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

You asked the Plan to cover Zyprexa Relprevv. 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 Zyprexa Relprevv.The drug is requested to treat unspecified personality disorder, mood disorder and bipolar disorder withdepressed features without psychotic features, which are off-label (non-FDA approved) uses. TheMedicare-approved compendia do not contain any citations to support the use of the requested drugformulation, as prescribed, for treatment of the noted conditions. Therefore, the requested drug is not beingprescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions requestbased on medical necessity cannot be considered because the requested drug, as prescribed, does not meetthe definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage underMedicare 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 Zyprexa Relprevv for the diagnosed conditions. As a result, thedrug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, itcannot be covered under the Medicare Part D benefit for these conditions. An exceptions request based onmedical necessity cannot be considered because this drug, as prescribed, does not meet the definition of aMedicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage forZyprexa Relprevv.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 Vardenafil 20 mg, 10 per 25 days. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law states that a Plan is permitted to use a number of different tools or approaches to manage the coverage of drugs, including quantity limits. Medicare law allows for exceptions to a Plan's quantity limit for Part D drugs only. Vardenafil is not covered by Medicare Part D because it is a drug used to treat sexual or erectile dysfunction. In this case, the Plan is providing coverage for Vardenafil under the enrollee's supplemental benefits. Although the Plan is providing coverage for Vardenafil as a supplemental benefit, this does not make it a Part D drug. Since Vardenafil is not a Part D drug it is not subject to the Medicare exception process. As a result, there is nothing in the Medicare law or rules that require the Plan review or approve an exception to their quantity limit for Vardenafil. Therefore, it is our decision that the Plan is not required to provide a quantity limit exception for Vardenafil. This decision does not concern the medical appropriateness of the requested drug. It only establishes if an exception can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Naltrexone HCL Dihydrate. 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 Naltrexone HCL Dihydrate is not FDA approved for both safety and effectiveness by checking FDA sources. Therefore, the Plan is not required to cover Naltrexone HCL Dihydrate. 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 provide a tiering exception for Fetzima ER. 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 Fetzima ER 40mg capsule. The drug is requested to treat major depressivedisorder. The drug is on Tier 4 of the Plan's formulary. There are no available (branded) lower tier drugs onthe Plan's formulary to treat the enrollee's condition. Therefore, the drug is not eligible for a tieringexception. 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 Fetzima ER.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Azathioprine. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Azathioprine 50mg tablet. The drug is requested to treat posterior scleritis, 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 Azathioprine for the diagnosed condition. As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Azathioprine. This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Diclofenac 1% 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 1% gel. The drug is requested to treat pain from femur fracture, 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 1% 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 1% 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

You asked the Plan to cover Modafinil. 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 Modafinil 100 mg.The drug is requested to treat ICD-10 diagnosis code R40.0, Daytime Somnolence, which is an off-label (non-FDA approved) use. Please note that relevant medical records were requested with the Reconsideration appeal dated 3/18/2020. Medical records were not provided. 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 Modafinil 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 Modafinil. 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 Ingrezza. 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 Ingrezza 80 mg.The drug is requested to treat Tardive dyskinesia. 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 Ingrezza.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lidocaine 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 Lidocaine 5% patch. The drug is requested to treat an unclear diagnosis. The prescriber was asked to clarify the enrollee's diagnosis, because the submitted diagnosis was changed. The initial diagnosis submitted was ICD-10 code M15.0, Primary generalized (osteo)arthritis. The prescriber changed the diagnosis to post-herpetic neuralgia in a letter dated 3/13/2020. It was unclear from the case file if the underlying etiology of the enrollee's condition is osteoarthritis or post-herpetic neuralgia. The prescriber was also asked to address the Plan's prior authorization criteria. Relevant medical records to support the diagnosis were requested but were not provided. A response from the prescriber was not received. Therefore, based on the current record, there is insufficient documentation that the requested medication is being prescribed for a medically accepted indication as defined by Medicare law. In addition, prior authorization exception criteria are not met.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 needed additional information from the prescriber to determine whether the enrollee is using Lidocaine patch for an FDA-approved use, or a use listed in the Medicare-approved compendia. The requested information was not received. As a result, we could not confirm that the drug is being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit. An exceptions request based on medical necessity cannot be considered because it cannot be confirmed that the drug meets the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Lidocaine patch. 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 provide reimbursement for Duloxetine purchased on January 31, 2020, from the Pharmacy. The Plan did not grant this request. We received this case to conduct an independent review. Your appeal also involves a grievance.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. The Plan required a $141 copayment for a long-term (up to 90 days) supply of a Tier 3 drug purchased from a retail pharmacy in 2020. A request for reimbursement was submitted to the Plan. In this case, the Plan provided documentation showing that this claim was covered by the Plan at the time of purchase. The record shows that Duloxetine was purchased for an amount that is 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 Duloxetine purchased on January 31, 2020, from the Pharmacy.Your appeal also involves a grievance. Your complaint regarding the Plan's unclear explanation of changes of the price of Duloxetine is a grievance. A grievance is any complaint or dispute, other than one that involves a coverage determination or at-risk determination, expressing dissatisfaction with any aspect of the operations, activities, or behavior of a Part D plan. Grievance procedures are separate and distinct from appeal procedures. Medicare defines a coverage determination as (1) a decision not to provide or pay for a Part D drug, (2) failure to provide a coverage determination in a timely manner, when a delay would adversely affect the health of the enrollee, (3) a decision concerning an exceptions request, or (4) a decision on the amount of cost-sharing for a drug. (42 CFR ??423.560, 423.564(b), 423.566(b)).Since your complaint involves a grievance, the Part D Plan must review this complaint under the Plan's grievance procedures. Each Part D Plan must provide meaningful procedures for timely hearing and resolving grievances between enrollees and the Part D Plan (or any other entity or individual through whom the Part D Plan provides covered benefits under any Part D Plan it offers). At this time, you should contact the Plan for information on how to proceed with having this complaint reviewed under the Plan's grievance procedures. 42 CFR Section 423.564(a).
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Vyndamax. 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 Vyndamax is currently being covered for the enrollee through a formulary exception. Therefore, our decision is the Plan is not required to provide a tiering exception for Vyndamax.
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 0.625mg-gm cream. Premarin 0.625mg-gm cream is requested to treatyour condition. The requested drug is a brand drug on Tier 3 of the Plan's formulary. There are noavailable lower tier brand drugs on the Plan's formulary to treat your condition. Therefore, the requesteddrug is not eligible for a tiering exception. Our Physician Reviewer's opinion is that tiering exceptioncriteria 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

You asked the Plan to cover Klor-Con/EF. 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 Klor-Con/EF is not FDA approved for both safety and effectiveness by checking FDA sources. Therefore, the Plan is not required to cover Klor-Con/EF. 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 Armour Thyroid. The Plan did not grant this request. We received this case toconduct an independent review.Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. Wedetermined that Armour Thyroid is not FDA approved for both safety and effectiveness by checking FDAsources. Therefore, the Plan is not required to cover Armour Thyroid.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
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Eliquis, 5 mg tablet. The Plan did not grant this request. We received this case to conduct an independent review.Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in a lower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug is being used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met because there are no lower cost-sharing tiered drugs of the same type for treating the enrollee's condition. Therefore, our decision is the Plan is not required to provide a tiering exception for Eliquis, 5 mg tablet.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Estradiol, 0.5 mg tablet, as prescribed. 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 Estradiol, 0.5 mg.The drug is requested to treat post-surgical menopause. The prescriber clarified the diagnosis in a statement dated 3/31/2020. The physician states that he has assessed risk versus benefit in using this High Risk medication (HRM) in this enrollee and has confirmed that he would still like to continue therapy. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. Based on the available documentation, our Physician Reviewer's opinion is that prior approval criteria are met. Therefore, our decision is the Plan is required to cover Estradiol, 0.5 mg tablet, as prescribed.