Mackay Christine B, Gurley-Calvez Tami, Erickson Kirsten D, Jensen Roy A
University of Kansas Medical Center, Department of Health Policy and Management, 3901 Rainbow Boulevard, Kansas City, KS 66160, USA.
University of Kansas Cancer Center, 4350 Shawnee Mission Parkway, Fairway, KS 66205, USA.
Contemp Clin Trials Commun. 2015 Dec 17;2:69-74. doi: 10.1016/j.conctc.2015.12.002. eCollection 2016 Apr 15.
Participation in cancer clinical trials has been shown to increase overall survival with minimal increase in cost, but enrollment in adult cancer clinical trials remains low. One factor limiting enrollment is lack of insurance coverage, but this barrier should be reduced under the 2010 Patient Protection and Affordable Care Act (ACA), which includes a provision requiring coverage for clinical trial participation as of 2014.
To assess the number of Kansas adults aged 19-64, newly covered with health insurance for participation in oncology clinical trials as a result of the ACA, a cross sectional design using extracted data from the 2012 American Community Survey, Public Use Microdata Sample to estimate the number of individuals covered by insurance and data from the 2014 Department of Health and Human Services Health Insurance Marketplace enrollment to estimate those newly enrolled through ACA.
In 2014, there was an estimated increase of 3% (54,397; 95% CI: 44,149-64,244) for a total of 72% (1,171,041) of Kansans aged 19 to 64 with health insurance coverage for clinical trial participation.
Three main factors limit the effectiveness of the ACA provisions in expanding clinical trial coverage: 1) 'grandfathered' self-funded employer plans not subject to state Employee Retirement Income Security Act (ERISA) regulations, 2) Medicaid coverage limits not addressed under the ACA, 3) populations that remain uninsured. Kansas saw a negligible increase in insurance coverage as a result of the ACA thus lack of insurance coverage is likely to remain a concern for cancer patients.
参与癌症临床试验已被证明可提高总体生存率，且成本增加极少，但成人癌症临床试验的入组率仍然很低。限制入组的一个因素是缺乏保险覆盖，但根据2010年《患者保护与平价医疗法案》（ACA），这一障碍应会减少，该法案包括一项规定，要求自2014年起为临床试验参与提供保险覆盖。
为评估因ACA而新获得医疗保险以参与肿瘤学临床试验的19至64岁堪萨斯州成年人的数量，采用横断面设计，利用从2012年美国社区调查公共使用微数据样本中提取的数据来估计有保险覆盖的个体数量，并利用2014年美国卫生与公众服务部医疗保险市场注册数据来估计通过ACA新注册的人数。
2014年，估计增加了3%（54,397人；95%置信区间：44,149 - 64,244人），19至64岁有医疗保险覆盖以参与临床试验的堪萨斯人总数达到72%（1,171,041人）。
三个主要因素限制了ACA条款在扩大临床试验覆盖范围方面的有效性：1）不受州《雇员退休收入保障法》（ERISA）监管的“祖父条款”下的自筹资金雇主计划；2）ACA未涉及的医疗补助覆盖范围限制；3）仍未参保的人群。由于ACA，堪萨斯州的保险覆盖增加微不足道，因此缺乏保险覆盖可能仍然是癌症患者关注的问题。
