furnished incident to a physician's service as drugs andbiologicals. This coverage includes FDA approved prodrugs used as anti-cancer drugs. The oral anti-cancerdrug must be used for the same anti-cancer chemotherapeutic indications, including unlabeled or offlabeluses, as the non-self-administrable form of the drug. A claim denied for the reason that the diagnosisdoes 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 medicallyaccepted indication, as defined by Medicare law for oral anti-cancer chemotherapeutic agents.In this case the record shows that Cyclophosphamide is being prescribed for a diagnosis of multiplemyeloma. Medicare Part B provides coverage for oral anti-cancer drugs when used as anti-cancerchemotherapeutic agents. It appears Cyclophosphamide may be eligible for coverage under Medicare PartB for the diagnosis provided in this case. Drugs which are eligible for Part B coverage are excluded fromPart D coverage by Medicare law. Therefore, our decision is that the Part D Plan is not required to coverCyclophosphamide.This decision does not concern the medical necessity or appropriateness of the requested drug. It onlyestablishes 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 Suboxone 8-2 mg film. 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 Suboxone 8-2 mg film. The drug is requested to treat opioid dependence. 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 Suboxone.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Atropine Sulfate. 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 Atropine Sulfate 1% solution. The drug is requested to treat excessive salivation/drooling associated with Parkinson's disease. 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 AHFS-DI, a Medicare approved compendium, supports the use of the requested drug for the enrollee's condition: Antimuscarinics may be especially useful in the treatment of excessive salivation associated with parkinsonian syndrome. Therefore, the requested drug is being prescribed for a medically accepted indication. Upon reconsideration, the prescribing physician has submitted a sufficiently strong statement as to why the formulary alternatives are inappropriate for the enrollee. The prescriber has indicated why all alternatives required by the Plan would likely not be as effective as the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that formulary exception criteria are met.A Plan must grant an exception for a drug that is not on its formulary if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that formulary exception criteria are met. Therefore, the Plan is required to cover Atropine Sulfate.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 Repatha. 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 Repatha. The drug is requested to treat hyperlipidemia and coronary artery disease. Praluent is available on the Plan's formulary. You have not indicated why this alternative 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 Repatha.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Taltz 80 mg/mL syringe. 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 Taltz 80 mg/mL syringe.The drug is requested to treat moderate to severe psoriatic arthropathy and psoriasis. 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 Taltz 80 mg/mL syringe.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Alosetron HCL, 1 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 Alosetron HCL, 1 mg tablet.Alosetron HCL, 1 mg tablet is requested for ongoing use for treatment of severe diarrhea predominant irritable bowel syndrome in this male enrollee, which is an off-label (non-FDA approved) use. The prescriber has discussed the enrollee's clinical history and has noted that the enrollee has been stable on the requested drug for years, and has provided information from Up to Date; however 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 in males. 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 Alosetron HCL, 1 mg tablet 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 Alosetron HCL, 1 mg tablet. 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 Potassium Bicarbonate. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. We determined that Potassium Bicarbonate is not FDA approved for both safety and effectiveness by checking FDA sources. Therefore, the Plan is not required to cover Potassium Bicarbonate. 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 Capecitabine. 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 Capecitabine is being prescribed for a diagnosis of breast cancer. Medicare Part B provides coverage for oral anti-cancer drugs when used as anti-cancer chemotherapeutic agents. It appears Capecitabine 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. Additionally, drugs eligible to be covered under Parts A and/or B are considered available (and excluded from Part D) even if a beneficiary chooses not to pay premiums or if a beneficiary has enrolled in Part B but that coverage has not yet taken effect. Medicare records show that the enrollee is entitled to Part B coverage at this time, even though the beneficiary may have chosen not to pay premiums and/or coverage may not have taken effect. Therefore, our decision is the Part D Plan is not required to cover Capecitabine. 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 your Part D Plan to provide reimbursement for Shingrix Kit purchased at yourPharmacy on January 4, 2020. The Plan did not grant this request. We received this case to conduct anindependent review.Medicare law states that Part D sponsors are required to coordinate with other providers of prescriptiondrug coverage with respect to the payment of premiums and coverage, as well as coverage supplementingthe benefits available under Part D. Which insurance company provides benefits first will depend on thesituation. The Plan denied the request for reimbursement for Shingrix Kit purchased at your Pharmacy on January 4, 2020 on the basis that the Explanation of Benefits from your other insurance wasnot provided. The Reconsideration appeal request submitted to MAXIMUS Federal also did not include theExplanation of Benefits.The Plan's file is unclear if the Medicare Part D Plan is the primary or secondary insurance provider.However, the file does state the EOB from the other Plan is required in order to process any claim. TheEOB has not been provided. Please return to the pharmacy to have them re-run the claim using yourMedicare Part D insurance as an error was made the first time. If needed, please resubmit your info to thePlan to ensure it was re-run correctly in order to get your reimbursement covered.The case record indicates that the Plan provided coverage in accordance with the Part D Plan contract.Therefore, our decision is the Plan is not required to provide reimbursement for Shingrix Kit purchased atyour Pharmacy on January 4, 2020.You may wish to submit a copy of the Explanation of Benefits from your other insurance directly toyour Part D Plan in order for them to process your request