Whitworth Pat, Beitsch Peter, Arnell Christopher, Cox Hannah C, Brown Krystal, Kidd John, Lancaster Johnathan M
Nashville Breast Center, Nashville, TN; Dallas Surgical Group, Dallas, TX; and Myriad Genetic Laboratories, Inc., Salt Lake City, UT.
J Oncol Pract. 2017 Jan;13(1):e47-e56. doi: 10.1200/JOP.2016.013581. Epub 2016 Oct 23.
With increased demand for hereditary cancer genetic testing, some large national health-care insurance payers (LNHPs) have implemented policies to minimize inappropriate testing by mandating consultation with a geneticist or genetic counselor (GC). We hypothesized such a restriction would reduce access and appropriate testing.
Test cancellation rates (ie, tests ordered that did not result in a reported test result), mutation-positive rates, and turnaround times for comprehensive BRCA1/2 testing for a study LNHP that implemented a GC-mandate policy were determined over the 12 months before and after policy implementation (excluding a 4-month transition period). Cancellation rates were evaluated based on the reason for cancellation, National Comprehensive Cancer Network testing criteria, and self-identified ancestry. A control LNHP was evaluated over the same period for comparison.
The study LNHP cancellation rate increased from 13.3% to 42.1% ( P < .001) after policy implementation. This increase was also observed when only individuals who met National Comprehensive Cancer Network criteria for hereditary breast and ovarian cancer testing were considered (9.5% to 37.7%; P < .001). Cancellation rates increased after policy introduction for all ancestries; however, this was more pronounced among individuals of African or Latin American ancestry, for whom cancellation rates rose to 48.9% and 49.6%, respectively, compared with 33.9% for individuals of European ancestry. Over this same time period, control LNHP cancellation rates decreased or stayed the same for all subgroups.
These findings demonstrate that a GC-mandate policy implemented by a LNHP substantially decreased access to appropriate genetic testing, disproportionately impacting minority populations without any evidence that inappropriate testing was decreased.
随着对遗传性癌症基因检测需求的增加，一些大型国家医疗保险支付方（LNHPs）已实施政策，通过强制要求与遗传学家或遗传咨询师（GC）进行咨询，以尽量减少不适当的检测。我们推测这种限制会减少检测机会和适当的检测。
对于实施了GC强制政策的研究性LNHPs，在政策实施前后的12个月内（不包括4个月的过渡期），确定了全面BRCA1/2检测的检测取消率（即已订购但未产生报告检测结果的检测）、突变阳性率和周转时间。根据取消原因、国家综合癌症网络检测标准和自我认定的血统评估取消率。同期对一个对照LNHPs进行评估以作比较。
政策实施后，研究性LNHPs的取消率从13.3%增至42.1%（P <.001）。仅考虑符合国家综合癌症网络遗传性乳腺癌和卵巢癌检测标准的个体时，也观察到了这种增加（从9.5%增至37.7%；P <.001）。政策出台后，所有血统的取消率均上升；然而，非洲或拉丁美洲血统的个体中这种情况更为明显，他们的取消率分别升至48.9%和49.6%，而欧洲血统个体的取消率为33.9%。在同一时期，对照LNHPs所有亚组的取消率下降或保持不变。
这些发现表明，LNHPs实施的GC强制政策大幅减少了获得适当基因检测的机会，对少数族裔人群产生了不成比例的影响，且没有任何证据表明不适当检测有所减少。
