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Payer reimbursement practices and incentives for improving interpretation of germline genetic testing
Journal of Law and the Biosciences ( IF 3.4 ) Pub Date : 2023-07-11 , DOI: 10.1093/jlb/lsad020
Patricia Deverka 1 , Janis Geary 2 , Charles Mathews 3 , Matan Cohen 3 , Gillian Hooker 4 , Mary Majumder 5 , Zuzana Skvarkova 2 , Robert Cook-Deegan 2
Affiliation  

Germline genetic testing for inherited cancer risk has shifted to multi-gene panel tests (MGPTs). While MGPTs detect more pathogenic variants, they also detect more variants of uncertain significance (VUSs) that increase the possibility of harms such as unnecessary surgery. Data sharing by laboratories is critical to addressing the VUS problem. However, barriers to sharing and an absence of incentives have limited laboratory contributions to the ClinVar database. Payers can play a crucial role in the expansion of knowledge and effectiveness of genetic testing. Current policies affecting MGPT reimbursement are complex and create perverse incentives. Trends in utilization and coverage for private payers and Medicare illustrate opportunities and challenges for data sharing to close knowledge gaps and improve clinical utility. Policy options include making data sharing (i) a condition of payment, and (ii) a metric of laboratory quality in payment contracts, yielding preferred coverage or enhanced reimbursement. Mandating data sharing sufficient to verify interpretations and resolve discordance among labs under Medicare and federal health programs is an option for the US Congress. Such policies can reduce the current waste of valuable data needed for precision oncology and improved patient outcomes, enabling a learning health system.

中文翻译:

付款人报销实践和改进生殖系基因检测解释的激励措施

针对遗传性癌症风险的种系基因检测已转向多基因组合检测 (MGPT)。虽然 MGPT 检测到更多的致病性变异,但它们也检测到更多意义不确定的变异 (VUS),这些变异增加了不必要的手术等伤害的可能性。实验室的数据共享对于解决 VUS 问题至关重要。然而,共享障碍和缺乏激励措施限制了实验室对 ClinVar 数据库的贡献。付款人可以在基因检测知识的扩展和有效性方面发挥至关重要的作用。目前影响 MGPT 报销的政策很复杂,并且会产生不正当的激励措施。私人付款人和医疗保险的利用和覆盖趋势说明了数据共享在缩小知识差距和提高临床效用方面的机遇和挑战。政策选择包括将数据共享(i)作为付款条件,以及(ii)支付合同中实验室质量的衡量标准,从而产生优先承保范围或增强报销。强制数据共享足以验证解释并解决医疗保险和联邦卫生计划下的实验室之间的不一致是美国国会的一个选择。此类政策可以减少当前精准肿瘤学所需的宝贵数据的浪费,并改善患者的治疗结果,从而实现学习型医疗系统。
更新日期:2023-07-11
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