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

You asked the Plan to cover Androgel Pump. 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 Androgel. Androgel pump 1.62% is requested to treat low testosterone level associated with erectile dysfunction in this 65 year old enrollee with major depressive disorder. The Plan denied coverage of the requested drug because they concluded that Androgel is not being prescribed for a medically accepted indication. Laboratory tests were submitted with the request for reconsideration which were notable for a normal free testosterone level of 6.9 (normal 6.6-18.1) on January 16, 2020, a low free testosterone level of 5.4 on January 23, 2020, normal FSH (follicle stimulating hormone), and elevated LH (leutinizing hormone) of 10.0 (normal 1.7 - 8.6). There was no clarification of the enrollee's diagnosis with the request for reconsideration. Based on the information provided, there is insufficient documentation that the requested drug is 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 based on the documentation provided.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 Androgel Pump 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 Androgel Pump.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 provide a tiering exception for Trelegy Ellipta. 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 Trelegy Ellipta.Trelegy Ellipta is requested to treat the enrollee's condition. The requested drug is a brand drug on tier 3 of the Plan's formulary. There are no available lower tier brand drugs on the Plan's formulary to treat the enrollee's condition. Therefore, the requested drug is not eligible for a tiering exception. 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 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 Trelegy Ellipta.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Zortress. 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 the beneficiary receiving the drug was enrolled in Medicare Part A at the time of the organ transplant. The case record indicates that Zortress is needed for a Kidney transplant performed December 16, 2011. According to Medicare enrollment records, the enrollee was determined to be entitled to Medicare Part A coverage at the time of the transplant. Thus, the transplant is considered a Medicare covered transplant and Zortress 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 Zortress.This decision does not concern the medical necessity or appropriateness of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.You may wish to submit this request to the Medicare Part B carrier.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Amantadine, 100 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 Amantadine, 100 mg tablet.The drug is requested to treat Parkinson's disease. Amantadine, 100 mg tablet is not on the Plan's formulary. Amantadine, 100 mg capsule and Amantadine oral solution are on the Plan's formulary. The prescriber has not indicated why all alternatives required by the Plan would likely not be as effective for the enrollee as the requested drug; and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is that formulary exception criteria are not met.A Plan must grant an exception for a drug that is not on its formulary if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that formulary exception criteria are not met. Therefore, the Plan is not required to cover Amantadine, 100 mg tablet.Please note that no redetermination for a tiering exception for Amantadine, 100 mg capsule has been completed. You may wish to submit this request to the Plan at this time.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Fluticasone-Salmeterol Aero powder. 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-Salmeterol Aero powder. The drug is requested to treat chronic obstructive pulmonary disease. 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 Fluticasone-Salmeterol Aero powder.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover First-Lansoprazole. 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 First-Lansoprazole is not FDA approved for both safety and effectiveness by checking FDA sources. Therefore, the Plan is not required to cover First-Lansoprazole. 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 Linzess. The Plan did not grant this request. We received this case to conduct an independent review.Medicare rules do not require the Part D plan to grant a tiering exception for a brand or biologic drug of the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) if the lower tier(s) on the formulary only contain(s) generic alternative drugs. Linzess is a Tier 3 brand drug. The lower cost-sharing tier(s) only contain(s) generic alternative drugs. Therefore, our decision is the Plan is not required to provide a tiering exception for Linzess.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Sumatriptan. 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 Sumatriptan 6 mg/0.5 ml vial injection. The drug is requested to treat the enrollee's condition. The drug is a generic drug on tier 4 of the Plan's formulary. There are no available lower tier injectable drugs on the Plan's formulary to treat the enrollee's condition. Therefore, the drug is not eligible for a tiering exception. 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 the same type 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 Sumatriptan.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Otezla. 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 Otezla. The drug is requested to treat L40.0 - plaque psoriasis. You sent a letter dated February 29, 2020 clarifying the medical history. You state the enrollee has tried and failed Clobetasol, Ultravate, Triamcinolone and Hydrocortisone. Otezla is not on the Plan's formulary. 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 Otezla.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Hysingla ER, 20 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 Hysingla ER, 20 mg tablet.The drug is requested to treat the enrollee's condition. A request for prescriber statement was sent and not returned. 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 Hysingla ER, 20 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Levetiracetam. 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 Levetiracetam. The drug is requested to treat chronic headache, 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 Levetiracetam 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 Levetiracetam. 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: 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 us as required by Medicare rules because it did not make a timely decision.You asked the Plan to provide a tiering exception for Desloratadine 5 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 Desloratadine 5 mg tablet. Desloratadine 5 mg tablet is requested for treatment of allergic rhinitis. You have indicated that Cetirizine was ineffective and resulted in hallucinations and palpitations, and that Levocetirizine is contraindicated in a patient who had side effects to Ceterizine. Desloratadine 5 mg tablet is on Tier 3 of the Plan's formulary. Ceterizine oral solution is on Tier 2 of the Plan's formulary, and Levocetirizine is on Tier 1 formulary. You have indicated why all eligible 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. Our Physician Reviewer's opinion is that tiering exception criteria are met.Medicare rules permit a Plan to grant an exception to its tiering structure whenever it determines that the non-preferred or higher cost-sharing 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 met. Therefore, our decision is the Plan is required to provide a tiering exception for Desloratadine 5 mg tablet from the date of the Plan's initial denial.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 Acyclovir 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 Acyclovir 5% ointment.The drug is requested to treat shingles in the absence of documentation of immunocompromised state, 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 Acyclovir 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 Acyclovir 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: Favorable

You asked the Plan to cover Vyndaqel, 20 mg capsule, 120 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 Vyndaqel 20 mg 120/30.The drug is requested to treat amyloidosis with chronic diastolic heart failure. Upon reconsideration, the prescribing physician has submitted additional documentation indicating that the enrollee has had slowing of clinical decline on treatment with Vyndaqel, with decrease in number of admissions (no admissions since starting treatment), improvement of symptoms, and improvement of ejection fraction. 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 Vyndaqel, 20 mg capsule, 120 per 30 days.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 Lansoprazole ODT. 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 Lansoprazole ODT. The drug is requested to treat Gastroesophageal reflux disease. 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 Lansoprazole ODT.