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

At issue is coverage for Thalomid 50 milligram capsules, 30 capsules per 30 days, to be given with Elotuzumab, to treat relapsed/refractory multiple myeloma. The Part D plan denied the request for coverage because the drug was being prescribed for a non-medically accepted indication. 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 documentations shows that the enrollee was originally diagnosed with progressive multiple myeloma in 2019, which was initially treated with Revlimid and Dexamethasone. Velcade was then added to the enrollees treatment regimen, as the enrollee had disease progression. The records show that the enrollee continued to have progression with the Revlimid, Dexamethasone, and Velcade combination. Due to the progression, the enrollees treatment regimen was changed to Elotuzumab, Pomalyst, and Dexamethasone. However, the enrollee experienced severe urticaria on this regimen, which was thought to be due to the Pomalyst. The prescriber is now requesting Thalomid to be given in combination with Elotuzumab. As outlined in the Medicare approved compendia and the Food and Drug Administration (FDA) product label, Thalomid is not indicated in combination with Elotuzumab to treat relapsed/refractory myeloma. However, the prescriber has submitted a peer-reviewed journal article from The British Journal of Haematology, a Medicare approved journal, titled Elotuzumab in Combination with Thalidomide and low dose Dexamethasone; A Phase 2 Single arm Safety study in Patients with Relapsed/Refractory Multiple Myeloma. This article is directly applicable to the enrollee, as patients in study had previously had Revlimid and Velcade. The study indicated that the combination of Thalidomide and Elotuzumab showed clinical benefit in patients who had the same types of previous treatments as the enrollee has had. As such, the submitted peer-reviewed journal article from a Medicare approved journal supports that the drug is being used for a medically accepted indication.The plans prior authorization requirement for the requested drug is that either the enrollee has an FDA-approved indication for the drug or, for non-FDA approved indications, there must be a Category 1 or 2A recommendation in the National Comprehensive Cancer Network (NCCN) compendium or there must be a Class I or IIa recommendation in the Medicare approved compendium, DrugDex. However, since the prescriber has submitted a peer-reviewed journal article from a Medicare approved journal that includes study results to support the use of Thalidomide in combination with Elotuzumab in the treatment of relapsed/refractory multiple myeloma, an exception to the plans prior authorization requirement is supported. As such, the submitted documentation supports coverage for the requested drug, Thalomid. A physician reviewed the appeal and determined that the requested drug is eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Favorable

At issue is Ditropan XL 10 milligram extended-release tablets to treat neurogenic bladder. 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 drug at issue is not on the plans formulary. The prescriber provided patient specific clinical rationale supported by documentation, indicating why the formulary alternatives, required by the plan, would likely not be as effective as the requested drug for this diagnosis, and/or would likely cause adverse reaction(s) or other harm. Specifically, the prescriber statement and/or medical records indicate the enrollee has tried and failed therapy with the formulary alternatives Myrbetriq and Oxybutynin extended-release. Therefore, an exception to the plans formulary coverage criteria is medically necessary.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 Eplerenone 25 milligram tablets to treat hypertension. 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 Erythromycin 250 milligram tablets to increase gastrointestinal motility in an enrollee with gastroparesis and early satiety. 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 Abiraterone Acetate 250 milligram tablet prescribed as subsequent therapy to treat nonmetastatic castration-resistant prostate cancer. 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 Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted condition. The prescriber did not submit any clinically relevant, peer-reviewed journal articles from a Medicare approved journal to support this appeal. As such, 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 Repatha Sureclick 140 milligram per milliliter injection solution to treat pure hypercholesterolemia. 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 a tiering exception request for Eplerenone 25 milligram tablets to treat hypertension. 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.Eplerenone is a generic drug on Tier 3 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.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Acthar 80 unit per milliliter injection gel to treat dermatomyositis. 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 plan has prior authorization requirements for this drug that must be met before coverage can be approved. The submitted documentation does not support that all of the plans requirements for coverage have 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 coverage for Promacta 50 milligram tablet prescribed for thrombocytopenia in the setting of chronic myelomonocytic leukemia. 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 Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for treatment of the noted condition. The prescriber did not submit any clinically relevant, peer-reviewed journal articles from a Medicare approved journal to support this appeal. As such, 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 a tiering exception request for Omnipod Dash Pods (GEN 4) insulin delivery system to treat type I diabetes mellitus. 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.Omnipod Dash Pod (Gen 4) is an insulin delivery system on Tier 3 of the plans formulary. There are no insulin delivery systems of the same type on the lower tiers of the plans formulary to treat the same diagnosis. Therefore, this insulin delivery system is not eligible for a tiering exception.A physician reviewer determined that the tiering exception criteria are not met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Austedo 12 milligram tablet. The Part D plan denied the request for coverage because the drug was being prescribed for a non-medically accepted indication. 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 diagnosis initially provided to the plan for the requested drug was generalized chorea disorder. However, 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. At reconsideration, it has now been noted that the requested drug has been prescribed to treat tardive dyskinesia. However, no medical records have been submitted to confirm the change in diagnosis. As such, due to conflicting information provided and a lack of supporting documentation, it cannot be determined if the requested drug is being 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 coverage for Cinacalcet Hydrochloride 60 milligram tablet to treat secondary hyperparathyroidism associated with chronic kidney disease. The Part D plan denied the request because coverage of the drug would be available under Medicare Part B, as the enrollee was currently receiving dialysis. 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 has clarified at reconsideration that the enrollee is not currently receiving dialysis. Medicare records confirm that the enrollee does not have end stage renal disease coverage and is not receiving dialysis. As such, coverage for the drug would not be available under Medicare Part B. However, the use of the requested drug to treat secondary hyperparathyroidism associated with chronic kidney disease in an enrollee who is not receiving dialysis is not a medically accepted indication for the drug. As noted in the Food and Drug Administration (FDA) product label for the drug, Cinacalcet is not to be used in patients with chronic kidney disease who are not receiving dialysis, as hypocalcemia may occur. Therefore, the documentation supports that 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 Scopolamine 1 milligram per 72 hour patch. 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.At initial coverage determination, a diagnosis of dizziness and giddiness was submitted. At redetermination, a diagnosis of vertigo was given. At reconsideration, a diagnosis of excessive salivation was given. However, no documentation was provided by the prescriber to support this diagnosis. We are not able to determine whether the requested drug(s) was prescribed for a medically accepted indication. Therefore, the 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 Namenda 5 milligram and 10 milligram titration pack to treat uncomplicated senile dementia. 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 Telmisartan/Hydrochlorothiazide 80 milligram/25 milligram tablets to treat essential hypertension. 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 Benlysta 200 milligram per milliliter injection solution to treat systemic lupus erythematosus. 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. The prescriber has indicated the enrollee has severe, active central nervous system lupus. Per the Medicare approved compendium DrugDex, 'The efficacy of Belimumab has not been evaluated in patients with severe active central nervous system lupus, or in combination with other biologics. Use of Belimumab is not recommended in these situations.'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 Sirolimus 1 milligram tablets for prophylaxis of rejection in a liver transplant recipient. 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 compendium DrugDex contains the following citation, 'Sirolimus is not recommended in liver transplant patients; an increase in hepatic artery thrombosis has been associated with sirolimus therapy.' 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: Partially Favorable

At issue is coverage for Tramadol Hydrochloride ER (extended release) 100 milligram capsules, 90 capsules per 30 days, to treat chronic pain requiring a long-term daily around-the-clock opioid analgesic. The Part D plan denied the request for coverage because the following coverage requirement was not met: There was no indication that the prescribing physician checked the enrollee's history of controlled substance prescriptions using the state prescription drug-monitoring program.  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 supports that the plans prior authorization requirements for the drug have been satisfied. The use of the drug to the noted condition is a medically accepted indication for the drug outlined in the Medicare approved compendia. The prescriber has indicated that the enrollee is not opioid naive. The prescriber has indicated that non-opioid therapies been optimized and are being used in conjunction with opioid therapy. The prescriber has indicated that the risks and realistic benefits of opioid therapy been discussed with the enrollee. Finally, at reconsideration, the prescriber has clarified that the enrollees history of controlled substance prescriptions is being monitored through the state prescription drug-monitoring program. As such, the documentation supports the requested drug is being used for a medically accepted indication and that the plans coverage requirements for the drug have been met. Therefore, coverage of the drug is supported.However, the quantity requested of 90 capsules per 30 days exceeds the plans quantity limit for the drug of 30 capsules per 30 days. The submitted documentation does not support exceeding the plans quantity limit for the drug. A physician reviewed the appeal and determined that the requested drug is eligible for Part D coverage at an amount of 30 capsules per 30 days. As such, the decision of the QIC is partially favorable.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Zerbaxa 1.5 gram solution to treat pseudomonas aeruginosa endocarditis of the native pulmonic and aortic valves. 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.