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

You asked the Plan to cover Humira Pen. 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 Humira Pen. The drug is requested to treat psoriasis. 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'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 Humira Pen.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Mimvey 1-0.5 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 Mimvey 1-0.5 mg tablet. The drug is requested to treat the enrollee's postmenopausal state. The prescriber has not indicated why all alternatives required by the Plan (Estring) 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. A request for medical records was sent to the prescriber in order to clarify the need for the formulary exception - a statement was received from the prescriber but without supporting medical records. The Medicare-approved compendia and the manufacturer's prescribing information do not report a contraindication to use of Estring after healing from bladder surgery. 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 Mimvey.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Samsca. 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 Samsca 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 Samsca.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Breo Ellipta. 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. Breo Ellipta 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 Breo Ellipta.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to provide reimbursement for Zolpidem. 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. In this situation, the enrollee submitted a request indicating that coverage for Zolpidem had been approved but they were being denied applicable reimbursement. Upon reaching out to the plan, no case record has been submitted after numerous outreach attempts. Therefore, we have no information regarding the plan's reason for denying this reimbursement. Without a case record, we are unable to discern whether the Plan provided coverage in accordance with the Part D Plan contract. Therefore, our decision is the Plan is now required to provide any applicable reimbursement for Zolpidem purchased by the enrollee, less the applicable copayment amount.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Budesonide 2 mg /act foam. 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 Budesonide 2 mg/act foam.The drug is requested to treat radiation proctitis, which is an off-label (non-FDA approved) use. The prescriber clarified the diagnosis in a letter dated 1/30/2020. 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 Budesonide 2 mg /act foam 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 Budesonide 2 mg /act foam. 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 Monurol. 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 Monurol. The drug is requested to treat pyelonephritis in an enrollee with extended-spectrum beta-lactamase-positive Escherichia coli, which is an off-label (non-FDA approved) use. The following citation in DrugDex, a Medicare approved compendium states: Fosfomycin is not indicated for the treatment of pyelonephritis or perinephric abscess [4]. 4. Product Information: MONUROL(R) sachet oral solution, Fosfomycin tromethamine oral solution. Zambon Switzerland Ltd, Cadempino, Switzerland, 2007.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 Monurol 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 Monurol. 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 Mycophenolate Mofetil, 500 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 Mycophenolate Mofetil, 500 mg.The drug is requested to treat uveitis and cystoid macular edema, 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 conditions.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, 500 mg tablet for the diagnosed conditions. 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 these conditions. 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, 500 mg tablet. 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 Zolpidem ER. 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 Zolpidem ER 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 Zolpidem ER.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Horizant ER, 600 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 Horizant ER, 600 mg.The drug is requested to treat lumbar radiculopathy, Myofascial pain syndrome and left shoulder pain, which are off-label (non-FDA approved) uses. These are the diagnoses provided in the office note dated 1/22/2020. 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 conditions.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 Horizant ER, 600 mg tablet for the diagnosed conditions. 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 these conditions. 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 Horizant ER, 600 mg tablet. 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 Levemir FlexTouch. 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. Levemir FlexTouch is a Tier 3 brand drug. 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 Levemir FlexTouch.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Forteo and Cyanocobalamin (Vitamin B12). The Plan did not grant this request. We received this case to conduct an independent review.Forteo:We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Forteo 600mcg/2.4 mL. The drug is requested to treat osteoporosis. Tymlos is available on the Plan's formulary. The prescriber has not indicated why this alternative required by the Plan would likely not be as effective for you as the requested drug; and/or would likely cause adverse reaction(s) or other harm to you. 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 Forteo.Cyanocobalamin (Vitamin B12):Medicare law excludes certain drugs from Part D coverage. Cyanocobalamin (Vitamin B12) is one of those excluded drugs because it is a prescription vitamin and mineral product. The record submitted by the Plan does not indicate that they provide supplemental coverage for Cyanocobalamin (Vitamin B12). Therefore, the Plan is not required to cover Cyanocobalamin (Vitamin B12). 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 Lansoprazole DR compound. The Plan did not grant this request. We received this case to conduct an independent review.Lansoprazole DR, part of a compound:We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Lansoprazole 3mg/ml oral liquid (compounded medication via PEG tube), part of a compound. The drug is requested to treat dysphagia, oropharyngeal stage and post-dilation of a Schatzki ring, 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 Lansoprazole DR, part of a compound 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 Lansoprazole DR, part of a compound. Sodium Bicarbonate, part of a compound: Medicare Part D does not cover drugs that are not FDA approved. A representative of the pharmacy stated that bulk powder was used or would be used when compounding the prescription for Sodium Bicarbonate, part of a compound. Bulk powders used in pharmacy compounding are not reviewed and approved for safety and efficacy by the FDA. Therefore, the Plan is not required to cover Sodium Bicarbonate, part of a compound. Purified Water, part of a compound: Medicare Part D only covers items that meet the definition of a Part D drug. The requested item does not meet the definition of a Part D drug because it either does not require a prescription, it is not approved by the FDA for safety and effectiveness, or it is otherwise excluded. Therefore, our decision is the Plan is not required to cover Purified Water, part of a compound. 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 Ocrevus 300 mg/10 ml vial. 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 Ocrevus 300 mg/10 mL. The drug is requested to treat relapsing multiple sclerosis. Upon reconsideration, you have submitted an additional statement and chart notes. You state the enrollee has failed treatment with Rebif (Interferon Beta) and Gilenya. You have 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 formulary exception criteria are 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 met. Therefore, the Plan is required to cover Ocrevus 300 mg/10 ml vial.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Panzyga. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law specifically excludes coverage for any drug for which payment would be available under Parts A or B of Medicare for that individual. Medicare Part B provides coverage of IVIG for the treatment of primary immune deficiency diseases (See Diagnosis Codes that Support Medical Necessity section in the Article cited above) in the home.The case record indicates that Panzyga is prescribed for the treatment of a primary immune deficiency disease, ICD-10 D80.1 Malignant (primary) neoplasm, unspecified and D84.9 Immunodeficiency, unspecified and will be administered in the home. It appears that this medication qualifies for coverage under Part B rather than Part D. As a result, the record does not establish that Panzyga is a Part D drug in this case. Therefore, it is our decision that the Part D Plan is not required to provide coverage for Panzyga {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.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 Belbuca, 75 mcg film. The Plan did not grant this request. We received thiscase to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Belbuca, 75 mcg film.The drug is requested to treat chronic pain. The prescriber has not indicated why all alternatives required bythe Plan would likely not be as effective for the enrollee as the requested drug; and/or would likely causeadverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria isnot 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 requesteddrug is medically necessary, consistent with the prescriber's statement. Based on a review of the availabledocumentation, our Physician Reviewer's opinion is that formulary exception criteria are not met.Therefore, the Plan is not required to cover Belbuca, 75 mcg film.