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

You asked the Plan to cover Budesonide. The Plan did not grant this request. We received this case toconduct an independent review.We sent the case file to a Physician Reviewer. We asked this doctor to determine whether the Plan wascorrect in denying the request for Budesonide.Our Physician Reviewer noted that Budesonide was requested for an enrollee with a diagnosis of J45.90Unspecified asthma. We asked our Physician Reviewer to determine whether the Part D Plan was correct indenying the request for Budesonide 0.5mg/2mL inhalation suspension. The drug is requested to treatunspecified asthma, which is an off-label (non-FDA approved) use. The Medicare-approved compendia donot contain any citations to support the use of the requested drug, as prescribed, for treatment of the notedcondition. Therefore, the requested drug is not being prescribed for a medically accepted indication asdefined by Medicare law. As such, an exceptions request based on medical necessity cannot be consideredbecause 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.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 Budesonide for the management of obstructive pulmonary disease.In this case, the record shows that Budesonide is administered for a diagnosis of J45.90 Unspecifiedasthma. Medicare Part B does not provide coverage for Budesonide for this diagnosis. Thus, Budesonidewould not be eligible for Part B coverage in this case. We therefore asked our Physician Reviewer todetermine if Part D coverage criteria have been met.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Lantus Solostar . 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 Lantus Solostar is currentlybeing covered for the enrollee through a formulary exception. Therefore, our decision is the Plan is notrequired to provide a tiering exception for Lantus Solostar.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Chlordiazepoxide HCL. 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 Chlordiazepoxide HCL 5 mg capsule.The drug is requested to treat irritable bowel syndrome without diarrhea, 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 Chlordiazepoxide HCL 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 Chlordiazepoxide HCL. This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Favorable

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 Omeprazole DR 20 mg tablet, 60 tablets per 30 days. The Plan did not grantthis 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 Omeprazole DR 20 mg tablet, 60 tablets for 30 days. The drug is requested to treat Barrett's esophaguswith dysplasia and gastroesophageal reflux disease. The Plan limits the amount of the drug to 30 tablets per30 days. On April 15, 2020 you sent additional information and medical records addressing the Plan'squantity limit and providing a sufficient medical rationale for an exception. You have indicated that thenumber of doses of the requested drug allowed by the Plan has been ineffective in treating the enrollee'scondition. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our PhysicianReviewer's opinion is that quantity limit exception criteria 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 Omeprazole DR 20 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Lumigan. 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 Lumigan. 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 brand drugs on the Plan'sformulary to treat the enrollee's condition. Therefore, the drug is not eligible for a tiering exception. OurPhysician 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 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 Lumigan.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Diovan. 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 Diovan.Diovan is requested for ongoing treatment of hypertension. The Plan has indicated in their denial letter that several angiotensin converting enzyme/hydrochlorothiazide combination drugs are available on their formulary. You have indicated that the enrollee has tried and failed Losartan/HCTZ and Amlodipine, the enrollee was unable to tolerate generic Valsartan, and that the enrollee has been successfully treated with the requested drug; however you 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. 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 Diovan.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Vyvanse. 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 Vyvanse 70 mg capsule.The drug is requested to treat attention deficit hyperactivity disorder. The drug is on tier four of the Plan's formulary. There are no available (branded) lower tier drugs on the Plan's formulary to treat the enrollee's condition. Therefore, the drug is not eligible for a tiering exception. Our Physician Reviewer's opinion is that tiering exception criteria are not met.Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in a lower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug is being used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met because there are no lower cost-sharing tiered drugs of the same type for treating the enrollee's condition. Therefore, our decision is the Plan is not required to provide a tiering exception for Vyvanse.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Creon. 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 Creon capsules.The drug is requested to treat other specified diseases of pancreas. The drug is on tier 3 of the Plan'sformulary. There are no available lower tier drugs on the Plan's formulary to treat the enrollee's condition.Therefore, the drug is not eligible for a tiering exception. Our Physician Reviewer's opinion is that tieringexception 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 Creon.
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 us as 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. 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 pain due to unilateral primary osteoarthritis, left hip. 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. DrugDex cites the following medical reference in the Comparative Efficacy section of their Lidocaine monograph in the discussion of chronic back pain, and chronic osteoarthritis of the hip and knee, for multiple drugs: Krebs EE, Gravely A, Nugent S, et al: Effect of opioid vs non-opioid 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. The study demonstrated that among patients with chronic back pain or hip or knee osteoarthritis pain, treatment with opioids compared with non-opioid medications did not result in significantly better pain-related function over 12 months, and that opioids caused significantly more medication-related adverse symptoms than non-opioid medications. The noted reference states that topical Lidocaine was included in the non-opioid prescribing strategy. 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 as prescribed for the diagnosed condition. As a result, Lidocaine 5% Patch as 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 are met. 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 Aprepitant, 80 mg capsule. 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 Aprepitant, 80 mg capsule.The drug is requested to treat nausea and vomiting due to gastroparesis, 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 Aprepitant, 80 mg capsule 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 Aprepitant, 80 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: Unfavorable

You asked the Plan to cover Invokana. The Plan did not grant this request. We received this case to conductan independent review.We asked our Physician Reviewer to determine whether the Plan was correct in denying the request forInvokana. Invokana is requested for treatment of type II diabetes mellitus. The prescriber has indicated thatInvokana will be used in addition to Metformin ER and Januvia which have not sufficiently controlled theenrollee's condition. The Plan's coverage criteria for Invokana require a trial of Farxiga in combination witha Metformin containing product. The Plan's denial letter specifically indicated in their denial letter that steptherapy with Farxiga is required prior to coverage of Invokana. The prescriber has not indicated that theenrollee has tried all alternatives required by the Plan, or why the Plan's required step therapy drugs wouldlikely not be as effective for the enrollee as the requested drug, and/or would likely cause adverse reactionsor other harm to the enrollee. Our Physician Reviewer's opinion is that neither step therapy nor step therapyexception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring step therapy for certain drugs. APlan must grant an exception if it determines that the requested drug is medically necessary, consistent withthe prescriber's statement. Based on a review of the available documentation, our Physician Reviewer'sopinion is that an exception to step therapy criteria is not met. Therefore, the Plan is not required to coverInvokana.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Fentanyl 12 mcg/hr 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 Fentanyl 12 mcg/ hr transdermal patch. The drug is requested to treat chronic pain due to lumbar spinal stenosis in an 83 year old enrollee with chronic kidney disease. You do not satisfy the Plan's coverage criteria. The prescriber has not sufficiently addressed the Plan's coverage criteria and/or has not indicated why all alternatives required by the Plan would likely not be as effective for you as the requested drug, and/or would likely cause adverse reaction(s) or other harm to you. Our Physician's opinion is that neither prior authorization nor prior authorization exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. 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 Fentanyl 12 mcg/hr Patch.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Zolpidem Tartrate. 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 Zolpidem Tartrate 10 mg.The drug is requested to treat insomnia. Zaleplon is available on the Plan's formulary. The prescriber has not indicated why this alternative 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 Zolpidem Tartrate.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Dronabinol 5 mg, #60 per 30 days. 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 Dronabinol 5 mg 60/30.The drug is requested to treat cancer related loss of appetite. Upon reconsideration, the prescribingphysician has submitted an additional statement and chart notes which support that the enrollee has lungcancer and cancer-related pain with loss of appetite.For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for amedically accepted indication. Our Physician Reviewer found that the Medicare-approved resources docontain citations to support the use of the requested drug for treatment of the noted condition.The following citation in DrugDex, a Medicare-approved compendium, supports the use of the requesteddrug for the enrollee's condition: In a double-blind, multicenter trial, DRONABINOL was found toprovide significantly less amelioration of anorexia than MEGESTROL in patients with advanced cancerexperiencing anorexia. and On patient questionnaires, 75% of those receiving megestrol reportedincreased appetite compared with 49% of those receiving dronabinol. Therefore, the requested drug isbeing prescribed for a medically accepted indication.The requested drug is not eligible for coverage under Medicare Part B. The enrollee satisfies the Plan'scoverage 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 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 ofDronabinol for the diagnosed condition. As a result, Dronabinol is being prescribed for a medicallyaccepted 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 Dronabinol.