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

You asked the Plan to cover Stelara 90 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 Stelara 90 mg/mL.The drug is requested to treat pyoderma gangrenosum, which is an off-label (non-FDA approved) use. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted condition. 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 Stelara 90 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 Stelara 90 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

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 Antacid and Allergy Relief being used as ingredients in a compound drug. The Plan did not grant this request. We received this case to conduct an independent review. This request also involves Lidocaine being used as an ingredient in a compound drug.Medicare Part D does not cover non-prescription drugs. We checked FDA approved sources for the drugs' classification or determined from other available resources that the drugs are non-prescription or OTC drugs. Therefore, Antacid and Allergy Relief being used as ingredients in a compound drug are not eligible for Part D coverage, and the Plan is not required to cover them under the Part D benefit. This decision does not address the medical necessity or appropriateness of the requested drugs. It only establishes that payment cannot be made under the Medicare Part D benefit.We are dismissing the request for Lidocaine being used as an ingredient in a compound drug. The Plan has agreed to pay for Lidocaine, so there is no need for a reconsideration review. Contact the Plan to learn more about how and when the Plan will pay for Lidocaine.
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 Antacid and M-Dryl being used as ingredients in a compound drug. The Plan did not grant this request. We received this case to conduct an independent review. The request also involves Lidocaine and Nystatin being used as ingredients in a compound drug.Medicare Part D does not cover non-prescription drugs. We checked FDA approved sources for the drugs' classification or determined from other available resources that the drugs are non-prescription or OTC drugs. Therefore, Antacid and M-Dryl being used as ingredients in a compound drug are not eligible for Part D coverage, and the Plan is not required to cover them under the Part D benefit. This decision does not address the medical necessity or appropriateness of the requested drugs. It only establishes that payment cannot be made under the Medicare Part D benefit.We are dismissing the request for Lidocaine and Nystatin being used as ingredients in a compound drug. The Plan has agreed to pay for Lidocaine and Nystatin, so there is no need for a reconsideration review. Contact the Plan to learn more about how and when the Plan will pay for Lidocaine and Nystatin.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Ramelton 8 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 Ramelteon 8 mg. The drug is requested to treat insomnia. Upon reconsideration, you have submitted additional information and chart notes. You state that Belsomra is not appropriate for the enrollee due to interaction with the enrollee's additional medication Diltiazem. You have indicated why all alternatives 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 the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that formulary exception criteria are 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 met. Therefore, the Plan is required to cover Ramelton 8 mg tablet.Please note that if the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The health plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will notify you in writing that the case is being reviewed again and the outcome of the reopening.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lidocaine-Prilocaine. The Plan did not grant this request. We received thiscase to conduct an 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, Lidocaine-Prilocaine is being prescribed to an enrollee who has ESRD or AKI and is ondialysis. Lidocaine-Prilocaine is a class of medication which is always considered ESRD or AKI-related forpurposes of the Part B ESRD payment bundle. Thus, the requested drug is eligible for coverage under thePart B ESRD payment bundle, regardless of the reason why the drug is being prescribed and regardless ofwhether or not the drug is being furnished by a dialysis facility. Drugs which are eligible for Part Bcoverage are excluded from Part D coverage by Medicare law. Therefore, our decision is the Part D Plan isnot required to cover Lidocaine-Prilocaine.This decision does not concern the medical necessity or appropriateness of the requested drug. It onlyestablishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Mycophenolate Mofetil, 500 mg tablet. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for a tiering exception for Mycophenolate Mofetil, 500 mg tablet.The drug is requested to treat interstitial lung disease. Mycophenolate Mofetil, 500 mg tablet is a generic drug on Tier 3 of the Plan's formulary. The prescriber does not state why all available lower tier alternatives on the Plan's formulary to treat the enrollee's condition (1) would not be as effective for the enrollee as the requested drug and/or (2) would have adverse effects for the enrollee. Therefore, an exception to these criteria is not supported. Our Physician Reviewer's opinion is that tiering exception criteria are not met.Medicare rules require a Plan to grant an exception to its tiering structure whenever it determines that the higher cost-sharing tiered drug for treatment of the enrollee's condition is medically necessary consistent with the prescriber's statement. Our Physician Reviewer's opinion is that tiering exception criteria are not met. Therefore, our decision is the Plan is not required to provide a tiering exception for Mycophenolate Mofetil, 500 mg tablet.
Appeal type: Prescription Drug
Decision: Favorable

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 Repatha Sureclick. 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 Repatha Sureclick 140 mg/ml. Repatha Sureclick 140 mg/ml is requested for ongoing treatment ofprimary hyperlipidemia in a patient without clinical atherosclerotic cardiovascular disease (ASCVD), andstatin intolerance. The enrollee does not satisfy the Plan's coverage criteria. The prescriber has indicatedwhy all alternatives required by the Plan would likely not be as effective as the requested drug for theenrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, anexception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is thatprior 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 Repatha Sureclick.Please note that if the Plan does not agree with our decision, they can ask us toopen a case again. We only open a case again if we believe there was a mistake or if there is newinformation to review. The health plan has to show us the mistake and/or send us the new information. Thisdoes not happen often. If we decide to open the case again, we will notify you in writing that the case isbeing reviewed again and the outcome of the reopening.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Diclofenac 3% gel. 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 Diclofenac Sodium 3% Gel. The drug is requested to treat hip pain due to trochanteric bursitis, which is an off-label (non-FDA approved) use. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted condition. 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 Diclofenac 3% gel 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 Diclofenac 3% gel. 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 Esbriet. 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 Esbriet. The drug is requested to treat idiopathic pulmonary fibrosis. You do not satisfy the Plan'scoverage criteria (forced vital capacity pulmonary function testing was 47% of predicted -prior authorization criteria require this measurement to be at least 50%). The prescriber has not sufficientlyaddressed the Plan's coverage criteria and/or has not indicated why all alternatives required by the Planwould likely not be as effective for you as the requested drug, and/or would likely cause adverse reaction(s)or other harm to you. 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 Esbriet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Hydroxychloroquine Sulfate and Methotrexate. ThePlan 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 Hydroxychloroquine Sulfate and Methotrexate. The drugs are requested to treatthe enrollee's condition. The drugs are generic drugs on Tier 2 of the Plan's formulary. There are noavailable lower tier drugs on the Plan's formulary to treat the enrollee's condition. Therefore, the drugs arenot eligible for a tiering exception. Our Physician Reviewer's opinion is that tiering exception criteria forHydroxychloroquine Sulfate and Methotrexate 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 HydroxychloroquineSulfate and Methotrexate.You asked the Plan to cover Folic Acid. The Plan did not grant this request. We received this case toconduct an independent review.Medicare law excludes certain drugs from Part D coverage. Folic Acid is one of those excluded drugsbecause it is a prescription vitamin and mineral product. The record submitted by the Plan does not indicatethat they provide supplemental coverage for Folic Acid. Therefore, the Plan is not required to cover FolicAcid.This decision does not address the medical necessity or appropriateness of the requested drug. It onlyestablishes that payment cannot be made under the Medicare Part D benefit.PLEASE NOTE: the Plan indicates Folic Acid will pay under the supplemental portion of the benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Hydroxychloroquine Sulfate, 200 mg tablet, 60 per 30 days. The Plan did notgrant 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 Hydroxychloroquine Sulfate, 200 mg tablet.The drug is requested to treat cutaneous sarcoidosis, which is an off-label (non-FDA approved) use. TheMedicare-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 Hydroxychloroquine Sulfate, 200 mg tablet, 60 per 30 days forthe diagnosed condition. As a result, the drug is not being prescribed for a medically accepted indication asdefined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit for thiscondition. An exceptions request based on medical necessity cannot be considered because this drug, asprescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Planis not required to provide coverage for Hydroxychloroquine Sulfate, 200 mg tablet, 60 per 30 days.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

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 Quinine Sulfate, 324 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 Quinine Sulfate, 324 mg capsule. The drug is requested to treat the enrollee's condition. A request for prescriber statement was sent and not returned. The enrollee does not satisfy the Plan's coverage criteria. The prescriber has not sufficiently addressed the Plan's coverage criteria and/or 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. Our Physician's opinion is that neither prior authorization nor prior authorization exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. A Plan must grant an exception to prior approval rules if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on the available documentation, our Physician Reviewer's opinion is that an exception to prior approval criteria is not met. Therefore, the Plan is not required to cover Quinine Sulfate, 324 mg capsule.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Basaglar Qwikpen 100 units/mL. The Plan did not grant this request. We received this case to conduct an independent review.We asked a Physician Reviewer to determine whether the Plan was correct in denying the request for Basaglar Qwikpen 100 units/mL, which is not on the Plan's formulary. Our Physician Reviewer needed additional information from the prescriber to make this determination. The prescriber was asked to address whether the drugs offered by the Plan would: (1) not be as effective as the requested non-formulary drug; and/or (2) have adverse effects. The requested information was not received. Based on a review of the available documentation, 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 Basaglar Qwikpen 100 units/mL.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Envarus XR. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law specifically excludes coverage for any drug under the Part D program for which payment would be available under Parts A or B of Medicare for that individual. Coverage is available under Medicare Part B for prescription drugs used in immunosuppressive therapy furnished to a beneficiary who has received an organ transplant, provided that Medicare Part A paid for the transplant in question. The case record indicates that Envarus XR is needed for a kidney transplant performed June 16, 2020. According to the case record, the transplant in question was paid for by Medicare Part A. Thus, the transplant is considered a Medicare covered transplant and Envarus XR is eligible for coverage under Medicare Part B. Drugs which are eligible for Part B coverage are excluded from Part D coverage by Medicare law. Therefore, our decision is that Part D Plan is not required to cover Envarus XR. 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.