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

You asked the Plan to cover Testosterone Cypionate. 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 Testosterone Cypionate 200 mg/mL. The drug is requested to treat hypogonadism. Additional medical information was requested by the Part D QIC. The prescribing physician was asked to address the Plan's prior authorization criteria. 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 Testosterone Cypionate.
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 Symbicort. 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 Symbicort 160/4.5 mcg inhaler. The drug is requested to treat chronic obstructive pulmonary disease. The drug is a brand drug on Tier 3 of the Plan's formulary. There are no available lower tier brand drugs of the same type 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 (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 Symbicort.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Gabapentin. 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 Gabapentin 400 mg. The drug is requested to treat cervical and lumbar radiculopathy. 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 AHFS-DI, a Medicare approved compendium, supports the use of the requested drug for the enrollee's condition: Gabapentin also has been used for the management of other types of neuropathic pain including central neuropathic pain associated with spinal cord injury, complex regional pain syndrome (CRPS), cancer-related neuropathic pain, pain associated with multiple sclerosis, phantom limb pain, radicular pain, and HIV-related peripheral neuropathy. Therefore, the requested drug is being prescribed for a medically accepted indication. The drug is on Tier 2 of the Plan's formulary. There are no available lower tier 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 (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 Gabapentin.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Enbrel 50 mg/mL, 4 per 28 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 Enbrel 50 mg/mL, 4 per 28 days. The drug is requested to treat rheumatoid arthritis. Additional medical information was requested by the Part D QIC. The prescribing physician was asked to address the Plan's prior authorization criteria. The prescribing physician has submitted documentation that the enrollee has had an inadequate response to a 6 month trial of Humira, a 3 month trial of Xeljanz, and a three month trial of Actemra, as well as prior inadequate response to Otezla and Methotrexate of unspecified duration of treatment. 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 Enbrel 50 mg/mL, 4 per 28 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 Hydroxychloroquine, 200 mg tablet, 24 per 90 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 Hydroxychloroquine.Hydroxychloroquine is requested for ongoing treatment of a cutaneous vasculitis, which is an off-label (non-FDA approved) use. The prescriber states that the enrollee has been on the requested drug and that the enrollee is responding well to the requested drug; 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 Hydroxychloroquine, 200 mg tablet, 24 per 90 days 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 Hydroxychloroquine, 200 mg tablet, 24 per 90 days. 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 Balsalazide Disodium. 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 Balsalazide Disodium 750 mg cp. The drug is requested to treat ulcerative colitis. The drug is a generic drug on Tier 4 of the Plan's formulary. You sent a letter clarifying the medical history. You did 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 Balsalazide Disodium.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Otrexup. 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 Otrexup 10mg 0.4 ML AUTO INJ. The drug is requested to treat rheumatoid arthritis with rheumatoid factor, unspecified. Otrexup 10mg 0.4 ML AUTO INJ 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 Otrexup.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ensure Plus Liquid. 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, Ensure Plus Liquid 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 Hydromorphone HCL. 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 Hydromorphone HCL is not FDA approved for both safety and effectiveness by checking FDA sources. Therefore, the Plan is not required to cover Hydromorphone HCL. 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 Fiorinal . 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 Fiorinal 50-325-40 mg capsule. The drug is requested to treat migraine headaches, 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 Fiorinal 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 Fiorinal. 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 Epidiolex. 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 Epidiolex 1 Solution 100 mg per ml. Epidiolex 1 Solution 100 mg per ml is requested for treatment of refractory epilepsy not associated with Lennox-Gastaut or Dravet Syndrome, which is an off-label (non-FDA approved) use. You have discussed the enrollee's clinical history and why the requested drug is medically necessary, and has provided medical literature to support the noted request; 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 Epidiolex 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 Epidiolex. 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 cover or provide reimbursement for Ventolin HFA you received while a patient at the hospital. The Plan did not grant this request. We received this case to conduct an independent review.The Part D Plan covers prescriptions filled at an out-of-network pharmacy only in certain limited circumstances. If an enrollee must use an out-of-network pharmacy, the enrollee will generally have to pay the full cost when the prescription is filled. The enrollee may submit a request for reimbursement with proof of payment to ask the Plan to pay its share of the cost. In this case, the record shows that you were a patient at urgent care or hospital. You received Ventolin HFA for a medical emergency or urgent care. You submitted a request for reimbursement with a copy of an itemized hospital bill. However, the record does not include proof of payment in full of the self-administered drug portion of the bill. In addition, the National Drug Code (NDC) is missing or invalid. The Plan's criteria for out-of-network coverage and reimbursement have not been met. Therefore, our decision is the Plan is not required to cover or provide reimbursement for Ventolin HFA received as a patient at the hospital.If you are able to provide the required documentation, you may submit to your Plan for reimbursement review.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Testosterone 1.62% Gel. 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 Testosterone 1.62% Gel. The drug is requested to treat unspecified testicular hypofunction, 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 Testosterone 1.62% Gel 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 Testosterone 1.62% Gel. 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 Gattex, 5 mg, 45/90 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 Gattex, 5 mg, 45/90.The drug is requested to treat Short bowel syndrome. The Plan limits the amount of the drug to a repeating 30 day supply for three months. The Plan stated that specialty drugs are limited to a recurring 30 day supply, regardless of tier placement on the Plan's formulary.The DEPARTMENT OF HEALTH & HUMAN SERVICES, Centers for Medicare & Medicaid Services in a bulletin with the subject: Information Related to Coronavirus Disease 2019 - COVID-19, stated: Part D sponsors must permit enrollees to obtain the total days supply prescribed for a covered Part D drug (as defined in 42 CFR ? 423.100) up to a 90-day supply in one fill (or one refill) if:1. Requested by the enrollee, 2. PA or ST requirements have been satisfied; and 3. No safety edits otherwise limit the quantity or days supply. This requirement also applies to transition fills.The Plan has already approved a 30 day supply of the drug. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that quantity limit exception criteria are 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 met. Therefore, the Plan is required to cover the requested quantity of Gattex, 5 mg, 45/90 as prescribed.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 Freestyle Libre 14 Day Sensor Kit. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover devices. Freestyle Libre has been classified by the FDA as a device, not as a drug. Therefore, our decision is the Part D Plan is not required to cover Freestyle Libre. This decision does not address the medical necessity or appropriateness of the requested item. It only establishes that payment cannot be made under the Medicare Part D benefit.