Government Regulation and Percutaneous Coronary Intervention Volume, Access and Outcomes: Insights From the Washington State Cardiac Care Outcomes Assessment Program.

Background It is unclear how to geographically distribute percutaneous coronary intervention (PCI) programs to optimize patient outcomes. The Washington State Certificate of Need program seeks to balance hospital volume and patient access through regulation of elective PCI. Methods and Results We performed a retrospective cohort study of all non-Veterans Affairs hospitals with PCI programs in Washington State from 2009 to 2018. Hospitals were classified as having (1) full PCI services and surgical backup ( hospitals, n=17); (2) full services without surgical backup ( hospitals, n=9); or (3) only nonelective PCI without surgical backup ( hospitals, n=9). Annual median hospital-level volumes were highest at hospitals (605, interquartile range, 466-780), followed by , (243, interquartile range, 146-287) and , (61, interquartile range, 23-145). Compared with hospitals, risk-adjusted mortality for nonelective patients was lower for (odds ratio [OR], 0.59 [95% CI, 0.48-0.72]) and hospitals (OR, 0.55 [95% CI, 0.45-0.65]). hospitals provided access within 60 minutes for 90% of the population; addition of and hospitals resulted in only an additional 1.5% of the population having access within 60 minutes. Conclusions Many PCI programs in Washington State do not meet minimum volume standards despite regulation designed to consolidate elective PCI procedures. This CON strategy has resulted in a tiered system that includes low-volume centers treating high-risk patients with poor outcomes, without significant increase in geographic access. CON policies should re-evaluate the number and distribution of PCI programs.