The US Oncology Network, The Woodlands, TX.
CVS/Aetna, Woonsocket, RI.
JCO Oncol Pract. 2024 Nov;20(11):1501-1507. doi: 10.1200/OP.23.00812. Epub 2024 Nov 12.
This paper discusses the administrative aspects of molecular diagnostics in oncology, including US Food and Drug Administration (FDA) oversight, the regulatory approval process, clinical, and operational workflows, and payment models. Comprehensive molecular testing is important to deliver optimal oncology care and improve patient outcomes. Despite the potential benefits of testing, utilization remains low. The FDA regulatory approval process is reviewed for in vitro diagnostic products, which includes classification into three regulatory classes on the basis of risk. Companion diagnostic devices are used to guide treatment decisions. The clinical and operational challenges associated with molecular testing in oncology are also discussed, including the rapidly evolving landscape of precision oncology, the wide range of biomarker testing options, and complexities of test ordering, interpretation, and result delivery. There is a need for a multifaceted support approach involving education, technology enhancements, and workflow support to overcome these challenges. In terms of payment models, coverage policies between Medicare and commercial payers are compared with differences in coverage criteria, with Medicare focusing on FDA approval or clearance, whereas commercial payers consider additional factors such as National Comprehensive Cancer Network and ASCO guidelines. Commercial payers tend to cover smaller panels on the basis of guideline-recommended biomarkers, whereas coverage for broad tumor profiling is limited. Several strategies can increase the utilization of molecular testing, including integrating test results into electronic medical record platforms, standardizing billing practices, increasing clinical trials, and primary literature supporting the use of molecular testing, educating physicians, and using tumor boards for result interpretation and treatment discussions.
本文讨论了肿瘤分子诊断的管理方面，包括美国食品和药物管理局 (FDA) 的监督、监管审批流程、临床和运营工作流程以及支付模式。全面的分子检测对于提供最佳的肿瘤护理和改善患者预后至关重要。尽管检测具有潜在的益处，但利用率仍然较低。本文回顾了体外诊断产品的 FDA 监管审批流程，其中包括根据风险将产品分为三类监管类别。伴随诊断设备用于指导治疗决策。本文还讨论了肿瘤分子检测相关的临床和运营挑战，包括精准肿瘤学的快速发展、广泛的生物标志物检测选择以及测试订购、解释和结果交付的复杂性。需要采取多方面的支持方法，包括教育、技术增强和工作流程支持，以克服这些挑战。在支付模式方面，比较了医疗保险和商业支付者之间的覆盖政策，以及覆盖标准的差异，医疗保险侧重于 FDA 的批准或清除，而商业支付者则考虑了其他因素，如国家综合癌症网络和 ASCO 指南。商业支付者倾向于根据指南推荐的生物标志物覆盖较小的面板，而对广泛的肿瘤分析的覆盖有限。有几种策略可以提高分子检测的利用率，包括将测试结果整合到电子病历平台中、标准化计费实践、增加临床试验以及支持分子检测使用的主要文献、教育医生以及使用肿瘤委员会进行结果解释和治疗讨论。
