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

We previously requested additional information from the prescriber to determine whether the Plan's formulary exception criteria for Estradiol 0.01% Cream were satisfied. We did not receive the information from the prescriber. As a result, we issued an unfavorable reconsideration decision. We subsequently received the additional information previously requested from the prescriber. We reopened this appeal to conduct a second review with the additional information.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Estradiol 0.01% Cream. Estradiol 0.01% Cream is requested to treat atrophic vaginitis. Upon the reopening of this case, the prescriber statement was returned. The prescriber has not indicated why all alternatives required by the Plan (Premarin vaginal cream, Estradiol vaginal insert, and Yuvafem vaginal insert) 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 Estradiol 0.01% Cream.This decision affirms our previous unfavorable decision.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tudorza Pressair, 400 mcg/act. 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 Tudorza Pressair 400 mcg/act.The drug is requested to treat emphysema. Additional medical information was requested by the Part D QIC. The prescribing physician was asked to address the diagnosis and formulary alternatives tried and failed. The prescriber has not indicated why all alternatives required by the Plan (Atrovent HFA and Incruse Ellipta) 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 Tudorza Pressair, 400 mcg/act.
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 Indomethacin. 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 Indomethacin 50 mg capsule. Indomethacin 50 mg capsule is requested to treat gouty arthritis. The prescriber was asked questions to clarify the diagnosis being treated and to provide documentation to support the noted diagnosis. The prescriber was also asked questions to address the Plan's coverage/exception criteria. A response from the prescriber was not received. Therefore, based on the current record, there is insufficient documentation to support an exception to the Plan's coverage criteria.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 Indomethacin.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lidocaine 5% 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. Lidocaine 5% Patch is requested to treat an unknown diagnosis. The prescriber was asked to state your diagnosis, because there was no prescriber statement of your diagnosis in the case file. The prescriber was also asked to address medical necessity for the requested drug. 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, 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.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 Lidocaine 5% Patch 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 Lidocaine 5% 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 Victoza. The Plan did not grant this request. We received this case to conduct an independent review.In this case, the records show that when Victoza purchased from the Pharmacy, the claim straddled both the deductible stage and the initial coverage stage of the Part D benefit. An enrollee is responsible for the full cost of covered drugs until the deductible amount is satisfied. The initial coverage phase requires a 50% coinsurance amount for this drug and day supply purchased. The Plan documentation shows that the total drug cost was $2,683.13. There was $362.07 remaining in the deductible phase of coverage. This amount is subtracted from the total cost of the drug. This left a remaining total drug cost owed of $2,321.06. This remaining balance was subject to the initial coverage stage 50% coinsurance amount. 50% of the remaining balance is $1,160.53. The total of the two figures owed during each benefit phase (deductible and initial coverage) is $1,522.60. The record shows that the enrollee was charged an amount that is less than or equal to the required copayment for each phase the claim was processed in. The cost of Victoza was applied to your yearly true out-of-pocket (TrOOP) costs. The case record indicates that the Plan provided coverage in accordance with the Part D Plan contract. Therefore, the Plan is not required to provide additional payment and/or reimbursement for Victoza.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 50% coinsurance for up to a 90 day supply of a Tier 7 drug purchased from a preferred mail order pharmacy. 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 Victoza 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 Victoza.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide reimbursement or a tiering exception for Myrbetriq ER purchased from the Pharmacy. The Plan did not grant this request. We received this case to conduct an independent review.The Plan approved coverage for Myrbetriq ER. However, because the enrollee is in the Coverage Gap Stage of the enrollee's benefit, Myrbetriq ER is not eligible for a tiering exception or further cost-share reduction. During the Coverage Gap Stage, the enrollee pays 25%. The Plan pays the rest of the cost. It is noted that the tiering exception process is limited to the Initial Coverage Stage and since the enrollee is in the Coverage Gap Stage, the enrollee's covered drugs are not eligible for tiering exceptions. Therefore, our decision is the Plan is not required to provide a tiering exception for Myrbetriq ER while the enrollee is in the Coverage Gap Stage of the enrollee's benefit.This decision does not concern the medical necessity or appropriateness of the requested drug. It only establishes if an exception can be made under the Medicare Part D benefit.In addition, your complaint regarding the initial coverage copay does not apply to the coverage gap is a complaint. 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 cover Taltz. 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 Taltz. The drug is requested to treat plaque psoriasis. You state the enrollee has tried and failed Methotrexate, Cosentyx and Stelara. You have 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 Taltz.
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 Aripiprazole. 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 Aripiprazole 5 mg tab, #45 per 30 days. Aripiprazole 5 mg tab, #45 per 30 days, is requested for ongoing treatment of depression, major, recurrent, moderate, in this enrollee who also has anxiety. It is noted that the enrollee has been stable on the requested drug. The Plan limits the amount of Aripiprazole 5 mg tab, to #30 per 30 days. Aripiprazole 15 mg, is available on the plan's formulary with a quantity limit of #30 per 30 day. 'The prescriber states that the enrollee takes 5 mg, 1 and a half (7.5 mg) daily, and that 15 mg, 1/2 daily would be an appropriate substitute The prescriber has indicated that the total daily dose of Aripiprazole can be met by taking 1/2 of a 15 mg tablet once daily, which is within the plan's quantity limit. The prescriber has not indicated that the number of doses of the requested drug allowed by the plan would likely be ineffective in treating the enrollee's condition and/or would likely cause harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is that quantity limit exception criteria are not met.Medicare rules allow a Part D Plan to manage its formulary by covering a limited quantity of certain drugs. A Plan must grant an exception if it determines that the requested dosage is medically reasonable and necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that an exception to the quantity limit criteria is not met. Therefore, the Plan is not required to cover the requested quantity of Aripiprazole.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lidocaine 5% Ointment. 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% ointment. The drug is requested to treat post-surgical incisional site pain and itching, 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 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 Lidocaine 5% Ointment 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 Lidocaine 5% Ointment. 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 Fluticasone Propionate, 2 bottles per 30 days. 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 Fluticasone 50 mcg (2 sprays in each nostril, twice daily or a total of 2 bottles per 30 days). The drug is requested to treat allergic rhinitis. The Plan limits the amount of Fluticasone 50 mcg to 1 bottle per 30 days. This amount is sufficient to allow for the maximum FDA labeled dosing. The following citation in DrugDex, a Medicare approved compendium states: NASAL INHALATION, initial, 2 sprays/nostril daily or 1 spray/nostril twice daily, MAX 2 sprays/nostril/day (200 mcg/day) [5] [5] Product Information: fluticasone propionate nasal spray, fluticasone propionate nasal spray. Prasco Laboratories (per DailyMed), Mason, OH, 2012. Note that your dosing exceeds the maximum FDA labeled dosing by 100%. You have not indicated that the number of doses of the requested drug allowed by the Plan would likely be ineffective in treating the enrollee's condition and/or would likely cause harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is that quantity limit exception criteria are not met.Medicare rules allow a Part D Plan to manage its formulary by covering a limited quantity of certain drugs. A Plan must grant an exception if it determines that the requested dosage is medically reasonable and necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that an exception to the quantity limit criteria is not met. Therefore, the Plan is not required to cover the requested quantity of Fluticasone Propionate, 2 bottles per 30 days.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Diclofenac Epolamine 1.3% 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 Diclofenac Epolamine 1.3% Patch. Diclofenac Epolamine 1.3% Patch is requested for treatment of chronic pain associated with multiple chronic musculoskeletal conditions, which is an off-label (non-FDA approved) use. You state that the requested drug is medically necessary because the enrollee cannot take oral medications; 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 Diclofenac Epolamine 1.3% Patch 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 Epolamine 1.3% 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 cover Lidocaine HCL 4% solution. 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 4% solution. Lidocaine 4% solution is requested for treatment of leg pain due to a leg wound which is worsened with dressing changes, which is an off-label (non-FDA approved) use. The benefits of the requested drug for this enrollee have been noted; 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 Lidocaine HCL 4% solution 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 Lidocaine HCL 4% solution. 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.