Contemporary impact of state certificate-of-need regulations for cardiac surgery: an analysis using the Society of Thoracic Surgeons' National Cardiac Surgery Database.

BACKGROUND: Prior research using administrative data associated certificate-of-need (CON) regulation for open heart surgery with higher hospital coronary artery bypass grafting (CABG) volume and lower CABG operative mortality rates in elderly patients. It is unclear whether these findings apply in a general population and after controlling for detailed clinical characteristics and region. METHODS AND RESULTS: Using the Society of Thoracic Surgeons' (STS) National Cardiac Surgery Database, we examined isolated CABG surgery volume, operative mortality, and the composite end point of operative mortality or major morbidity for the years 2000 to 2003. The presence of CON regulations for open heart surgery was ascertained from the National Directory of the American Health Policy Association and by contacting CON administrators. Results were analyzed nationally, by state, and by region (West, Northeast, Midwest, South) and were adjusted for clinical factors and both population density and region with mixed-effects hierarchical logistic regression models. During 2000 to 2003, there were 314,710 isolated CABG surgeries performed at 294 STS hospitals in CON states (n=27, including Washington, DC) and 280 512 procedures at 343 STS hospitals in non-CON states (n=24). Patient clinical characteristics were similar among CON and non-CON hospitals. States with CON regulations tended to have higher population densities and had significantly higher median hospital annual CABG volumes in each of the years 2000 to 2003 (P<0.005). This difference remained significant after adjustment for region and population density. Operative mortality was 2.52% for CON versus 2.62% for non-CON states (P=0.32). There was a significant association between CON law and operative mortality in the South. After adjustment for patient risk factors and region, there was a marginally significant reduction of mortality risk in states with CON regulation (adjusted OR 0.92, 95% CI 0.86 to 1.00). However, this difference was not statistically significant when a revised model accounted for random state effects. Similar volume and outcomes results were seen when the analysis was repeated with data from the national Medicare database. CONCLUSIONS: CON states have significantly higher hospital CABG surgery volumes but similar mortality compared with non-CON states. CON regulation alone is not a sufficient mechanism to ensure quality of care for CABG surgery.

Duke Scholars

Author Sean Michael O'Brien Biostatistics & Bioinformatics, Division of Biostatistics