Long-term Impact of Reduced Patient Out-of-pocket Costs on Diabetes Complications

项目摘要/摘要 该项目试图确定三项减少糖尿病自付费用的自然实验是否 从长远来看，患者可以改善急性和慢性糖尿病并发症。这些自然实验 包括：(1)雇主采用预防药物清单(PDL)，使糖尿病相关药物的价格为0美元，(2) 州立法限制患者自掏腰包购买胰岛素的费用，以及(3)雇主从高收入到高收入的转变 免赔额医疗计划(HDHP)，为大多数服务设置了大量的财务障碍，以实现慷慨的低成本 免赔额计划。结果可以为在多个层面上改善可操作的干预措施提供证据 糖尿病患者的健康。研究将利用一个大型的国家健康保险索赔数据库 2007-2023年，研究小组在以前的项目下进行了细化。该项目的具体目标是： 1.评估国家在以下方面的15年趋势：(A)糖尿病并发症和(B)联邦、州和 雇主自然感兴趣的实验。分析将评估2009-2023年急性可预防和 慢性微血管和大血管并发症，包括按感兴趣的关键亚组进行分层。 与自然实验摄取相关的措施将包括每年的PDL采用率、州水平的胰岛素成本 趋势，以及HDHP向低免赔额计划的转变。这些分析将使用纵向日历时间序列 结合连接点进行设计，根据不断变化的人口统计、社会经济地位和共患病情况进行调整。 2.确定减少自付药物成本是否会改善糖尿病并发症。超过4次跟进 年，Aim 2a将检查雇主是否从高健康储蓄账户(HSA)-HDHPS PDL HSA-HDHP的自付药物费用为0美元的预防性药物可减少急性和慢性糖尿病 并发症。Aim 2b将评估美国大约10个州限制胰岛素前后的结果 成本分担。分析将使用高度严格的中断时间序列，并采用对照序列研究设计和 Aim 2a也将采用分段生存与对照组设计。 3.确定减少门急诊自付费用是否能改善糖尿病 并发症。分析将评估从高成本分担费用的HDHPS转向门诊和 急诊科护理慷慨的低免赔额计划可降低急性和慢性糖尿病的风险 术后4年随访并发症。这一目标还将使用严格控制的中断时间序列和 分段生存设计。 4.研究降低自付费用对主要糖尿病亚组的长期影响，包括 低收入和高发病率成员。目标4将涉及对目标2和目标3进行分层分析 收入、发病率、种族/民族和糖尿病严重程度等特征。这个目标将使用相同的 研究设计与目标2和目标3相同，但按感兴趣的因素分层。

PROJECT SUMMARY/ABSTRACT This project seeks to determine whether 3 natural experiments that reduce out-of-pocket costs for diabetes patients improve acute and chronic diabetes complications over the longer term. These natural experiments include: (1) employer adoption of preventive drug lists (PDLs) that make diabetes-related medications $0, (2) state legislation capping patient out-of-pocket costs for insulin, and (3) employer transitions from high- deductible health plans (HDHPs) with substantial financial barriers for most services to generous low- deductible plans. Results could provide evidence about actionable interventions at multiple levels that improve the health of diabetes patients. Studies will leverage a large, national health insurance claims database from 2007-2023 that the research team has refined under previous projects. The Specific Aims of the project are to: 1. Assess 15-year national trends in (a) diabetes complications and (b) uptake of federal, state, and employer natural experiments of interest. Analyses will assess 2009-2023 trends in acute preventable and chronic microvascular and macrovascular complications, including stratification by key subgroups of interest. Measures related to natural experiment uptake will comprise annual PDL adoption, state-level insulin cost trends, and HDHP to low-deductible plan switches. These analyses will use a longitudinal, calendar time series design with joinpoints, adjusted for changing demographics, socio-economic status, and co-morbidity. 2. Determine if reducing drug out-of-pocket costs improves diabetes complications. Over 4 follow-up years, Aim 2a will examine whether employer switches from health savings account (HSA)-HDHPs with high drug out-of-pocket costs to PDL HSA-HDHPs with $0 preventive drugs reduce acute and chronic diabetes complications. Aim 2b will assess these outcomes before and after approximately 10 US states limit insulin cost sharing. Analyses will use a highly rigorous interrupted time series with control series study design and Aim 2a will also apply a segmented survival with control group design. 3. Determine if reducing outpatient and emergency department out-of-pocket costs improves diabetes complications. Analyses will assess if switching from HDHPs with high cost sharing for outpatient and emergency department care to generous low-deductible plans reduces the risk of acute and chronic diabetes complications over 4 follow-up years. This aim will also use rigorous controlled interrupted time series and segmented survival designs. 4. Examine the long-term impact of reduced out-of-pocket costs on key diabetes subgroups including low-income and high-morbidity members. Aim 4 will involve stratifying Aims 2 and 3 analyses by characteristics such as income, morbidity, race/ethnicity, and diabetes severity. This aim will use the same study designs as for Aims 2 and 3 but stratified by the factors of interest.