In the past two months, two studies have found little to no association between CMS’ sepsis care rule and improved mortality.
By fiscal 2026, hospitals face losing federal funding if they fail to comply with CMS’ Severe Sepsis and Septic Shock: Management Bundle. Several U.S. healthcare associations have pushed back on the bundle, also known as SEP-1, arguing that it promotes outdated clinical practice recommendations.
In an observational study published March 19 in JAMA Network Open, researchers reviewed medical records of 590 adults with sepsis between 2019 and 2022. The patients received care in the emergency department of four academic hospitals in California, Iowa and Massachusetts.
Among these patients, 56.8% received SEP-1-compliant care and 43.2% did not. Patients in the noncompliant group were more likely to be 65 or older, have multiple comorbidities, and have a higher incidence of septic shock, kidney dysfunction and thrombocytopenia.
SEP-1 compliance was associated with lower crude mortality rates, the study found, but there was no statistically significant difference after adjusting for demographics and comorbidities, severity of illness, and clinical complexity.
“The lack of an association between SEP-1 compliance and mortality after adjusting for these factors raise concerns that CMS’ decision to transition SEP-1 to a pay-for-performance measure may not catalyze meaningful gains in sepsis survival,” lead study author Chanu Rhee, MD, said in a news release.
Last month, researchers from the University of California San Diego published findings from a meta-analysis of 17 observational studies. The research included three- or six-hour sepsis bundles defined by SEP-1, and each was evaluated for improved mortality rates. For most patients, there was no moderate-to-high level evidence of an association between improved sepsis mortality and SEP-1 compliance or implementation, according to results published in Annals of Internal Medicine.