Study Raises More Questions on Effectiveness of SEP-1 Sepsis Guidelines

March 24, 2025
In 2023, CMS announced that hospitals would be rewarded for SEP-1 compliance, but studies have cast doubt on its correlation with improved mortality rates.

A new study raises further questions about the effectiveness of a federally mandated hospital protocol aimed at improving sepsis care and management. CIDRAP has the news.

According to the study, sepsis patients who “received care that was noncompliant with the Centers for Medicare and Medicaid Services (CMS) Severe Sepsis and Septic Shock Management Bundle (SEP-1) tended to be older, have more comorbidities, and have more complex clinical presentation than those who received compliant care. When those factors were accounted for, SEP-1 compliance was no longer associated with improved mortality.”

HPN previously reported on a systematic review and meta-analysis that found no evidence of SEP-1 compliance being correlated with improved mortality. The measure was originally adopted “based on evidence that bundle compliance was associated with lower mortality rates. In 2023, CMS announced it was transitioning SEP-1 from a pay-for-reporting to a pay-for-performance measure. That means hospitals will be rewarded for SEP-1 compliance.”

A team of researchers analyzed data on “adult sepsis patients treated at four academic teaching hospitals in Massachusetts, Iowa, and California from January 2019 through December 2022.” Overall, the study included 590 patients; 335 of them received SEP-1-compliant care, and 255 received noncompliant care. After successfully adjusting for demographics and comorbidities, infection source, severity of illness, and clinical markers of complexity, there was “no statistically significant difference between groups.”

About the Author

Matt MacKenzie | Associate Editor

Matt is Associate Editor for Healthcare Purchasing News.