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

You asked the Plan to cover Leukine. 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 Leukine. The drug is requested to treat prostate cancer, which is an off-label (non-FDA approved) use.  The enrollee is an 81-year-old man with metastatic castration resistant prostate cancer. He has been treated in the past with Leukine and his PSA has decreased below 0.02. Off the drug his PSA rose to 0.03 and it dropped again after resuming the drug in 7/2020. Additional treatment or extent of disease information was not submitted for review. The prescriber requests Leukine 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 not find any supporting citations in a PubMed search. 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 Leukine 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 Leukine.  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: Favorable

You asked the Plan to cover Praluent 75 mg/mL. The Plan did not grant this request. We received this case to conduct an independent review.   We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Praluent 75 mg/mL.  Praluent is requested to treat hyperlipidemia with elevated LDL levels in a patient without clinical atherosclerotic cardiovascular disease (ASCVD), an intolerance to statin therapy, and previous trial/failure with Zetia. The enrollee does not satisfy the Plan's coverage criteria.   However, 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 prior authorization exception criteria are met.   Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. APlan must grant an exception to prior approval rules if it determines that the requested drug is medicallynecessary, consistent with the prescriber's statement. Based on the available documentation, our PhysicianReviewer's opinion is that an exception to prior approval criteria is met. Therefore, our decision is the Planis required to cover Praluent 75 mg/mL.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide reimbursement for Cyclobenzaprine 5 mg purchased July 28, 2020. 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 Cyclobenzaprine. The drug is requested to treat chronic unspecified muscle spasms in a patient with lower extremity edema and right lower extremity cellulitis, 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 Cyclobenzaprine 5 mg purchased July 28, 2020 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 reimbursement for Cyclobenzaprine 5 mg purchased July 28, 2020.  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 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. The drug is requested to treat atrial fibrillation. The drug is 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

You asked the Plan to provide a tiering exception for Nuedexta. 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 Nuedexta 20-10 mg. The drug is requested to treat pseudobulbar affect.  The drug is on tier 5 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.  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. Nuedexta 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 Nuedexta.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Buprenorphine 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 Buprenorphine HCL 2mg Tab Sublingual. The drug is requested to treat chronic pain syndrome in an enrollee with scoliosis, which is an off-label (non-FDA approved) use. On June 11, 2020, you provided the diagnoses of chronic pain syndrome with scoliosis. On September 1, 2020, you changed the diagnosis and attested that the requested drug is being prescribed for the diagnosis of opioid dependence. Relevant medical records to support the new diagnosis were requested but not provided with the request for reconsideration. You had originally provided medical records from dates of service August 18, 2020, May 12, 2020, February 11, 2020, and October 15, 2019 which document the diagnoses of severe back pain and scoliosis. The medical records provided do not support a diagnosis of opioid dependence. 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.  The following citation in DrugDex, a Medicare approved compendium, does not support the use of the requested drug for the enrollee's condition: Buprenorphine hydrochloride sublingual tablets are not appropriate as an analgesic (off-label usage) [17]. [17]. Product Information: buprenorphine HCl sublingual tablets, buprenorphine HCl sublingual tablets. Roxane Laboratories, Inc. (per DailyMed), Columbus, OH, 2015.  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 Buprenorphine HCL 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 Buprenorphine HCL.  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 Opsumit. 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 Opsumit. The drug is requested to treat primary pulmonary hypertension. 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 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. APlan must grant an exception to prior approval rules if it determines that the requested drug is medicallynecessary, consistent with the prescriber's statement. Based on the available documentation, our PhysicianReviewer's opinion is that an exception to prior approval criteria is not met. Therefore, the Plan is notrequired to cover Opsumit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Nourianz, 20 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 Nourianz, 20 mg.   The drug is requested to treat Parkinson's disease. 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 Nourianz, 20 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Myrbetriq ER. The Plan did not grant this request. We received this case to conduct an independent review.   We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for a tiering exception for Myrbetriq ER 25 mg. The drug is requested to treat bladder leakage. The drug is 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 Myrbetriq ER.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ondansetron HCL 4 mg/2 mL. The Plan did not grant this request. We received this case to conduct an independent review.   We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Ondansetron HCL 4 mg/2 mL. The drug is requested to treat nausea and vomiting due to short bowel syndrome related to small bowel removal due to prolapsed ostomy, 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.  In this case, Ondansetron HCL is not a drug that is addressed in the Medicare Part B coverage rules for infusion pumps. Therefore, it is not eligible for coverage under Medicare Part B and we sent the request to our physician reviewer to review for coverage under Medicare Part D.  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 Ondansetron HCL 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 Ondansetron HCL.  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 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. The drug is requested to treat prostate cancer, which is an off-label (non-FDA approved) use.  The enrollee is a 69-year-old man with metastatic prostate cancer involving bones and liver. He has been treated with Lupron, Sipuleucel-T, Abiraterone/Prednisone, Ra-223, Enzalutamide, Docetaxel, Cabazitaxel, Pembrolizumab, Dexamethasone and Denosumab and red cell transfusions. The prescriber states he is a poor candidate for invasive chemotherapy. The tumor has a PIK3A mutation. The prescriber requests Piqray to treat him. A journal article was submitted in support of the request and was reviewed.  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 cover Albuterol Sulfate neb sol . 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 Albuterol Sulfate neb sol for the management of obstructive pulmonary disease.  We requested additional medical information to determine if criteria for Medicare Part D have been met. We requested the enrollee's diagnosis and ICD-10 code for which Albuterol Sulfate neb sol has been prescribed, and confirmation of where this drug is being administered. A response to our request was not received in the timeframe required for review of this case. There is insufficient information to show that this drug is not eligible for Medicare Part B coverage. As a result, the record does not establish that Albuterol Sulfate neb sol is a Part D drug in this case. Therefore, it is our decision that the Part D Plan is not required to cover Albuterol Sulfate neb sol. 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 provide a tiering exception for Humalog Kwikpen U-100. 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 Humalog Kwikpen U-100. The drug is requested to treat type 1 diabetes mellitus. The drug is on tier 3 of the Plan's formulary. There are no available lower tier biologic 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 Humalog Kwikpen U-100.