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

You asked the Plan to cover Androgel. 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 reviewed this file and determined that there are no citations in the Medicare approved compendia that support the use of Androgel 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 Androgel. 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 usas required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Diclofenac 1.3% patch. 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 Diclofenac 1.3% patch.Diclofenac 1.3% patch is requested to treat an unknown diagnosis. The prescriber was asked to state theenrollee's diagnosis, because there was no prescriber statement of the enrollee's diagnosis in the case file.The prescriber was also asked to address medical necessity for the requested drug. A response from theprescriber was not received. Therefore, based on the current record, there is insufficient documentation thatthe requested medication is being prescribed for a medically accepted indication as defined by Medicarelaw. In addition, an exceptions request based on medical necessity cannot be considered because it cannotbe confirmed that the 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 Diclofenac 1.3% patch for an FDA-approved use, or a use listed in the Medicare-approvedcompendia. The requested information was not received. As a result, we could not confirm that the drug isbeing prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot becovered under the Medicare Part D benefit. An exceptions request based on medical necessity cannot beconsidered 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 Diclofenac 1.3% patch.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 Tymlos . The Plan did not grant this request. We received this case to conductan independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Tymlos 80 mcg. The drug is requested to treat osteoporosis, which is an off-label (non-FDA approved)use. The prescriber sent a letter dated May 20, 2020 clarifying the medical history. Medical records fromdate of service March 11, 2020 were provided which support this diagnosis. The Medicare-approvedcompendia do not contain any citations to support the use of the requested drug, as prescribed, for treatmentof the noted condition. Therefore, the requested drug is not being prescribed for a medically acceptedindication as defined by Medicare law. As such, an exceptions request based on medical necessity cannotbe considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part Ddrug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the notedcondition.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 Tymlos for the diagnosed condition. As a result, the drug is notbeing prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot becovered under the Medicare Part D benefit for this condition. An exceptions request based on medicalnecessity cannot be considered because this drug, as prescribed, does not meet the definition of a MedicarePart D drug. Therefore, our decision is that the Plan is not required to provide coverage for Tymlos.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 Ramelteon, 8 mg tablet. 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 Ramelton, 8 mg tablet.The drug is requested to treat difficulty sleeping. The prescriber has not indicated why all alternativesrequired by the Plan would likely not be as effective for the enrollee as the requested drug; and/or wouldlikely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan'scoverage criteria is not supported. Our Physician Reviewer's opinion is that formulary exception criteria arenot 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 Ramelteon, 8 mg tablet.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Fluticasone-Salmeterol 100-50 mcg/dose, 2 inhalers per 30 days. The Plan didnot 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 Fluticasone-Salmeterol 100-50 mcg/dose 2 inhalers (120 blisters) per 30 days.The drug is requested to treat asthma. The Plan limits the amount of the drug to one inhaler (60 blisters) per30 days. Based on the CMS memorandum of April 21, 2020, due to the COVID-19 public healthemergency Part D sponsors must permit enrollees to obtain the total days supply prescribed for a coveredPart D drug (as defined in 42 CFR - 423.100) up to a 90-day supply in one fill (or one refill) if:- Requested by the enrollee,- Prior Approval or Step Therapy requirements have been satisfied; and- No safety edits otherwise limit the quantity or days supply.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 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 met. Therefore, our decision is the Planis required to cover Fluticasone-Salmeterol.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Balanced Salt Solution part of a compound. 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. 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. Balanced Salt Solution is used as a used as dilutant in the reconstitution of the Interferon Alpha (Intron A) compound. Balanced Salt Solution use in this instance is not therapeutic. Thus, Balanced Salt Solution does not meet the definition of a Part D drug. Therefore, the Plan is not required to cover Balanced Salt Solution.The Part D Plan provided documentation that the request for coverage or payment for Interferon Alpha (Intron A) was approved as requested. Since the Plan has agreed to provide coverage or payment, there is no need for a reconsideration review. Contact the Part D Plan to learn more about how and when coverage or payment will be provided for Interferon Alpha (Intron A).
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Tolterodine Tartrate ER, 2 mg capsule. The Plan didnot 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 a tiering exception for Tolterodine Tartrate ER, 2 mg.The drug is requested to treat the enrollee's condition. The drug is a Generic drug on Tier 4 of the Plan'sformulary. The prescriber does not state why all available lower tier alternatives on the Plan's formulary totreat 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. OurPhysician 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 thehigher cost-sharing tiered drug for treatment of the enrollee's condition is medically necessary consistentwith the prescriber's statement. Our Physician Reviewer's opinion is that tiering exception criteria are notmet. Therefore, our decision is the Plan is not required to provide a tiering exception for TolterodineTartrate ER, 2 mg capsule.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lyrica, 75 mg capsule. 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 Lyrica, 75 mg capsule.The drug is requested to treat alcoholic polyneuropathy, 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, asprescribed, for treatment of the noted condition. Therefore, the requested drug is not 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 for the noted condition.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 Lyrica, 75 mg capsule 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, itcannot be covered under the Medicare Part D benefit for this condition. An exceptions request based onmedical necessity cannot be considered because this drug, as prescribed, does not meet the definition of aMedicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage forLyrica, 75 mg capsule.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: Favorable

You asked the Plan to cover Wixela Inhub 250-50 mcg 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 requestfor Wixela Inhub 250-50 mcg.The drug is requested to treat chronic obstructive pulmonary disease. The prescriber clarified the diagnosisin the request for reconsideration dated 7/6/2020. Medical records from date of service 6/18/2020 wereprovided which support this diagnosis. For coverage under the prescription drug benefit, Medicare requiresthat the drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that theMedicare-approved resources do contain citations to support the use of the requested drug for treatment ofthe noted condition. 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 priorauthorization criteria are met.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 reviewedthis file and determined that there are citations in the Medicare approved compendia that support the use ofWixela Inhub 250-50 mcg as prescribed for the diagnosed condition. As a result, Wixela Inhub 250-50 mcgas prescribed 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 aremet. Therefore, our decision is the Plan is required to cover Wixela Inhub 250-50 mcg as prescribed.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Megestrol Acetate, 20 mg tablet. 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 Megestrol Acetate, 20 mg tablet.The drug is requested to treat anorexia and cachexia in a patient with Parkinson's disease and dementia,which are off-label (non-FDA approved) uses. The Medicare-approved compendia do not contain anycitations 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 byMedicare law. As such, an exceptions request based on medical necessity cannot be considered because therequested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, therequested 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 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 Megestrol Acetate, 20 mg tablet for the diagnosed conditions.As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicarelaw. As such, it cannot be covered under the Medicare Part D benefit for these conditions. An exceptionsrequest based on medical necessity cannot be considered because this drug, as prescribed, does not meet thedefinition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to providecoverage for Megestrol Acetate, 20 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 Alprazolam. The Plan did not grant this request. We received this case toconduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Alprazolam 0.25 mg tablet.The drug is requested to treat insomnia, vertigo and anxiety. The prescriber sent a statement on 6/17/2020,stating that the patient did not have anxiety, panic disorder or depression. The prescriber stated that theenrollee has insomnia and that the patient uses sm [sic] dose of Alprazolam at bedtime to help her sleep.The prescriber clarified the diagnosis in the request for reconsideration dated 6/19/2020, stating that thepatient uses Xanax for vertigo and anxiety, not for insomnia. Relevant medical records were requested withthe request for reconsideration but were not provided.The prescriber was asked to clarify the enrollee's diagnosis, because it was unclear from the case file if theunderlying etiology of the enrollee's condition is insomnia or anxiety with vertigo. The prescriber was alsoasked to provide supporting medical records. A response from the prescriber was not received. Therefore,based on the current record, there is insufficient documentation that the requested medication is beingprescribed for a medically accepted indication as defined by Medicare law. In addition, prior authorizationexception criteria are not met.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 Alprazolam for an FDA-approved use, or a use listed in the Medicare-approvedcompendia. The requested information was not received. As a result, we could not confirm that the drug isbeing prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot becovered under the Medicare Part D benefit. An exceptions request based on medical necessity cannot beconsidered 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 Alprazolam.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 Hydroquinone 4% Cream. The Plan did not grant this request. We receivedthis case to conduct an independent review.Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. Wedetermined that Hydroquinone 4% Cream is not FDA approved for both safety and effectiveness bychecking FDA sources. Therefore, the Plan is not required to cover Hydroquinone 4% Cream.This decision does not address the medical necessity or appropriateness of the requested drug. It onlyestablishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Oxiconazole Nitrate 1% 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 Oxiconazole Nitrate 1% cream.The drug is requested to treat tinea pedis. 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 Oxiconazole Nitrate 1% Cream.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Bystolic, 10 mg tablet. 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 Bystolic, 10 mg.The drug is requested to treat essential hypertension. The prescriber has not indicated why additionalformulary alternatives required by the Plan (Atenolol, Bisoprolol, and Carvedilol) would likely not be aseffective for the enrollee as the requested drug; and/or would likely cause adverse reaction(s) or other harmto the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. Our PhysicianReviewer'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 Bystolic, 10 mg tablet.