Medicare Study of Cost-sharing Ramifications and Prescription Drug Benefits

描述（由申请人提供）：根据《医疗保险处方药、改进和现代化法案》颁布的医疗保险D部分，从2006年1月开始，数百万医疗保险受益人享有新的处方药福利。几乎所有D部分计划都涉及大量和新型的患者费用分摊，例如覆盖范围差距;然而，对潜在的不良临床后果或对患者的总体和具体财务后果知之甚少。我们建议在凯萨医疗机构的北方和南加州（KPNC & KPSC）地区内，采用准实验性前后设计和同期对照，评估2005-2009年D部分相关费用分摊对药物使用、临床事件和直接医疗费用的影响。在这个综合的输送系统中，有700，699名年龄在65岁以上的受试者正在进行自然实验。这些受试者中有近一半（47%）在2006年面临着作为KP医疗保险优势（MA）D部分计划的一部分的药物费用分摊增加。其余53%的受试者，雇主补充计划（对照），有较低的药物费用分摊水平，从2005-2006年没有显着变化。KP Part D计划内的费用分摊水平和类型因地区而异，因此可以进行三项主要比较：1）在KPNC中，基本的Part D MA计划的共同负担费用高，覆盖范围有差距，而雇主补充计划的共同负担费用低，没有覆盖范围差距; 2）在KPSC中，增强的Part D计划的共同负担费用高，只覆盖一般保险，而不是覆盖范围有差距，而雇主补充计划;以及3）基本与增强的Part D MA计划，例如在差距时段期间无覆盖与仅通用覆盖。我们将使用重复测量方法来检验以下假设：1）具有较高水平的成本分担的计划与较低的药物使用和较高的不良临床结局（艾德就诊、住院和死亡）率相关; 2）较高的成本分担计划与较低的年度药房和总医疗成本相关，但与较高的非药房和患者自付成本相关。我们将在总体人群和选定的弱势人群（如慢性病患者或社会经济地位较低的患者）中调查这些结局。我们将调整相关因素，如合并症水平和既往住院情况。这项研究将是第一个检查新的医疗保险D部分计划的临床和经济影响，使用D部分引入前后的全面自动化数据，针对明确定义的人群。

DESCRIPTION (provided by applicant): Millions of Medicare beneficiaries have new prescription drug benefits starting in January 2006, under Medicare Part D enacted by the Medicare Prescription Drug, Improvement, and Modernization Act. Nearly all Part D plans involve substantial and new types of patient cost-sharing, e.g. coverage gaps; however, little is known about potential adverse clinical consequences, or the financial consequences overall and specifically for patients. We propose to evaluate the effects of Part D-related cost-sharing on drug use, clinical events, and direct medical costs between 2005-2009, using a quasi-experimental pre-post design with concurrent controls, within Kaiser Permanente's Northern and Southern California (KPNC & KPSC) regions. Within this integrated delivery system, there is an ongoing natural experiment among 700,699 subjects age 65+ years old. Nearly half of these subjects (47%) face increases in their drug cost-sharing as part of KP's Medicare Advantage (MA) Part D plan in 2006. The remaining 53% of subjects, with employer-supplemented plans (controls), have lower drug cost-sharing levels with no significant changes from 2005-2006. The levels and types of cost-sharing within the KP Part D plans differ by region, permitting three main comparisons: 1) a basic Part D MA plan with high copayments and a coverage gap vs. employer-supplemented plans with bwer copayments and no coverage gap, both in KPNC; 2) an enhanced Part D plan with high copayments and generic-only coverage instead of a gap vs. employer-supplemented plans, both in KPSC; and 3) basic vs. enhanced Part D MA plans, e.g. no coverage vs. generic-only coverage during the gap period. We will use repeated measures methods to test the hypotheses that 1) plans with higher levels of cost-sharing are associated with lower drug use and higher rates of adverse clinical outcomes (ED visits, hospitalizations, and deaths); and 2) higher cost-sharing plans are associated with lower annual pharmacy and total medical costs, but higher non-pharmacy and patient out-of-pocket costs. We will investigate these outcomes within the Overall Population, and within select Vulnerable Populations, e.g. patients with chronic diseases or low socioeconomic status. We will adjust for relevant factors, such as comorbidity levels and prior hospitalizations. This study will be the first to examine the clinical and economic effects of new Medicare Part D plans, using comprehensive automated data from before and after the introduction of Part D, for a well- defined population.