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

You asked the Plan to cover Shingrix vial kit. 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 Shingrix vial kit. The drug is requested for Herpes zoster; Prophylaxis in an enrollee who is under 50 years of age, 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 Shingrix vial kit 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 Shingrix vial kit. 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 benefi
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Dupixent. The Plan did not grant this request. Wereceived 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 Dupixent is currently beingcovered for the enrollee through a formulary exception. Therefore, our decision is the Plan is not requiredto provide a tiering exception for Dupixent.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Albuterol Sulfate nebulizer solution. 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 Albuterol Sulfate nebulizer solution for the management of obstructive pulmonarydisease.In this case, the record shows that Albuterol Sulfate nebulizer solution is administered through a nebulizerin the home for a diagnosis of chronic obstructive pulmonary disease, unspecified (ICD-10 J44.9). There isno indication that it is not administered through a small volume nebulizer. It appears that this medication iseligible for coverage under Part B rather than Part D. Drugs which are eligible for coverage under Part Bare excluded from Part D coverage by Medicare law. Therefore, it is our decision that the Part D Plan is notrequired to cover Albuterol Sulfate nebulizer solution.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 cover Cinacalcet HCL 30 mg. 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 Cinacalcet HCL 30 mg. The drug is requested to treat secondary hyperparathyroidism related to chronickidney disease not on dialysis and in the absence of renal transplant, 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 Cinacalcet HCL 30 mg 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 Cinacalcet HCL 30 mg.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.Please note: the request for a tiering exception (lower copayment) for Cinacalcet HCL 30 mg was notreviewed. We cannot consider a tiering exception for a drug for which the Part D Plan is unable to providecoverage.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide reimbursement for Cephalexin purchased May 19, 2019. The Plan did not grant this request. We received this case to conduct an independent review.  Cephalexin purchased May 19, 2019 is not covered by Medicare because it was purchased outside the United States. Therefore, our decision is that the Part D Plan is not required to pay for Cephalexin purchased May 19, 2019.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Rhopressa 0.02%, 2.5 bottles per 30 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 Rhopressa 0.02% eye drop, 2.5 bottles per 30 days.The drug is requested to treat glaucoma. The Plan limits the amount of Rhopressa 0.02% to 2.5 mL (1 bottle) per 30 days. Medical records were provided which document that Rhopressa 0.02% eye drops is prescribed as 1 drop to each eye once a day at bedtime. Two bottles per 30 days would be sufficient quantity to satisfy the prescriber's dosing schedule, not 2.5 bottles per 30 days. The prescriber has not indicated that the number of doses of the requested drug allowed by the Plan would likely be ineffective in treating the enrollee's condition and/or would likely cause harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported.Our Physician Reviewer's opinion is that quantity limit exception criteria are not 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 and necessary, 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 not met. Therefore, the Plan is not required to cover the requested quantity of Rhopressa 0.02%, 2.5 bottles per 30 days.Please note that the Part D Plan has provided documentation that the request for coverage or payment for Rhopressa at a quantity of 1 bottle (2.5 mL) per 30 days was approved as requested. Contact the Part D Plan to learn more about how and when coverage or payment will be provided for Rhopressa at a quantity of 1 bottle per 30 days.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cialis. 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 Cialis (Tadalafil). The drug is requested to treat Buerger's disease (to improve circulation), which is anoff-label (non-FDA approved) use. Erectile dysfunction drugs (denoted by a specific National Drug Code[NDC]) will not meet the definition of a Part D drug when used off-label, even when the off-label use islisted in one of the Medicare drug reference books (compendia). Therefore, the requested drug is not beingprescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions requestbased on medical necessity cannot be considered because the requested drug, as prescribed, does not meetthe definition 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 Cialis 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 Cialis.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 provide a tiering exception for Vimpat. 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 Vimpat 200mg. The drug is requested to treat the enrollee's condition. The drugis a brand drug on Tier 4 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.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 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 Vimpat.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cyclobenzaprine. 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 Cyclobenzaprine 10 mg tablet. The drug is requested to treat rheumatoid arthritis in an enrollee with osteoarthritis, 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 Cyclobenzaprine 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 Cyclobenzaprine. 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 Xifaxan. 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 Xifaxan. The drug is requested to treat hepatic encephalopathy. The drug is on Tier 4 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 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 Xifaxan.
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 Albuterol HFA. 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 Albuterol HFA is currentlybeing covered for the enrollee through a formulary exception. Therefore, our decision is the Plan is notrequired to provide a tiering exception for Albuterol HFA.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Vimpat. The Plan did not grant this request. Wereceived 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 thespecialty tier are not eligible for a tiering exception. Vimpat is in the specialty tier. The record indicates thePlan has chosen to exclude the specialty tier from the tiering exception process. Therefore, the Plan is notrequired to provide a tiering exception for Vimpat.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Lidocaine 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 lumbar radiculopathy and right hip strain, 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 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 Lidocaine Patch 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 Lidocaine Patch. 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 Buprenorphine SL HCL. 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 Buprenorphine HCL 2 mg sublingual tablet.The drug is requested to treat chronic pain syndrome, which is an off-label (non-FDA approved) use. TheMedicare-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 Buprenorphine SL HCL 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 Buprenorphine SL HCL.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 provide a tiering exception for Livalo. 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 Livalo. The drug is requested to treat hyperlipidemia. The drug is a brand drugon tier 4 of the Plan's formulary. There are no available lower tier brand drugs of the same type on thePlan'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 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 Livalo.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Orencia Clickjet. 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 Orencia Clickjet. The drug is requested to treat Rheumatoid Arthritis. The prescriber states the enrolleehas tried and failed Humira and Plaquenil. The enrollee does not satisfy the Plan's coverage criteria. Theprescriber has not sufficiently addressed the Plan's coverage criteria and/or has not indicated why allalternatives 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 thatneither 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. 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 Orencia Clickjet.