340B药物定价计划在4.3万亿美元的美国医疗保健行业中每100美元支出中大约占1美元。影响该计划的决定将在整个美国安全网中产生广泛的影响。我们的范围审查提供了有关340B计划的问题的路线图以及答案的初步综合。最高质量的证据表明非营利组织,不成比例的份额医院可能会以利润动机的方式使用340B计划,增加安全网参与的证据不一致;然而,这一发现在其他医院类型和公共卫生诊所中并不一致,面临不同的激励结构和报告要求。
背景:尽管340B药品定价计划在当前的医疗保健实践和政策辩论中取得了显着增长和相关性,学术文献审查340B滞后。本次范围界定综述的目的是总结i)发表的关于340B的常见研究问题,Ii)关于340B的经验知识及其含义,和iii)剩余的知识差距,所有这些都以一种对从业者有益的方式组织起来,研究人员,和决策者。
方法:我们对同行评审的范围审查,实证340B文献(数据库始于2023年3月)。我们通过内部效度设计的适用性对研究进行分类,所研究的被覆盖实体的类型,和按范围划分的动机类别。
结果:最终产量包括44个同行评审,2003年至2023年发表的实证研究。我们在文献中确定了15个常见问题,跨6个类别的询问动机(保证金或任务)和范围(外部,涵盖的实体,和护理交付接口)。具有最大内部有效性的文献倾向于在外部环境和涵盖的实体层面上的边际动机行为的证据,与不一致的结果支持这些级别的任务动机的行为;这尤其是在参与不成比例的共享医院(DSHs)的情况.然而,纳入的案例研究一致证明了340B计划对执行提供者的安全网任务的积极影响。
结论:在我们对340B计划的范围审查中,最高质量的证据表明非营利组织,DSH可能会以保证金动机的方式使用340B计划,增加安全网参与的证据不一致;然而,这一发现在其他医院类型和公共卫生诊所中并不一致,面临不同的激励结构和报告要求。未来的研究应该按涵盖的实体类型检查异质性(即,医院vs.公共卫生诊所),特点,和340B注册的时间段。我们的发现为当前有关340B计划的卫生政策讨论提供了额外的背景。
Policy Points The 340B Drug Pricing Program accounts for roughly 1 out of every 100 dollars spent in the $4.3 trillion US health care industry. Decisions affecting the program will have wide-ranging consequences throughout the US safety net. Our scoping review provides a roadmap of the questions being asked about the 340B program and an initial synthesis of the answers. The highest-quality evidence indicates that nonprofit, disproportionate share hospitals may be using the 340B program in margin-motivated ways, with inconsistent evidence for increased safety net engagement; however, this finding is not consistent across other hospital types and public health clinics, which face different incentive structures and reporting requirements.
BACKGROUND: Despite remarkable growth and relevance of the 340B Drug Pricing Program to current health care practice and policy debate, academic literature examining 340B has lagged. The objectives of this scoping review were to summarize i) common research questions published about 340B, ii) what is empirically known about 340B and its implications, and iii) remaining knowledge gaps, all organized in a way that is informative to practitioners, researchers, and decision makers.
METHODS: We conducted a scoping review of the peer-reviewed, empirical 340B literature (database inception to March 2023). We categorized studies by suitability of their design for internal validity, type of covered entity studied, and motivation-by-scope category.
RESULTS: The final yield included 44 peer-reviewed, empirical studies published between 2003 and 2023. We identified 15 frequently asked research questions in the literature, across 6 categories of inquiry-motivation (margin or mission) and scope (external, covered entity, and care delivery interface). Literature with greatest internal validity leaned toward evidence of margin-motivated behavior at the external environment and covered entity levels, with inconsistent findings supporting mission-motivated behavior at these levels; this was particularly the case among participating disproportionate share hospitals (DSHs). However, included case studies were unanimous in demonstrating positive effects of the 340B program for carrying out a provider\'s safety net mission.
CONCLUSIONS: In our scoping review of the 340B program, the highest-quality evidence indicates nonprofit, DSHs may be using the 340B program in margin-motivated ways, with inconsistent evidence for increased safety net engagement; however, this finding is not consistent across other hospital types and public health clinics, which face different incentive structures and reporting requirements. Future studies should examine heterogeneity by covered entity types (i.e., hospitals vs. public health clinics), characteristics, and time period of 340B enrollment. Our findings provide additional context to current health policy discussion regarding the 340B program.