Comprehensive Cancer Center of Northwestern University, Chicago, IL, USA.
J Clin Oncol. 2012 Feb 10;30(5):548-53. doi: 10.1200/JCO.2011.37.8190. Epub 2011 Dec 27.
The Affordable Care Act (ACA) of 2010 implemented dramatic changes in our health care system. The new law requires that insurers and health plans provide coverage for individuals participating in clinical trials. Currently, there are states that already have laws or agreements requiring clinical trial coverage, but there remain deficiencies that will need to be addressed to achieve compliance with the new law.
State mandates were reviewed to determine current laws and agreements. The ACA was reviewed to outline its provisions, and these were compared with current mandates to identify deficiencies.
Eighteen states meet the requirements set forth by the ACA either through a state law or agreement; 33 states do not meet the requirements. Of these 33 states, 15 do not have any existing laws or agreements in place regarding clinical trials. In states that have deficient policies in place, the most common deficiency is the lack of phase I coverage. The second most common deficiency in policy is coverage of only therapeutic studies.
Most states currently do not meet the requirements of the ACA and will be required to make changes by 2014. The implications of the ACA with regard to insurance coverage of clinical trials remain unclear as implementation of the legislation unfolds. State governments can take steps to ensure insurance coverage by creating and expanding agreements with insurance companies.
2010 年平价医疗法案（ACA）对我们的医疗体系进行了重大改革。新法律要求保险公司和健康计划为参与临床试验的个人提供保险。目前，有些州已经有要求提供临床试验保险的法律或协议，但仍存在需要解决的缺陷，以符合新法的要求。
回顾州命令以确定现行法律和协议。审查《平价医疗法案》以概述其规定，并将这些规定与现行命令进行比较，以确定缺陷。
18 个州通过州法律或协议满足了 ACA 规定的要求；33 个州不符合要求。在这 33 个州中，有 15 个州没有关于临床试验的任何现行法律或协议。在制定了有缺陷政策的州中，最常见的缺陷是缺乏 I 期保险。政策的第二个最常见缺陷是仅涵盖治疗性研究。
大多数州目前不符合 ACA 的要求，到 2014 年将需要进行更改。随着立法的实施，ACA 对临床试验保险的影响仍不清楚。州政府可以通过与保险公司签订和扩大协议来采取措施确保保险覆盖。
