Persius/hicric huggingface dataset:
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 Tadalafil. 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 Tadalafil. The drug is requested to treat the enrollee's condition. A request for prescriber statement was sent and not returned. 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 Tadalafil.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Lialda DR. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law and Plan rules do not allow tiering exceptions for non-formulary drugs being covered through a formulary exception. The documentation in the record shows that Lialda DR is currently being covered for the enrollee through a formulary exception. Therefore, our decision is the Plan is not required to provide a tiering exception for Lialda DR.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Folic Acid 1 mg. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law excludes certain drugs from Part D coverage. Folic Acid 1 mg is one of those excluded drugs because it is a prescription vitamin and mineral product. The record submitted by the Plan does not indicate that they provide supplemental coverage for Folic Acid 1 mg. Therefore, the Plan is not required to cover Folic Acid 1 mg. This decision does not address the medical necessity or appropriateness of the requested drug. It only establishes that payment cannot be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Haloperidol 0.5 mg tablet and Lorazepam 0.5 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 Haloperidol and Lorazepam. Haloperidol and Lorazepam are prescribed as part of a compound drug to be administered topically for use in this enrollee with dementia, anxiety disorder, and depressive disorder, 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 Haloperidol 0.5 mg tablet and Lorazepam 0.5 mg tablet 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 Haloperidol 0.5 mg tablet and Lorazepam 0.5 mg tablet.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 Azathioprine. 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 Azathioprine. The drug is requested to treat collagenous colitis, 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 Azathioprine 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 Azathioprine. 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 Mycophenolate Mofetil, 500 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 Mycophenolate Mofetil, 500 mg tablet.The drug is requested to treat interstitial lung disease (ILD), 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 Mycophenolate Mofetil, 500 mg tablet for the diagnosedcondition. As a result, the drug is not being prescribed for a medically accepted indication as defined byMedicare law. As such, it cannot be covered under the Medicare Part D benefit for this condition. Anexceptions request based on medical necessity cannot be considered because this drug, as prescribed, doesnot meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required toprovide coverage for Mycophenolate Mofetil, 500 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

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 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. Cyclobenzaprine was requested on 2/28/19 for treatment of other muscle spasm. It is noted that the enrollee tried and failed Zanaflex. The prescriber 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. 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 Cyclobenzaprine.
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 Ventolin HFA Inhaler. The Plan did not grant thisrequest. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor a tiering exception for Ventolin HFA Inhaler.The drug is requested to treat the enrollee's condition. The drug is a brand drug on tier 3 of the Plan'sformulary. There are no available lower tier brand drugs on the Plan's formulary to treat the enrollee'scondition. Therefore, the drug is not eligible for a tiering exception. Our Physician Reviewer's opinion isthat tiering exception criteria are not met.Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of thesame type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in alower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug isbeing used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met becausethere are no lower cost-sharing tiered drugs of the same type for treating the enrollee's condition.Therefore, our decision is the Plan is not required to provide a tiering exception for Ventolin HFA Inhaler.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Qutenza patch. The Plan did not grant this request. We received this case toconduct an independent review.CMS publishes a list of participating brand name drug manufacturers that have signed the MedicareCoverage Gap discount agreement. Qutenza is a brand name drug, and its manufacturer is not on this list.Therefore, the Part D Plan is not required to cover Qutenza.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Repatha SureClick 140 mg/mL. 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 Repatha SureClick 140 mg/mL.The drug is requested to treat hyperlipidemia with atherosclerotic cardiovascular disease. The enrollee doesnot satisfy the Plan's coverage criteria. Documentation does not support the enrollee has trialed highintensity statins as required. The prescriber has not sufficiently addressed the Plan's coverage criteria and/orhas not indicated why all alternatives required by the Plan would likely not be as effective for the enrolleeas the requested drug, and/or would likely cause adverse reaction(s) or other harm to the enrollee. OurPhysician'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. 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 SureClick 140 mg/mL.
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 Amlodipine-Olmesartan/HCTZ. 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 Amlodipine-Olmesartan/HCTZ.Amlodipine-Olmesartan/HCTZ is requested for ongoing treatment of hypertension. You have indicated theenrollee is stable on the requested drug. The records do not indicate a history of sequelae of poorlycontrolled hypertension such as heart disease, etc. The Plan has indicated that there are multiple drugs ontheir formulary to treat hypertension. You have not addressed the alternatives. You have not indicated whyall 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 thePlan's coverage criteria is not supported. Our Physician Reviewer's opinion is that formulary exceptioncriteria 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 Amlodipine-Olmesartan.
Appeal type: Prescription Drug
Decision: Unfavorable

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will find abbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.A Part D Plan may establish tiered cost-sharing for drugs on its formulary. The Plan groups covered drugs into different cost-sharing levels or tiers. Medicare rules permit an enrollee to request a tiering exception to cover a higher cost-sharing tiered drug at a lower cost-sharing tier level so long as there is a drug on a lower cost-sharing tier that is approved for treating the same condition that the requested higher cost-sharing tiered drug is being used to treat. However, Medicare rules also permit a Plan to design its tiering exception procedures so that a Plan does not have to grant a tiering exception for brand or biologic drugs if the lower cost-sharing tier or tiers only contain generic drugs approved for treating the same condition. 42 CFR Sections 423.4; 423.578(a); 423.578(a)(6); 423.578(c)(3)(ii); Parts C & D Grievances, Organization/Coverage Determinations, and Appeals Guidance Manual, Section 40.5.1. The prescription drug benefit offered by the Part D Plan must meet criteria requirements pertaining to the annual deductible, the initial coverage limit, the coverage gap and catastrophic coverage. For the initial coverage limit, the rules provide for a benefit of shared coverage of costs between the enrollee and Plan. An enrollee in a Part D Plan may be subject to annual deductibles, coinsurance and copayments (including tiered copayments) specified by the Plan. 42 CFR Section 423.104.Each drug on the Plan's formulary is assigned to a cost-sharing tier. The Part D Plan contract allows an enrollee to request an exception to the Plan's cost-sharing structure to pay less for a drug. This is called a tiering exception. The prescriber must provide medical reasons to support a tiering exception. The Plan cannot grant a tiering exception for any drug in the specialty cost-sharing tier. The Plan cannot grant a tiering exception for a non-formulary drug being covered under an exception to the formulary. Please refer to the Plan's Evidence of Coverage.
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 Taltz. 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 Taltz 80 mg/mL. The drug is requested to treat psoriasis vulgaris and psoriatic arthritis. The prescriberhas not indicated why all alternatives required by the Plan (Cimzia, Enbrel, Otezla, Skyrizi) would likelynot be as effective for the enrollee as the requested drug; and/or would likely cause adverse reaction(s) orother harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. OurPhysician Reviewer's opinion is that formulary exception criteria are not met.A Plan must grant an exception for a drug that is not on its formulary if it determines that the requesteddrug is medically necessary, consistent with the prescriber's statement. Based on a review of the availabledocumentation, our Physician Reviewer's opinion is that formulary exception criteria are not met.Therefore, the Plan is not required to cover Taltz.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Xarelto, 20 mg tablet. The Plan did not grant thisrequest. We received this case to conduct an independent review.Medicare rules do not require the Part D Plan to grant a tiering exception for a brand or biologic drug of thesame type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) ifthe lower tier(s) on the formulary only contain(s) generic alternative drugs. Xarelto, 20 mg tablet is a Tier 3brand [biologic] drug. The lower cost-sharing tier(s) only contain(s) generic alternative drugs. Therefore,our decision is the Plan is not required to provide a tiering exception for Xarelto, 20 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Trihexyphenidyl 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 Trihexyphenidyl HCL. The drug is requested to treat Parkinson's disease. The enrollee does not satisfythe Plan's coverage criteria. The prescriber has not sufficiently addressed the Plan's coverage criteria and/orhas not indicated why all alternatives required by the Plan would likely not be as effective for the enrolleeas the requested drug, and/or would likely cause adverse reaction(s) or other harm to the enrollee. OurPhysician'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. 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 Trihexyphenidyl HCL.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ipratropium Bromide/Albuterol Sulfate. The Plan did not grant this request.We received this case to conduct an independent review.Medicare law specifically excludes coverage for any drug for which payment would be available under PartA or Part B of Medicare for that individual. Medicare Part B may pay for supplies necessary for theeffective use of durable medical equipment, including drugs and biologicals which must be put directly intothe equipment in order to achieve the therapeutic benefit of the durable medical equipment. Medicare PartB local policy states that a small volume nebulizer and related compressor are covered when medicallynecessary to administer Ipratropium Bromide/Albuterol Sulfate for the management of obstructivepulmonary disease.In this case, the record shows that Ipratropium Bromide/Albuterol Sulfate is administered through anebulizer in the home for a diagnosis of J45.991 Cough variant asthma. There is no indication that it is notadministered through a small volume nebulizer. It appears that this medication is eligible for coverageunder Part B rather than Part D. Drugs which are eligible for coverage under Part B are excluded from PartD coverage by Medicare law. Therefore, it is our decision that the Part D Plan is not required to coverIpratropium Bromide/Albuterol Sulfate.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.