Study: CMS sepsis care protocol shows no clear mortality benefit

Editor's Note

A systematic review found no strong evidence that compliance with the CMS Severe Sepsis and Septic Shock Management Bundle (SEP-1) reduces mortality, raising questions about its inclusion in hospital performance measures, according to a February 19 report from the University of Minnesota’s Center for Infectious Disease Research and Policy (CIDRAP). Researchers analyzed 17 observational studies and found inconsistent results, with only limited indications of mortality benefit in specific patient subgroups.

CMS implemented SEP-1 in 2015 as a standardized sepsis care protocol requiring hospitals to administer broad-spectrum antibiotics within three hours of sepsis onset, rapidly infuse fluids, conduct blood cultures, and initiate vasopressors for fluid-refractory hypotension, CIDRAP reports. The bundle aims to improve sepsis outcomes, which affect more than 1.7 million Americans annually and result in an estimated 250,000 deaths. In 2023, CMS announced that SEP-1 compliance would influence Medicare reimbursement under the Hospital Value-Based Purchasing (VBP) program, reinforcing financial incentives for hospitals to follow the protocol.

However, the study—published in Annals of Internal Medicine—found no definitive link between SEP-1 compliance and reduced mortality. Among the 12 studies assessing mortality outcomes, five showed a statistically significant benefit in at least one patient subgroup, while seven showed no benefit. Notably, only one study demonstrated a significant overall reduction in mortality. The remaining four studies had limitations, such as failing to adjust for confounders or focusing only on specific patient populations, such as Medicare beneficiaries or those with septic shock.

Researchers concluded that while SEP-1 may help certain subgroups, there is no high- or moderate-quality evidence supporting its broad use as a mortality-reducing measure. Given concerns about potential antibiotic overuse and the financial implications for hospitals, the authors suggest reconsidering SEP-1’s role in CMS performance-based reimbursement until stronger evidence is available.