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获得了新的处方药福利。几乎所有的D部分计划都涉及大量和新型的患者费用分摊，例如覆盖缺口；然而，对潜在的不良临床后果，或对患者的总体和具体的经济后果知之甚少。我们建议在Kaiser Permanente北加州和南加州（KPNC & KPSC）地区，采用具有并发对照的准实验前后设计，评估2005-2009年间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。在这个综合输送系统中，700,699名年龄在65岁以上的受试者正在进行自然实验。作为2006年KP的医疗保险优势（MA） D部分计划的一部分，这些受试者中近一半（47%）面临药品费用分摊的增加。其余53%参加雇主补充计划（对照）的受试者的药物费用分担水平较低，2005-2006年无显著变化。KP D部分计划内的成本分担水平和类型因地区而异，允许进行三种主要比较：1)在KPNC，基本的D部分MA计划具有较高的共付额和覆盖缺口，而雇主补充计划具有较低的共付额和没有覆盖缺口；2)增强的D部分计划，包括高共付额和一般保险，而不是与雇主补充计划的差距，两者都在KPSC；3)基本与增强的D部分医疗保险计划，例如，在空档期没有保险与只有一般保险。我们将使用重复测量方法来检验以下假设：1)费用分摊水平较高的计划与较低的药物使用和较高的不良临床结果（急诊科就诊、住院和死亡）率相关；2)较高的费用分摊计划与较低的年度药房和总医疗费用相关，但较高的非药房和患者自付费用。我们将在总体人口中调查这些结果，并在选定的弱势群体中调查这些结果，例如慢性病患者或社会经济地位低的患者。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效果的研究，使用全面的自动化数据，从引入D部分之前和之后，对一个明确定义的人群。

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.