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

You asked the Plan to cover Freestyle Libre. The Plan did not grant this request. We received this case to conduct an independent review.Medicare rules require a Part D Plan to issue a coverage decision or a redetermination decision within the specified timeframes. If the Plan does not make a timely decision, this is considered a denial. In these circumstances, the Plan is required to forward the coverage request or the redetermination request to the Part D QIC. The case record indicates multiple requests were submitted to the Plan. The Plan did not properly process these requests to move the case forward to the next appeal level. Therefore, the applicable time frames have been exceeded, and the Part D QIC has jurisdiction to process this case.Medicare Part D does not cover devices. Freestyle Libre has been classified by the FDA as a device, not as a drug. Therefore, our decision is the Part D Plan is not required to cover Freestyle Libre. This decision does not address the medical necessity or appropriateness of the requested item. It only establishes that payment cannot 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 the Progesterone ingredient of the Testosterone-Estradiol-Estriol-Progesterone Compound purchased February 5, 2020 from Expert Compounding Pharmacy. 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. A representative of the pharmacy stated that bulk powder was used or would be used when compounding the prescription for the Progesterone ingredient of the Testosterone-Estradiol-Estriol-Progesterone Compound purchased February 5, 2020 from Expert Compounding Pharmacy. Bulk powders used in pharmacy compounding are not reviewed and approved for safety and efficacy by the FDA. Therefore, the Plan is not required to cover the Progesterone ingredient of the Testosterone-Estradiol-Estriol-Progesterone Compound purchased February 5, 2020 from Expert Compounding Pharmacy. This decision does not address 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: Unfavorable

You asked the Plan to cover Nourianz. The Plan did not grant this request. We received this case to conductan independent review.We asked a Physician Reviewer to determine whether the Plan was correct in denying the request forNourianz which is subject to prior approval. Our Physician Reviewer needed additional information fromthe prescriber to make this determination. The prescriber was asked to address whether the drugs offered bythe Plan for the treatment of the enrollee's condition would: (1) not be as effective as the requested drug;and/or (2) have adverse effects. The requested information was not received. Based on a review of theavailable documentation, neither prior authorization criteria nor prior authorization exception criteria aremet.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 Nourianz.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Rivastigmine patch 4.6 mg/24 hr. 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 Rivastigmine patch 4.6 mg/24 hr.The drug is requested to treat chronic dementia of unspecified etiology, 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 Rivastigmine patch 4.6 mg/24 hr for the diagnosed condition.As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicarelaw. As such, it cannot be covered under the Medicare Part D benefit for this condition. An exceptionsrequest based 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 Rivastigmine patch 4.6 mg/24 hr.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 Cimzia Starter Kit. The Plan did not grant this request. We received this caseto conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Cimzia starter kit - 200 mg/1 mL solution. The drug is requested to treat autoimmune bilateral posterioruveitis/unspecified iridocyclitis, which is an off-label (non-FDA approved) use. The Medicare-approvedcompendia do not contain any citations to support the use of the requested drug, as prescribed, for treatmentof the noted condition. Therefore, the requested drug is not being prescribed for a medically acceptedindication as defined by Medicare law. As such, an exceptions request based on medical necessity cannotbe considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part Ddrug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the notedcondition.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 Cimzia Starter Kit for the diagnosed condition. As a result, thedrug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, itcannot be covered under the Medicare Part D benefit for this condition. An exceptions request based onmedical necessity cannot be considered because this drug, as prescribed, does not meet the definition of aMedicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage forCimzia Starter Kit.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Cresemba. 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 Cresemba 186 mg capsule.The drug is requested for fungal prophylaxis in an enrollee with neutropenic fever and pneumonia, which isan off-label (non-FDA approved) use. Medical records were submitted from date of service 6/29/2020which documented that the enrollee had bronchoalveolar lavage which did not document organisms andnegative silver stain. In a statement dated 7/1/2020, the prescriber states the enrollee does not have invasiveAspergillosis, invasive Mucormycosis, invasive candidiasis/candidemia, or esophageal candidiasis. 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 Cresemba for the diagnosed condition. As a result, the drug isnot being 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 Cresemba.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 Bromfenac 0.09% sol. 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 Bromfenac 0.09% sol.The drug is requested to treat post-operative inflammation and pain related to cataract surgery. Forcoverage 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 prescriber has not indicated why all alternatives required by the Plan would likely not be as effectivefor the enrollee as the requested drug; and/or would likely cause adverse reaction(s) or other harm to theenrollee. Therefore, an exception to the Plan's coverage criteria is not supported. Our Physician Reviewer'sopinion is that formulary exception criteria are not met.A Plan must grant an exception for a drug that is not on its formulary if it determines that the requesteddrug is medically necessary, consistent with the prescriber's statement. Based on a review of the availabledocumentation, our Physician Reviewer's opinion is that formulary exception criteria are not met.Therefore, the Plan is not required to cover Bromfenac.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Onglyza, 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 Onglyza, 5 mg tablet.The drug is requested to treat Type 2 diabetes mellitus. Onglyza 5 mg tablet is not on the Plan's formulary. Januvia and Tradjenta are on the Plan's formulary. 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 Onglyza, 5 mg tablet.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Shingrix Vaccine. 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 requestfor a tiering exception for Shingrix. The drug is requested for the prophylaxis of Herpes zoster. Shingrix isa biologic drug on Tier 4 of the Plan's formulary. There are no available lower tier biologic drugs of thesame type on the Plan's formulary to treat the enrollee's condition. Therefore, the drug is not eligible for atiering 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 in alower cost-sharing tier approved for treating the same condition that the higher cost-sharing tier drug isbeing used to treat. In this case, the Plan covers vaccines as a Tier 4 item only. There are no lower costsharingtier vaccines available on the Plan's formulary. Because there are no lower cost-sharing tiervaccines, Shingrix Vaccine is not eligible for a tiering exception. Therefore, our decision is the Plan is notrequired to provide a tiering exception for Shingrix Vaccine.
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 Buprenorphine Patch 5 mcg/hr. 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 Buprenorphine Patch 5 mcg/hr.The drug is requested to treat chronic pain syndrome. Buprenorphine Patch 5 mcg/hr is not on the Plan'sformulary. Methadone, Morphine sulfate ER, and Fentanyl patch are on the Plan's formulary. Theprescriber has not indicated why all alternatives required by the Plan 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 Buprenorphine Patch 5 mcg/hr.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Repatha SureClick 140 mg/mL as prescribed. 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 Repatha SureClick 140 mg/mL.The drug is requested to treat hyperlipidemia with elevated LDL levels in a patient without clinicalatherosclerotic cardiovascular disease (ASCVD), calcium score 369, and an intolerance to statin therapy.The enrollee does not satisfy the Plan's coverage criteria.The prescriber has indicated why all alternatives required by the Plan would likely not be as effective as therequested 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'sopinion is that 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 met. Therefore, our decision is the Planis required 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 Aranesp. The Plan did not grant this request. We received this case to conductan independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Aranesp 300 mcg/0.6 ml syringe. The drug is requested to treat anemia - Myelodysplastic syndrome inan enrollee who is low to intermediate risk. This diagnosis was submitted by you in the appeal. Forcoverage 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. You also stated in the appealthat you would use Retacrit. Therefore, you have not indicated why all alternatives required by the Planwould likely not be as effective for the enrollee as the requested drug; and/or would likely cause adversereaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is notsupported. 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 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 Aranesp.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Dronabinol. 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 Dronabinol 2.5 mg. The drug is requested to treat pain in an enrollee with M47.818 Spondylosiswithout myelopathy or radiculopathy, sacral and sacrococcygeal region, which is an off-label (non-FDAapproved) use. Medical records were provided which support this diagnosis. The Medicare-approvedcompendia do not contain any citations to support the use of the requested drug, as prescribed, for treatmentof the noted condition. Therefore, the requested drug is not being prescribed for a medically acceptedindication as defined by Medicare law. As such, an exceptions request based on medical necessity cannotbe considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part Ddrug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the notedcondition.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 Dronabinol for the diagnosed condition. As a result, the drug isnot being 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 Dronabinol.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 Repatha Sureclick. The Plan did not grant this request. We received this caseto 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 hypercholesterolemia. Repatha Sureclick140 mg/mL is not on the Plan's formulary. The prescriber has not indicated why all alternatives required bythe Plan would likely not be as effective for the enrollee as the requested drug; and/or would likely causeadverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria isnot 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 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 Repatha Sureclick.