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

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 Lidocaine 5% patch as prescribed. 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 Lidocaine 5% patch.Lidocaine 5% patch is requested for ongoing treatment of neuralgia causing back pain. The prescriberstates that the enrollee has tried and failed Tylenol, Naprosyn, and Ibuprofen. For coverage under theprescription drug benefit, Medicare requires that the drug prescribed be used for a medically acceptedindication. Our Physician Reviewer found that the Medicare-approved resources do contain citations tosupport the use of the requested drug for treatment of the noted condition.Drugdex cites the following medical reference in the Comparative Efficacy section of their Lidocainemonograph in the discussion of chronic back pain, and chronic osteoarthritis of the hip and knee, formultiple drugs: Krebs EE, Gravely A, Nugent S, et al: Effect of opioid vs nonopioid medications on painrelatedfunction in patients with chronic back pain or hip or knee osteoarthritis pain: the SPACErandomized clinical trial. JAMA 2018; 319(9):872-882. The study demonstrated that among patients withchronic back pain or hip or knee osteoarthritis pain, treatment with opioids compared with nonopioidmedications did not result in significantly better pain-related function over 12 months, and that opioidscaused significantly more medication-related adverse symptoms than nonopioid medications. The notedreference states that topical Lidocaine was included in the nonopioid prescribing strategy. Therefore, therequested 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 ofLidocaine 5% patch as prescribed for the diagnosed condition. As a result, Lidocaine 5% patch asprescribed 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 Lidocaine 5% patch as prescribed.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Sildenafil 20 mg. 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 Sildenafil 20 mg.The drug is requested to treat erectile dysfunction. Upon reconsideration, the prescribing physiciansubmitted an additional diagnosis of pulmonary hypertension; however, the documentation submitted doesnot support the presence of WHO Group 1 pulmonary hypertension confirmed by right heartcatheterization. In addition, chart notes indicate that the requested drug will be used as needed.Sexual/erectile dysfunction drugs prescribed to treat sexual/erectile dysfunction or other conditions forwhich the drug is not FDA approved are excluded from coverage under Medicare Part D. Therefore therequested drug is excluded from coverage.Medicare law excludes certain drugs from Part D coverage. Sildenafil is one of those excluded drugsbecause it is a drug used to treat sexual or erectile dysfunction. The record submitted by the Plan does notindicate that they provide supplemental coverage for Sildenafil. Therefore, the Plan is not required to coverSildenafil.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 Zolpidem Tartrate, 10 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 Zolpidem Tartrate, 10 mg.The drug is requested to treat the enrollee's condition. A request for prescriber statement was sent and notreturned. The enrollee does not satisfy the Plan's coverage criteria. The prescriber has not sufficientlyaddressed the Plan's coverage criteria and/or has not indicated 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. Our Physician's opinion is that neither prior authorization nor priorauthorization 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 Zolpidem Tartrate, 10 mg tablet.
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 and provide reimbursement for Doxycycline Monohydrate and Benzonatate purchased on May 18, 2019, from your pharmacy. The Plan did not grant this request. We received this case to conduct an independent review.Regarding the request for Doxycycline Monohydrate: we asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Doxycycline Monohydrate 100 mg capsule.Doxycycline Monohydrate 100 mg capsule is requested to treat an unknown diagnosis. The prescriber was asked to state the enrollee'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 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, 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.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 the prescriber to determine whether the enrollee is using Doxycycline Monohydrate 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 cover or provide reimbursement for Doxycycline Monohydrate.Regarding the request for Benzonatate: Medicare law excludes certain drugs from Part D coverage. Benzonatate is one of those excluded drugs because it is a drug used for the symptomatic relief of coughs and colds. The record submitted by the Plan does not indicate that they provide supplemental coverage for Benzonatate. Therefore, the Plan is not required to cover or provide reimbursement for Benzonatate.This decision does not concern the medical necessity of the requested drugs. 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 Repatha. 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 Repatha Sureclick 140 mg/mL solution.The drug is requested to treat hyperlipidemia. The enrollee does not satisfy the Plan's coverage criteria(LDL cholesterol does not remain greater than or equal to 70 mg/dL on statin therapy). The prescriber hasnot sufficiently addressed the Plan's coverage criteria and/or has not indicated why all alternatives requiredby the Plan would likely not be as effective for the enrollee as the requested drug, and/or would likelycause adverse reaction(s) or other harm to the enrollee.Our Physician Reviewer's opinion is that neither prior authorization nor prior authorization exceptioncriteria 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 Repatha.
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 and provide reimbursement for Suprep Bowel Prep Kit purchased on February21, 2020, from your pharmacy. The Plan did not grant this request. We received this case to conduct anindependent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Suprep Bowel Prep Kit.Suprep Bowel Prep Kit 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 Suprep Bowel Prep Kit 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 cover or provide reimbursement forSuprep Bowel Prep Kit.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 Nuedexta. 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 Nuedexta. The drug is requested to treat ataxic cerebral palsy, mood disorder, and intellectual functioning disability, 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 Nuedexta 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 Nuedexta. 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 Armodafinil, 250 mg tablet. The Plan did not grant this request. We receivedthis case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Armodafinil, 250 mg tablet.The drug is requested to treat chronic fatigue due to multiple sclerosis, which is an off-label (non-FDAapproved) use. The Medicare-approved compendia do not contain any citations to support the use of therequested drug, as prescribed, for treatment of the noted condition. Therefore, the requested drug is notbeing prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptionsrequest based on medical necessity cannot be considered because the requested drug, as prescribed, doesnot meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverageunder Medicare 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 Armodafinil, 250 mg tablet for the diagnosed condition. As aresult, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. Assuch, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions requestbased 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 Armodafinil, 250 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 Belbuca, 75 mcg film. 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 Belbuca, 75 mcg film.The drug is requested to treat chronic pain syndrome. For coverage under the prescription drug benefit,Medicare requires that the drug prescribed be used for a medically accepted indication. Our PhysicianReviewer found that the Medicare-approved resources do contain citations to support the use of therequested drug for treatment of the noted condition. Therefore, the requested drug is being prescribed for amedically accepted indication.The prescriber has not indicated why all alternatives required by the Plan would likely not be as effectivefor the enrollee as the requested drug; and/or would likely cause adverse reaction(s) or other harm to theenrollee. Therefore, an exception to the Plan's coverage criteria is not supported. Our Physician Reviewer'sopinion 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 Belbuca, 75 mcg film.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Gilotrif, 40 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 Gilotrif, 40 mg tablet.The drug is requested as monotherapy for non-squamous, recurrent, non-small cell lung cancer, 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. 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 Gilotrif, 40 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 Gilotrif, 40 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: Unfavorable

You asked the Plan to cover Nuzyra. 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 Nuzyra, which is subject to prior approval. 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 for the treatment of the enrollee's condition would: (1) not be as effective as the requested drug; and/or (2) have adverse effects. The requested information was not received. Based on a review of the available documentation, neither prior authorization criteria 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 Nuzyra.