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

You asked the Plan to provide a tiering exception for Prolia. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for a tiering exception for Prolia. The drug is requested to treat postmenopausal osteoporosis. The drug is on Tier 4 of the Plan's formulary. There are no available (equivalent biologic) lower tier drugs on the Plan's formulary to treat your 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 your condition. Therefore, our decision is the Plan is not required to provide a tiering exception for Prolia.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Nuedexta. 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 Nuedexta. The drug is requested to treat G30.1, Alzheimer's disease with late onset and F22, Delusionaldisorders, which are off-label (non-FDA approved) uses. In the appeal to the Plan dated March 26, 2020you listed the diagnoses as G30.1, Alzheimer's disease with late onset and F22, Delusional disorders. Thenin the Reconsideration request dated April 28, 2020 you stated that the enrollee had Pseudobulbar affect.This same appeal letter dated April 28, 2020 states that, Therapy initiated on 11/22/20 (sic) with effectiveresults. You were contacted and asked to provide medical records to support the diagnosis. Medicalrecords were not provided. The Medicare-approved compendia do not contain any citations to support theuse of the requested drug, as prescribed, for treatment of the noted conditions. 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 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 Nuedexta for the diagnosed conditions. 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 these conditions. 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 Nuedexta.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 Mycophenolate Mofetil as prescribed. 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 Mycophenolate Mofetil (MMF) (Cellcept).The drug is requested for ongoing treatment of systemic lupus erythematosus (SLE). For coverage underthe prescription 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.The following citation in DrugDex, a Medicare-approved compendium, supports the use of the requesteddrug for the enrollee's condition:Favorable efficacy and safety results of several clinical trials conducted over the past 10 years have led tothe adoption of MMF for the treatment of lupus nephritis and nonrenal lupus. [Curr Opin Rheumatol. 2011Sep;23(5):454-8. doi: 10.1097/BOR. 0b013e328349a1e5. Mycophenolate Mofetil in the treatment ofsystemic lupus erythematosus. Dall'Era M1.]Therefore, the requested drug is being prescribed for a medically accepted indication. The requested drug issubject to B versus D prior authorization criteria. The requested drug is not eligible for coverage under PartB rules. The enrollee satisfies the Plan's coverage criteria.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 ofMycophenolate Mofetil for the diagnosed condition. As a result, Mycophenolate Mofetil is beingprescribed for a medically accepted indication as 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 Mycophenolate Mofetil.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Dronabinol. 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 Dronabinol. The drug is requested to treat end stage renal disease, dependence on renal dialysis, and chronic pancreatitis, 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 Dronabinol 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 Dronabinol. 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 provide a tiering exception for Altace. The Plan did not grant this request. Wereceived this case to conduct an independent review.Medicare law and Plan rules do not allow tiering exceptions for non-formulary drugs being coveredthrough a formulary exception. The documentation in the record shows that Altace is currently beingcovered for the enrollee through a formulary exception. Therefore, our decision is the Plan is not requiredto provide a tiering exception for Altace.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Trokendi XR, 25 mg capsule, 30 per 30 days. The Plan did not grant thisrequest. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Trokendi XR, 25 mg capsule.The drug is requested to treat essential tremor and trigeminal neuralgia. The prescriber sent a letter on6/15/2020 clarifying the medical history. The prescriber states the enrollee takes the requested medicationsince 2018 for trigeminal neuralgia and essential tremor. 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.The following citation in DrugDex, a Medicare approved compendium, supports the use of the requesteddrug for the enrollee's condition:Topiramate compared with placebo resulted in a significant improvement in functional disability in asystematic review and meta-analysis of randomized trials in patients with essential tremor.Therefore, the requested drug is being prescribed for a medically accepted indication.The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that priorauthorization 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 ofTrokendi XR, 25 mg capsule, 30 per 30 days for the diagnosed condition. As a result, Trokendi XR, 25 mgcapsule, 30 per 30 days is being prescribed for a medically accepted indication as 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 Trokendi XR, 25 mg capsule, 30 per 30 days.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Myrbetriq ER. 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 Myrbetriq ER. The drug is requested to treat overactive bladder. 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 your 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 your condition. Therefore, our decision is the Plan is not required to provide a tiering exception for Myrbetriq ER.
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 Lipitor (Atorvastatin Calcium) 10 mg, Aspirin 325 mg,Claritin (Loratadine) 10 mg and Protonix (Pantoprazole Sodium) 40 mg received January 1, 2020 andJanuary 2, 2020. The Plan did not grant this request. We received this case to conduct an independentreview.The Part D Plan covers prescriptions filled at an out-of-network pharmacy only in certain limitedcircumstances. If an enrollee must use an out-of-network pharmacy, the enrollee will generally have to paythe full cost when the prescription is filled. The enrollee may submit a request for reimbursement withproof of payment to ask the Plan to pay its share of the cost.In this case, the record shows that you were a patient at the hospital from January 1, 2020 to January 2,2020. You received Lipitor (Atorvastatin Calcium) 10 mg, Aspirin 325 mg, Claritin (Loratadine) 10 mgand Protonix (Pantoprazole Sodium) 40 mg for a medical emergency or urgent care. You submitted arequest for reimbursement with a copy of an itemized hospital bill. However, the record does not includeproof of payment in full of the self-administered drug portion of the bill. Additionally, a representativefrom MAXIMUS Federal verified on June 16, 2020 that the self-administered drug portion of the bill hasnot yet been paid in full. The Plan's criteria for out-of-network coverage and reimbursement have not beenmet. Therefore, our decision is the Plan is not required to cover or provide reimbursement for Lipitor(Atorvastatin Calcium) 10 mg, Aspirin 325 mg, Claritin (Loratadine) 10 mg and Protonix (PantoprazoleSodium) 40 mg received January 1, 2020 and January 2, 2020 at this time.Please note: once you have paid the remaining balance of the self-administered drug portion of the bill,you may wish to obtain a statement showing a zero balance and submit that to the Plan as proof ofpayment. Until proof of payment is established, the Plan will not process the claims or providereimbursement.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Lumigan. 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 Lumigan. The drug is requested to treat glaucoma. The drug is on Tier 3 of thePlan's formulary. There are no available (branded) lower tier drugs on the Plan's formulary to treat theenrollee's condition. Therefore, the drug is not eligible for a tiering exception. Our Physician Reviewer'sopinion is that tiering exception criteria are not met.Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of thesame type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in alower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug isbeing used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met becausethere are no lower cost-sharing tiered drugs of the same type for treating the enrollee's condition.Therefore, our decision is the Plan is not required to provide a tiering exception for Lumigan.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lopressor. 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 Lopressor.Lopressor is requested for treatment of your condition. The Plan has indicated that several beta blockers areon their formulary. You have indicated that you have tried and failed and/or had adverse effects to some ofthe Plan's alternatives. Additional information requested from the prescriber regarding the appropriatenessof the formulary alternatives was not received. (Of note, the request for information form was returnedsigned, but none of the questions were answered.) The prescriber has not indicated why all alternativesrequired by the Plan would likely not be as effective for the enrollee as the requested drug; and/or wouldlikely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan'scoverage criteria is not supported. Our Physician Reviewer's opinion is that formulary exception criteria arenot 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 Lopressor.
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 Simponi. 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 Simponi 50 mg. The drug is requested to treat rheumatoid arthritis. The prescriber has not indicatedwhy all alternatives required by the Plan would likely not be as effective for the enrollee as the requesteddrug; and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exceptionto the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is that formularyexception 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 Simponi.
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.Additionally, drugs eligible to be covered under Parts A and/or B are considered available (and excludedfrom Part D) even if a beneficiary chooses not to pay premiums or if a beneficiary has enrolled in Part Bbut that coverage has not yet taken effect. Medicare records show that the enrollee is entitled to Part Bcoverage at this time, even though the beneficiary may have chosen not to pay premiums and/or coveragemay not have taken effect. Thus, Sensipar is not considered a Part D drug in this case. Therefore, ourdecision 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.You may wish to submit this request to the Medicare Part B carrier.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Repatha SureClick. The Plan did not grant this request. We received 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 the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) if the lower tier(s) on the formulary only contain(s) generic alternative drugs. Repatha SureClick is a Tier 3 biologic drug. The lower cost-sharing tier(s) only contain(s) generic alternative drugs. Therefore, our decision is the Plan is not required to provide a tiering exception for Repatha SureClick.
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 cover Polyethylene glycol 3350. The Plan did not grant this request. We received this case to conduct an independent review. Medicare Part D does not cover non-prescription drugs. We checked FDA approved sources for the drug's classification or determined from other available resources that the drug is a non-prescription or OTC drug. Therefore, Polyethylene glycol 3350 is not eligible for Part D coverage, and the Plan is not required to cover it under the Part D benefit.This decision does not address the medical necessity or appropriateness of the requested drug. It only establishes that payment cannot be made under the Medicare Part D benefit.