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 (legacy hospitals, n=17); (2) full services without surgical backup (new certificate of need [CON] hospitals, n=9); or (3) only nonelective PCI without surgical backup (myocardial infarction [MI] access hospitals, n=9). Annual median hospital‐level volumes were highest at legacy hospitals (605, interquartile range, 466–780), followed by new CON, (243, interquartile range, 146–287) and MI access, (61, interquartile range, 23–145). Compared with MI access hospitals, risk‐adjusted mortality for nonelective patients was lower for legacy (odds ratio [OR], 0.59 [95% CI, 0.48–0.72]) and new‐CON hospitals (OR, 0.55 [95% CI, 0.45–0.65]). Legacy hospitals provided access within 60 minutes for 90% of the population; addition of new CON and MI access 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.