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

You asked the Plan to cover Lidocaine 5% patch. The Plan did not grant this request. We received this caseto conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Lidocaine 5% patch. Lidocaine 5% patch is requested for ongoing treatment of chronic back pain.Additionally, it is noted that the enrollee has osteoarthritis affecting multiple joints including the right hip.The enrollee's medication list includes, but is not limited to, over the counter Acetaminophen preparations,as well as Celebrex, Skelaxin and Hydrocodone.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. Drugdexcites the following medical reference in the Comparative Efficacy section of their Lidocaine monograph inthe discussion of chronic back pain, and chronic osteoarthritis of the hip and knee, for multiple drugs:Krebs EE, Gravely A, Nugent S, et al: Effect of opioid vs nonopioid medications on pain-related functionin patients with chronic back pain or hip or knee osteoarthritis pain: the SPACE randomized clinical trial.JAMA 2018; 319(9):872-882.The study demonstrated that among patients with chronic back pain or hip or knee osteoarthritis pain,treatment with opioids compared with nonopioid medications did not result in significantly better painrelatedfunction over 12 months, and that opioids caused significantly more medication-related adversesymptoms than nonopioid medications. The noted reference states that topical Lidocaine was included inthe nonopioid prescribing strategy. Therefore, the requested drug is being prescribed for a medicallyaccepted indication.The enrollee does not satisfy the Plan's coverage criteria. However, the prescriber has indicated why allalternatives required by the Plan would likely not be as effective as the requested drug for the enrollee,and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to thePlan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that prior authorizationexception 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 met. Therefore, our decision is the Planis required to cover Lidocaine 5% patch.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Voriconazole. 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. Voriconazole is in the specialty tier. The recordindicates the Plan has chosen to exclude the specialty tier from the tiering exception process. Therefore, thePlan is not required to provide a tiering exception for Voriconazole.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Soliris. 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 Soliris. The drug is requested to treat recurrent C3 nephropathy, which is an off-label (non-FDAapproved) use. The Medicare-approved compendia do not contain any citations to support the use of therequested drug, as prescribed, for treatment of the noted condition. 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. 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 Soliris 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 Soliris.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 Cutaquig. 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 Cutaquig Sol 4 gm/24 ml. The drug is requested to treat nonfamilial hypogammaglobulinemia/primary immune deficiency disease. Upon reconsideration, you submitted additional information. You stated that the enrollee has a diagnosis of nonfamilial hypgammaglobulinemia D80.1. You also stated that the requested medication will be administered in the home. The requested drug is not eligible for coverage under Medicare Part B. 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 Cutaquig
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Azathioprine. 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 Azathioprine 50 mg.Azathioprine 50 mg is requested for ongoing treatment of psoriatic arthritis, which is an off-label (non-FDA approved) use. The prescriber has indicated that the enrollee has failed multiple medications including several biologic drugs, and has been stable since 2019 on the requested drug; however 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 Azathioprine 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 Azathioprine. 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 Vosevi. 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 Vosevi for an additional 12 weeks. Vosevi is requested for an additional 12 weeks to treat chronichepatitis C, genotype 1a, with compensated cirrhosis, with relapse after prior treatment with Epclusa. Forcoverage 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 do contain citations to support the useof the requested drug for treatment of the noted condition. The following citation in DrugDex, a Medicareapproved compendium, supports the use of the requested drug for the enrollee's condition:Sofosbuvir/Velpatasvir/Voxilaprevir is indicated to treat chronic hepatitis C virus (HCV) infection (anysubtype of genotype 1) in patients who have had previous treatment with a regimen containing an NS5Ainhibitor and who do not have cirrhosis or who have compensated cirrhosis (Child-Pugh A) . Therefore,the requested drug is being prescribed for a medically accepted indication.The documentation submitted indicates that the enrollee has had 12 weeks of treatment with Vosevi plusRibavirin, and that the prescriber is requesting an additional 12 weeks of treatment with Vosevi to be usedin combination with Ribavirin. The prescriber states that the enrollee's viral load has decreased withtreatment with Vosevi plus Ribavirin but that there is still evidence of a viral load present, which wasmeasured at 2057 IU/mL on 2/27/2020. The requested regimen is not supported in the AmericanAssociation for the Study of Liver Diseases (AASLD) guidelines for the treatment of Hepatitis C.The enrollee does not satisfy the Plan's coverage criteria. The prescriber has not sufficiently addressed thePlan's coverage criteria and/or has not indicated why all alternatives required by the Plan would likely notbe as effective for the enrollee as the requested drug, and/or would likely cause adverse reaction(s) or otherharm to the enrollee. Our Physician's opinion is that neither prior authorization nor prior authorizationexception 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 Vosevi.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Soliris. 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 Soliris 300 mg/30 mL.Soliris 300 mg/30 mL is requested for treatment of antibody mediated rejection with new onset donor specific antibodies in this enrollee who is status post heart transplant in 1999, which is an off-label (non-FDA approved) use. The prescriber has discussed the rationale for prescribing the requested drug, and has provided medical literature supporting the use the requested drug for treatment of renal transplant patients with antibody mediated rejection; however the Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of antibody mediated rejection in heart transplant patients. 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 Soliris 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 Soliris. This decision does not concern the medical necessity
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lidocaine 5% Ointment. 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 Lidocaine 5% Ointment.The drug is requested to treat pain due to lower extremity (traumatic) compartment syndrome, neck pain, and back pain, 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 Lidocaine 5% Ointment 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 Lidocaine 5% Ointment. 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 Levemir. The Plan did not grant this request. We received this case to conductan independent review. You also requested we consider reimbursement for Levemir.We asked our Physician Reviewer to determine whether the Plan was correct in denying the request forLevemir Flextouch 100 units/mL.Levemir Flextouch 100 units/mL is requested to treat diabetes. The prescriber has not indicated that theenrollee has tried all alternatives required by the Plan, or why the Plan's required step therapy drugs wouldlikely not be as effective for the enrollee as the requested drug, and/or would likely cause adverse reactionsor other harm to the enrollee.Our Physician 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 coverLevemir.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Albuterol Sulfate neb sol. The Plan did not grant this request. We received thiscase to conduct an independent review.Medicare law specifically excludes coverage for any drug for which payment would be available under PartA or Part B of Medicare for that individual. Medicare Part B may pay for supplies necessary for theeffective use of durable medical equipment, including drugs and biologicals which must be put directly intothe equipment in order to achieve the therapeutic benefit of the durable medical equipment. Medicare PartB local policy states that a small volume nebulizer and related compressor are covered when medicallynecessary to administer Albuterol Sulfate neb sol for the management of obstructive pulmonary disease.In this case, the record shows that Albuterol Sulfate neb sol is administered through a nebulizer in the homefor a diagnosis of J45.909 - Unspecified asthma, uncomplicated. There is no indication that it is notadministered through a small volume nebulizer. It appears that this medication is eligible for coverageunder Part B rather than Part D. Drugs which are eligible for coverage under Part B are excluded from PartD coverage by Medicare law. Therefore, it is our decision that the Part D Plan is not required to coverAlbuterol Sulfate neb sol.This decision does not concern the medical necessity or appropriateness of the requested drug. It onlyestablishes if payment can be made under the Medicare Part D benefit.You may wish to submit this request to the Medicare Part B carrier.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Promethazine HCL. The Plan did not grant this request. We received this caseto conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Promethazine 25 mg. The drug is requested to treat nausea due to migraine, which is an off-label (non-FDA approved) use. The Medicare-approved compendia do not contain any citations to support the use ofthe requested drug, as prescribed, for treatment of the noted condition. 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. 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 Promethazine 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, 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 forPromethazine HCL.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 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 250 mg. The drug is requested to treat multiple sclerosis related fatigue, which is an offlabel(non-FDA approved) use. The Medicare-approved compendia do not contain any citations to supportthe use of the requested drug, as prescribed, for treatment of the noted condition. Therefore, the requesteddrug is 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 Armodafinil 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 Armodafinil.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 Synthroid. 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 Synthroid 88 mcg.The drug is requested to treat hypothyroidism. The drug is on tier 4 of the Plan's formulary. There are no available lower tier brand 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 Synthroid.