Recent studies have questioned the effectiveness of the Centers for Medicare & Medicaid Services’ (CMS) Severe Sepsis and Septic Shock: Management Bundle, colloquially referred to as SEP-1. This systemic rule, under which non-compliant hospitals risk losing federal funding by fiscal year 2026, has been met with resistance from several U.S. healthcare institutions who argue that SEP-1 enforces outmoded clinical practices. These studies have investigated the association between SEP-1 compliance and improved sepsis mortality, the results bringing into question the outcomes achieved with this rule.
One study, published in the JAMA Network Open, analyzed medical records from 590 adults with sepsis who were treated in the emergency departments of four academic hospitals located in California, Iowa, and Massachusetts between 2019 and 2022. Findings reveal that 56.8% of these patients received SEP-1-compliant care while the remaining 43.2% did not. It was noted that patients outside the SEP-1 compliance were largely 65 or older with multiple comorbidities and higher instances of septic shock, kidney dysfunction, and thrombocytopenia.
Although the study found that SEP-1 adherence was associated with decreased crude mortality rates, after adjusting for demographics, comorbidities, the severity of illness, and clinical complexity, the difference was statistically insignificant. This led lead study author Chanu Rhee, M.D., to voice concerns over CMS’s decision to transition SEP-1 to a pay-for-performance measure and its potential impact on improving sepsis survival rates.
Another recent analysis echoed these findings, as researchers from the University of California, San Diego conducted a meta-analysis of 17 observational studies. They observed the three- or six-hour sepsis bundles defined by SEP-1 and evaluated their impact on improved mortality rates. Just like the previous study, they found no moderate-to-high level evidence to suggest that SEP-1 compliance or implementation was associated with improved sepsis mortality rates. These reports taken in entirety seem to paint a worrying picture of whether SEP-1’s enforcement will bring about the desired improvements in sepsis survival.
Given the diverse mix of patients’ age, comorbidities, and disease severity, suggesting an intricate relationship between these factors and SEP-1 compliance, it appears crucial that there’s a comprehensive reevaluation of CMS’s rule — before risking federal funding for the numerous hospitals across the U.S.
Source: https://www.beckershospitalreview.com/quality/another-study-questions-sep-1-bundle/