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

You asked the Plan to provide reimbursement for Esomeprazole Magnesium DR 40 mg purchased June 8, 2020. 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. In this case, documentation in the record shows that the enrollee was in the deductible stage when Esomeprazole Magnesium DR 40 mg was purchased on June 8, 2020. During the deductible stage, the Plan requires that the enrollee pay the full cost of Tier 3, Tier 4 and Tier 5 drugs purchased in 2020 before the Plan would pay a share of the cost. Esomeprazole Magnesium DR 40 mg is on the Plan's 2020 formulary and classified as a Tier 3 drug. The Plan provided documentation showing that this claim was covered by the Plan at the time of purchase, and that the full cost of the purchase in dispute was applied to the required deductible amount. The case record indicates that the Plan provided coverage in accordance with the Part D Plan contract. Therefore, our decision is the Plan is not required to provide reimbursement for Esomeprazole Magnesium DR 40 mg purchased June 8, 2020.
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 Oxycodone HCL. 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 Oxycodone HCL 20 mg, 30 tablets per 30 days. Oxycodone HCL 20 mg is requested to treat anunknown diagnosis. You were asked to state the enrollee's diagnosis, because there was no prescriberstatement of the enrollee's diagnosis in the case file. You were also asked to address medical necessity forthe requested drug and to provide documentation to support the noted diagnosis. In addition, you wereasked questions to address the Plan's coverage/exception criteria. In a statement dated October 26, 2020,you stated that the desired accumulated morphine equivalent dose is 15 mg per day. Oxycodone HCL 20mg, 30 tablets per 30 days, provides a morphine equivalent dose of 30 mg per day. You were asked toaddress the enrollee's current cumulative Morphine Equivalent Dose (MED) dose. A response from youwas not received. Therefore, based on the current record, there is insufficient documentation to support anexception to the Plan's coverage criteria.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 Oxycodone HCL.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Pilocarpine HCL, 5 mg tablet for the 2021 Planbenefit year. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor a tiering exception for Pilocarpine HCL, 5 mg tablet.Pilocarpine HCL tablet, 5 mg is requested for treatment of the enrollee's condition. Pilocarpine HCL tablet,5 mg is on tier 3 of the Plan's formulary. There are no available lower tier drugs on the Plan's formulary totreat the enrollee's condition. Therefore, the drug is not eligible for a tiering exception. Our PhysicianReviewer'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 Pilocarpine HCL, 5 mgtablet for the 2021 Plan benefit year.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide reimbursement for Heplisav-B vaccine received July 10, 2020 and September 3, 2020. The Plan did not grant this request. We received this case to conduct an independent review.CMS publishes a list of participating brand name drug manufacturers that have signed the Medicare Coverage Gap discount agreement. The Heplisav-B vaccine received July 10, 2020 and September 3, 2020 is a brand name drug, and its manufacturer is not on this list. Therefore, the Part D Plan is not required to cover or provide reimbursement for Heplisav-B vaccine received July 10, 2020 and September 3, 2020.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Rivastigmine 9.5 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 Part D Plan was correct in denying the request for Rivastigmine 9.5 mg/24 hr patch.The drug is requested to treat Alzheimer's disease - Dementia. This diagnosis was clarified by the prescriber. For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of the requested drug for treatment of the noted condition. Therefore, the requested drug is being prescribed for a medically accepted indication.The prescriber stated that the enrollee tried and failed oral Rivastigmine and Donepezil. The prescriber further stated that the enrollee required a cholinesterase inhibitor. The prescriber was asked to provide medical records. No medical records were provided. 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 Rivastigmine 9.5 mg/24 hr patch.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Corlanor. 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 Corlanor.Corlanor is requested for treatment of postural orthostatic tachycardia syndrome, which is an off-label (non-FDA approved) use. You have outlined the enrollee's clinical history, and have discussed why Corlanor is being prescribed; 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 Corlanor 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 Corlanor. 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 us as required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Eszopiclone, 2 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 Eszopiclone, 2 mg.The drug is requested to treat insomnia. The prescriber states the enrollee has tried and failed Trazodone. Eszopiclone, 2 mg is not on the Plan's formulary. 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 Eszopiclone, 2 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Doxepin HCL. The Plan did not grant this request.We received 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 Doxepin HCL is currentlybeing covered for the enrollee through a formulary exception. Therefore, our decision is the Plan is notrequired to provide a tiering exception for Doxepin HCL.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Vyvanse, 70 mg capsule. 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 Vyvanse, 70 mg capsule.The drug is requested to treat attention deficit hyperactivity disorder. Vyvanse, 70 mg capsule is not on the Plan's formulary. 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 Vyvanse, 70 mg capsule.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lidocaine/Hydrocortisone/Acetate Kit . The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. We determined that Lidocaine/Hydrocortisone/Acetate Kit is not FDA approved for both safety and effectiveness by checking FDA sources. Therefore, the Plan is not required to cover Lidocaine/Hydrocortisone/Acetate Kit. 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.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Vitamin D2 50,000u. The Plan did not grant this request. We received this case to conduct an independent review.Medicare rules require a Part D Plan to issue a coverage decision or a redetermination decision within the specified timeframes. If the Plan does not make a timely decision, this is considered a denial. In these circumstances, the Plan is required to forward the coverage request or the redetermination request to the Part D QIC. The case record indicates multiple requests were submitted to the Plan. The Plan did not properly process these requests to move the case forward to the next appeal level. Therefore, the applicable time frames have been exceeded, and the Part D QIC has jurisdiction to process this case.Medicare law excludes certain drugs from Part D coverage. Vitamin D2 50,000u is one of those excluded drugs because it is a Prescription vitamin. The record submitted by the Plan does not indicate that they provide supplemental coverage for Vitamin D2 50,000u. Therefore, the Plan is not required to cover Vitamin D2 50,000u. 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.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to provide reimbursement for Primidone 50 mg, Atorvastatin 10 mg and Gabapentin 800 mg received August 12, 2020 and August 13, 2020. The Plan did not grant this request. We received this case to conduct an independent review.The Plan covers prescriptions filled at an out-of-network pharmacy only in certain limited circumstances. In this case, you received several self-administered drugs while at the hospital for an emergency or urgent care in August 2020. You are requesting reimbursement for Primidone 50 mg (National Drug Code (NDC) 6808420211), Atorvastatin 10 mg (NDC 6808409711) and Gabapentin 800 mg (NDC 6808480211) received during this stay. The Plan denied reimbursement on the basis that the products given were re-packaged. It is reasonable that a hospital would provide self-administered drugs that have been discontinued and/or repackaged. Proof of payment has been provided for these Part D eligible drugs.The Plan's out-of-network coverage rules were followed. Therefore, our decision is the Plan is required to provide coverage and reimbursement for Primidone 50 mg, Atorvastatin 10 mg and Gabapentin 800 mg received August 12, 2020 and August 13, 2020.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Azathioprine, 50 mg tablet. 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 Azathioprine, 50 mg.Azathioprine, 50 mg is requested for treatment of Stiff-man syndrome (G25.82) which is an off-label (non-FDA approved) use. The prescriber states that there are no FDA approved drugs for treatment of theenrollee's condition, and that common immunosuppressant medications are used to manage thisautoimmune condition; however 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 Azathioprine, 50 mg tablet for the diagnosed condition. 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 this condition. 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 Azathioprine, 50 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 provide a tiering exception for Tadalafil 5 mg. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law and Plan rules do not allow tiering exceptions for non-formulary drugs being covered through a formulary exception. The documentation in the record shows that Tadalafil 5 mg is currently being covered for you through a formulary exception. Therefore, our decision is the Plan is not required to provide a tiering exception for Tadalafil 5 mg.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Orencia, 125 mg/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 Orencia 125 mg/mL.The drug is requested to treat common variable immune deficiency-induced autoimmune enteropathy and colitis, which is an off-label (non-FDA approved) use. The prescriber clarified the diagnosis in a letter sent on December 4, 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 Orencia, 125 mg/mL 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 Orencia, 125 mg/mL. 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 Calcitriol . The Plan did not grant this request. We received this case to conduct an independent review.Medicare law requires that all drugs and biologicals used in the treatment of ESRD or AKI be included in the ESRD PPS payment bundle, regardless of the reason why the drug is being prescribed and regardless of whether or not the drug is furnished by a dialysis facility. Drugs that are always considered ESRD and AKI-related include access management drugs, anemia management drugs, anti-infectives to treat site access infection, bone and mineral metabolism drugs and cellular management drugs.In this case, Calcitriol is being prescribed to an enrollee who has ESRD or AKI and is on dialysis. Calcitriol is a class of medication which is always considered ESRD or AKI-related for purposes of the Part B ESRD payment 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 being furnished by a dialysis facility. Drugs which are eligible for Part B coverage are excluded from Part D coverage by Medicare law. Therefore, our decision is the Part D Plan is not required to cover Calcitriol. This decision does not concern the medical necessity or appropriateness of the requested drug. It only establishes 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

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 a tiering exception for BD UF Mini Pen Needle. The Plan did not grant this request. We received this case to conduct an independent review.A Part D Plan may establish tiered cost-sharing for drugs on its formulary of the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug). BD UF Mini Pen Needle is classified as a Tier 1 drug on the Plan's formulary. Tier 1 drugs are not eligible for a tiering exception because they are already classified as the lowest tier on the Plan's formulary. Therefore, our decision is the Part D Plan is not required to provide a tiering exception for BD UF Mini Pen Needle.