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

You asked the Plan to cover Imatinib Mesylate, 100 mg tablet as prescribed. 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 Imatinib Mesylate, 100 mg; 90/30.The drug is requested to treat chronic myelogenous leukemia (CML). The enrollee is a 61 year old woman with CML since at least 1991. She has been treated with allogeneic bone marrow transplant and multiple DLI (donor lymphocyte infusions). She has been treated in the past with Gleevec, with good control. She has been treated with Dasatinib which was stopped due to pneumonia felt to be secondary to the drug, Tasigna which was stopped due to bloating, and Bosulif which was stopped due to rising creatinine and liver function tests. Her BCR-ABL levels were 0.32% in 1/2020, 0.36% in 2/2020, and 0.28% in 5/2020. The prescriber states she only tolerates Gleevec (Imatinib Mesylate.) The prescriber requests Imatinib Mesylate to treat her.Per the NCCN compendium, Imatinib Mesylate is indicated as post-allogeneic HCT follow-up therapy in patients with molecular relapse (BCR-ABL1 transcript positive) following complete cytogenetic response (CCyR). The enrollee has molecular relapse as shown by her BCR-ABL positive status. She has tried other tyrosine kinase inhibitors but they were stopped due to toxicity, not due to lack of response or progression of CML.For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that the Medicare-approved resources do contain 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 enrollee satisfies the Plan'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 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 citations in the Medicare approved compendia that support the use of Imatinib Mesylate, 100 mg tablet as prescribed for the diagnosed condition. As a result, Imatinib Mesylate, 100 mg tablet as prescribed is being prescribed for a medically accepted 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 are met. Therefore, our decision is the Plan is required to cover Imatinib Mesylate, 100 mg tablet as prescribed.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Kineret solution. 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 Kineret solution.Kineret solution is requested for treatment of Prednisone dependent, Colchicine resistant pericarditis, which is an off-label (non-FDA approved) use. The prescriber has provided medical literature to support the use of Kineret solution for the stated diagnosis; however 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 Kineret solution 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 Kineret solution. 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 provide a tiering exception for Flovent HFA. 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. Flovent HFA is a Tier 3 branddrug. The lower cost-sharing tier(s) only contain(s) generic alternative drugs. Therefore, our decision is thePlan is not required to provide a tiering exception for Flovent HFA.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Doxepin, 10 mg capsule. 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 Doxepin, 10 mg capsule.Doxepin, 10 mg is requested for treatment of chronic idiopathic pruritis, 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 Doxepin, 10 mg capsule for the diagnosed condition. As aresult, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. Assuch, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions requestbased 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 Doxepin, 10 mg capsule.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 Pennsaid. 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 Pennsaid 2%. Pennsaid 2% is requested for treatment of lateral and medial epicondylitis (tennis and golfer's elbow), which are off-label (non-FDA approved) uses. The prescriber has indicated that other treatment options were ineffective or are inappropriate for this enrollee; however Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted conditions. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted conditions.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia that support the use of Pennsaid 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 Pennsaid. 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 Motegrity, 1 mg tablet. 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 Motegrity 1 mg tablet.The drug is requested to treat irritable bowel syndrome with diarrhea (IBS-D), and small intestinal bacterialovergrowth (SIBO), which are off-label (non-FDA approved) uses. The Medicare-approved compendia donot contain any citations to support the use of the requested drug, as prescribed, for treatment of the notedconditions. The appeal request documented a change in the diagnosis to IBS with constipation (IBS-C).However, progress notes submitted did not support that the requested drug is being used to treat IBS-C.Additional medical information was requested by the Part D QIC. The prescribing physician was asked toaddress the diagnosis and formulary alternatives tried and failed. The prescriber statement was returned.The prescriber documented that Xifaxan is being taken concurrently with the requested drug. The diagnosesdocumented were irregular bowel movements, idiopathic constipation, anal spasm (ICD-10 K59.4),diverticulosis, and small intestinal bacterial overgrowth. The Medicare-approved compendia do not containany citations to support the use of the requested drug, as prescribed, for treatment of these noted conditions.Therefore, the requested drug is not being prescribed for a medically accepted indication as defined byMedicare law. As such, an exceptions request based on medical necessity cannot be considered because therequested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, therequested 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 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 Motegrity, 1 mg tablet for the diagnosed conditions. As aresult, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. Assuch, it cannot be covered under the Medicare Part D benefit for these conditions. An exceptions requestbased 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 Motegrity, 1 mg tablet.This decision does not concern the medical necessity of the requested drug. It only establishes if paymentcan be made under the Medicare Part D benefit.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Procrit. 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 Procrit.Procrit is requested to treat an unclear diagnosis. The prescriber was asked to clarify the enrollee'sdiagnosis, because there was a change of the enrollee's diagnosis in the case file. The prescriber was alsoasked to address medical necessity for the requested drug. A response from the prescriber was not received.Therefore, based on the current record, there is insufficient documentation that the requested medication isbeing prescribed for a medically accepted indication as defined by Medicare law. In addition, an exceptionsrequest based on medical necessity cannot be considered because it cannot be confirmed that the drugmeets 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 Procrit 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 Procrit.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 provide a tiering exception for Sucralfate 1 gm/10 mL. 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 Sucralfate 1 gm/10 mL.The drug is requested to treat the enrollee's condition. The drug is a brand drug on Tier 4 of the Plan's formulary. A request for prescriber statement was sent and not returned. The prescriber does not state why all available lower tier alternatives on the Plan's formulary to treat the enrollee's condition (1) would not be as effective for the enrollee as the requested drug and/or (2) would have adverse effects for the enrollee. 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 the higher cost-sharing tiered drug for treatment of the enrollee's condition is medically necessary consistent with the prescriber'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 Sucralfate 1 gm/10 mL.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Sildenafil. 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 Sildenafil. The drug is requested to treat your condition. A request for prescriber statement was sent andnot returned. You do not satisfy the Plan's coverage criteria. The prescriber has not sufficiently addressedthe Plan's coverage criteria and/or has not indicated why all alternatives required by the Plan would likelynot be as effective for you as the requested drug, and/or would likely cause adverse reaction(s) or otherharm to you. Our Physician's opinion is that neither prior authorization 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 Sildenafil.
Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover the Lidocaine-Ocean Nasal Compounded Spray. The Plan did not grant this request. We received this case to conduct an independent review.Lidocaine IngredientMedicare Part D does not cover drugs that are not FDA approved. A representative of the pharmacy stated that bulk powder was used for the Lidocaine ingredient of the Lidocaine-Ocean Nasal Compounded Spray. Bulk powders used in pharmacy compounding are not reviewed and approved for safety and efficacy by the FDA.Ocean Nasal Spray IngredientMedicare Part D does not cover non-prescription drugs. We checked FDA approved sources for the drug's classification or determined from other available resources that the drug is a non-prescription or OTC drug. Therefore, the Ocean Nasal Spray ingredient of the Lidocaine-Ocean Nasal Compounded Spray is not eligible for Part D coverage, and the Plan is not required to cover it under the Part D benefit.Therefore, the Plan is not required to cover the Lidocaine-Ocean Nasal Compounded Spray. 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 Metformin HCl solution. The Plan did not grant this request. We received thiscase to conduct an independent review.CMS publishes a list of participating brand name drug manufacturers that have signed the MedicareCoverage Gap discount agreement. Metformin HCl solution is a brand name drug, and its manufacturer isnot on this list. Therefore, the Part D Plan is not required to cover Metformin HCl solution.
Appeal type: Prescription Drug
Decision: Partially Favorable

You asked the Plan to provide reimbursement for Breo Ellipta 100-25 mcg received May 14, 2019 and March 4, 2020. The Plan did not grant this request. We received this case to conduct an independent review.The Plan covers prescriptions filled at an out-of-network pharmacy only in certain limited circumstances. If an enrollee must use an out-of-network pharmacy, the enrollee will generally have to pay the full cost when the prescription is filled. The enrollee may submit a request for reimbursement with proof of payment to ask the Plan to pay its share of the cost. In this case, you were a patient at the hospital in May 2019 and March 2020. This was an emergency or urgent care situation. During this stay you received several self-administered drugs. One of those drugs (Breo Ellipta) has not been paid for by the Plan. The Plan indicates coverage and reimbursement cannot be approved due to the National Drug Code (NDC) provided not being a valid NDC. However, we check ed with Medicare approved resources and verified the NDC provided (0173085914) is a valid, Part D eligible NDC for Breo Ellipta. Additionally, a representative from Maximus Federal verified the self-administered drug portion of the May 2019 bill has been paid for in full. Therefore, the Plan's out-of-network coverage rules were followed for the May 14, 2019 date of service. Therefore, our decision is the Plan is required to provide coverage and reimbursement for Breo Ellipta 100-25 mcg received May 14, 2019. However, the representative from the hospital also verified the self-administered drug portion of the March 2020 bill has not yet been paid in full. Therefore, our decision is the Plan is not required to cover or provide reimbursement for Breo Ellipta 100-25 mcg March 4, 2020.
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 Butalbital-Acetaminophen-Caffeine, 50-325-40 mg tablet. The Plan did notgrant 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 Butalbital-Acetaminophen-Caffeine, 50-325-40 mg.The drug is requested to treat the enrollee's condition. A request for prescriber statement was sent and notreturned. The enrollee does not satisfy the Plan's coverage criteria. The prescriber has not sufficientlyaddressed the Plan's coverage criteria and/or has 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 Butalbital-Acetaminophen-Caffeine, 50-325-40 mg tablet.