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

You asked the Plan to cover Pulmozyme. 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 Pulmozyme 1 mg/mL.The drug is requested to treat J95.00, Unspecified tracheostomy complication, 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 Pulmozyme 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 Pulmozyme. 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 Zolpidem Tartrate 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 Zolpidem Tartrate ER.Zolpidem Tartrate ER is requested to treat R52, pain, unspecified, which is an off-label (non-FDA approved) use. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia that support the use of Zolpidem Tartrate ER 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 Zolpidem Tartrate ER. 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 Ipratropium Bromide neb sol, Budesonide neb sol, and Albuterol Sulfate nebsol . 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 PartA or Part B of Medicare for that individual. Medicare Part B may pay for supplies necessary for theeffective use of durable medical equipment, including drugs and biologicals which must be put directly intothe equipment in order to achieve the therapeutic benefit of the durable medical equipment. Medicare PartB local policy states that a small volume nebulizer and related compressor are covered when medicallynecessary to administer Ipratropium Bromide neb sol, Budesonide neb sol, and Albuterol Sulfate neb solfor the management of obstructive pulmonary disease.In this case, the record shows that Ipratropium Bromide neb sol, Budesonide neb sol, and Albuterol Sulfateneb sol are administered through a nebulizer in the home for a diagnosis of bronchial pneumonia. There isno indication that it is not administered through a small volume nebulizer. It appears that this medication iseligible for coverage under Part B rather than Part D. Drugs which are eligible for coverage under Part Bare excluded from Part D coverage by Medicare law. Therefore, it is our decision that the Part D Plan is notrequired to cover Ipratropium Bromide neb sol, Budesonide neb sol, and Albuterol Sulfate neb sol.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 Latuda. 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 Latuda. The drug is requested to treat an unclear diagnosis. In the original appeal the prescriber stated that the diagnoses were F34.1, Dysthymic disorder and F43.10, Post-traumatic stress disorder, unspecified. Then in the Reconsideration appeal the prescriber stated that the new diagnosis was F31.81, Bipolar II disorder. The prescriber was asked to clarify the enrollee's diagnosis and to provide supporting medical records. A response from the prescriber was not received. Therefore, based on the current record, there is insufficient documentation that the requested medication is being prescribed for a medically accepted indication as defined by Medicare law. In addition, prior authorization exception criteria are not met.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 Latuda 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 Latuda. 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 time frame. 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 Imvexxy. 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 Imvexxy. The drug is requested to treat the enrollee's condition. A request for prescriber statement was sent and not returned. 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 Imvexxy.
Appeal type: Prescription Drug
Decision: Unfavorable

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified time frame. 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 Prolia . 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 Prolia 60 mg/ml, 1 syringe per day. Prolia 60 mg/ml is requested to treat osteoporosis. There was insufficient documentation to substantiate that the requested drug is being used to treat the stated condition. You were asked questions to clarify the diagnosis being treated and/or to provide documentation to support the noted diagnosis. You were also asked questions to address the Plan's coverage/exception criteria. A response from you was not received. Therefore, based on the current record, there is insufficient documentation to support an exception to the Plan's coverage criteria.Medicare rules allow a Part D Plan to manage its formulary by covering a limited quantity of certain drugs. A Plan must grant an exception if it determines that the requested dosage is medically reasonable and necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that an exception to the quantity limit criteria is not met. Therefore, the Plan is not required to cover the requested quantity of Prolia.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Aripiprazole 2 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 Aripiprazole 2 mg. The drug is requested to treat major depressive disorder. Additional medical information was requested by the Part D QIC. The prescribing physician was asked to address the Plan's prior authorization criteria and to submit chart notes supporting a diagnosis of major depressive disorder. The prescribing physician has submitted the requested chart notes and has addressed the Plan's prior authorization criteria. The prescriber states that Aripiprazole will be given concurrently with the antidepressant Cymbalta. 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 Aripiprazole.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 Amitriptyline. 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 Amitriptyline. The drug is requested to treat primary 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.The initial request indicated a diagnosis of primary insomnia. The prescribing physician subsequently submitted a diagnosis of depression. Additional medical information was requested by the Part D QIC. The prescribing physician was asked to submit chart notes supporting the change in diagnosis. The requested chart notes were not submitted. Therefore, based on the current record, 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 Amitriptyline 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 Amitriptyline. 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 Inrebic, 100 mg capsule as prescribed. 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 Inrebic, 100 mg capsule. The drug is requested to treat Myelofibrosis, Intermediate-2 or high-risk. Theprescriber sent a statement dated 1/2/2020 clarifying the medical history. The prescriber states the enrolleehas tried and had adverse effects with Jakafi. Medical records were provided. The enrollee satisfies thePlan'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 aremet. Therefore, our decision is the Plan is required to cover Inrebic, 100 mg capsule as prescribed.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Linzess 72 mcg. The Plan did not grant this request. We received this case toconduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Linzess 72 mcg. The drug is requested to treat chronic idiopathic constipation. Additional medicalinformation was requested by the Part D QIC. The prescribing physician was asked to address the Plan'sprior authorization criteria. The enrollee has had ongoing constipation since 2010. The enrollee has triedand failed treatment with Lactulose. The enrollee satisfies the Plan's coverage criteria. Our PhysicianReviewer'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 aremet. Therefore, our decision is the Plan is required to cover Linzess 72 mcg.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Freestyle Libre reader and Freestyle Libre 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 reader and Freestyle libre sensor have been classified by the FDA as devices, not as drugs. Therefore, our decision is the Part D Plan is not required to cover Freestyle Libre reader and Freestyle Libre sensor. This decision does not address the medical necessity or appropriateness of the requested items. 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 Ipratropium-Albuterol Solution . The Plan did not grant this request. Wereceived this case to conduct an independent review.Medicare law specifically excludes coverage for any drug for which payment would be available under PartA or Part B of Medicare for that individual. Medicare Part B may pay for supplies necessary for theeffective use of durable medical equipment, including drugs and biologicals which must be put directly intothe equipment in order to achieve the therapeutic benefit of the durable medical equipment. Medicare PartB local policy states that a small volume nebulizer and related compressor are covered when medicallynecessary to administer Ipratropium-Albuterol Solution for the management of obstructive pulmonarydisease.In this case, the record shows that Ipratropium-Albuterol Solution is administered through a nebulizer inthe home for a diagnosis of J44.9 Chronic obstructive pulmonary disease. There is no indication that it isnot administered through a small volume nebulizer. It appears that this medication is eligible for coverageunder Part B rather than Part D. Drugs which are eligible for coverage under Part B are excluded from PartD coverage by Medicare law. Therefore, it is our decision that the Part D Plan is not required to coverIpratropium-Albuterol Solution.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

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified time frame. 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 Megestrol Acetate. 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 Megestrol Acetate. The drug is requested to treat an unspecified diagnosis, 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. Additional medical information was requested by the Part D QIC. You were asked to address the Plan's prior authorization criteria and to provide the enrollee's diagnosis. A response from you was not received. 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 Megestrol Acetate 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 Megestrol Acetate. 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.Please note: the Plan approved this request under the enhanced portion of the benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Auryxia. 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 Auryxia. The drug is requested to treat the enrollee's condition. A request for prescriber statement was sent and not returned. The prescriber has not indicated why all alternatives required by the Plan 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. 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 Auryxia.