Association of State Certificate of Need Regulation With Procedural Volume, Market Share, and Outcomes Among Medicare Beneficiaries

Abstract

IMPORTANCE Certificate of need laws provide state-level regulation of health system expenditure. These laws are intended to limit spending and control hospital expansion in order to prevent excess capacity and improve quality of care. Several states have recently introduced legislation to modify or repeal these regulations, as encouraged by executive order 13813, issued in October 2017 by the Trump administration.OBJECTIVE To evaluate the difference in markers of hospital activity and quality by state certificate of need status. These markers include hospital procedural volume, hospital market share, county-level procedures per 10 000 persons, and patient-level postoperative outcomes. DESIGN, SETTING, AND PARTICIPANTSA cross-sectional study involving Medicare beneficiaries aged 65 years or older who underwent 1 of the following 10 procedures from January 1, 2016, through November 30, 2018: total knee or hip arthroplasty, coronary artery bypass grafting, colectomy, ventral hernia repair, lower extremity vascular bypass, lung resection, pancreatic resection, cystectomy, or esophagectomy.EXPOSURES State certificate of need regulation status as determined by data from the National Conference of State Legislatures. MAIN OUTCOMES AND MEASURESOutcomes of interest included hospital procedural volume; hospital market share (range, 0-1; reflecting 0%-100% of market share); county-level procedures per 10 000 persons; and patient-level postoperative 30-day mortality, surgical site infection, and readmission.RESULTS A total of 1 545 952 patients (58.0% women; median age 72 years; interquartile range, 68-77 years) at 3631 hospitals underwent 1 of the 10 operations. Of these patients, 468 236 (30.3%) underwent procedures in the 15 states without certificate of need regulations and 1 077 716 (69.7%) in the 35 states with certificate of need regulations. The total number of procedures ranged between 729 855 total knee arthroplasties (47.21%) and 4558 esophagectomies (0.29%). When comparing states without vs with certificate of need regulations, there were no significant differences in overall hospital procedural volume (median hospital procedure volume, 241 vs 272 operations per hospital for 3 years; absolute difference, 31; 95% CI, −27.64 to 89.64; P = .30). There were no statistically significant differences between states without vs with certificate of need regulations for median hospital market share (median, 28% vs 52%; absolute difference, 24%; 95% CI, −5% to 55%; P = .11); procedure rates per 10 000 Medicare-eligible population (median, 239.23 vs 205.41 operations per Medicare-eligible population in 3 years; absolute difference, 33.82; 95% CI, −84.08 to 16.43; P = .19); or 30-day mortality (1.17% vs 1.33%, odds ratio [OR], 1.04; 95% CI, 0.93 to 1.16; P = .52), surgical site infection (1.24% vs 1.25%; OR, 0.93; 95% CI, 0.83 to 1.04; P = .21), or readmission rate (9.69% vs 8.40%; OR, 0.80; 95% CI, 0.57 to 1.12; P = .19).CONCLUSIONS AND RELEVANCE Among Medicare beneficiaries who underwent a range of surgical procedures from 2...

Associations Between Certificate of Need Policies and Hospice Quality Outcomes

“…6 An additional study did not observe an association between CON status and hospital volume or quality of care in Medicare beneficiaries who underwent a range of surgical procedures from 2016-2018. 8 Though the impact of CON laws on various types of medical procedures, hospital quality, and health outcomes has been examined, we have found no studies examining hospice quality outcomes against state CON status. With the recent trends in reevaluating CON provisions, coupled with the increased need for hospice care with an aging US population, 17 lawmakers and hospice stakeholders would benefit from such data to help inform policy decisions.…”

“…1,2,5,6 By 2022, some states had moved towards revising or repealing their CON laws, spurred by the 2017 executive order 13813 7 under the Trump administration which encouraged health care choice and competition across the US. 8 In addition, the COVID-19 pandemic forced states to revisit their CON statutes as they loosened provisions to expand hospital bed availability given the surge in demand. 9 Given the momentum towards loosening CON provisions, several states with CON laws impacting hospice agencies are reevaluating their positions.…”

The Effects of Certificate-of-Need Laws on the Quality of Hospital Medical Services

“…Two studies of 1990s data have reported that higher CABG mortality rates in non-CON states (Vaughan-Sarrazin et al 2002;Rosenthal and Sarrazin 2001). Related studies include (Browne et al 2018;Casp et al 2019;Ettner et al 2020;Herb et al 2021;Ohsfeldt and Li 2018;Rahman et al 2016;Schultz et al 2021;Stratmann and Wille 2016;Wu et al 2019;Yuce et al 2020;Ziino et al 2021).…”

Revisiting States’ Experience With Certificate of Need

“…Yet at least 9 states took steps in 2019 to modify their certificate of need rules, often because those laws are viewed as ineffective in controlling overutilization or improving quality . As Yuce and colleagues observed in this issue of JAMA , most of the literature examining the association between certificate of need and measures of utilization and patient outcomes is more than a decade old, and advances in quality measurement and improvement warrant the updated analysis that these authors undertook.…”

“…Yuce et al 3 acknowledge that there is variation in the scope and implementation of the regulation between states that is unaccounted for in their analysis. Certificate of need programs often regulate many facilities and services besides hospitals including long-term care, outpatient surgery centers, purchases of major medical equipment, and transplant services.…”