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

You asked the Plan to cover Pregabalin. 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 Pregabalin. The drug is requested to treat pain right leg, which is an off-label (non-FDA approved) use. The provided medical records dated August 28, 2020 state that the diagnosis is, Pain right leg, patient unable to take Gabapentin wants to try Lyrica.  The visit impression is, Hip pain, right.  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 Pregabalin 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 Pregabalin.  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 Ozempic. 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 if the lower tier(s) on the formulary only contain(s) generic alternative drugs. Ozempic 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 Ozempic.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Temazepam. 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 Temazepam 7.5mg capsule. The drug is requested to treat a 97 year old enrollee with insomnia. You do 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 you as the requested drug, and/or would likely cause adverse reaction(s) or other harm to you.   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. APlan must grant an exception to prior approval rules if it determines that the requested drug is medicallynecessary, consistent with the prescriber's statement. Based on the available documentation, our PhysicianReviewer's opinion is that an exception to prior approval criteria is not met. Therefore, the Plan is notrequired to cover Temazepam.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Estradiol. The Plan did not grant this request. We received this case to conduct an independent review.   We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for a tiering exception for Estradiol 0.1mg/gm vaginal cream. The drug is requested to treat your condition. The drug is a generic drug on Tier 3 of the Plan's formulary. There are no available lower tier drugs of the same type on the Plan's formulary to treat your 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 Estradiol.
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 tablet, 180/90.  The drug is requested to treat dermatomyositis, 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 Mycophenolate Mofetil, 500 mg tablet 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, 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: Favorable

You asked the Plan to cover Radicava 30 mg/100 mL. 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 Radicava 30 mg/100 mL. The drug is requested to treat amyotrophic lateral sclerosis.  Upon reconsideration, you have submitted a report of MRI of the lumbar spine dated July 29, 2020 showing minimal degenerative changes and no acute findings.  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 Radicava 30 mg/100 mL.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Olmesartan Medoxomil. 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 Olmesartan Medoxomil 40 mg. The drug is requested to treat Essential hypertension. 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 Olmesartan Medoxomil.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ozempic. 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 Ozempic. The drug is requested to treat insulin resistance, prediabetes, and cardiovascular disease, 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 Ozempic 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 Ozempic.  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 Deferasirox. 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 Deferasirox 180 mg. The drug is requested to treat iron overload due to hemochromatosis and acquired sideroblastic anemia likely due to myelodysplastic syndrome, 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 Deferasirox 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 Deferasirox.  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 Modafinil 200 mg tablet, 225 tablets 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 Modafinil 200 mg tablet (225 tablets per 90 days = 75 tablets per 30 days or 500 mg/day). The drug is requested to treat fatigue associated with multiple sclerosis. For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of the requested drug for treatment of the noted condition. Therefore, the requested drug is being prescribed for a medically accepted indication. Additional medical information was requested by the Part D QIC. You were asked to address the requested quantity limit. The prescriber statement was returned. The Plan limits the amount of the drug to 60 tablets per 30 days. According to DrugDex, a Medicare approved compendium, In a 9-week, phase 2, single-blind, 2-center pilot study (n=72), 2 weeks of modafinil 200 mg daily significantly improved Fatigue Severity Scale (FSS) scores compared with placebo in patients with relapsing-remitting or progressive multiple sclerosis (MS); however, there was no significant difference between groups in FSS scores after continued modafinil dosing at 400 mg daily.  You indicated that the number of doses of the requested drug allowed by the Plan would likely be ineffective in treating the enrollee's condition, however, has not indicated that the requested doses would likely cause harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is that quantity limit exception criteria are not met.Medicare rules allow a Part D Plan to manage its formulary by covering a limited quantity of certain drugs. A Plan must grant an exception if it determines that the requested dosage is medically reasonable and necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that an exception to the quantity limit criteria is not met. Therefore, the Plan is not required to cover the requested quantity of Modafinil.
Appeal type: Prescription Drug
Decision: Partially Favorable

You asked the Plan to provide reimbursement for Tylenol (Acetaminophen) 500 mg, Melatonin 5 mg, Diphenhydramine HCL 25 mg, Hydralazine 25 mg, Carvedilol 6.25 mg, Tamsulosin 0.4 mg, Isosorbide Dinitrate 10 mg, Pantoprazole DR 20 mg, Losartan Potassium 25 mg, Hydrochlorothiazide 25 mg, Gabapentin 100 mg, Spironolactone 25 mg, Rosuvastatin 10 mg and Ondansetron HCL 4 mg received January 6, 2020 through January 7, 2020. The Plan did not grant this request. We received this case to conduct an independent review.    Hydralazine, Carvedilol, Tamsulosin, Isosorbide Dinitrate, Pantoprazole DR, Losartan Potassium, Hydrochlorothiazide, Gabapentin, Spironolactone, Rosuvastatin and Ondansetron HCL  The Plan covers prescriptions filled at an out-of-network pharmacy only in certain limited circumstances. In this case you received several self-administered drugs while at the hospital for an emergency medial situation. You requested reimbursement from the Part D Plan. The Plan did not process the request. Your request includes proof of payment in full as well as a detailed itemized statement for each claim. The Plan's out-of-network coverage rules were followed. Therefore, our decision is the Plan is required to provide coverage and reimbursement for Hydralazine 25 mg, Carvedilol 6.25 mg, Tamsulosin 0.4 mg, Isosorbide Dinitrate 10 mg, Pantoprazole DR 20 mg, Losartan Potassium 25 mg, Hydrochlorothiazide 25 mg, Gabapentin 100 mg, Spironolactone 25 mg, Rosuvastatin 10 mg and Ondansetron HCL 4 mg received January 6, 2020 through January 7, 2020. The Plan can use the costs for the individual claims as down on the itemized statement to calculate reimbursement.  Tylenol (Acetaminophen), Melatonin and Diphenhydramine  Medicare Part D does not cover non-prescription drugs. We checked FDA approved sources for the drugs classification or determined from other available resources that the drugs are a non-prescription or OTC drugs. Therefore, Tylenol (Acetaminophen) 500 mg, Melatonin 5 mg, Diphenhydramine HCL 25 mg received January 6, 2020 through January 7, 2020 are not eligible for Part D coverage, and the Plan is not required to cover or provide reimbursement for them 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

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 Vascepa. The Plan did not grant this request. We received this case to conduct an independent review.   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 needed additional information from you to determine whether the enrollee is using Vascepa for an FDA-approved use, or a use listed in the Medicare-approved compendia. The requested information was not received. As a result, we could not confirm that the drug is being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit. An exceptions request based on medical necessity cannot be considered because it cannot be confirmed that the drug meets the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Vascepa.  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 Basaglar Kwikpen U100. The Plan did not grant this request. We received this case to conduct an independent review.   We asked a Physician Reviewer to determine whether the Plan was correct in denying the request for Basaglar Kwikpen U100, which is not on the Plan?s formulary. Our Physician Reviewer needed additional information from the prescriber to make this determination. The prescriber was asked to address whether the drugs offered by the Plan would: (1) not be as effective as the requested non-formulary drug; and/or (2) have adverse effects. The requested information was not received. Based on a review of the available documentation, 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 Basaglar Kwikpen U100.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cathflo Activase. The Plan did not grant this request. We received this case to conduct an independent review.   A written request for Reconsideration must be filed within 60 days from the date of the Plan?s Redetermination Letter. This request was not filed within the required 60-day time limit. However, the case record reflects there is good cause for the late filing. Therefore the Reconsideration request is being processed.   For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. If a drug is not used for a medically accepted indication of therapeutic value on the body, it cannot satisfy the definition of a Part D drug. Cathflo Activase is used to restore the function of a peripheral inserted central catheter occlusion. Cathflo Activase use in this instance is not therapeutic. Thus, Cathflo Activase does not meet the definition of a Part D drug. Therefore, the Plan is not required to cover Cathflo Activase.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tretinoin 0.05% Cream. 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 Tretinoin 0.05% Cream. The drug is requested to treat photoaging. Drugs prescribed for cosmetic purposes are excluded from coverage under Medicare Part D. Therefore the requested drug is excluded from coverage.  Medicare law excludes certain drugs from Part D coverage. Tretinoin 0.05% Cream is one of those excluded drugs because it is a drug used for cosmetic purposes or to promote hair growth. The record submitted by the Plan does not indicate that they provide supplemental coverage for Tretinoin 0.05% Cream. Therefore, the Plan is not required to cover Tretinoin 0.05% Cream.   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.