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

You asked the Plan to cover Repatha SureClick 140 mg/mL 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 Repatha SureClick 140 mg/mL.   Repatha SureClick 140 mg/mL is requested for treatment of hyperlipidemia in this enrollee with severe peripheral vascular disease requiring multiple surgeries/interventions, hypertension, type II diabetes mellitus, carotid bruit, and tobacco abuse. The prescriber has indicated that the enrollee has been unable to take statins - trials of Lovastatin and Atorvastatin noted in the medical record.   The enrollee does not satisfy the Plan's coverage criteria. The prescriber has indicated why all alternatives required by the Plan would likely not be as effective as the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that 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 met. Therefore, our decision is the Plan is required to cover Repatha SureClick 140 mg/mL as prescribed.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Amitiza. 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 Amitiza 24 mcg. Amitiza 24 mcg is requested for treatment of irritable bowel disease with constipation. The Plan's coverage criteria require failure of, or intolerance/contraindication to Lactulose. The Plan has documented at least two conversations with your office indicating that there has been no trial of Lactulose. You indicated with the request for reconsideration that the enrollee did not respond to Lactulose. Thorough medical records have been submitted; the records indicate that the enrollee has tried many prescriptions and over the counter drugs including Linzess, Movantik, Trulance, Miralax, Senna/Exlax, Magnesium citrate and Biscodyl suppositories. However, the medical records do not specifically document that the enrollee tried and failed Lactulose. There is insufficient documentation that the enrollee satisfies the Plan's coverage criteria. You have not sufficiently addressed the Plan's coverage criteria and/or 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. Our Physician's opinion is that neither prior authorization nor prior authorization exception criteria are met.   Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. A Plan must grant an exception to prior approval rules if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on the available documentation, our Physician Reviewer's opinion is that an exception to prior approval criteria is not met. Therefore, the Plan is not required to cover Amitiza.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Vimpat . 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 Vimpat 200 mg.  Vimpat 200 mg is requested to treat the enrollee's condition.  Vimpat 200 mg is a brand drug on tier 4 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 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 Vimpat.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Avycaz. 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 Avycaz.    Avycaz is requested to treat ESBL Klebsiella (extended spectrum beta lactamase producing Klebsiella) left plantar foot infection, which is an off-label (non-FDA approved) use. You have detailed the enrollee's clinical history and rationale for prescribing Avycaz; you state that there are limited options for treatment of the enrollee's multi-resistant organism and that there is ample evidence in the literature that the use of Avycaz is appropriate for this enrollee's specific condition. 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 Avycaz 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 Avycaz.  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 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.  Lidocaine 5% Ointment is requested for treatment of constant bilateral cervical pain/spasm with radiation into the upper extremities, 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 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 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 provide a tiering exception for Shingrix. 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 Shingrix Vaccine. The drug is requested for the enrollee's condition. The drug is a brand drug on Tier 4 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 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 in a lower cost-sharing tier approved for treating the same condition that the higher cost-sharing tier drug is being used to treat. In this case, the Plan covers vaccines as a Tier 4 item only. There are no lower cost-sharing tier vaccines available on the Plan's formulary. Because there are no lower cost-sharing tier vaccines, Shingrix is not eligible for a tiering exception. Therefore, our decision is the Plan is not required to provide a tiering exception for Shingrix.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Vimpat for Plan year 2021. The Plan did not grant this request. We received this case to conduct an independent review.   If a Plan maintains a specialty tier, the Plan may design its exception process so that drugs placed in the specialty tier are not eligible for a tiering exception. Vimpat is in the specialty tier for the Plan year 2021. The record indicates the Plan has chosen to exclude the specialty tier from the tiering exception process. Therefore, the Plan is not required to provide a tiering exception for Vimpat for Plan year 2021.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Methylfolate. The Plan did not grant this request. We received this case to conduct an independent review.   Medicare Part D does not cover medical foods. Methylfolate is a medical food. Therefore, Methylfolate 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 product. 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 Megestrol Acetate. 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 Megestrol Acetate.    Megestrol Acetate is requested for treatment of poor appetite related to non-alcoholic fatty liver, 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 Megestrol Acetate 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 Megestrol Acetate.  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 Fetzima ER. 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 Fetzima ER.    Fetzima ER is requested for treatment of bipolar affective disorder I, depressed, moderate severity, which is an off-label (non-FDA approved) use. You have discussed the enrollee's clinical history and why the requested drug has been prescribed; 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 Fetzima ER 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 Fetzima ER.  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 Nasonex. 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 Plan was correct in denying the request for Nasonex 50 mcg nasal spray.  Nasonex 50 mcg nasal spray is requested for ongoing treatment of allergic rhinitis.  The plan's coverage criteria for Nasonex require previous treatment with two of the following: Fluticasone nasal spray, Azelastine nasal spray, Flunisolide nasal spray.  The prescriber states, the patient cannot use generic, doesn't work for her, makes her have bad nose bleeding when she uses it.  Nasonex 50 mcg is only thing that works.  Medical records submitted with the request for reconsideration do not provide sufficient documentation the all alternatives required by the plan are not medically appropriate for this enrollee.  The prescriber has not provided sufficient documentation that the enrollee has tried all alternatives required by the Plan, or why the Plan's required step therapy drugs would likely not be as effective for the enrollee as the requested drug, and/or would likely cause adverse reactions or other harm to the enrollee. Our Physician Reviewer's opinion is that neither step therapy or step therapy exception criteria are met.  Medicare rules allow a Part D Plan to manage its formulary by requiring step therapy for certain drugs. A Plan must grant an exception 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 an exception to step therapy criteria is not met. Therefore, the Plan is not required to cover Nasonex.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Mycophenolate Mofetil. 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 Mycophenolate Mofetil.    Mycophenolate Mofetil is requested for ongoing treatment of pneumonitis associated with the use of Pembrolizumab, which is an off-label (non-FDA approved) use. You have indicated that Pembrolizumab was utilized to successfully treat the enrollee's CNS (central nervous system) lymphoma. You have described the benefits of the requested drug realized by this patient; 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 Mycophenolate Mofetil 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 Mycophenolate Mofetil.  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 reimbursement for Dulera 200-5 mcg purchased July 31, 2020. The Plan did not grant this request. We received this case to conduct an independent review.   Medicare rules allow a Part D Plan to apply coinsurance and copayments to covered drugs. The amount of the copayment or coinsurance will vary depending on the drug's tier and place of purchase. Dulera is not on the Plan's 2020 Formulary. However, a formulary exception has already been approved for the 2020 coverage year, allowing coverage for Dulera at the Tier 4 copayment amount. In this case, you purchased Dulera (National Drug Code (NDC) 0085-4610-01) on July 31, 2020 from an in-network pharmacy. The Plan denied coverage and reimbursement on the basis that the NDC purchased is not FDA approved. Medicare approved resources were checked. NDC 0085-4610-01 is a Part D eligible NDC that was FDA approved with a marketing start date of June 22, 2010. There is no marketing end date. The resources do show the NDC was temporarily inactive from July 22, 2020 through August 4, 2020. Therefore, based on the research conducted, this NDC is a Part D eligible drug and it is reasonable that the pharmacy would have provided this NDC at the time of purchase.The case record indicates that the Plan did not provide coverage in accordance with the Part D Plan contract. Therefore, our decision is the Plan is required to cover and provide reimbursement for Dulera 200-5 mcg purchased July 31, 2020.