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

You asked the Plan to cover Xifaxan. 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 Xifaxan 550 mg. The drug is requested to treat irritable bowel syndrome with constipation and smallintestinal bacterial overgrowth, which are off-label (non-FDA approved) uses. The Medicare-approvedcompendia do not contain any citations to support the use of the requested drug, as prescribed, for treatmentof the noted conditions. Therefore, the requested drug is not being prescribed for a medically acceptedindication as defined by Medicare law. As such, an exceptions request based on medical necessity cannotbe considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part Ddrug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the notedconditions.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 Xifaxan for the diagnosed condition. As a result, the drug isnot being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot becovered under the Medicare Part D benefit for this condition. An exceptions request based on medicalnecessity cannot be considered because this drug, as prescribed, does not meet the definition of a MedicarePart D drug. Therefore, our decision is that the Plan is not required to provide coverage for Xifaxan.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: Favorable

You asked the Plan to cover Testosterone 1.62% 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 Testosterone 1.62% gel. The drug is requested to treat primary hypogonadism due to testicular hypofunction. Additional medical information was requested by the Part D QIC. You were asked to address the Plan's prior authorization criteria. You have submitted additional documentation and laboratory reports. You state the enrollee does not have age related late onset hypogonadism. The enrollee had a testosterone level of 175 on October 12, 2017 and a testosterone level of 240 on July 18, 2015. 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 Testosterone 1.62% gel.
Appeal type: Prescription Drug
Decision: Unfavorable

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified timeframe. If the Plan does not make a timely decision, this is considered a denial. The Plan forwarded this case to us as required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Taurine Solopharm purchased October 4, 2019 while traveling in Vietnam. The Plan did not grant this request. We received this case to conduct an independent review.Taurine Solopharm is not covered by Medicare because it was purchased outside the United States. Therefore, our decision is that the Part D Plan is not required to pay for Taurine Solopharm. 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: Favorable

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified timeframe. If the Plan does not make a timely decision, this is considered a denial. The Plan forwarded this case to us as required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Cosentyx, 300 mg dose as prescribed. 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 Cosentyx, 300 mg.The drug is requested to treat plaque psoriasis. A request for prescriber statement was sent and returned along with medical records that indicate the enrollee satisfies the Plan's prior authorization criteria. 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 Cosentyx, 300 mg dose as prescribed.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 Gralise. 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 Gralise. The drug is requested to treat osteoarthritis of knee, thoracic intervertebral disc displacement, and radiculopathy, which are off-label (non-FDA approved) uses. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted conditions. 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 conditions.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 Gralise 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 Gralise. 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 Methylphenidate HCL ER. The Plan did not grant this request. We receivedthis case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Methylphenidate HCL ER. The drug is requested to treat a major depressive disorder and adjustmentdisorders, which are off-label (non-FDA approved) uses. The Medicare-approved compendia do notcontain any citations to support the use of the requested drug, as prescribed, for treatment of the notedconditions. Therefore, the requested drug is not being prescribed for a medically accepted indication asdefined by Medicare law. As such, an exceptions request based on medical necessity cannot be consideredbecause 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 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 Methylphenidate HCL ER for the diagnosed condition. As aresult, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. Assuch, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions requestbased on medical necessity cannot be considered because this drug, as prescribed, does not meet thedefinition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to providecoverage for Methylphenidate HCL ER.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 cover Spravato . The Plan did not grant this request. We received this case to conduct an independent review.For a drug to be covered under Medicare Part D, it must meet the definition of a Part D drug. A Part D Drug is defined, in part, as a drug that requires a prescription for dispensing, and is a drug that is not otherwise excluded from coverage under Part D law and rules. As Spravato cannot be dispensed upon a prescription from a retail pharmacy, Spravato fails to meet the definition of a Part D Drug. Drugs which do not meet the definition of a Part D Drug are excluded from Part D coverage by Medicare law. In addition, because the manufacturer of Spravato requires monitoring services while the drug is administered, Spravato is also an excluded drug under the Part D law and rules. Therefore, it is our decision that the Part D Plan is not required to cover Spravato. 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 note, while Spravato is not covered by your Part D Plan, it may be covered by Medicare Part B. Please contact your Medicare Part B carrier for more information.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Amphetamine-Dextroamphetamine. The Plan did notgrant 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 requestfor a tiering exception for Amphetamine-Dextroamphetamine. The drug is requested to treat attentiondeficithyperactivity disorder. The prescriber sent a statement dated 1/30/2020 clarifying the medicalhistory. Medical records were requested but were not provided. Amphetamine-Dextroamphetamine 30 mgis a generic drug on tier 3 of the Plan's formulary. There are no available lower tier generic drugs of thesame type on the Plan's formulary to treat the enrollee's condition. Therefore, the drug is not eligible for atiering 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 thesame type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in alower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug isbeing used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met becausethere 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 Amphetamine-Dextroamphetamine.
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 usas required by Medicare rules because it did not make a timely decision.You asked the Plan to provide a tiering exception for Trelegy Ellipta. The Plan did not grant this request.We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor a tiering exception for Trelegy Ellipta 100/62.5. The drug is requested to treat chronic obstructivepulmonary disease. Trelegy Ellipta 100/62.5 is a brand drug on tier 3 of the Plan's formulary. There are noavailable lower tier brand drugs of the same type 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 tieringexception 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 thesame type in a lower cost-sharing tier approved for treating the same condition that the higher cost-sharingtiered drug is being used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are notmet because there are no lower cost-sharing tiered drugs of the same type for treating the enrollee'scondition. Therefore, our decision is the Plan is not required to provide a tiering exception for TrelegyEllipta.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Calictrol 0.5 mg. 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 Calcitriol 0.5 mcg 90/90. The drug is requested to treat secondary hyperparathyroidism related tochronic kidney disease not on dialysis. Upon reconsideration, you submitted chart notes which indicate thatthe enrollee underwent kidney transplant in 2010 and has not been on dialysis since that time. Therequested drug is not eligible for coverage under Medicare Part B. The enrollee satisfies the Plan's coveragecriteria. 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 Calictrol.Please note the Plan denied Calictrol as being covered under Medicare B; however documentationsubmitted show that the enrollee is not on dialysis. Since Calictrol is not eligible under Medicare B, wereviewed coverage of Calictrol under Medicare Part D.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Mycophenolate Mofetil 250 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 Mycophenolate Mofetil 250 mg. The drug is requested to treat lung transplant, 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 Mycophenolate Mofetil 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 Mycophenolate Mofetil. 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 Ursodiol. 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 Ursodiol 300 mg capsules. The drug is requested to treat Primary biliary cholangitis. The drug is a generic drug on Tier 3 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.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 Ursodiol.
Appeal type: Prescription Drug
Decision: Unfavorable

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified timeframe. If the Plan does not make a timely decision, this is considered a denial. The Plan forwarded this case to us as required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Sancoba purchased on October 4, 2019 while in Vietnam. The Plan did not grant this request. We received this case to conduct an independent review.Sancoba is not covered by Medicare because it was purchased outside the United States. Therefore, our decision is that the Part D Plan is not required to pay for Sancoba. 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

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified timeframe. If the Plan does not make a timely decision, this is considered a denial. The Plan forwarded this case to us as required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Oseltamivir Phosphate 75 mg capsule received August 27, 2019 while you were on the Cruise Ship. The Plan did not grant this request. We received this case to conduct an independent review.Oseltamivir Phosphate received August 27, 2019 while you were on the Cruise Ship is not covered by Medicare because it was purchased outside the United States. Therefore, our decision is that the Part D Plan is not required to pay for Oseltamivir Phosphate received August 27, 2019 while you were on the Cruise Ship. 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 Sirolimus Solution. 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 Sirolimus 1 mg/ml solution. The drug is requested to treat induced liver injury, oral cavity cancer, prevention of relapses of hepatitis and squamous cell carcinoma, which are off-label (non-FDA approved) uses. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted conditions. 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 conditions.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 Sirolimus Solution for the diagnosed conditions. 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 these conditions. 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 Sirolimus Solution. 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.