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

You asked the Plan to cover Gammagard. 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 Parts A or B of Medicare for that individual. Medicare Part B provides coverage of IVIG for the treatment of primary immune deficiency diseases (ICD-10 diagnosis codes D80.0, D80.2, D80.3, D80.4, D80.5, D80.6, D80.7, D81.0, D81.1, D81.2, D81.5, D81.6, D81.7, D81.89, D81.9, D82.0, D82.1, D82.4, D83.0, D83.1, D83.2, D83.8, D83.9, G11.3) in the home.   The case record indicates that Gammagard is prescribed for the treatment of a primary immune deficiency disease, ICD-10 D83.9 (Common variable immunodeficiency, unspecified) and will be administered in the home. It appears that this medication qualifies for coverage under Part B rather than Part D. As a result, the record does not establish that Gammagard is a Part D drug in this case. Therefore, it is our decision that the Part D Plan is not required to provide coverage for Gammagard {under the Part D benefit.}  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.  You may wish to submit this request to the Medicare Part B carrier.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Kombiglyze XR . The Plan did not grant this request. We received this case to conduct an independent review.   A written request for Reconsideration must be filed within 60 days from the date of the Plan's Redetermination Letter. This request was not filed within the required 60-day time limit. However, the case record reflects there is good cause for the late filing. Therefore the Reconsideration request is being processed. 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 Kombiglyze XR 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 Kombiglyze XR.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Vyndamax. 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 Vyndamax. The drug is requested to treat hereditary transthyretin related familial amyloid cardiomyopathy. The enrollee does not satisfy the Plan's coverage criteria. You state the enrollee will be taking the requested drug concurrently with Tegsedi.  You state Tegsedi will be used to treat the enrollee's polyneuropathy.  The requested drug Vyndamax, has an FDA orphan drug designation for the treatment of familial amyloid polyneuropathy. You have not sufficiently addressed the Plan's coverage criteria and/or have 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 Vyndamax.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Myrbetriq ER. The Plan did not grant this request. We received this case to conduct an independent review.   We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for a tiering exception for Myrbetriq ER. The drug is requested to treat your condition. The drug is a brand drug on Tier 3 of the Plan's formulary. There are no available lower tier brand drugs of the same type on the Plan's formulary to treat your condition. Therefore, the drug is not eligible for a tiering exception. Our Physician Reviewer's opinion is that tiering exception criteria are not met.  Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in a lower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug is being used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met because there are no lower cost-sharing tiered drugs of the same type for treating your condition. Therefore, our decision is the Plan is not required to provide a tiering exception for Myrbetriq ER.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Doxycycline Hyclate. The Plan did not grant this request. We received this case to conduct an independent review.   We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for a tiering exception for Doxycycline Hyclate. The drug is requested to treat furuncle and folliculitis. The drug is a generic drug on Tier 3 of the Plan's formulary. Doxycycline Monohydrate 100 mg capsule is on Tier 2 of the Plan's formulary. The prescriber does not state why all available lower tier alternatives on the Plan's formulary to treat your condition (1) would not be as effective for you as the requested drug and/or (2) would have adverse effects for you. Therefore, an exception to these criteria is not supported. Our Physician Reviewer's opinion is that tiering exception criteria are not met.  Medicare rules require a Plan to grant an exception to its tiering structure whenever it determines that thehigher cost-sharing tiered drug for treatment of your condition is medically necessary consistent with theprescriber's statement. Our Physician Reviewer's opinion is that tiering exception criteria are not met.Therefore, our decision is the Plan is not required to provide a tiering exception for Doxycycline Hyclate.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Rivastigmine 4.6 mg/24 hr Patch. The Plan did not grant this request. We received this case to conduct an independent review.   We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for a tiering exception for Rivastigmine 4.6 mg/24 hr Patch. The drug is requested to treat Alzheimer's disease - Dementia. The drug is a generic drug on Tier 4 of the Plan's formulary. There are no available lower tier generic drugs of the same type on the Plan's formulary to treat the enrollee's condition. Therefore, the drug is not eligible for a tiering exception. Our Physician Reviewer's opinion is that tiering exception criteria are not met.  Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in a lower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug is being used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met because there are no lower cost-sharing tiered drugs of the same type for treating the enrollee's condition. Therefore, our decision is the Plan is not required to provide a tiering exception for Rivastigmine 4.6 mg/24 hr Patch.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Dronabinol. 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 Dronabinol. The drug is requested to treat nausea and vomiting related to Crohn's disease, 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 Dronabinol 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 Dronabinol. 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 Hetlioz, 20 mg capsule. 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 Hetlioz, 20 mg capsule.The drug is requested to treat circadian rhythm sleep disorder, unspecified type, 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. A request for medical records was sent to the prescriber as the diagnosis for the requested drug was not clear in the provided documentation. Diagnoses of circadian rhythm sleep disorder, unspecified type and circadian rhythm sleep disorder, free running type were both present. In the medical records themselves the only documented diagnosis is circadian rhythm sleep disorder, unspecified type which is not a medically accepted indication. 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 Hetlioz, 20 mg capsule 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 Hetlioz, 20 mg capsule. 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

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 Alprazolam 1 mg, 270 per 90 days and Temazepam 15 mg, 90 per 90 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 Alprazolam 1 mg, 270 tablets per 90 days. The drug is requested to treat anxiety. The Plan limits the amount of the drug to 120 tablets per 30 days. We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Temazepam 15 mg, 90 capsules per 90 days. The drug is requested to treat insomnia. The Plan limits the amount of the drug to 30 capsules per 30 days. The prescriber clarified the diagnoses and medical history in a statement. The prescriber stated he is requesting a 90 day supply to limit the number of trips to the drugstore to avoid COVID-19. Per CMS Department of Health and Human Services Guidance: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). 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. 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 Alprazolam 1 mg, 270 per 90 days and Temazepam 15 mg, 90 per 90 days.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 provide a tiering exception for Dialantin. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for a tiering exception for Dialantin. The drug is requested to treat your condition. The drug is a brand drug on Tier 4 of the Plan's formulary. There are no available lower tier brand drugs of the same type on the Plan's formulary to treat your condition. Therefore, the drug is not eligible for a tiering exception. Our Physician Reviewer's opinion is that tiering exception criteria are not met.Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in a lower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug is being used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met because there are no lower cost-sharing tiered drugs of the same type for treating your condition. Therefore, our decision is the Plan is not required to provide a tiering exception for Dialntin.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide a tiering exception for Ozempic injection. 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 (such as brand or biologic drugs when considering an exception for a brand or biologic drug) if the lower tier(s) on the formulary only contain(s) generic alternative drugs. Ozempic injection is a Tier 3 brand drug. The lower cost-sharing tiers only contain generic alternative drugs. Therefore, our decision is the Plan is not required to provide a tiering exception for Ozempic injection.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Zovirax. 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 Zovirax is not FDA approved for both safety and effectiveness by checking FDA sources. Therefore, the Plan is not required to cover Zovirax. Please note: the Plan provided documentation that National Drug Code 40076094955 is being used which is not FDA approved for both safety and effectiveness. There may be other National Drug Codes that can be used that are Part D eligible. You should work with the Plan/pharmacy to verify which National Drug Codes are Part D eligible. 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 Shingrix. The Plan did not grant this request. We received this case to conduct an independent review.Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug in a lower cost-sharing tier approved for treating the same condition that the higher cost-sharing tier drug is being used to treat. In this case, the Plan covers vaccines as Tier 3 and Tier 4 items only. The Shingrix vaccine is on Tier 4. There are no lower cost-sharing tier vaccines available on the Plan's formulary for the prevention of Shingles. Because there are no lower cost-sharing tier vaccines, Shingrix is not eligible for a tiering exception. Therefore, our decision is the Plan is not required to provide a tiering exception for Shingrix.Please note: although the tiering exception was not approved, you may wish to purchase the vaccine and have the vaccine administered at a preferred in-network pharmacy and not your prescriber's office. The prescriber's office is considered an out-of-network pharmacy and may charge more for the vaccine than the Plan's copayment amount, they may also charge for the administration of the vaccine. You may wish to discuss pharmacy options and costs with the Plan.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Nexletol. 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 Nexletol. The drug is requested to treat hyperlipidemia, 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. Upon reconsideration, the prescribing physician submitted an additional diagnosis of heterozygous familial hypercholesterolemia; however, chart notes do not support the change in diagnosis. 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 Nexletol 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 Nexletol. 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 us as required by Medicare rules because it did not make a timely decision.You asked the Plan to cover Metronidazole 0.75% Lotion. 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 Metronidazole 0.75% Lotion. The drug is requested to treat Candidiasis of the Vulva and Vagina, 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 Metronidazole 0.75% Lotion 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 Metronidazole 0.75% Lotion. 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.