Hospitals must comply with the Severe Sepsis and Septic Shock Management Bundle (SEP-1) by fiscal year 2026 or risk losing federal funding from the Hospital Value-Based Purchasing Program.
Healthcare organizations, including the American Hospital Association, have criticized the rule. Some concerns focus on CMS’ effort to develop a 30-day mortality electronic clinical quality measure for sepsis, which some say is outdated and conflicts with the CDC’s Adult Sepsis Event surveillance metric.
Researchers from the University of California San Diego analyzed 17 observational studies of sepsis cases that included three- or six-hour sepsis bundles defined by SEP-1. They examined whether SEP-1 compliance at the patient level was associated with improved sepsis mortality and whether implementation at the system level was associated with mortality rates.
With the exception of certain subgroups, including Medicare beneficiaries and septic shock patients, the study found no moderate-to-high level evidence linking SEP-1 compliance or implementation to improved sepsis mortality.
Other studies have assessed SEP-1’s effects on mortality, but UC San Diego researchers said this is the first review that examines “the level of evidence for the effect of both SEP-1 compliance and implementation on mortality,” according to the American College of Physicians.
Based on their findings, the researchers recommend that CMS reconsider including SEP-1 in the Hospital Value-Based Purchasing Program.
