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)

项目总结 药品制造商和医院之间就340B计划是否能继续存在展开了激烈的辩论 对于国会声明的政策意图：“尽可能扩大稀缺的联邦资源，覆盖更多符合条件的人 并提供更全面的服务。该计划允许某些“安全网”医疗服务提供者，如 作为不成比例的份额(DSH)医院，从制造商那里以大幅折扣购买药品。反过来，这些 供应商可能会以较低的成本向未参保或参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。供应商也可以将这些折扣购买的药品以正常价格出售给 患者和他们的保险公司，创造收入，几乎没有关于这笔钱是如何使用的报告要求。这有 引发了要求改革的呼声。与此同时，现有证据表明，340B计划可能在 在美国提供艾滋病毒、物质使用障碍(SUD)和精神疾病(MI)(“合并症”)护理。 然而，许多问题仍然存在。以前对340B的研究一直无法克服选择偏见；即， 340B实体由于是安全网提供者，因此本质上不同于非340B实体。此外，这些研究 只检查了340B家医院的支出，没有提供相关的微利服务。还没有研究检查过 340B注册提供者的护理结果利用率或质量。这项提议的直接目标是测试 假设医院将注册该计划获得的收入再投资于至关重要的(但利润较低) HIV、SUD和MI护理等服务。此外，这项研究将检查340B计划可能如何影响 边缘化患者群体的行为健康和艾滋病毒服务的利用和质量--特别是 女同性恋者、男同性恋者、双性恋者、变性人和同性恋/提问(LGBTQ)人口。LGBTQ人群看空 HIV、SUD和MI的共同负担不成比例。事实上，这项研究的长期目标是确定潜在的 改善所有人获得护理的机会和消除健康差距的政策杠杆。 该提案的具体目的是：(1)评估340B项目参与对医院的影响 用于安全网和微利服务线的支出；(2)量化#年提供的艾滋病毒、SUD和MI保健服务 参加340B计划后的医院；以及(3)评估340B计划后的综合医疗服务的利用率和质量 马萨诸塞州DSH医院的招生人数。因为DSH医院的340B资格在一定程度上取决于 医疗补助患者数量，医疗补助扩大为检查下游设立了一个新的天然实验 340B的影响。这项拟议的研究具有创新性，利用医疗补助扩展作为一项自然实验，以 评估准随机的340B注册人数，并重点关注该政策对LGBTQ人口的影响。它是 尽管我们的发现将对数十亿美元的医疗服务如何为美国的安全提供资金具有重要意义- 网络提供者，同时确定利用这些美元来减少共同健康差距的潜在机会。 对这个项目的支持将为我作为一名研究可操作的科学家的职业生涯中的未来研究奠定基础 针对LGBTQ个人和其他边缘人群中HIV、SUD和MI共同感染的政策解决方案。

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.