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 Basaglar Kwikpen. 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 Basaglar Kwikpen. Basaglar Kwikpen was requested to treat type II diabetes mellitus. The medical records indicate that the enrollee was previously treated with Lantus; however, it is not noted why Lantus was stopped. There are other long acting insulins 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 Basaglar Kwikpen.
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 Sumatriptan Succinate 50 mg tablet, 9 tablets per 23 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 Sumatriptan Succinate 50 mg tablet, 9 tablets per 23 days. Sumatriptan Succinate 50 mg tablet, 9 tablets per 23 days, is requested for treatment of migraine headaches. The Plan has a quantity limit for Sumatriptan Succinate 50 mg tablet of 9 tablets per 30 days. Additional information was requested from you to address the medical necessity for the requested quantity of Sumatriptan. Although you confirmed that the requested quantity of Sumatriptan 50 mg is 9 tablets per 23 days, you did not answer the questions related to medical necessity for the requested quantity which exceeds the Plan's quantity limit. You have 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 Sumatriptan Succinate 50 mg.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Ondansetron ODT. 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 Ondansetron ODT 4 mg tablet.The drug is requested to treat nausea related to dialysis, 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 Ondansetron ODT 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 Ondansetron ODT. 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 Afrezza. 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 Afrezza 12 unit cartridge. The drug is requested to treat type 1 diabetes mellitus with hyperglycemia. The prescriber has not indicated why all alternatives required by the Plan would likely not be as effective for you as the requested drug; and/or would likely cause adverse reaction(s) or other harm to you. 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 Afrezza.
Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Valacylovir HCL. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Valacyclovir HCL 1 gram tablet 42 tablets per 10 days. The drug is requested to treat shingles. The Plan limits the amount of the drug to 42 tablets per 28 days. Based on the CMS memorandum with regard to the COVID-19 public health emergency, Part D sponsors must permit enrollees to obtain the total days supply prescribed for a covered Part D drug (as defined in 42 CFR 423.100) up to a 90-day supply in one fill (or one refill) if requested by the enrollee, prior authorization or step therapy requirements have been satisfied and no safety edits otherwise limit the quantity or days supply. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that quantity limit exception criteria are met. The requested quantity is within the number of doses allowed by Medicare given the COVID-19 emergency. Our Physician Reviewer's opinion is that quantity limit criteria are met.Medicare rules allow a Part D Plan to manage its formulary by covering a limited quantity of certain drugs. A Plan must grant an exception if it determines that the requested dosage is medically reasonable 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 met. Therefore, the Plan is required to cover the requested quantity of Valacylovir HCL.Please note that if the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The health plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will notify you in writing that the case is being reviewed again and the outcome of the reopening.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Albuterol 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 Albuterol nebulizer solution for the management of obstructive pulmonary disease. In this case, the record shows that Albuterol nebulizer solution is administered through a nebulizer in the home for a diagnosis of mild intermittent asthma, uncomplicated (ICD-10 J45.20). 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 Albuterol 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.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 Lansoprazole DR. 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 Lansoprazole DR disintegrating tablet 15 mg. The drug is requested to treat gastroesophageal reflux disease without esophagitis. The prescriber has not indicated why all alternatives required by the Plan (including Omeprazole capsules) would likely not be as effective for you as the requested drug; and/or would likely cause adverse reaction(s) or other harm to you. 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 Lansoprazole DR.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Enemeez Plus . The Plan did not grant this request. We received this case toconduct an independent review.Medicare Part D does not cover non-prescription drugs. We checked FDA approved sources for the drug'sclassification or determined from other available resources that the drug is a non-prescription or OTC drug.Therefore, Enemeez Plus is not eligible for Part D coverage, and the Plan is not required to cover it underthe Part D benefit.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

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 Cosopt PF 2%-5% ophthalmic drops. The Plan did not grant this request. Wereceived this case to conduct an independent review.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.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Cosopt PF 2%-5% ophthalmic drops. Cosopt PF 2%-5% ophthalmic drops are requested to treat anunknown diagnosis. The prescriber was asked to state your diagnosis, because there was no prescriberstatement of your diagnosis in the case file. The prescriber was also asked to address medical necessity forthe requested drug. A response from the prescriber was not received. Therefore, based on the currentrecord, there is insufficient documentation that the requested medication is being prescribed for a medicallyaccepted indication as defined by Medicare law. In addition, an exceptions request based on medicalnecessity cannot be considered because it cannot be confirmed that the drug meets the definition of aMedicare Part D drug.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 Ciclopirox Nail Lacquer. 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 Ciclopirox Nail Lacquer.Ciclopirox Nail Lacquer is requested for ongoing treatment of onychomycosis without lunula involvementof the right treat toe nail plate. There is no documentation that any testing has been done to confirm thediagnosis; therefore the enrollee does not satisfy the Plan's coverage criteria. You have not sufficientlyaddressed the Plan's coverage criteria and/or 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. Our Physician's opinion is that neither prior authorization nor priorauthorization 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 Ciclopirox Nail Lacquer.
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 Zolpidem. 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 Zolpidem. Zolpidem is requested to treat an unknown diagnosis. The prescriber was asked to state theenrollee's diagnosis, because there was no prescriber statement of the enrollee's diagnosis in the case file.The prescriber was also asked to address medical necessity for the requested drug. A response from theprescriber was not received. Therefore, based on the current record, there is insufficient documentation thatthe requested medication is being prescribed for a medically accepted indication as defined by Medicarelaw. In addition, an exceptions request based on medical necessity cannot be considered because it cannotbe confirmed that the drug meets the definition of a Medicare Part D drug.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 needed additional information from the prescriber to determine whether theenrollee is using Zolpidem for an FDA-approved use, or a use listed in the Medicare-approved compendia.The requested information was not received. As a result, we could not confirm that the drug is beingprescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be coveredunder the Medicare Part D benefit. An exceptions request based on medical necessity cannot be consideredbecause it cannot be confirmed that the drug meets the definition of a Medicare Part D drug. Therefore, ourdecision is that the Plan is not required to provide coverage for Zolpidem.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 Ubrelvy. 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 Ubrelvy. The drug is requested to treat chronic migraine headaches. Additional medical information was requested by the Part D QIC. The prescribing physician was asked to address formulary alternatives tried and failed. The prescriber statement was not returned. The prescriber has not indicated why one additional formulary alternative required by the Plan would likely not be as effective for the enrollee as the requested drug; and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. Our Physician Reviewer's opinion is that formulary exception criteria are not met.A Plan must grant an exception for a drug that is not on its formulary if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that formulary exception criteria are not met. Therefore, the Plan is not required to cover Ubrelvy.
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 and provide reimbursement for Nifedipine Ointment compound purchased March 3, 2020 at your 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 Nifedipine Ointment compound. 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 or provide reimbursement for Nifedipine Ointment compound purchased March 3, 2020 at your 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 Levalbuterol 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 Levalbuterol nebulizer solution for the management of obstructive pulmonary disease.In this case, the record shows that Levalbuterol nebulizer solution is administered through a nebulizer in the home for a diagnosis of unspecified asthma, uncomplicated (ICD-10 J45.909). 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 Levalbuterol 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.You may wish to submit this request to the Medicare Part B carrier.