Persius/hicric huggingface dataset:
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 Advair Diskus. 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 Advair Diskus 500-50 mcg/dose. Advair Diskus 500-50 mcg/dose is requested to treat an unknowndiagnosis. The prescriber was asked to state the enrollee's diagnosis, because there was no prescriberstatement of the enrollee's diagnosis in the case file. The prescriber was also asked to address medicalnecessity for the requested drug. A response from the prescriber was not received. Therefore, based on thecurrent record, there is insufficient documentation that the requested medication is being prescribed for amedically accepted indication as defined by Medicare law. In addition, an exceptions request based onmedical necessity cannot be considered because it cannot be confirmed that the drug meets the definition ofa Medicare Part D drug.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 Advair Diskus for the diagnosed condition. As a result, thedrug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, itcannot be covered under the Medicare Part D benefit for this condition. An exceptions request based onmedical necessity cannot be considered because this drug, as prescribed, does not meet the definition of aMedicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage forAdvair Diskus.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

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 Calquence 100 mg capsule, 60 capsules per 30 days. 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 Calquence 100 mg capsule, 60 capsules per 30 days. The drug is requested to treat relapsed chroniclymphocytic leukemia (CLL).You are a 70 year old man with CLL. You were treated in 2018 with six cycles ofBendamustine/Rituximab. You relapsed and were started on Calquence in February 2020 with positiveresponse and good tolerability. No other clinical information was submitted for review. The prescriberrequests Calquence to treat you as monotherapy. Per the FDA website, Calquence is indicated for thetreatment of adult patients with chronic lymphocyticleukemia (CLL) or small lymphocytic lymphoma(SLL). You have CLL.For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for amedically accepted indication. Our Physician Reviewer found that the Medicare-approved resources docontain citations to support the use of the requested drug for treatment of the noted condition. Therefore,the requested drug is being prescribed for a medically accepted indication. You satisfy the Plan's coveragecriteria. Our Physician Reviewer's opinion is that prior authorization criteria are met.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 reviewedthis file and determined that there are citations in the Medicare approved compendia that support the use ofCalquence 100 mg capsule, 60 capsules per 30 days, for the diagnosed condition. As a result,Calquence 100 mg capsule, 60 capsules per 30 days, is being prescribed for a medically accepted indicationas defined by Medicare law.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 Calquence 100 mg capsule, 60 capsules per 30days.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ibrance. 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 Ibrance. The drug is requested to treat esophageal cancer, which is an off-label (non-FDA approved)use. The enrollee is a 69 year old man with a history of pancreatic cancer in 2016. He now has progressiveadenocarcinoma of the gastro-esophageal junction that is locally advanced and is not a candidate forsurgery. His tumor is HER2 positive. He has been treated with Taxol, Carboplatin, Herceptin and radiation.PET scan on 7/7/20 showed progression of the cancer. Guardant360 testing identified a CDKN2A mutationsuggesting possible response to Palbociclib (Ibrance.) The prescriber requests Ibrance to treat him. Journalarticles and a abstract were submitted in support of the request and were reviewed.The Medicare-approved compendia do not contain any citations to support the use of the requested drug, asprescribed, for treatment of the noted condition. There was no peer-reviewed, clinically relevant, medicalliterature from an approved journal submitted to support this appeal. Therefore, the requested drug is notbeing prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptionsrequest based on medical necessity cannot be considered because the requested drug, as prescribed, doesnot meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverageunder Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. For Part D drugs used in an anticancer chemotherapeutic regimen, a medically acceptedindication means a use that is approved by the FDA or a use that is supported by one or more citations inMedicare approved compendia or peer-reviewed medical literature in CMS-approved journals orpublications.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia and there was no peer-reviewed literature from an approved journal submitted tosupport the use of Ibrance for the diagnosed condition. As a result, the drug is not being prescribed for amedically accepted indication as defined by Medicare law. As such, it cannot be covered under theMedicare Part D benefit for this condition. An exceptions request based on medical necessity cannot beconsidered 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 Ibrance.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 Rituxan. 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 Rituxan 10 mg/mL. The drug is requested to treat T86.10, Unspecified complication of kidney transplant (antibody mediated rejection), 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 Rituxan 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 Rituxan. 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 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 ZTLido. 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 ZTLido 1.8% Patch. The drug is requested to treat low back pain and neuropathy, 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 ZTLido for the diagnosed condition. As a result, the drug is notbeing 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 ZTLido.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 Colestipol 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 Colestipol HCL 1 gm tab. The drug is requested to treat bile acid diarrhea, which is an off-label (non-FDA approved) use. The prescriber clarified the diagnosis in a letter dated 7/8/2020. 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 Colestipol 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 Colestipol 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 Armodafinil. 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 Armodafinil. The drug is requested to treat narcolepsy. The enrollee does not satisfy the Plan's coveragecriteria. You sent a statement dated July 9, 2020 clarifying the medical history. Medical records wereprovided which document that the enrollee has Stage IV lung cancer and narcolepsy without cataplexy.You state that the enrollee has daytime somnolence from side effects of pain + anxiety meds. You wereasked to provide confirmation of a sleep lab evaluation for the diagnosis of narcolepsy. Sleep lab resultswere not provided. You have not sufficiently addressed the Plan's coverage criteria and/or have notindicated why all alternatives required by the Plan would likely not be as effective for the enrollee as therequested drug, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Our Physician'sopinion 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 Armodafinil.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Travatan. 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 Travatan. The drug is requested to treat the enrollee's condition. The drug is abrand drug on tier 3 of the Plan's formulary. There are no available lower tier brand drugs on the Plan'sformulary to treat the enrollee's 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 the enrollee's condition.Therefore, our decision is the Plan is not required to provide a tiering exception for Travatan.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Emgality. 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 Emgality. The drug is requested to treat the enrollee's condition. The drug is abrand drug on tier 4 of the Plan's formulary. There are no available lower tier brand drugs on the Plan'sformulary to treat the enrollee's 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 the enrollee's condition.Therefore, our decision is the Plan is not required to provide a tiering exception for Emgality.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Aristada 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 Aristada ER. The drug is requested to treat an unspecified mood disorder and autistic disorder, whichare off-label (non-FDA approved) uses. The Medicare-approved compendia do not contain any citations tosupport the use of the requested drug, as prescribed, for treatment of the noted conditions. Therefore, therequested drug is not being prescribed for a medically accepted indication as defined by Medicare law. Assuch, an exceptions 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 Aristada ER for the diagnosed condition. As a result, the drugis not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannotbe covered 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 Aristada 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 provide a tiering exception for Ventolin HFA. 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 Ventolin HFA. The drug is requested to treat chronic obstructive pulmonarydisease. The drug is a brand drug on Tier 4 of the Plan's formulary. In a statement dated June 24, 2020 youstated that the enrollee has tried and failed Advair, Albuterol, and Symbicort. You were then askedquestions to address the Plan's coverage/exception criteria. You were asked to specifically address theformulary lower tier alternative Proair HFA. A response from you was not received. You do not state whyall available lower tier alternatives on the Plan's formulary to treat the enrollee's condition (1) would not beas 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 tieringexception criteria are not met.Medicare rules require a Plan to grant an exception to its tiering structure whenever it determines that thehigher cost-sharing tiered drug for treatment of the enrollee's condition is medically necessary consistentwith the prescriber's statement. Our Physician Reviewer's opinion is that tiering exception criteria are notmet. Therefore, our decision is the Plan is not required to provide a tiering exception for Ventolin HFA.
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 Aztreonam. The Plan did not grant this request. We received this case toconduct an independent review.Medicare law specifically excludes coverage for any drug for which payment would be available underParts A or B of Medicare for that individual. Medicare Part B pays for services and supplies incident to theservice of a physician (or other practitioner).We requested additional medical information to determine if criteria for Medicare Part D have been met.We requested confirmation of how and where this drug is supplied and billed. A response to our requestwas not received in the timeframe required for review of this case. Aztreonam is a type of drug that is notusually self-administered. There is insufficient information to show that this drug is not eligible forMedicare Part B coverage. As a result, the record does not establish that Aztreonam is a Part D drug in thiscase. Therefore, it is our decision that the Part D Plan is not required to cover Aztreonam.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.Please contact the Plan for more information regarding coverage of Aztreonam under the Part B benefit.