{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,23]],"date-time":"2026-07-23T16:10:27Z","timestamp":1784823027604,"version":"3.55.0"},"reference-count":58,"publisher":"American Medical Association (AMA)","issue":"7","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"\n Importance<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To examine second-level appeals for denied anticancer medications in Medicare Part D to assess the quality of UM decisions.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n We included 4952 second-level appeals from 2020 to 2024 by beneficiaries with hematological (n\u2009=\u20091155 [23.3%]), prostate (n\u2009=\u2009876 [17.7%]), digestive (n\u2009=\u2009650 [13.1%]), breast (n\u2009=\u2009613 [12.%]), and lung, bronchus, and respiratory (n\u2009=\u2009430 [8.7%]) cancers. Most appeals were for targeted therapy (n\u2009=\u20092889 [58.9%]) or hormonal therapy (n\u2009=\u2009959 [19.4%]). The most common reasons for initial denial or appeals were \u201cnon\u2013medically acceptable\u201d 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.<\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2026.24772","type":"journal-article","created":{"date-parts":[[2026,7,23]],"date-time":"2026-07-23T15:30:31Z","timestamp":1784820631000},"page":"e2624772","source":"Crossref","is-referenced-by-count":0,"title":["Second-Level Appeals of Denied Anticancer Medication Claims in Medicare Part D"],"prefix":"10.1001","volume":"9","author":[{"given":"Youngmin","family":"Kwon","sequence":"first","affiliation":[{"name":"Department of Health Policy, Vanderbilt University School of Medicine, Nashville, Tennessee"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenji V.","family":"Aoki","sequence":"additional","affiliation":[{"name":"John A. Burns School of Medicine, University of Hawai\u2019i at Manoa, Honolulu, Hawaii"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shelley A.","family":"Jazowski","sequence":"additional","affiliation":[{"name":"Department of Social Sciences and Health Policy, Wake Forest University of School of Medicine, Winston-Salem, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xin","family":"Hu","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Emory University School of Medicine, Atlanta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lindsay M.","family":"Sabik","sequence":"additional","affiliation":[{"name":"Department of Health Policy and Management, University of Pittsburgh School of Public Health, Pittsburgh, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stacie B.","family":"Dusetzina","sequence":"additional","affiliation":[{"name":"Department of Health Policy, Vanderbilt University School of Medicine, Nashville, Tennessee"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K. Robin","family":"Yabroff","sequence":"additional","affiliation":[{"name":"Surveillance, Prevention & Health Services Research Department, American Cancer Society, Atlanta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhiyuan","family":"Zheng","sequence":"additional","affiliation":[{"name":"Surveillance, Prevention & Health Services Research Department, American Cancer Society, Atlanta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","published-online":{"date-parts":[[2026,7,23]]},"reference":[{"issue":"9","key":"zoi260693r1","doi-asserted-by":"publisher","first-page":"997","DOI":"10.1001\/jama.2009.1279","article-title":"Assessing the appropriateness of care\u2014its time has come.","volume":"302","author":"Brook","year":"2009","journal-title":"JAMA"},{"issue":"8","key":"zoi260693r2","doi-asserted-by":"publisher","first-page":"951","DOI":"10.1200\/JCO.23.01693","article-title":"Prior authorization and association with delayed or 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JF, Sroczynski? N, Freed? M, Published? TN. Medicare Advantage insurers made nearly 50 million prior authorization determinations in 2024. KFF. January 28, 2026. Accessed May 13, 2026. https:\/\/www.kff.org\/medicare\/issue-brief\/nearly-50-million-prior-authorization-requests-were-sent-to-medicare-advantage-insurers-in-2023\/"},{"key":"zoi260693r12","unstructured":"Levinson? DR. Medicare Advantage appeal outcomes and audit findings raise concerns about service and payment denials. US Department of Health and Human Services. September 2018. Accessed May 13, 2026. https:\/\/oig.hhs.gov\/documents\/evaluation\/3140\/OEI-09-16-00410-Complete%20Report.pdf"},{"key":"zoi260693r13","unstructured":"Grimm? C. Some Medicare Advantage organization denials of prior authorization requests raise concerns about beneficiary access to medically necessary care. April 27, 2022. Accessed May 13, 2026. https:\/\/oig.hhs.gov\/reports\/all\/2022\/some-medicare-advantage-organization-denials-of-prior-authorization-requests-raise-concerns-about-beneficiary-access-to-medically-necessary-care\/"},{"key":"zoi260693r17","unstructured":"Grimm? CA. Some Medicare Advantage organization denials of prior authorization requests raise concerns about beneficiary access to medically necessary care. April 27, 2022. Accessed May 13, 2026. https:\/\/oig.hhs.gov\/documents\/evaluation\/3150\/OEI-09-18-00260-Complete%20Report.pdf"},{"key":"zoi260693r18","unstructured":"Sutton? JP. More Medicare Advantage beneficiaries are filing appeals for denied services or treatments. The Commonwealth Fund. October 8, 2024. Accessed May 13, 2026. https:\/\/www.commonwealthfund.org\/blog\/2024\/more-medicare-advantage-beneficiaries-are-filing-appeals-denied-services-or-treatments"},{"key":"zoi260693r19","unstructured":"Denied: the harmful role of prior authorization & claim denials. 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Accessed November 24, 2025. https:\/\/www.oncologynewscentral.com\/rare-cancers-and-disorders\/oncologists-turn-to-off-label-drug-use-for-rare-cancers-what-to-know"},{"key":"zoi260693r48","unstructured":"O\u2019Rourke? KM. Oncologists\u2019 off-label prescribing pits access against reimbursement. October 15, 2018. Accessed November 24, 2025. https:\/\/www.medscape.com\/viewarticle\/903321?form=fpf"},{"key":"zoi260693r49","unstructured":"Hargrave? E, Hoadley? J, Thompson? J. Coverage and pricing of drugs that can be covered under Part B and Part D. October 2007. Accessed November 23, 2025. https:\/\/www.medpac.gov\/wp-content\/uploads\/import_data\/scrape_files\/docs\/default-source\/contractor-reports\/Oct07_PartB_D_contractor_JS.pdf"},{"key":"zoi260693r50","unstructured":"Number of cancer cases with prescription drugs on the durable medical equipment files. National Cancer Institute. March 31, 2025. 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Phil. 5 takeaways from health insurers\u2019 new pledge to improve prior authorization. KFF Health News. September 3, 2025. Accessed December 1, 2025. https:\/\/kffhealthnews.org\/news\/article\/5-takeaways-from-insurers-pledge-to-improve-prior-authorization\/"},{"key":"zoi260693r55","unstructured":"Kyle? MA, Sachs? R. Understanding CMS\u2019s proposed rule regarding prior authorization for drugs. HealthAffairs. May 8, 2026. Accessed May 22, 2026. https:\/\/www.healthaffairs.org\/do\/10.1377\/forefront.20260505.411452\/full\/"},{"key":"zoi260693r56","unstructured":"O\u2019Reilly? KB. 2 big insurers take small steps to ease prior authorization burden. September 18, 2023. Accessed December 1, 2025. https:\/\/www.ama-assn.org\/practice-management\/prior-authorization\/2-big-insurers-take-small-steps-ease-prior-authorization"},{"key":"zoi260693r58","unstructured":"\u201cGold card\u201d laws let some providers skip prior authorization. Is that a good thing? Advisory Board. May 5, 2022. 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