ArticleJAMA network open2026
Second-Level Appeals of Denied Anticancer Medication Claims in Medicare Part D.
Article in JAMA network open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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8 authors.
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Abstract
Importance: Despite the goal of utilization management (UM) to facilitate high-value cancer care, concerns about care denials persist. Evaluating justifications for denied claims can clarify the quality of UM decisions. Objective: To examine second-level appeals for denied anticancer medications in Medicare Part D to assess the quality of UM decisions. Design, Setting, and Participants: This cross-sectional study used a large language model (ChatGPT 5 Mini, OpenAI) to analyze texts of second-level appeals decisions on denied Part D medications, rendered by a Medicare-contracted reviewer. Data were analyzed from March 13, 2025, to May 12, 2026. Main Outcomes and Measures: From decision summaries, the reasons for first-level denials (as cited by Part D plans) and the outcomes of second-level appeals (favorable vs unfavorable) were examined. The reasons for unfavorable reviews (clerical vs nonclerical) were also examined. Results: We included 4952 second-level appeals from 2020 to 2024 by beneficiaries with hematological (n = 1155 [23.3%]), prostate (n = 876 [17.7%]), digestive (n = 650 [13.1%]), breast (n = 613 [12.%]), and lung, bronchus, and respiratory (n = 430 [8.7%]) cancers. Most appeals were for targeted therapy (n = 2889 [58.9%]) or hormonal therapy (n = 959 [19.4%]). The most common reasons for initial denial or appeals were "non-medically acceptable" indications (ie, off-label use; 3410 [68.9%]), formulary exceptions (545 [11.0%]), and failure to meet preapproval coverage criteria (mostly on-label prescribing; 463 [9.3%]). Overall, 19.5% (95% CI, 18.4%-20.6%) received favorable reviews, and 55.2% (95% CI, 53.8%-56.6%) and 25.3% (95% CI, 24.1%-26.5%) received unfavorable reviews due to clerical and nonclerical issues, respectively. Favorable reviews were more prevalent among appeals for drugs initially failing to meet preapproval coverage criteria (61.1% [95% CI, 56.7%-65.6%]), but less so among appeals for off-label therapies (16.5% [95% CI, 15.2%-17.8%]). More than 87.9% (95% CI, 86.1%-89.6%) of successfully appealed off-label therapies were for medically acceptable indications supported by Medicare-approved clinical compendia and/or peer-reviewed literature. Conclusions and Relevance: In this cross-sectional study of second-level appeals for denied anticancer medications in Medicare Part D, a considerable number of successfully appealed claims (especially for therapies prescribed on label) were found, which suggests potentially inappropriate UM decisions by Part D plans. However, the appeal outcomes varied substantially by the nature of the denials. Streamlining the preapproval process for on-label therapies and establishing accessible, transparent criteria for off-label prescribing may optimize UM processes for anticancer medications.
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