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

You asked the Plan to provide a tiering exception for Timoptic Ocudose 0.5% Solution. The Plan did notgrant 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 coveredthrough a formulary exception. The documentation in the record shows that Timoptic Ocudose 0.5%Solution is currently being covered for the enrollee through a formulary exception. Therefore, our decisionis the Plan is not required to provide a tiering exception for Timoptic Ocudose 0.5% Solution.
Appeal type: Prescription Drug
Decision: Unfavorable

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

You asked the Plan to cover Ipratropium-Albuterol neb sol. The Plan did not grant this request. Wereceived this case to conduct an independent review.Medicare law specifically excludes coverage for any drug for which payment would be available under PartA or Part B of Medicare for that individual. Medicare Part B may pay for supplies necessary for theeffective use of durable medical equipment, including drugs and biologicals which must be put directly intothe equipment in order to achieve the therapeutic benefit of the durable medical equipment. Medicare PartB local policy states that a small volume nebulizer and related compressor are covered when medicallynecessary to administer Ipratropium-Albuterol neb sol for the management of obstructive pulmonarydisease.In this case, the record shows that Ipratropium-Albuterol neb sol is administered through a nebulizer in thehome for a diagnosis of J45. 21 - Mild intermittent asthma with (acute) exacerbation. There is no indicationthat it is not administered through a small volume nebulizer. It appears that this medication is eligible forcoverage under Part B rather than Part D. Drugs which are eligible for coverage under Part B are excludedfrom Part D coverage by Medicare law. Therefore, it is our decision that the Part D Plan is not required tocover Ipratropium-Albuterol neb sol.This decision does not concern the medical necessity or appropriateness of the requested drug. It onlyestablishes if payment can 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 provide a tiering exception for Cardizem LA 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 coveredthrough a formulary exception. The documentation in the record shows that Cardizem LA ER is currentlybeing covered for the enrollee through a formulary exception. Therefore, our decision is the Plan is notrequired to provide a tiering exception for Cardizem LA ER.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Repatha SureClick. The Plan did not grant this request. We received this caseto conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Repatha Sureclick. Repatha Sureclick is requested for ongoing treatment of hyperlipidemia in thisenrollee with statin intolerance who has been stable on Repatha. The prescriber states that the enrollee hasnot tried Praluent because Praluent is best used with a statin to which the enrollee is intolerant. Praluent isindicated in adults with established cardiovascular disease to reduce the risk of myocardial infarction,stroke, and unstable angina requiring hospitalization and in those with primary hyperlipidemia (includingheterozygous familial hypercholesterolemia) as an adjunct to diet, alone or in combination with other lipidloweringtherapies (eg, statins, ezetimibe), to reduce low-density lipoprotein cholesterol (LDL-C). Theprescriber has not provided a sufficiently strong statement as to why all alternatives required by the Planwould likely not be as effective for the enrollee as the requested drug; and/or would likely cause adversereaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is notsupported. 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 Repatha SureClick.
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 usas required by Medicare rules because it did not make a timely decision.You asked the Plan to provide a tiering exception for Trulicity. 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 Trulicity.Trulicity is requested to treat your condition. The requested drug is a biologic drug on Tier 3 of the Plan'sformulary. There are no available lower tier biologic drugs on the Plan's formulary to treat your condition.Therefore, the requested drug is not eligible for a tiering exception. Our Physician Reviewer's opinion isthat 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 your condition. Therefore, ourdecision is the Plan is not required to provide a tiering exception for Trulicity.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Desvenlafaxine Succinate ER, 100 mg tablet. The Plan did not grant thisrequest. 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 Desvenlafaxine Succinate ER, 100 mg tablet.Desvenlafaxine Succinate ER, 100 mg tablet is requested for treatment of the enrollee's condition. Thediagnosis requiring the requested drug was initially stated to be anxiety disorder unspecified. The prescriberwas asked to clarify the diagnosis being treated with the requested drug and to provide supportive medicalrecords. The prescriber amended the diagnosis to major depressive disorder; however no medical recordswere provided. There is insufficient documentation that the requested drug is being prescribed for amedically accepted indication as defined by Medicare law. As such, an exceptions request based onmedical necessity cannot be considered because the requested drug, as prescribed, does not meet thedefinition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage underMedicare Part D based on the available documentation.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicareapproved compendia that support the use of Desvenlafaxine Succinate ER, 100 mg tablet for the diagnosedcondition. As a result, the drug is not being prescribed for a medically accepted indication as defined byMedicare law. As such, it cannot be covered under the Medicare Part D benefit for this condition. Anexceptions request based on medical necessity cannot be considered because this drug, as prescribed, doesnot meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required toprovide coverage for Desvenlafaxine Succinate ER, 100 mg tablet.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Aimovig 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 Aimovig. The drug is requested to treat chronic vestibular headaches. You have not submitted medical records/progress notes to support that the enrollee has had a specific reduction in migraine days per month from baseline. 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 Aimovig.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Testosterone Cypionate. 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 Testosterone Cypionate.Testosterone Cypionate is requested to treat an unclear diagnosis. The prescriber was asked to state theenrollee's diagnosis, because there was a change of the enrollee's diagnosis in the case file. The prescriberwas also asked to address medical necessity for the requested drug. A response from the prescriber was notreceived. Therefore, based on the current record, there is insufficient documentation that the requestedmedication is being prescribed for a medically accepted indication as defined by Medicare law. In addition,an exceptions request based on medical necessity cannot be considered because it cannot be confirmed thatthe drug meets the definition of a Medicare Part D drug.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically acceptedindication. A medically accepted indication means a use that is approved by the FDA or a use that issupported by one or more citations in Medicare approved compendia.Our Physician Reviewer needed additional information from the prescriber to determine whether theenrollee is using Testosterone Cypionate for an FDA-approved use, or a use listed in the Medicareapprovedcompendia. The requested information was not received. As a result, we could not confirm thatthe drug is being prescribed for a medically accepted indication as defined by Medicare law. As such, itcannot be covered under the Medicare Part D benefit. An exceptions request based on medical necessitycannot be considered because it cannot be confirmed that the drug meets the definition of a Medicare PartD drug. Therefore, our decision is that the Plan is not required to provide coverage for TestosteroneCypionate.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Budesonide 0.5 mg/2 ml suspension. 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 Part A or Part B of Medicare for that individual. Medicare Part B may pay for supplies necessary for the effective use of durable medical equipment, including drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic benefit of the durable medical equipment. Medicare Part B local policy states that a small volume nebulizer and related compressor are covered when medically necessary to administer Budesonide for the management of obstructive pulmonary disease.In this case, the record shows that Budesonide is not administered using a small-volume nebulizer. Therefore, Medicare Part B does not provide coverage for Budesonide with this route of administration. Thus, Budesonide would not be eligible for Part B coverage in this case. We therefore asked our Physician Reviewer to determine if Part D coverage criteria have been met.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Budesonide 0.5 mg/2 ml suspension.The drug is requested to treat chronic sinusitis and nasal polyps, 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 Budesonide 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.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 Forteo. 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 Forteo.Forteo is requested to treat the enrollee's condition. The requested drug is a brand drug on Tier 3 of the Plan's formulary. There are no available lower tier brand drugs on the Plan's formulary to treat the enrollee's condition. Therefore, the requested 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 Forteo.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover 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 Symbicort 160-4.5 mcg HFA AER.The drug is requested to treat shortness of breath with a addendum diagnosis of COPD, which is an off-label (non-FDA approved) use. Review of documentation does not include testing results, discussion, or ongoing diagnosis of COPD. 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 Symbicort 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 Symbicort. 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 Intron A Intracular Inj and Intron A Ophthalmic Drops. 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 Intron A 1 million units/0.1 ml and Intron A 1 million units/ml; 1 vial per 1 day. Intron A 1 million units/0.1 ml and Intron A 1 million units/ml are requested to treat conjunctival squamous cell cancer, which is an off-label (non-FDA approved) use.The enrollee is a 74 year old woman with conjunctival squamous cell cancer of the right eye. She was started on eye drops with Intron A 1 million units/ml four times a day and office intraocular injections of Intron A 1 million units/0.1 ml in 2/2020. The prescriber requests the drugs to treat her.The eye drops are being self-administered at home by the enrollee. The intraocular drug has been dispensed by a retail pharmacy and paid for by the enrollee for administration by the prescriber. Therefore they meet Medicare criteria for part D.However, they do not meet the Medicare rules for a medically accepted use.This reviewer searched the Medicare-approved compendia and they do not contain any citations to support the use of this drug for this condition. There was no peer-reviewed medical literature from an approved journal submitted to support this appeal. This reviewer did a PubMed search and found no citations to support the request. Therefore, this drug is not being prescribed for a medically accepted indication as defined by Medicare law.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 Intron A Intracular Inj and Intron A Ophthalmic Drops 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 Intron A Intracular Inj and Intron A Ophthalmic Drops. 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.Since coverage cannot be made under the Medicare Part D benefit, the request for reimbursement has not been reviewed at this time.