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

You asked the Plan to cover Ajovy 225 mg/1.5 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 Ajovy 225 mg/1.5 mL.Ajovy 225 mg/1.5 mL is requested to decrease headaches in this enrollee with chronic migraine headaches who has failed Topamax. The Plan has indicated in their denial letter that Aimovig and Emgality are on their formulary. The prescriber states that Aimovig is unaffordable, and that the patient is ineligible for the manufacturer bridge program. 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 Ajovy 225 mg/1.5 mL.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tacrolimus, 1 mg capsule. 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 Tacrolimus, 1 mg.The drug is requested to treat polymyositis, interstitial lung disease, and anti-synthetase syndrome, 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 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 Tacrolimus, 1 mg capsule for the diagnosed conditions. 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 these conditions. 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 Tacrolimus, 1 mg capsule.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 Januvia. The Plan did not grant this request. Wereceived this case to conduct an independent review.Medicare rules do not require the Part D plan to grant a tiering exception for a brand or biologic drug of thesame type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) ifthe lower tier(s) on the formulary only contain(s) generic alternative drugs. Januvia is a Tier 2 brand drug.The lower cost-sharing tier(s) only contain(s) generic alternative drugs. Therefore, our decision is the Planis not required to provide a tiering exception for Januvia.
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 Xtandi. The Plan did not grant this request. Wereceived this case to conduct an independent review.If a Plan maintains a specialty tier, the Plan may design its exception process so that drugs placed in thespecialty tier are not eligible for a tiering exception. Xtandi is in the specialty tier. The record indicates thePlan has chosen to exclude the specialty tier from the tiering exception process. Therefore, the Plan is notrequired to provide a tiering exception for Xtandi.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Evoxac. 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 Evoxac 30 mg. The drug is requested to treat sicca syndrome. The prescriber has not indicated why allalternatives 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 Evoxac.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover and provide reimbursement for Esomeprazole Magnesium 40 mg. The Plan didnot grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Plan was correct in denying the request forEsomeprazole Magnesium DR 40 mg. Esomeprazole Magnesium DR 40 mg is requested to treatlaryngopharyngeal reflux and K21.9 Gastro-esophageal reflux disease without esophagitis. You clarifiedthe diagnoses in a statement. For coverage under the prescription drug benefit,Medicare requires that the drug prescribed be used for a medically accepted indication. Our PhysicianReviewer found that the Medicare-approved resources do contain citations to support the use of therequested drug for treatment of the noted condition. Therefore, the requested drug is being prescribed for amedically accepted indication. You have not indicated that the enrollee has tried all alternatives required bythe Plan, or why the Plan's required step therapy drugs would likely not be as effective for the enrollee asthe requested drug, and/or would likely cause adverse reactions or other harm to the enrollee. OurPhysician Reviewer's opinion is that neither step therapy or step therapy exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring step therapy for certain drugs. APlan must grant an exception if it determines that the requested drug is medically necessary, consistent withthe prescriber's statement. Based on a review of the available documentation, our Physician Reviewer'sopinion is that an exception to step therapy criteria is not met. Therefore, the Plan is not required to coveror provide reimbursement for Esomeprazole Magnesium 40 mg purchased prior to approval of coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Sensipar. The Plan did not grant this request. We received this case to conductan independent review.Medicare law requires that all drugs and biologicals used in the treatment of ESRD or AKI be included inthe ESRD PPS payment bundle, regardless of the reason why the drug is being prescribed and regardless ofwhether or not the drug is furnished by a dialysis facility. Drugs that are always considered ESRD andAKI-related include access management drugs, anemia management drugs, anti-infectives to treat siteaccess infection, bone and mineral metabolism drugs and cellular management drugs.In this case, Sensipar is being prescribed to an enrollee who has ESRD or AKI and is on dialysis. Sensiparis a class of medication which is always considered ESRD or AKI-related for purposes of the Part B ESRDpayment 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 beingfurnished by a dialysis facility. Drugs which are eligible for Part B coverage are excluded from Part Dcoverage by Medicare law. Therefore, our decision is the Part D Plan is not required to cover Sensipar.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.
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 Hydrocodone/Acetaminophen purchased at your pharmacy.The Plan did not grant this request. We received this case to conduct an independent review.We asked a Physician Reviewer to determine whether the Plan was correct in denying the quantity ofHydrocodone/Acetaminophen requested. Our Physician Reviewer neededadditional information from the prescriber to make this determination. We asked the prescriber to addresswhy it is medically necessary for you to have a greater quantity than that allowed by the Plan for a firsttime fill. The requested information was not received. Based on a review of the available documentation,our Physician Reviewer's opinion is that an exception to the quantity limit criteria for a first time fill forHydrocodone/Acetaminophen is not met.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 andnecessary, 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 for a first time fill is notmet. Therefore, the Plan is not required to cover or reimburse the requested quantity ofHydrocodone/Acetaminophen purchased at you pharmacy.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Diovan. 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 Diovan 160 mg. The drug is requested to treat hypertension. 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 Diovan.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Trazodone 300 mg tablet. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for a tiering exception for Trazodone 300 mg tablet. The drug is requested to treat dyssomnia in an enrollee with major depressive disorder. You sent a letter clarifying the medical history. Medical records were provided which support these diagnoses. Trazodone 300 mg tablet is a generic drug on Tier 3 of the Plan's formulary. Trazodone HCL 150 mg and 100 mg oral tablets are on Tier 1 of the Plan's formulary. You do not state why 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 Trazodone 300 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Zilretta. 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 Zilretta 32 mg. Zilretta 32 mg is requested for treatment of osteoarthritis involving the knee. It is notedthat the enrollee has tried and failed Tylenol, Naproxen, and Celebrex. The plan has indicated that otherinjectable corticosteroids are on their formulary. The prescriber states that Zilretta is the most appropriateinjection to use in diabetic patients. It is stated in the medical record that the enrollee has previouslyreceived corticosteroid injections in her other knee, and that caution is recommended given the enrollee'shistory of diabetes. There is no documentation that other intra-articular steroid injections resulted inworsening glycemic control. The prescriber has not provided sufficient documentation that all alternativesrequired by the Plan would likely not be as effective as the requested drug for the enrollee, and/or wouldlikely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan'scoverage criteria is not medically necessary. Our Physician Reviewer's opinion is that formulary exceptioncriteria are not metA 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 Zilretta.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lynparza. 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 Lynparza. The drug is requested to treat Primary Mediastinal Nonseminomatous Germ Cell Tumor, 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. There was no peer-reviewed, clinically relevant, medical literature from an approved journal submitted to support this appeal. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted condition.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. For Part D drugs used in an anticancer chemotherapeutic regimen, a medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia or peer-reviewed medical literature in CMS-approved journals or publications.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia and there was no peer-reviewed literature from an approved journal submitted to support the use of Lynparza 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 Lynparza. 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 EEMT DS. The Plan did not grant this request. We received this case toconduct an independent review.Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. Wedetermined that EEMT DS is not FDA approved for both safety and effectiveness by checking FDAsources. Therefore, the Plan is not required to cover EEMT DS.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 Repatha SureClick 140 mg/mL. 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 Repatha SureClick 140 mg/mL.The drug is requested to treat hyperlipidemia in an enrollee with clinical atherosclerotic cardiovasculardisease. The prescriber sent a letter clarifying the medical history. The prescriber states theenrollee has tried and failed or had adverse effects with Atorvastatin, Crestor and Pravastatin. RepathaSureclick is not on the Plan's formulary. Praluent is on the Plan's formulary. The prescriber has 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. Therefore, anexception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is thatformulary 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 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 Repatha SureClick 140 mg/mL.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ofev, 150 mg capsule. The Plan did not grant this request. We received thiscase to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Ofev, 150 mg capsule.The drug is requested to treat systemic sclerosis associated interstitial lung disease. The enrollee does notsatisfy the Plan's coverage criteria. The prescriber has not sufficiently addressed the Plan's coverage criteriaand/or has not indicated why all alternatives required by the Plan (cyclophosphamide) would likely not beas effective for the enrollee as the requested drug, and/or would likely cause adverse reaction(s) or otherharm to the enrollee. A request for clarification was sent to the prescriber, as a notation indicating thatcyclophosphamide was not appropriate for the enrollee, was added at the reconsideration level. On thereturned information no additional detail was given as to why the Plan's required drug (cyclophosphamide)would not be appropriate for the enrollee's condition. Our Physician's opinion is that neither priorauthorization 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 Ofev, 150 mg capsule.
Appeal type: Prescription Drug
Decision: Partially Favorable

You asked the Plan to cover Dalfampridine ER 10 mg tablet. 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 Dalfampridine ER 10 mg tablet. Dalfampridine ER 10 mg tablet is requested to improve ambulation andother symptoms associated with the enrollee's diagnosis of multiple sclerosis. It is noted that the enrolleehas been treated with the requested medication for several years with improvement in symptoms; howeverhas been off it the last 2 - 3 months due to insurance issues. Documentation has been provided of a 25 feetwalking time with a walker of 40 seconds. The enrollee satisfies the Plan's coverage criteria. Our PhysicianReviewer's opinion is that prior authorization criteria are met.It is also our decision that the Plan is not required to provide a tiering exception for Dalfampridine ER. If aPlan maintains a specialty tier, the Plan may design its exception process so that drugs placed in thespecialty tier are not eligible for a tiering exception. Dalfampridine ER 10 mg tablet is in the specialty tier.The record indicates the Plan has chosen to exclude the specialty tier from the tiering exception process.Therefore, the Plan is not required to provide a tiering exception for Dalfampridine ER 10 mg tablet.