Department of Clinical Pharmacy and Institute for Health Policy Studies, University of California, San Francisco, 3333 California St, San Francisco, CA 94118, USA.
JAMA Intern Med. 2013 Mar 11;173(5):338-43. doi: 10.1001/jamainternmed.2013.2522.
Drug selection decisions for state Medicaid reimbursement programs should be based on the best available evidence and free of conflicts of interest (COIs), but little is known about how the committees identify and manage COIs of the members. The objectives of this study were to (1) describe the content of Medicaid drug selection committees' COI policies for the US states and the District of Colombia, (2) categorize the policies by strength, and (3) identify characteristics of a strong policy.
For all states with Medicaid Preferred Drug Lists (47 states and the District of Columbia), we conducted a systematic search of official Medicaid websites and contacted Medicaid staff by e-mail and/or telephone to identify drug selection committee COI policies. We conducted a content analysis of the policies, extracting data on COI disclosure parameters, management strategies, and review processes using predefined categories modified through an iterative process.
Policy documents were obtained for 27 of the programs (56%)-14 from websites and 13 by contacting Medicaid officials. We found high variability in COI policies, lack of public availability, and inconsistent enforcement and management of COI among states. The most common management strategy was disclosure of COI in 67% of policies (18 of 27), followed by self-recusal in 52% of policies (14 of 27). Only 15% of policies (4 of 27) ban certain relationships with industry.
Current policies are not transparent and not standardized, and no state policy included all model components. Wide variations suggest that some policies may not adequately protect drug selection decisions against COI and industry influence. With expected growth of Medicaid due to health care reform, the selection of drugs for Medicaid patients should be protected from the influence of COI.
州医疗补助计划的药物选择决策应基于最佳现有证据,且不受利益冲突(COI)的影响,但人们对委员会如何识别和管理成员的 COI 知之甚少。本研究的目的是:(1) 描述美国各州和哥伦比亚特区医疗补助药物选择委员会 COI 政策的内容;(2) 按强度对政策进行分类;(3) 确定强有力政策的特征。
对于所有拥有医疗补助首选药物清单的州(47 个州和哥伦比亚特区),我们对官方医疗补助网站进行了系统搜索,并通过电子邮件和/或电话联系医疗补助工作人员,以确定药物选择委员会 COI 政策。我们对政策进行了内容分析,使用通过迭代过程修改的预定义类别提取 COI 披露参数、管理策略和审查流程的数据。
获得了 27 个计划(56%)的政策文件-14 个来自网站,13 个通过联系医疗补助官员获得。我们发现 COI 政策存在高度差异,缺乏公开可用性,各州对 COI 的执行和管理不一致。最常见的管理策略是在 67%的政策(27 个中的 18 个)中披露 COI,其次是 52%的政策(27 个中的 14 个)中自我回避。只有 15%的政策(27 个中的 4 个)禁止与行业的某些关系。
当前政策不透明且不标准化,且没有州政策包含所有模型组件。广泛的差异表明,一些政策可能无法充分保护药物选择决策免受 COI 和行业影响。随着医疗改革导致医疗补助的预期增长,应保护医疗补助患者的药物选择免受 COI 的影响。