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

You asked the Plan to cover Guanfacine ER. 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 Guanfacine ER 2 mg. The drug is requested to treat hypertension. The prescriber has not indicated whyall 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 thePlan's coverage criteria is not supported. Our Physician Reviewer's opinion is that formulary exceptioncriteria 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 Guanfacine ER.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Hydroxychloroquine Sulfate. 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 Hydroxychloroquine Sulfate 200 mg. The drug is requested to treat osteoarthritis, which is an off-label(non-FDA approved) use. The Medicare-approved compendia do not contain any citations to support theuse of the requested drug, as prescribed, for treatment of the noted condition. Therefore, the requested drugis not being prescribed for a medically accepted indication as defined by Medicare law. As such, anexceptions request based on medical necessity cannot be considered because the requested drug, asprescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is noteligible for coverage under Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Hydroxychloroquine Sulfate 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 Hydroxychloroquine Sulfate.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 Diclofenac Epolamine 1.3% Patch. 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 Diclofenac Epolamine 1.3% Patch. The drug is requested to treat rib and back pain, cervicalgia andpleurodynia, 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 conditions.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 Diclofenac Epolamine 1.3% Patch for the diagnosedconditions. As a result, the drug is not being prescribed for a medically accepted indication as defined byMedicare law. As such, it cannot be covered under the Medicare Part D benefit for these conditions. Anexceptions request based on medical necessity cannot be considered because this drug, as prescribed, doesnot meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required toprovide coverage for Diclofenac Epolamine 1.3% Patch.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Fenofibrate. 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 a tiering exception for Fenofibrate. The drug is requested to treat your condition. The drug is a genericdrug on Tier 2 of the Plan's formulary. There are no available lower tier drugs on the Plan's formulary totreat your condition. Therefore, the drug is not eligible for a tiering exception. Our Physician Reviewer'sopinion 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 your condition. Therefore, ourdecision is the Plan is not required to provide a tiering exception for Fenofibrate.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for CombiPatch 0.05/0.14 mg. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law and Plan rules do not allow tiering exceptions for non-formulary drugs being covered through a formulary exception. The documentation in the record shows that CombiPatch 0.05/0.14 mg is currently being covered for the enrollee through a formulary exception. Therefore, our decision is the Plan is not required to provide a tiering exception for CombiPatch 0.05/0.14 mg.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Risedronate Sodium 150 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 a tiering exception for Risedronate Sodium 150 mg.Risedronate Sodium 150 mg is requested to treat post menopausal osteoporosis. Risendronate 150 mg is on tier 3 of the plan's formulary. The plan indicated in their notes that the enrollee has tried brand Actonel. The medical record from a patient encounter on June 8, 2020 states that the enrollee had side effects (myalgias/arthralgias) to Alendronate in the past, she needs a bisphosphonate, and she can only tolerate Risendronate 150 mg monthly, but insurance refuses to cover. It is also noted during the visit June 8, 2020 that the medication list includes both Ibandronate 150 mg and Risendronate 150 mg per month; it is noted that both drugs were started May 3, 2019, and requested/ordered for May 11, 2020. The plan has indicated in the case file that the requested drug is being covered at the cost-sharing listed in their drug guide. The prescriber has not provided sufficient documentation that all available lower tier alternatives on the Plan's formulary to treat the enrollee's condition (1) would not be as effective for the enrollee as the requested drug and/or (2) would have adverse effects for the enrollee. Therefore, an exception to these criteria is not supported. Our Physician Reviewer's opinion is that tiering exception criteria are not met.Medicare rules require a Plan to grant an exception to its tiering structure whenever it determines that the higher cost-sharing tiered drug for treatment of the enrollee's condition is medically necessary consistent with the prescriber's statement. Our Physician Reviewer's opinion is that tiering exception criteria are not met. Therefore, our decision is the Plan is not required to provide a tiering exception for Risedronate Sodium.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Calcitriol. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law requires that all drugs and biologicals used in the treatment of ESRD or AKI be included in the ESRD PPS payment bundle, regardless of the reason why the drug is being prescribed and regardless of whether or not the drug is furnished by a dialysis facility. Drugs that are always considered ESRD and AKI-related include access management drugs, anemia management drugs, anti-infectives to treat site access infection, bone and mineral metabolism drugs and cellular management drugs.In this case, Calcitriol is being prescribed to an enrollee who has ESRD or AKI and is on dialysis. Calcitriol is a class of medication which is always considered ESRD or AKI-related for purposes of the Part B ESRD payment bundle. Thus, the requested drug is eligible for coverage under the Part B ESRD payment bundle, regardless of the reason why the drug is being prescribed and regardless of whether or not the drug is being furnished by a dialysis facility. Drugs which are eligible for Part B coverage are excluded from Part D coverage by Medicare law. Therefore, our decision is the Part D Plan is not required to cover Calcitriol. 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.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Velphoro. 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 Velphoro.Velphoro is requested for treatment of hyperphosphatemia in this enrollee with end stage kidney disease on hemodialysis. You have indicated that the enrollee has previously tried calcium acetate, had gastrointestinal side effects to Auryxia, and has been on the requested drug since August 2019. Calcium acetate was added on May 2020 due to hypocalcemia. The Plan has indicated that Renvala and Sevelamer carbonate oral powder packet are on the Plan's formulary. You have indicated that the enrollee has been stable on the current treatment, and that a change is not recommended because of the possible side effects or risks of elevated phosphorus. You have not provided a sufficiently strong statement indicating that 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 Velphoro.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Nature-Throid. The Plan did not grant this request. We received this case to conduct an independent review. A written request for Reconsideration must be filed within 60 days from the date of the Plan's Redetermination Letter. This request was not filed within the required 60-day time limit. However, the case record reflects there is good cause for the late filing. Therefore the Reconsideration request is being processed. Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. We determined that Nature-Throid is not FDA approved for both safety and effectiveness by checking FDA sources. Therefore, the Plan is not required to cover Nature-Throid.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 provide a tiering exception for Oxycodone-Acetaminophen. The Plan did not grantthis 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 Oxycodone-Acetaminophen. The drug is requested to treat your condition. Thedrug is a brand drug on Tier 3 of the Plan's formulary. There are no available lower tier brand drugs on thePlan's formulary to treat your condition. Therefore, the drug is not eligible for a tiering exception. OurPhysician 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 your condition. Therefore, ourdecision is the Plan is not required to provide a tiering exception for Oxycodone-Acetaminophen.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for 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 a tiering exception for Prolia. The drug is requested to treat osteoporosis. The drug is on Tier 4 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 Prolia.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Zolpidem Tartrate, 5 mg tablet as prescribed. The Plan did not grant thisrequest. 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 Zolpidem Tartrate, 5 mg tablet, 30/30.The drug is requested to treat insomnia. Upon reconsideration, the prescribing physician has submitted anadditional statement and chart notes. The enrollee has tried and failed treatment with Trazodone. Thedocumentation submitted supports that the benefit of the requested medication outweighs risks. Theenrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorizationcriteria 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 Zolpidem Tartrate, 5 mg tablet as prescribed.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Insulin Aspartame-Insulin Aspart 70/30 100 unit/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 Insulin Aspartame-Insulin Aspart 70/30 100 unit/mL. The drug is requested to treat Type 2 diabetes mellitus. Insulin Aspartame-Insulin Aspart 70/30 100 unit/mL is not on the Plan's formulary. The prescriber states the formulary alternative Novolog has been effective for the enrollee. 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 Insulin Aspartame-Insulin Aspart.Please note: the request for a tiering exception (lower copayment) for Insulin Aspartame-Insulin Aspart was not reviewed. We cannot consider a tiering exception for a drug for which the Part D Plan is unable to provide coverage.Please note: the request reviewed is for generic Insulin Aspartame-Insulin Aspart, which is not on the Plan's 2020 formulary. When the Plan agrees to provide coverage for drugs that are not on the formulary they are covered at the Tier 4 copayment amount. Brand Novolog 70/30 is on the Plan's 2020 Formulary and is covered at the Tier 3 copayment level. You may wish to discuss the option of brand Novolog 70/30 which would result in a lower copayment (Tier 3).
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 cover a Compound prescription. The Plan did not grant this request. We received thiscase to conduct an independent review.Nystatin Suspension, part of a compound:We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Nystatin 100,000 unit/ml Suspension, part of a compound. The drug is requested to treat radiationesophagitis, which is an off-label (non-FDA approved) use. The Medicare-approved compendia do notcontain any citations to support the use of the requested drug, as prescribed, for treatment of the notedcondition. 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 Nystatin Suspension, part of a compound for the diagnosedcondition. As a result, the drug is not being prescribed for a medically accepted indication as defined byMedicare law. As such, it cannot be covered under the Medicare Part D benefit for this condition. Anexceptions request based on medical necessity cannot be considered because this drug, as prescribed, doesnot meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required toprovide coverage for Nystatin Suspension, part of a compound.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.Mintox Suspension and Allergy Child Liquid, parts of a compound:Medicare Part D does not cover non-prescription drugs. We checked FDA approved sources for the drug'sclassification or determined from other available resources that the drugs are non-prescription or OTCdrugs. Therefore, Mintox Suspension and Allergy Child Liquid, parts of a compound are not eligible forPart D coverage, and the Plan is not required to cover them under the Part D benefit.This decision does not address the medical necessity or appropriateness of the requested drug. It onlyestablishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Trokendi XR. 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 Trokendi XR.Trokendi XR is requested for ongoing use for treatment of migraine headaches. It is noted that the enrollee is also being treated with Botox. The Plan's denial letter states that Divalproex capsule delayed sprinkle is on their formulary. 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 Trokendi XR.