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

You asked the Plan to cover Lidocaine 5% Patch. 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% Patch. The drug is requested to treat chronic back pain. 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 - Krebs EE, Gravely A, Nugent S, et al: Effect of opioid vs nonopioid medications on pain-related function in patients with chronic back pain or hip or knee osteoarthritis pain: the SPACE randomized clinical trial. JAMA 2018; 319(9):872-882. Therefore, the requested drug is being prescribed for a medically accepted indication. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met.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 citations in the Medicare approved compendia that support the use of Lidocaine 5% Patch for the diagnosed condition. As a result, Lidocaine 5% Patch is being prescribed for a medically accepted indication as defined by Medicare law. 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 Lidocaine 5% Patch.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Naltrexone 1.5 mg Compound. 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 Naltrexone 1.5 mg Compound is not FDA approved for both safety and effectiveness by checking FDA sources. Therefore, the Plan is not required to cover Naltrexone 1.5 mg Compound. 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 Mirtazapine 15 mg, 135 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 Mirtazapine 15 mg. The drug is requested to treat sleep disorder, dementia, and Alzheimer's 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 conditionsFor 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 Mirtazapine 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 Mirtazapine. 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 Enbrace HR. 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 Enbrace HR 1.5-8.73 mg. The drug is requested to treat generalized anxiety disorder, post traumatic stress disorder, and bipolar disorder depressed, 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 Enbrace HR 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 Enbrace HR. 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 Eliquis. The Plan did not grant this request. Wereceived this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor a tiering exception for Eliquis. The drug is requested to treat the enrollee's condition. The drug is abrand drug on tier 3 of the Plan's formulary. There are no available lower tier drugs on the Plan's formularyto treat the enrollee's condition. Therefore, the drug is not eligible for a tiering exception. Our PhysicianReviewer'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 thesame type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in alower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug isbeing used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met becausethere 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 Eliquis.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Methylphenidate. 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 Methylphenidate ER 54 mg.The drug is requested to treat major depressive disorder, 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 Methylphenidate 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 Methylphenidate. 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 Epogen 4,000 units/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 Epogen 4,000 units/mL.The drug is requested to treat the enrollee's condition. A request for prescriber statement was sent and returned. The prescriber indicated that the Plan's formulary alternatives required prior authorization. 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 Epogen 4,000 units/mL.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cyclophosphamide. 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 Cyclophosphamide 50mg capsule. The drug is requested to treat pyoderma gangrenosum, 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 Cyclophosphamide 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 Cyclophosphamide. 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 Ibrance. 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 Ibrance. The drug is requested to treat metastatic gallbladder cancer, which is an off-label (non-FDA approved) use.The enrollee is a 67-year-old woman who has Crohn's disease and metastatic gallbladder cancer involving liver and mediastinal nodes. She has been treated with Cisplatin/Gemcitabine. Her CT on 2/25/20 showed progression in the liver. The prescriber states the risk of diarrhea from a fluoropyrimidine or Irinotecan therapy is too great due to the underlying Crohn's. GeneTrails testing identified CDK6 and CCND1 amplification suggesting possible response to Ibrance. The prescriber requests Ibrance to treat her. The prescriber cited several journal articles which were reviewed.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. There was no peer-reviewed, clinically relevant, medical literature from an approved journal submitted to support this appeal. 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. For Part D drugs used in an anticancer chemotherapeutic regimen, 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 or peer-reviewed medical literature in CMS-approved journals or publications.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia and there was no peer-reviewed literature from an approved journal submitted to support the use of Ibrance 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 Ibrance. 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 Nocdurna. 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 Nocdurna. The drug is requested to treat nocturia. Chart notes submitted indicate that the enrollee is concurrently prescribed Breo Ellipta, which contains an inhaled glucocorticoid. Concurrent use of systemic or inhaled glucocorticoids is a labeled contraindication to the prescribed drug. The enrollee does not satisfy 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 Nocdurna.
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 Latuda. 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. Latuda is in the specialty tier. 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 Latuda.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Percocet. 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 Percocet 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 Percocet.
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 QVAR Redihaler. 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 QVAR Redihaler. The drug is requested to treat mild persistent asthma with (acute) exacerbation. The prescriber was asked to clarify the enrollee's diagnosis, because it was unclear from the case file. According to DrugDex, a Medicare-approved compendium, Qvar(R) oral inhalation is indicated for asthma, as prophylactic therapy in the maintenance treatment, and for whom the goal of therapy is to reduce or eliminate the use of oral corticosteroids. Beclomethasone Dipropionate is not indicated for the treatment of acute bronchospasm. The prescriber was also asked about formulary alternatives tried and failed. A response from the prescriber was not received. Therefore, based on the current record, there is insufficient documentation that the requested medication is being prescribed for a medically accepted indication as defined by Medicare law. In addition, 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 QVAR Redihaler.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Hydrocodone-Acetaminophen 10-325 mg tablet, 300 tablets per 30 days . ThePlan 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 requestfor Hydrocodone-Acetaminophen 10-325 mg tablet, 300 tablets per 30 days. Hydrocodone-Acetaminophen10-325 mg tablet, 300 tablets per 30 days, is requested for ongoing treatment of chronic back painassociated with sciatica related to osteoporosis and post laminectomy syndrome in this 81 year old enrolleewith a history of vertebral compression fractures, status post back surgeries, injections, and a failedstimulator trial. It is noted that you have been stable on the requested dose/quantity of the requested drug incombination with Fentanyl 75 mcg/hr patch every 72 hours as well as Cymbalta and Trazodone. Theprescriber states that you have been on the same medication since June 2010, and are bed bound without it.The prescriber states that attempts have been made to taper your medication; however you are unable tofunction without the requested dose/quantity of the requested drug. Additionally, the prescriber has notedthat you are followed regularly, and documentation indicate no evidence of inappropriate use/diversion.The Plan denied coverage of the Hydrocodone-Acetaminophen 10-325 mg tablet, 300 tablets per 30 days,because they indicate that the requested dosing exceeds the FDA recommended dosing; the Plan indicatesthat they will cover 180 per 30 days, although per HPMS (Health Plan Management System - CMS'sofficial database for Plan formularies), it is noted that quantity limits do not apply. The prescriber hasindicated that the number of doses of the requested drug allowed by the Plan would likely be ineffective intreating your condition, and/or would likely cause harm to you. Therefore, an exception to the Plan'scoverage criteria is medically necessary. Our Physician Reviewer's opinion is that quantity limit exceptioncriteria 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 andnecessary, 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, thePlan is required to cover the requested quantity of Hydrocodone-Acetaminophen 10-325 mg tablet 300tablets per 30 days.