Doctoral Dissertation Research in Economics: The Effect of Deregulation on the Cost, Availability, and Quality of Health Care

经济学博士论文研究：放松管制对医疗保健成本、可用性和质量的影响

• 批准号: 2242324
• 负责人: Jeffrey Clemens
• 金额: $ 2.37万
• 依托单位: University of California-San Diego
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-03-01 至 2024-02-29
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2242324&HistoricalAwards=false
• 关键词: Doctoral; Dissertation; Research; Economics; Effect

The U.S. Food and Drug Administration (FDA) regulates a wide array of health care products to ensure their safety and efficacy before they can be sold to consumers. While these regulations are intended to protect consumers, they also inevitably make it more expensive and time-intensive for companies to bring new medical technology to the market. These hurdles could leave consumers with fewer products to choose from or even delay their access to potentially life-saving medical technology. Without the threat of new entrants, existing firms are able to charge higher prices, knowing that consumers have few alternatives. Focusing on medical devices, the author(s) asks whether relaxing FDA regulation could increase the quality and accessibility of health care and combat rising costs. This project combines new data on millions of medical products with statistical analysis to understand how deregulation affects competition, prices, quantity, and quality in the market for medical devices. Specifically, the author(s) will study an FDA deregulation event in 2015 that deregulated some medical devices but not others. The results of this study will be valuable for policymakers who seek to make informed decisions about how to balance the benefits of product regulation against the costs it imposes on firms and consumers.Products regulated by the U.S. Food and Drug Administration (FDA) account for 20 cents out of every dollar Americans spend (Food and Drug Administration, 2021). On the one hand, these regulations — which often take the form of pre-market approval processes — aim to ensure the safety and efficacy of consumer products. On the other hand, pre-market approvals can impose substantial costs on manufacturers, which prevent firm entry and can even reduce product safety (Rogers, 2022). This project considers how FDA regulation interacts with market forces and the resulting effect on the cost and quality of products in an important sector: medical devices. The author(s) bring together detailed data on market entry, device transactions, and insurance claims with econometric methods to answer this question. They exploit a 2015 FDA deregulation event that removed pre-market testing for 250 medical device types as a “natural experiment” and use difference-in-difference and event study techniques to compare the effects on deregulated versus unaffected device types. They first use FDA registration data to assess the effects on market structure, like the number and types of firms that sell these devices. Next, they use fine-grained data on millions of medical device purchases made by healthcare providers to study the effects on prices and quantities of devices purchased. Finally, they use insurer claims and consider whether the prices, quantity, and quality of procedures that use these devices change. The project’s findings will provide policymakers with a better understanding of how regulation interacts with market forces and causes ripple effects throughout the supply chain in an important industry.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

美国食品药品监督管理局（FDA）调节了各种各样的医疗保健产品，以确保其安全性和效率在将其出售给消费者之前。尽管这些法规旨在保护消费者，但它们也使公司将新的医疗技术推向市场更加昂贵和耗时。这些障碍可能会给消费者提供较少的产品可供选择，甚至延迟其潜在的挽救生命的医疗技术的机会。没有新条目的威胁，现有公司就能知道消费者几乎没有其他选择。作者专注于医疗设备，询问放松FDA法规是否可以提高医疗保健的质量和可及性，并打击成本上升​​的成本。该项目结合了数百万个医疗产品的新数据以及统计分析，以了解放松管制如何影响医疗设备市场的竞争，价格，数量和质量。具体来说，作者将在2015年研究FDA放松管制事件，该事件对某些医疗设备进行了管制，但没有受到管辖。这项研究的结果对于试图做出有关如何平衡产品调节收益与对公司和消费者所不可能的成本的明智决定的决策者将很有价值。一方面，这些法规（通常采用前市场批准流程的形式）旨在确保消费产品的安全性和效率。另一方面，预装前批准可以对制造商施加巨大的成本，从而阻止公司进入甚至可以降低产品安全性（Rogers，2022年）。该项目考虑了FDA法规如何与市场力量相互作用，以及对重要行业产品成本和质量的产生影响：医疗设备。作者通过经济方法将有关市场进入，设备交易和保险索赔的详细数据汇总在一起，以回答这个问题。他们探索了2015年FDA放松调节事件，该事件删除了250种医疗设备类型的预售测试作为“自然实验”，并使用差异差异和事件研究技术来比较对不受影响的设备类型的影响。他们首先使用FDA注册数据来评估对市场结构的影响，例如出售这些设备的公司的数量和类型。接下来，他们对医疗保健提供者进行数百万个医疗设备购买的精细数据来研究对购买设备的价格和数量的影响。最后，他们使用保险公司的主张，并考虑使用这些设备的程序的价格，数量和质量是否会发生变化。该项目的发现将使决策者更好地了解法规如何与市场力量相互作用，并在重要行业中在整个供应链中引起连锁反应。该奖项反映了NSF的法定任务，并被认为是通过基金会的知识分子优点和更广泛的影响审查标准通过评估来获得的支持。