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 provide reimbursement for the Shingrix vaccine received December 11, 2019. ThePlan did not grant this request. We received this case to conduct an independent review.The Part D Plan covers certain vaccines purchased and/or administered out-of-network. If an enrolleereceives a vaccine from an out-of-network provider, the enrollee will generally have to pay the full cost forthe vaccine. The enrollee may then submit a request for reimbursement with proof of payment to ask thePlan to pay its share of the cost.In this case, the record shows that you were administered the Shingrix vaccine on December 11, 2019. Yousubmitted a request for reimbursement however, the record does not include proof of payment in full forthe vaccine. Additionally, on June 17, 2020 a representative from MAXIMUS Federal verified with thebilling department and verified that although you have been making payments for the vaccine, there is stilla balance that has not yet been paid. The Plan's criteria for out-of-network coverage and reimbursementhave not been met. Therefore, our decision is the Plan is not required to cover or provide reimbursement forthe Shingrix vaccine received December 11, 2019 at this time.Please note: once you have paid the remaining balance of the vaccine and its administration fee, you maywish to obtain a statement showing a zero balance and submit that to the Plan as proof of payment. Untilproof of payment is established, the Plan will not process the claims or provide reimbursement.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cyclobenzaprien HCL, 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 Cyclobenzaprine HCL, 10 mg tablet. The drug is requested to treat chronic muscle spasms (since1/18/2017), 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 Cyclobenzaprien HCL, 10 mg tablet 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 Cyclobenzaprien HCL, 10 mg tablet.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 Rivastigmine 4.5 mg/24 hr patch. 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 Plan was correct in denying the request for Rivastigmine 4.5 mg/24 hour patch.Rivastigmine 4.5 mg/24 hour patch is requested to treat dementia. The prescriber has not indicated that the enrollee has tried all alternatives required by the Plan (Rivastigmine capsule), or why the Plan's required step therapy drugs would likely not be as effective for the enrollee as the requested drug, and/or would likely cause adverse reactions or 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. A Plan must grant an exception 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 an exception to step therapy criteria is not met. Therefore, the Plan is not required to cover Rivastigmine 4.5 mg/24 hr patch.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ondansetron ODT. 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 Ondansetron ODT. The drug is requested to treat nausea associated with gastroesophageal reflux disease, gastritis and H.Pylori, which is an off-label (non-FDA approved) use. You clarified the medical history in the request for reconsideration dated June 2, 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 Ondansetron ODT 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 Ondansetron ODT. 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 Dronabinol. 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 Dronbinol 10 mg. Dronbinol 10 mg is requested for treatment of nausea, vomiting and abdominal painrelated to Bechet's disease with autonomic dysfunction, which is an off-label (non-FDA approved) use.You have explained how the requested drug has been beneficial for the enrollee; however the Medicareapprovedcompendia do not contain any citations to support the use of the requested drug, as prescribed, fortreatment of the noted condition. Therefore, the requested drug is not being prescribed for a medicallyaccepted indication as defined by Medicare law. As such, an exceptions request based on medical necessitycannot be considered because the requested drug, as prescribed, does not meet the definition of a MedicarePart D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the notedcondition.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 Dronabinol for the diagnosed condition. As a result, the drug isnot being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot becovered under the Medicare Part D benefit for this condition. An exceptions request based on medicalnecessity cannot be considered because this drug, as prescribed, does not meet the definition of a MedicarePart D drug. Therefore, our decision is that the Plan is not required to provide coverage for Dronabinol.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 Premarin. 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 Premarin cream 0.625 mg/gram.The drug is requested to treat the enrollee's condition. The drug is on Tier 3 of the Plan's formulary. Thereare no available (equivalent, branded) lower tier drugs on the Plan's formulary to treat the enrollee'scondition. 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 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 Premarin.
Appeal type: Prescription Drug
Decision: Unfavorable

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified timeframe. If the Plan does not make a timely decision, this is considered a denial. The Plan forwarded this case to us as required by Medicare rules because it did not make a timely decision.You asked the Plan to provide reimbursement for Doxycycline Hyclate purchased on October 17 and November 7, 2019, and February 26, 2020, from your pharmacy. The Plan did not grant this request. We received this case to conduct an independent review.Medicare rules allow a Part D Plan to apply coinsurance and copayments to covered drugs. If an enrollee pays the full cost of a prescription, the enrollee may submit a request for reimbursement with proof of payment to ask the Plan to pay its share of the cost. A request for reimbursement was submitted to the Plan. In this case, the Plan provided documentation showing that the 2019 claims were already reprocessed for coverage and applicable reimbursement by the Plan in March 2020. The Plan also documented that the 2020 claim was covered by the Plan at the time of purchase. The record shows that Doxycycline Hyclate was purchased for amounts that are less than or equal to the required copayment amount. The case record indicates that the Plan provided coverage in accordance with the Part D contract. Therefore, our decision is the Plan is not required to provide reimbursement for Doxycycline Hyclate purchased on October 17 and November 7, 2019, and February 26, 2020, from your pharmacy.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Gralise. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Gralise. The drug is requested to treat pain in leg unspecified and polyneuropathy unspecified, which is an off-label (non-FDA approved) use. Medical records from date of service May 7, 2020 were provided which support these diagnoses. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted conditions. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted conditions.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia that support the use of Gralise for the diagnosed 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 Gralise. This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

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 Nadolol. 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 Nadolol 80 mg tablet.The drug is requested to treat primary hypertension. The prescriber has not indicated why all alternativesrequired by the Plan (Atenolol, Metoprolol, Carvedilol, Bisoprolol, and Metoprolol Succinate ER) wouldlikely not be as effective for the enrollee as the requested drug; and/or would likely cause adversereaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is notsupported.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 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 Nadolol.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cayston. 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 Cayston 75 mg. The drug is requested to treat Pseudomonas aeruginosa infection related to lungtransplant, 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 Cayston for the diagnosed condition. As a result, the drug isnot being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot becovered under the Medicare Part D benefit for this condition. An exceptions request based on medicalnecessity cannot be considered because this drug, as prescribed, does not meet the definition of a MedicarePart D drug. Therefore, our decision is that the Plan is not required to provide coverage for Cayston.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 Epidiolex. 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 Epidiolex 100 mg/mL. The drug is requested to treat medically refractory multifocal epilepsy in theabsence of Lennox-Gastaut syndrome or Dravet syndrome, 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, asprescribed, for treatment of the noted condition. Therefore, the requested drug is not being prescribed for amedically accepted indication as defined by Medicare law. As such, an exceptions request based onmedical necessity cannot be considered because the requested drug, as prescribed, does not meet thedefinition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage underMedicare 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 Epidiolex for the diagnosed condition. As a result, the drug isnot being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot becovered under the Medicare Part D benefit for this condition. An exceptions request based on medicalnecessity cannot be considered because this drug, as prescribed, does not meet the definition of a MedicarePart D drug. Therefore, our decision is that the Plan is not required to provide coverage for Epidiolex.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 Arikayce. 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 Arikayce. The drug is requested to treat pulmonary mycobacterium avium complex infection. You havenot indicated why all alternatives required by the Plan would likely not be as effective for the enrollee asthe 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 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 Arikayce.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Modafinil 200 mg tablet. 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 Modafinil 200 mg tablet.Modafinil 200 mg tablet is requested to treat fatigue associated with multiple sclerosis. The prescriberclarified the medical history in the request for reconsideration dated June 4, 2020. For coverage under theprescription drug benefit, Medicare requires that the drug prescribed be used for a medically acceptedindication. Our Physician Reviewer found that the Medicare-approved resources do contain citations tosupport the use of the requested drug for treatment of the noted condition.Drugdex includes the following citation in the off label uses section of Modafinil: Rammohan KW,Rosenberg JH, Lynn DJ, et al: Efficacy and safety of modafinil (Provigil) for the treatment of fatigue inmultiple sclerosis: a two centre phase 2 study. J Neurol Neurosurg Psychiatry 2002; 72(2):179-183. Thedaytime sleepiness score (Epworth Sleep Scale) was significantly improved with modafinil 200 mg (7.2)and 400 mg (7) compared with placebo (9.5; p less than 0.001 for both comparisons).Therefore, the requested drug is being prescribed for a medically accepted indication.You do not satisfy the Plan's coverage criteria. The prescriber has indicated why all alternatives required bythe Plan would likely not be as effective as the requested drug for you, and/or would likely cause adversereaction(s) or other harm to you. Therefore, an exception to the Plan's coverage criteria is medicallynecessary. Our Physician Reviewer's opinion is that 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 met. Therefore, our decision is the Planis required to cover Modafinil 200 mg tablet.