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

You asked the Plan to cover Cimzia. 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 Cimzia 200 mg/mL. The drug is requested to treat hidradenitis suppurativa, 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 Cimzia 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 Cimzia. This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

Medicare rules require a Part D Plan to issue a decision regarding coverage within the specified timeframe.If the Plan does not make a timely decision, this is considered a denial. The Plan forwarded this case to usas required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Dimethyl Sulfoxide. The Plan did not grant this request. We received this caseto conduct an independent review.Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. Wedetermined that Dimethyl Sulfoxide is not FDA approved for both safety and effectiveness by checkingFDA sources. Therefore, the Plan is not required to cover Dimethyl Sulfoxide.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 provide a tiering exception for Latuda. The Plan did not grant this request. Wereceived 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. Latuda is a Tier 3 brand drug.The lower cost-sharing tier(s) only contain(s) generic alternative drugs. Therefore, our decision is the Planis not required to provide a tiering exception for Latuda.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cyclobenzaprine . The Plan did not grant this request. We received this case toconduct an independent review.We asked a Physician Reviewer to determine whether the Plan was correct in denying the request forCyclobenzaprine which is subject to prior approval. Our Physician Reviewer needed additional informationfrom the prescriber to make this determination. The prescriber was asked to address whether the drugsoffered by the Plan for the treatment of the enrollee's condition would: (1) not be as effective as therequested drug; and/or (2) have adverse effects. The requested information was not received. Based on areview of the available documentation, neither prior authorization criteria 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 Cyclobenzaprine.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Tobramycin nebulizer solution. 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 Part A or Part B of Medicare for that individual. Medicare Part B may pay for supplies necessary for the effective use of durable medical equipment, including drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic benefit of the durable medical equipment. Medicare Part B local policy states that a small volume nebulizer and related compressor are covered when medically necessary to administer Tobramycin nebulizer solution for the management of cystic fibrosis orbronchiectasis. In this case, the record shows that Tobramycin nebulizer solution is administered through a nebulizer in the home for a diagnosis of ICD-10 J47.9 (Bronchiectasis, uncomplicated) and B96.5 (Pseudomonas (aeruginosa) (mallei) (pseudomallei). There is no indication that it is not administered through a small volume nebulizer. It appears that this medication is eligible for coverage under Part B rather than Part D. Drugs which are eligible for coverage under Part B are excluded from Part D coverage by Medicare law. Therefore, it is our decision that the Part D Plan is not required to cover Tobramycin nebulizer solution. This decision does not concern the medical necessity or appropriateness of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Mycophenolic Acid DR 180 mg tablet. The Plan did not grant this request. We received this case to conduct an independent review.Medicare law specifically excludes coverage for any drug under the Part D program for which payment would be available under Parts A or B of Medicare for that individual. Coverage is available under Medicare Part B for prescription drugs used in immunosuppressive therapy furnished to a beneficiary who has received an organ transplant, provided the transplant was paid for by Medicare Part A. The case record indicates that Mycophenolic Acid DR is needed for a Kidney transplant performed June 2007. In this case, we requested additional information from the Part D Plan. We requested the evidence the Plan used to determine that the transplant was paid for by Medicare. We received a response from the Part D Plan, however there is insufficient information to show that the transplant was paid for by Medicare. Based on the available information we are unable to verify that coverage for the requested drug would be available for coverage under Medicare Part B. Therefore, it appears that Mycophenolic Acid DR may be eligible for Part D coverage. We therefore asked our Physician Reviewer to determine if other Part D coverage criteria are met. We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Mycophenolic Acid DR 180 mg tablet. The drug is requested for the prophylaxis of renal transplant rejection and lung transplant rejection. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of this drug for this condition. There are no applicable utilization management criteria identified for coverage of the requested drug. Our Physician Reviewer's opinion is that Medicare Part D criteria for coverage of the requested drug have been met.
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 Diclofenac powder. The Plan did not grant this request. We received this case to conduct an independent review.Medicare Part D does not cover drugs that are not FDA approved for both safety and effectiveness. We determined that Diclofenac powder is not FDA approved for both safety and effectiveness by checking FDA sources. Therefore, the Plan is not required to cover Diclofenac powder. 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 Ajovy. 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 Ajovy 225 mg/1.5 mL solution. The drug is requested to treat migraine. The prescriber has not indicatedwhy all alternatives required by the Plan (including Divalproex DR) would likely not be as effective for theenrollee 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 opinionis 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 Ajovy.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover and provide reimbursement for Prednisolone AC-Moxifloxacin Ophthalmic Compound Drops purchased at your physician's office on January 2, 2019. The Plan did not grant this request. We received this case to conduct an independent review.Medicare does not cover drugs that are not FDA approved. Bulk powders used in pharmacy compounding are not reviewed and approved for safety and efficacy by the FDA. We requested information from your physician with regard to all ingredients in this compound no response was received. Therefore, the Plan is not required to cover or provide reimbursement for Prednisolone AC-Moxifloxacin Ophthalmic Compound Drops purchased at your physician's office on January 2, 2019. 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 provide a tiering exception for Restasis. The Plan did not grant this request. 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 the same type if the lower tier(s) on the formulary only contain(s) generic alternative drugs. Restasis is a Tier 3 brand 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 Restasis.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Budesonide and Perforomist. The Plan did not grant this request. We receivedthis case to conduct 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 and Perforomist.Our Physician Reviewer noted that Budesonide and Perforomist was requested for an enrollee with adiagnosis of ICD-10-CM Diagnosis Code J45.20 - mild intermittent asthma, uncomplicated. We asked ourPhysician Reviewer to determine whether the Part D Plan was correct in denying the request forBudesonide 0.5mg/2ml and Perforomist 20mcg/2ml nebulizer solutions. The drugs are requested to treatmild intermittent asthma. Based on the information provided, the drugs would be eligible for coverageunder Part B for the enrollee's condition. Our Physician Reviewer's opinion is that the requested drugs arenot eligible for Part D coverage in this case.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 and Perforomist for the management of obstructive pulmonary disease.In this case, the record shows that Budesonide and Perforomist is administered through a nebulizer in thehome for a diagnosis of ICD-10-CM Diagnosis Code J45.20 - mild intermittent asthma, uncomplicated.There is no indication that it is not administered through a small volume nebulizer. It appears that thismedication is eligible for coverage under Part B rather than Part D. Drugs which are eligible for coverageunder Part B are excluded from Part D coverage by Medicare law. Therefore, it is our decision that the PartD Plan is not required to cover Budesonide and Perforomist.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 Tymlos. 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 Tymlos 3120 mcg/1.56 mL. The drug is requested to treat osteoporosis in a male enrollee, 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 Tymlos 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 Tymlos. 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 Actemra 162 mg/0.9 mL syr.. 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 Actemra 162 mg/0.9 mL syr.The drug is requested to treat polymyalgia rheumatica, 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 Actemra 162 mg/0.9 mL syr. 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 Actemra 162 mg/0.9 mL syr.. 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

You asked the Plan to cover Lamictal. 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 Lamictal 200 mg tablet. The drug is requested to treat Lennox-Gastaut epilepsy. On 06/11/2020 the prescriber sent additional information and medical records addressing the Plan's coverage criteria indicating past trial and failure of the Plan's required formulary alternative lamotrigine. The prescriber has indicated why all alternatives required by the Plan would likely not be as effective as the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that formulary exception criteria are 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 met. Therefore, the Plan is required to cover Lamictal.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Ofev 150 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 Ofev 150 mg. The drug is requested to treat chronic fibrosing interstitial lung disease with a progressivephenotype. You clarified this diagnosis in the Reconsideration appeal. The enrollee has underlyingautoimmune interstitial lung disease. Supporting medical records were provided.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. Therefore,the requested drug is being prescribed for a medically accepted indication. The Plan also requires that: Theforced vital capacity is greater than or equal to 45% of the predicted value AND according to the prescriberthe patient has fibrosing lung disease impacting more than 10% of lung volume on high resolutioncomputed tomography AND according to the prescriber the patient has clinical signs of progression. All ofthese requirements were satisfied and supporting documentation was provided. The enrollee satisfies thePlan'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 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 ofOfev 150 mg for the diagnosed condition. As a result, Ofev 150 mg 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 Ofev 150 mg.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Hydroxychloroquine Sulfate. 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 Hydroxychloroquine Sulfate 200 mg tablet. The drug is requested to treat sarcoidosis, 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 Hydroxychloroquine Sulfate 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 Hydroxychloroquine Sulfate. 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.