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

You asked the Plan to cover Myrbetriq. 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 Myrbetriq 25 mg.The drug is requested to treat urinary retention, 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 Myrbetriq 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 Myrbetriq. 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.Please note: the request for a tiering exception (lower copayment) for Myrbetriq was not reviewed. We cannot consider a tiering exception for a drug for which the Part D Plan is unable to provide coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Humulin R U-500, Toujeo Max Solostar, Victoza, and BD Autoshield Duo needle. The Plan did not grant this request. We received this case to conduct an independent review.Regarding a tiering exception for Humulin R U-500, Toujeo Max Solostar, and Victoza: Medicare rules do not require the Part D plan to grant a tiering exception for a brand or biologic drug if the lower tiers on the formulary only contain generic alternative drugs. Humulin R U-500, Toujeo Max Solostar, and Victoza are Tier 3 brand drugs. The lower cost-sharing tiers only contain generic alternative drugs. Therefore, our decision is the Plan is not required to provide a tiering exception for Humulin R U-500, Toujeo Max Solostar, and Victoza. Regarding a tiering exception for BD Autoshield Duo needle: Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a 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. In this case, the Plan covers BD Autoshield Duo needle as a Tier 3 item only. There are no lower cost-sharing tier needles available on the Plan's formulary. Because there are no lower cost-sharing tier needles, BD Autoshield Duo needle is not eligible for a tiering exception. Therefore, our decision is the Plan is not required to provide a tiering exception for BD Autoshield Duo needle.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Alecensa. 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 Alecensa 150 mg; 240/30.Alecensa is requested to treat non-small cell lung cancer (NSCLC). The enrollee is an 80 year old woman with NSCLC involving lungs, bones, supraclavicular, mediastinal, hilar, and new retroperitoneal nodes. There is also a suspicious liver lesion on CT imaging done 2/26/20. A biopsy of a left supraclavicular node was done on 3/13/20. She has been treated with Carboplatin, Alimta, and Keytruda. She has progressed ontreatment. Foundation One Liquid testing identified an ALK mutation suggesting possible response to Alecensa. The prescriber requests Alecensa to treat her.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.Per Clinical Pharmacology, Alecensa is indicated for the treatment of metastatic, ALK-positive non-small cell lung cancer. The Plan's prior authorization criteria include FDA approved use. The FDA approved use requires an FDA approved test. Foundation One Liquid is not an FDA approved test for ALK mutations per fda.gov/medical-devices/vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-vitro-and-imaging-tools. Therefore the Plan's prior authorization criteria are not met.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 Reviewer'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 Alecensa.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cayston. 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 Cayston. The drug is requested to treat Kartagener's syndrome with bronchiectasis associated with recurrent Pseudomonas infections, 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 Cayston 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 Cayston. 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 Quetiapine 25 mg, #90 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 Quetiapine 25 mg, 90 per 30 days.The drug is requested to treat bipolar disorder, current episode depressed, moderate. Chart notes submitted upon reconsideration indicate that Quetiapine 25 mg is being prescribed for bipolar disorder, current episode depressed, moderate.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.The following citation in DrugDex, a Medicare-approved compendium, supports the use of the requested drug for the enrollee's condition:Immediate- and extended-release quetiapine is indicated for the acute treatment of depressive episodes associated with bipolar disorder.Therefore, the requested drug is being prescribed for a medically accepted indication.The Plan limits the amount of the drug to 60 per 30 days. 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 Quetiapine 25 mg, #90 per 30 days.
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 Aspirin EC 325 mg. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover non-prescription drugs. We checked FDA approved sources for the drug's classification or determined from other available resources that the drug is a non-prescription or OTC drug. Therefore, Aspirin EC 325 mg is not eligible for Part D coverage, and the Plan is not required to cover it under the Part D benefit. This decision does not address the medical necessity or appropriateness of the requested drug. It only establishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Diphenhydramine-Lidocaine-Glycerin-Methylcellulose-Potassium Sorbate compound (Magic Mouthwash). 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 Diphenhydramine-Lidocaine-Glycerin-Methylcellulose-Potassium Sorbate compound (Magic Mouthwash) is not FDA approved for both safety and effectiveness by checking FDA sources. Therefore, the Plan is not required to cover Diphenhydramine-Lidocaine-Glycerin-Methylcellulose-Potassium Sorbate compound (Magic Mouthwash). 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 Prevacid Solutab DR. 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 Prevacid Solutab DR.The drug is requested to treat gastroesophageal reflux disease (GERD). The prescriber has documented that the enrollee has difficulty swallowing pills. The prescriber has not indicated why the additional formulary alternative, Prilosec Packets (delayed-release oral suspension), 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 Prevacid Solutab DR.Please note: the request for a tiering exception (lower copayment) for Prevacid Solutab DR was not reviewed. We cannot consider a tiering exception for a drug for which the Part D Plan is unable to provide coverage.
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 reimbursement for Tylenol Extra Strength 500 mg received February 6, 2020. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover non-prescription drugs. We checked FDA approved sources for the drug's classification or determined from other available resources that the drug is a non-prescription or OTC drug. Therefore, Tylenol Extra Strength 500 mg received February 6, 2020 is not eligible for Part D coverage, and the Plan is not required to cover or provide reimbursement for it under the Part D benefit. This decision does not address the medical necessity or appropriateness of the requested drug. It only establishes that payment cannot be made under the Medicare Part D benefit.Please note: the Plan provided documentation that the other drugs submitted with you request (Pregabalin, Celecoxib and Tramadol) were reviewed and processed timely by the Plan. Therefore, they are not a part of this appeal. Please contact the Plan directly if you need more information regarding these additional drugs.
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 Novolog Flexpen. 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 Novolog Flexpen 100 units/mL.The drug is requested to treat Type 2 diabetes mellitus. 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 Novolog Flexpen.
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 Postherpetic neuralgia, 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 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.Please note: While Lidocaine 5% ointment cannot be covered by the Part D benefit, the Part D Plan has indicated that they have provided coverage under the enhanced portion of the benefits. Please contact the Part D Plan for more information.
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 Cefuroxime and Doxycycline purchased while on a cruise ship on December 14, 2019. The Plan did not grant this request. We received this case to conduct an independent review.Cefuroxime and Doxycycline are not covered by Medicare because they were purchased outside the United States. Therefore, our decision is that the Part D Plan is not required to pay for Cefuroxime and Doxycycline. This decision does not concern the medical appropriateness of the requested drugs. 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 a tiering exception for Estradiol 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 a tiering exception for Estradiol patch. The drug is requested to treat menopause. The drug 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 Estradiol patch.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Xeljanz XR. 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 Xeljanz XR. The drug is requested to treat M05.79 Rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems involvement. You sent a statement dated April 5, 2020 clarifying the medical history. You state the enrollee has tried and failed or had adverse effects with Methotrexate, Enbrel, Humira and Remicade infusion. You also stated that Xeljanz would be an acceptable alternative to the requested drug. 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 Xeljanz XR.