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

At issue is Ocaliva 5 milligram tablets to treat primary biliary cholangitis. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The documentation satisfies the plans coverage criteria. The submitted documentation supports the enrollee has a diagnosis of primary biliary cholangitis. The drug at issue was prescribed in consultation with a gastroenterologist. The submitted documentation supports the enrollee has failed to achieve an alkaline phosphatase level of less than 1.67 times the upper limit of normal after treatment with Ursodeoxycholic acid. Furthermore, the medical records indicate the enrollee does not have evidence of advanced cirrhosis or portal hypertension.A physician reviewed the appeal and determined that the requested drug is eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Kisqali 600 milligram tablets to treat metastatic breast cancer, HR positive, HER2 negative, in combination with Fulvestrant. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level. Medicare-approved compendia do not contain any citations to support the use of the requested drug as prescribed, for treatment of the noted diagnosis. There was no peer-reviewed, clinically relevant, medical literature from an approved journal submitted to support this appeal. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Testosterone Cypionate 200 milligram per milliliter injection solution to treat testicular hypofunction/testosterone deficiency of unknown origin. The Part D plan denied the request for coverage. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan and any information submitted at the reconsideration level.The use of the requested drug to treat the noted condition is an off-label use. The Medicare-approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of this condition. Therefore, the drug is being prescribed for a non-medically accepted indication.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Cresemba 186 milligram capsules for prophylaxis of fungal infections in an enrollee with acute myeloblastic leukemia. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The use of the requested drug to treat the provided diagnosis is an off-label use. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of this diagnosis. Therefore, the requested drug is not eligible for coverage under Medicare Part D.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Nourianz 40 milligram tablet to treat Parkinsons disease. The Part D plan denied the request for coverage. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan and any information submitted at the reconsideration level.The requested drug is not on the plans formulary. To grant an exception for a drug that is not on the plans formulary, alternative formulary drugs must have been tried and failed, or deemed contraindicated. In this case, the prescriber has not provided valid patient-specific clinical rationale with supporting documentation as to why the formulary alternative drugs listed by the plan would likely not be as effective as the requested drug and/or would likely cause adverse reactions or other harm. Therefore, the formulary exception criteria have not been met.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Favorable

At issue is coverage for Vonjo 100 milligram capsule, 120 capsules per 30 days, to treat myelofibrosis with JAK2 mutation. The Part D plan denied the request for coverage because the following prior authorization requirement was not met: the enrollees platelet count was not less than 50,000. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan and any information submitted at the reconsideration level.The submitted documentation shows that the enrollees myelofibrosis has been previously treated with Jakafi for several years; however, the enrollee has had progression of splenomegaly along with other symptoms while being treated with Jakafi. The prescriber is now requesting Vonjo to treat the enrollees condition.As outlined in the Food and Drug Administration (FDA) product labeling and the plans prior authorization requirements, Vonjo is indicated to treat myelofibrosis in patients with a platelet count below 50,000. The submitted medical records show that the enrollees platelet count in November 2022 was 87,000. However, it should be noted that the records show that in February 2022 the enrollees platelets were less than 45,000.As outlined in the National Comprehensive Cancer Network (NCCN) guidelines, it is a 2A recommendation for Vonjo to be used for the treatment of higher-risk myelofibrosis for patients with a platelet count greater than 50,000 if the patient has had no response or loss of response to one prior JAK inhibitor, one of the JAK inhibitors being Ruxolitinib (Jakafi). As noted previously, the enrollee had disease progression while on Jakafi. The submitted medical records support that the enrollee has higher-risk myelofibrosis, as the enrollee is above the age of 65, has a borderline white blood cell count of 24.5, had a platelet count less than 45,000 in February 2022, and has constitutional symptoms. As such, the submitted documentation supports that the requested drug is being used for a medically accepted indication outlined in the NCCN guidelines. Furthermore, the NCCN guidelines support an exception to the plans prior authorization requirement that the enrollees platelets must be less than 50,000. Finally, the amount requested does not exceed the plans quantity limit for the drug. Therefore, coverage for the drug is supported.A physician reviewed the appeal and determined that the requested drug is eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Eliquis 5 milligram tabltes. The Part D plan denied the request.We received the submitted documentation to perform an independent and de novo review.The submitted documentation does not include medical records or evidence of a prescribed diagnosis. Therefore, it cannot be determined if the drug was prescribed for a medically accepted indication. A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Fosfomycin Tromethamine 3 gram packet to treat urinary tract infection in a male enrollee. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The use of the requested drug to treat the provided diagnosis is an off-label use. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of this diagnosis. Therefore, the requested drug is not eligible for coverage under Medicare Part D.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Lidocaine 5 percent patch to treat rotator cuff arthropathy. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The use of the requested drug to treat the provided diagnosis is an off-label use. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of this diagnosis. Therefore, the requested drug(s) is not eligible for coverage under Medicare Part D.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Omnipod Dash Pods (Gen 4) 5 pack, 6 per 30 days, to treat type 1 diabetes mellitus. The case was auto-forwarded by the plan.We received the case to perform an independent and de novo review. To make our decision, we read the case file carefully. We reviewed all documentation submitted. This includes the case file from the plan, and any information submitted at the reconsideration level.We requested additional information from the prescriber. Specifically, we requested medical records and a prescriber statement to support the quantity prescribed was medically necessary for the enrollee. However, we did not receive the requested information.The plan limits the amount of Omnipod Dash Pods (Gen 4) 5 pack to 50 per 70 days. The prescriber has not indicated that the number of doses of the requested drug allowed by the plan would likely be ineffective in treating the diagnosis or would be likely to cause harm. Therefore, an exception to the plans coverage criteria is not supported. A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Chlorhexidine Gluconate 20 percent ophthalmic solution prescribed to treat acanthamoeba keratitis. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted. This includes the case file from the plan, and any information submitted at the reconsideration level.According to the Food and Drug Administration (FDA), drugs that fall into the category of bulk ingredients are not approved for coverage under Medicare Part D. The requested drug is part of a compound and considered a bulk liquid. Therefore, the requested drug does not meet the definition of a Part D drug and is excluded from coverage. 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

At issue is Polyhexamethylene Bigaunide (PHMB) Bacteriostatic Water 0.02 percent ophthalmic solution prescribed to treat acanthamoeba keratitis. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted. This includes the case file from the plan, and any information submitted at the reconsideration level.According to the Food and Drug Administration (FDA), drugs that fall into the category of bulk ingredients are not approved for coverage under Medicare Part D. The requested drug is part of a compound and considered a bulk liquid. Therefore, the requested drug does not meet the definition of a Part D drug and is excluded from coverage. 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

At issue is Nitroglycerin/Lidocaine 0.2/2 percent ointment prescribed for an unspecified diagnosis. The Part D plan auto-forwarded the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted. This includes the case file from the plan, and any information submitted at the reconsideration level.Medicare rules state, bulk powders for pharmaceutical compounding do not satisfy the definition of a Part D drug and are not covered by Part D. In addition, over the counter drugs are excluded from coverage under Medicare Part D. The requested compounded drug includes both bulk powder ingredients and over the counter ingredients and is therefore, excluded from coverage and not eligible for reimbursement. 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: Favorable

At issue is Shingrix 0.5 microgram per 0.5 milliliter injection kit prescribed for shingles prophylaxis. The Part D plan denied the request.We received the case to perform an independent and de novo review of this request for coverage. We reviewed all documentation submitted for review, including the case file from the plan, and any information submitted at the reconsideration level. The submitted documentation shows the enrollee received the vaccine at the prescriber's office. The enrollee submitted a valid National Drug Code number verified with the Food and Drug Administration. Therefore, the drug is eligible for coverage under Medicare Part D. The plan is required to reimburse you for the cost of the Shingrix vaccination.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Tavneos 10 milligram capsule to treat granulomatosis with polyangiitis, also known as Wegener's granulomatosis. The Part D plan denied the request for coverage because there was no documentation that the enrollee was positive for either antiproteinase 3 (PR3) or antimyeloperoxidase (MPO). We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan and any information submitted at the reconsideration level.The prescriber submitted medical records with laboratory results at reconsideration verifying that the enrollee is MPO positive. As such, the documentation supports that the drug is being used for a medically accepted indication. However, the requested drug is not on the plans formulary. In order to grant an exception for a drug not on the plans formulary, alternative formulary drugs must have been tried and failed, or deemed contraindicated. During this review, we requested medical records and a prescriber statement to address the formulary alternative drugs to treat the enrollees condition. We received additional documentation and included it in the review.In this case, the prescriber has not provided valid, sufficient patient-specific medical rationale as to why all of the formulary alternative drugs would likely not be as effective as the requested drug and/or would likely cause adverse reactions or other harm. Therefore, the formulary exception criteria have not been met.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Prolastin-C 1000 milligrams per 20 milliliter solution to treat alpha-1 antitrypsin deficiency and emphysema. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The plan has prior authorization requirements for this drug. These requirements must be met before coverage can be extended. The submitted documentation does not satisfy the plans coverage criteria.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Venclexta 100 milligram tablets to treat myelodysplastic syndrome, in combination with Cladribine and Cytarabine. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level. Medicare-approved compendia do not contain any citations to support the use of the requested drug as prescribed, for treatment of the noted diagnosis. There was no peer-reviewed, clinically relevant, medical literature from an approved journal submitted to support this appeal. Therefore, the requested drug is not being prescribed for a medically accepted indication as defined by Medicare.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Paliperidone 3 milligram extended release tablet to treat bipolar disorder, unspecified. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.We requested additional information from the prescriber. Specifically, we requested medical records to clarify the diagnosis. However, we did not receive the requested information.The use of the requested drug to treat the provided diagnoses are off-label uses. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of these diagnoses. Therefore, the requested drug(s) is not eligible for coverage under Medicare Part D.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Motegrity 2 milligram tablets to treat chronic constipation. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The requested drug is not on the plans formulary. In order to grant an exception for a drug not on the plans formulary, alternative formulary drugs must have been tried, failed, or deemed contraindicated. In this case, the documentation does not support why the formulary alternatives, required by the plan would likely not be as effective for this diagnosis, and/or would likely cause adverse reaction(s) or other harm.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Dupixent 300 milligrams per 2 milliliter solution to treat chronic rhinosinusitis with nasal polyposis. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level. The plan has prior authorization requirements for this drug. These requirements must be met before coverage can be extended. The submitted documentation does not satisfy the plans coverage criteria. A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Butalbital/Acetaminophen/Caffeine 50/325/40 milligram tablet to treat chronic migraine. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level. The use of the requested drug to treat the provided diagnosis is an off-label use. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of this diagnosis. Therefore, the requested drug(s) is not eligible for coverage under Medicare Part D. A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Zonisamide 100 milligram capsule to treat ulnar radiculopathy. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The use of the requested drug to treat the provided diagnosis is an off-label use. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of this diagnosis. Therefore, the requested drug(s) is not eligible for coverage under Medicare Part D.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Oxycontin 10 milligram extended release tablet to treat chronic back pain. The Part D plan denied the request.  We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level. The requested drug is not on the plans formulary. In order to grant an exception for a drug not on the plans formulary, alternative formulary drugs must have been tried, failed, or deemed contraindicated. In this case, the documentation does not support why the formulary alternatives, required by the plan would likely not be as effective for this diagnosis, and/or would likely cause adverse reaction(s) or other harm. A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Cefpodoxime 200 milligram tablet to treat maxillary sinusitis. The Part D plan denied the request.  We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level. Cefpodoxime 200 milligram tablet is a generic drug on Tier 4 of the plans formulary. The prescriber has not indicated if all alternatives required by the plan have been tried and failed, or why the plans lower tiered drugs would likely not be as effective as the requested drug. Therefore, this drug is not eligible for a tiering exception.A physician reviewer determined that tiering exception criteria are not met.