Implications of the US 340B Drug Pricing Program for the Availability, Quality of Care, and Equitability of Syndemic (HIV/SUD/MH) health Services (340B AQCESS)

美国 340B 药品定价计划对流行病 (HIV/SUD/MH) 卫生服务的可用性、护理质量和公平性的影响 (340B AQCESS)

• 批准号: 10560174
• 负责人: Timothy Levengood
• 金额: $ 4.26万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10560174
• 关键词: Implications; US; 340B; Drug; Pricing

PROJECT SUMMARY There is heated debate between drug manufacturers and hospitals about whether the 340B program lives up to Congress’ stated intent for the policy: “to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.” The program allows certain “safety-net” medical providers, such as disproportionate share (DSH) hospitals, to purchase drugs from manufacturers at substantial discounts. In turn, these providers may offer the drugs to uninsured or underinsured outpatients at a reduced cost, thereby increasing the accessibility and affordability of health care. Providers may also sell these discount-purchased drugs at regular price to patients and their insurers, generating revenue, with few reporting requirements for how this money is spent. This has led to calls for reform. At the same time, existing evidence suggests the 340B Program likely plays an important role in the delivery of HIV, substance use disorder (SUD), and mental illness (MI) (“syndemic”) care in the United States. However, many questions remain. Previous studies of 340B have been unable to overcome selection bias; namely, 340B entities are inherently different than non-340B entities by virtue of being safety-net providers. Further, these studies only examined spending at 340B hospitals, not provision of relevant low-profit services. No studies have examined utilization or quality of care outcomes at 340B-enrolled providers. The immediate objective of this proposal is to test the hypothesis that revenue gained from enrollment in the program is reinvested by hospitals into crucial (but low profit) services such as HIV, SUD, and MI care. Further, this study will examine how the 340B program might affect the utilization and quality of behavioral health and HIV services for marginalized patient populations—in particular, the lesbian, gay, bisexual, transgender, and queer/questioning (LGBTQ) population. The LGBTQ population bears disproportionate burden of syndemic HIV, SUD, and MI. Indeed, the long-term goal of this research is to identity potential policy levers to improve access to care for all and to eliminate health disparities. The specific aims of this proposal are to: (1) evaluate the impact of the 340B program participation on hospital spending for safety-net and low-profit service lines; (2) quantify the provision of HIV, SUD, and MI health services in hospitals following 340B enrollment; and (3) assess the utilization and quality of syndemic care following 340B enrollment for DSH hospitals in Massachusetts. Because DSH hospital eligibility for 340B is determined in part by Medicaid patient volume, Medicaid expansion sets up a novel natural experiment for examining the downstream implications of 340B. The proposed research is innovative by utilizing Medicaid expansion as a natural experiment to assess quasi-random 340B enrollment and by focusing on the implications of the policy for the LGBTQ population. It is significant as our findings will have implications for how billions of dollars of health services are funded for U.S. safety- net providers, while identifying a potential opportunity to leverage these dollars to reduce syndemic health disparities. Support for this project would lay the groundwork for future studies in my career as a scientist researching actionable policy solutions to the syndemic of HIV, SUD, and MI in LGBTQ individuals and other marginalized populations.

项目摘要 制药商和医院之间就340B计划是否可行展开了激烈的辩论 国会声明的政策意图："尽可能地利用稀缺的联邦资源， 患者并提供更全面的服务。”该计划允许某些“安全网”医疗提供者，如 作为不成比例份额（DSH）的医院，以大幅折扣从制造商购买药物。反过来，这些 提供者可以以降低的成本向未投保或投保不足的门诊患者提供药物，从而增加 卫生保健的可获得性和可负担性。供应商也可以以正常价格出售这些折扣购买的药物， 病人和他们的保险公司，创造收入，很少有报告要求如何这笔钱是花了。这 引发了改革的呼声。与此同时，现有证据表明，340B计划可能在以下方面发挥重要作用： 提供艾滋病毒，物质使用障碍（SUD），精神疾病（MI）（“syndemic”）护理在美国。 然而，许多问题仍然存在。以前对340B的研究无法克服选择偏倚;即， 340B实体由于是安全网提供者而与非340B实体本质上不同。此外，这些研究 只检查了340B医院的支出，而没有提供相关的低利润服务。没有研究探讨 在340B注册的提供者的利用或护理结果的质量。这项建议的直接目标是测试 假设从该计划中获得的收入由医院再投资到关键（但利润较低） 艾滋病毒、SUD和MI护理等服务。此外，这项研究将研究340B计划如何影响 为边缘化患者群体提供的行为健康和艾滋病毒服务的利用率和质量，特别是 女同性恋、男同性恋、双性恋、变性人和同性恋/质疑者（LGBTQ）人群。LGBTQ人群 不成比例的并发症HIV、SUD和MI的负担。事实上，这项研究的长期目标是确定潜在的 改善所有人获得保健的机会和消除保健差距的政策杠杆。 具体目的是：（1）评估参与340 B项目对医院的影响 安全网和低利润服务项目的支出;（2）量化艾滋病毒，SUD和MI卫生服务的提供， 340B入组后的医院;（3）评估340B入组后的综合护理的利用率和质量 马萨诸塞州的DSH医院的注册人数。因为DSH医院340B的资格部分取决于 医疗补助患者数量，医疗补助扩张建立了一个新的自然实验，以检查下游 340B的影响。拟议的研究是创新的，利用医疗补助扩张作为一个自然的实验， 评估准随机340B入学，并重点关注该政策对LGBTQ人群的影响。是 重要的是，我们的研究结果将对如何为美国的安全提供数十亿美元的医疗服务产生影响- 净供应商，同时确定一个潜在的机会，利用这些美元，以减少疾病的健康差距。 对这个项目的支持将为我作为一名研究可诉性的科学家的职业生涯奠定基础。 针对LGBTQ人群和其他边缘化人群中的艾滋病毒、南方型糖尿病和MI综合征的政策解决方案。