Impact of zero-markup consumable policy and national procurement of orthopedic spinal devices in China: a mixed-methods study.

Background: Since 2019, Chinese has launched a nationwide pricing reform targeting medical consumables in the public hospitals, aimed at reducing costs and alleviating the financial burdens. The key initiatives include the Zero Markup Consumables Policy (ZMCP, Reform1), implemented in 2019, and the Centralized Volume-Based Procurement (CVBP, Reform2) for orthopedic spinal devices, initiated in Shandong province in 2023. Objectives: The study aims to assess the impacts of the ZMCP and CVBP reforms on hospitalization expenditures and clinical outcomes for orthopedic spinal inpatients, and to identify challenges associated with policy implementation. Methods: Data concerning orthopedic spinal inpatients was extracted from Binzhou Medical University Hospital in China, the retrospective period spanning from January 2018 to June 2024. A mixed-methods design approach was adopted, combining a regression discontinuity design (RDD) ( Results: The study provides evidence that the expenses for total hospitalization and medical consumables demonstrated a significant decrease after the CVBP reform, dropping from 18,288.08 CNY (pre-reform) to 11,461.09 CNY (Reform2) and from 8,718.27 CNY (pre-reform) to 1,178.83 CNY (Reform2), respectively. Expenses in other categories did not show statistically significant changes during the reforms. The proportion of expenses for medical consumables decreased significantly, from 47.07% (pre-reform) to 43.27% (Reform1), and further to 10.19% (Reform2). The postoperative length of stay (post-LOS) and postoperative numerical rating scale (post-NRS) showed no statistically significant changes during the reform periods. The qualitative findings revealed that most notably financial strain on hospitals and policy-driven shifts in clinical decision-making. Conclusion: The study suggests that following the implementation of the CVBP policy in Chinese public hospitals, pricing reforms for medical consumables were associated with reductions in both medical consumable and total hospitalization expenditures, as well as a shift in the composition of expenses. In contrast, the reform of ZMCP appeared to have limited measurable impact within the specific context of this study. By integrating quantitative and qualitative evidence, this research helps to clarify the specific complexities and challenges involved in implementing health policy reforms in China, and it provides preliminary insights into the potential mechanisms driving these observed changes.