Boston, MA – A new study led by the Center for Sepsis Epidemiology and Prevention Studies (SEPSIS) at the Harvard Pilgrim Health Care Institute raises critical questions about the effectiveness of the Centers for Medicare and Medicaid Services' (CMS) sepsis quality measure, known as the Severe Sepsis/Septic Shock Management Bundle (SEP-1).
Sepsis, a life-threatening condition arising from dysregulated physiological response to infection, requires rapid treatment to improve survival. In 2015, CMS implemented SEP-1 to promote timely sepsis care. SEP-1 requires clinicians to complete a well-defined set of interventions within 3 hours of recognizing sepsis. These steps include measuring lactate levels, drawing blood cultures, administering antibiotics, and for some patients infusing large amounts of fluids. SEP was initially a pay-for-reporting measure but is now a pay-for-performance measure.
SEP-1 is controversial because of concern that its rigid protocol does not account for the complexity of patient presentations. Many illnesses can mimic the clinical presentation of sepsis so undue pressure on clinicians to treat sepsis rapidly and aggressively may lead to spillover treatment of uninfected patients which could be a source of harm.
CMS has presented data showing that patients who get SEP-1 compliant care have lower mortality rates than patients who do not get SEP-1 compliant care. It is not clear, though, whether lower mortality rates in patients who get SEP-1 compliant care is due to benefit from the SEP-1 bundle or whether it is because patients who get compliant care tend to be less sick and less complicated compared to patients who get non-compliant care.
In this study, published in JAMA Network Open and titled "Complex Sepsis Presentations, SEP-1 Bundle Compliance, and Outcomes," researchers from the SEPSIS Center at the Harvard Pilgrim Health Care Institute attempted to disentangle the impact of SEP-1 care vs differences in what kinds of patients get SEP-1-compliant care. The study team conducted detailed medical record reviews of 590 patients with sepsis from four academic hospitals between 2019 and 2022. The investigators rigorously catalogued and compared the characteristics of patients who did and did not receive SEP-1 compliant care. They put particular focus on identifying clinical factors that likely influence the care patients receive but have typically been overlooked in prior observational studies. Examples include patient's home language, mental status, need for urgent procedures, and level of concern for simultaneous non-infectious conditions.
The investigators found that patients who received SEP-1 compliant care were systematically different from those who received compliant care. Patients who received non-compliant care had more complex medical conditions, were more likely to present with unusual symptoms, were more likely to have concurrent non-infectious conditions, and were more likely to need urgent procedures. When the study team adjusted for these patient complexities, the observed association between SEP-1 compliance and lower mortality disappeared -- challenging the assumption that SEP-1 care is associated with better survival.
"Our study demonstrates that SEP-1 non-compliant care does not necessarily mean substandard care, but rather that it often reflects the complexity of sepsis presentations and competing clinical priorities," said Chanu Rhee, MD, MPH, lead author and Harvard Medical School Associate Professor of Population Medicine at the Harvard Pilgrim Health Care Institute. "The lack of an association between SEP-1 compliance and mortality after adjusting for these factors raise concerns that CMS's decision to transition SEP-1 to a pay-for-performance measure may not catalyze meaningful gains in sepsis survival," Rhee added.
The findings support growing calls from leading professional societies, including the Infectious Diseases Society of America, to rethink process-based sepsis mandates like SEP-1 and instead adopt risk-adjusted outcome measures.
"These findings underscore the need for quality measures that incentivize hospitals to improve the full spectrum of sepsis care -- from early recognition to post-hospital recovery -- while allowing flexibility to adapt treatment based on clinical judgment," said Michael Klompas, MD, MPH, senior author of the study and Harvard Medical School Professor of Medicine and Population Medicine. "If we truly want to improve sepsis outcomes, we must move beyond simple admission bundles and focus on strategies that address the full spectrum of sepsis care."
About the Harvard Pilgrim Health Care Institute's Department of Population Medicine
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