In this issue of Critical Care Medicine, Bourne et al (1) provide an important follow-up to their previously published data that demonstrated a significant improvement in mortality as a result of mandated sepsis reporting. In that report, they compared the results of New York State’s (NYS) public reporting initiative over a 4-year period to data from five control states (2). Further, the widely published survival benefit associated with compliance with sepsis bundles has led to multiple statewide and national initiatives (3–5). Given the cost burden of sepsis, an understanding of the impact of sepsis regulations on hospital resource utilization is crucial. This follow-up by Bourne et al (1) reports the effect of the NYS sepsis initiative, in which mandated compliance with sepsis metrics and protocols were publicly reported on costs of hospitalization over the 4-year study period. The importance of these results cannot be overstated. Not only did their previous study demonstrate a survival benefit, their current study by Bourne et al (1) has demonstrated a neutral effect on the cost burden of sepsis in NYS.
Why is this important? Currently, sepsis is the most expensive condition treated in the United States. Recently released data from the U.S. Department of Health and Human Services reported that the greater awareness of sepsis has resulted in higher number of reported cases, which in turn has led to an estimated overall increase in Medicare spending from $27.7 billion in 2012 to more than $41.5 billion in 2018 for inpatient hospital admissions and subsequent skilled nursing facility care for septic patients (6). Sepsis also is the most common cause of 30-day hospital readmissions in the United States (7). Improving survival by improving compliance with sepsis bundles via a statewide healthcare policy while not increasing cost burden to hospitals is, indeed, an important finding with significant implications for the care of septic patients and healthcare resources overall.
In the current study by Bourne et al (1), the authors conducted a comparative interrupted time series that compared changes in costs over time in New York with control states (Florida, Massachusetts, Maryland, and New Jersey) that did not adopt sepsis regulations during the same study period. The analysis was specifically designed to understand the economic impact of the statewide sepsis policy in New York. The authors used data from the Agency for Healthcare Research and Quality Healthcare Cost and Utilization Project and linked to a Centers for Medicare & Medicaid Services database to obtain hospital characteristics and cost-to-charge ratios. Implementation of the NYS policy mandating protocolized sepsis care throughout the state was not associated with major differences in overall cost per hospitalization or cost per hospital day in septic patients as submitted to the New York State Department of Health (NYSDOH), compared to costs for septic patients in five others states that did not have a similar healthcare policy.
Given the prior published work demonstrating that the NYS policy initiative and “Rory’s Regulations” were associated with improved risk-adjusted mortality and that increased compliance with the performance metrics was associated with even more significant improvements in mortality, the study by Bourne et al (1) suggests that statewide and national policies for mandating compliance with sepsis metrics are not only likely to improve survival in patients with sepsis, but are not likely to lead to increased burden on the healthcare system. This may reassure other states that are considering enacting similar policy regulations to those introduced by NYS.
Another important message is worth pointing out: The study also demonstrated a relative increase in costs in NYS hospitals that had not participated in an earlier sepsis quality improvement initiative coordinated by the Greater New York Hospital Association. As mentioned by the authors, this raises the possibility that hospitals that had made previous investments in quality improvement initiatives in improving and reporting protocolized sepsis care were less likely to demonstrate differences in costs caring for these patients. Therefore, it may well be that the initial investment in quality improvement for patients with sepsis can increase costs initially but might then be balanced by the resulting effect on improved patient care. As mentioned by the authors, “This is not to say that investing in sepsis quality isn’t worth the costs—only that in many hospitals investments in quality might reasonably be associated with increases in costs.”
Several flaws in the analysis by Bourne et al (1) must be pointed out. First, the use of Medicare cost-to-charge ratios are fraught with challenges and have been reported in several studies to lack good correlation with true hospital costs (8). Second, the costs calculated by the authors do not include the funding required to conduct quality improvement initiatives. To comply with sepsis mandates, hospitals may need to hire specific sepsis coordinators and further redirect the hospital information technology department to develop electronic tools for screening and identification of septic patients in the electronic health record. These efforts may lead to unrecognized increases in costs associated with sepsis mandates. Finally, some bias may be inherent in results of prospective cohort data. Multiple reports discussing the possibility of confounding in large, prospective cohort performance improvement analyses have been published (9).
The burden of sepsis is well recognized and formidable to healthcare systems in the United States and globally. Demonstrating improved survival and lack of increased economic burden associated with mandating public reporting of compliance with sepsis bundles and protocols on a statewide level is a major achievement of the authors and the NYSDOH. It is important to acknowledge the bravery and fortitude of Governor Andrew Cuomo and the NYSDOH in their willingness to mandate this important sepsis initiative.
Multiple publications have demonstrated the survival benefit associated with compliance with sepsis bundles, including several meta-analyses (10,11); this association is even stronger with higher bundle compliance (12). Given the results of the study by Bourne et al (1) and the work previously published by these authors, understanding the ongoing controversy about the wide application of the sepsis bundles in clinical practice is truly difficult, especially because some of the same authors have published meta-analyses confirming the survival benefit associated with bundle compliance (13). No published studies demonstrate any harm associated with sepsis bundles, and yet some groups continue to publish concerns about their implementation. Some of these opinion pieces have had to be retracted and corrected because of misinformation contained in them (14). Unfortunately, these publications detract from the most important role we have as clinicians—providing the best care possible for our vulnerable patients with sepsis and septic shock. This important study by Bourne et al (1) demonstrates that we can provide the best care while improving mortality without increasing the burden of cost on our healthcare system.
1. Bourne DS, Davis BS, Gigli KH, et al. Economic Analysis
of Mandated Protocolized Sepsis
Care in New York Hospitals. Crit Care Med2020; 48:1411–1418
2. Kahn JM, Davis BS, Yabes JG, et al. Association between state-mandated protocolized sepsis
care and in-hospital mortality among adults with sepsis
. JAMA 2019; 322:240–250
3. New York State: Regulations2014Available at: https://www.health.ny.gov/diseases/conditions/sepsis/
. Accessed July 2, 2020
5. Rhode Island Regulations.Available at: https://www.apnews.com/594c8607865044c8aea216b36c5896e6
. Accessed July 2, 2020
7. Mayr FB, Talisa VB, Balakumar V, et al. Proportion and cost of unplanned 30-day readmissions after sepsis
compared with other medical conditions. JAMA 2017; 317:530–531
8. Smith MW, Friedman B, Karaca Z, et al. Predicting inpatient hospital payments in the United States: A retrospective analysis. BMC Health Serv Res 2015; 15:372
9. Klompas M, Calandra T, Singer M. Antibiotics for sepsis
-finding the equilibrium. JAMA 2018; 320:1433–1434
10. Damiani E, Donati A, Serafini G, et al. Effect of performance improvement programs on compliance with sepsis bundles
and mortality: A systematic review and meta-analysis of observational studies. PLoS One 2015; 10:e0125827
11. Pepper DJ, Sun J, Cui X, et al. Antibiotic- and fluid-focused bundles potentially improve sepsis
management, but high-quality evidence is lacking for the specificity required in the Centers for Medicare and Medicaid Service’s Sepsis
Bundle (SEP-1). Crit Care Med 2019; 47:1290–1300
12. Levy MM, Gesten FC, Phillips GS, et al. Mortality changes associated with mandated public reporting
. The results of the New York State initiative. Am J Respir Crit Care Med 2018; 198:1406–1412
13. Wang J, Strich JR, Applefeld WN, et al. Driving blind: Instituting SEP-1 without high quality outcomes data. J Thorac Dis 2020; 12:S22–S36
14. Pepper DJ, Natanson C, Eichacker PQ. Evidence underpinning the Centers for Medicare & Medicaid Services’ Severe Sepsis
and Septic Shock Management Bundle (SEP-1). Ann Intern Med 2018; 168:610–612