Government Sepsis Rules Fail To Lower Mortality Rates: Study

Researchers called for CMS to reconsider its sepsis treatment rules to reduce the risk of severe and often deadly infections.

New research suggests that complying with federal Medicare guidelines for sepsis treatment has not led to a reduction in sepsis-related deaths in U.S. hospitals, leading to calls for updated rules regarding the proper care for management of the severe and life-threatening infections.

The Centers for Medicare & Medicaid Services (CMS) mandates rules on how to care for patients with sepsis, and those suspected of having sepsis, which are intended to help lower the risk of death. However, findings published in the journal Annals of Internal Medicine on February 18 suggest those rules may be ineffective.

Sepsis is a life-threatening condition that occurs when the body fails to fight off an infection properly, causing the immune system to overreact. The condition can cause a drastic drop in blood pressure, organ failure, and can lead to death if not treated quickly. Previous research has warned that sepsis is responsible for one in five deaths around the world.

For the new study, researchers from the University of California San Diego, led by Dr. James S. Ford, assessed the effectiveness of CMS’s Severe Sepsis and Septic Shock Management Bundle (SEP-1) rules by examining data from 4,400 patients across 12 different studies.

Among the 12 studies, five showed a significant benefit and seven studies did not show any benefit. However, an analysis of the studies led the researchers to conclude that there was no compelling evidence that the SEP-1 rules helped decrease sepsis deaths.

Ford’s team called for the CMS to reconsider the SEP-1 rules, and especially reconsider incentivizing the bundle. Hospitals might want to consider using other techniques like electronic screening programs, they advised.

A study published in late 2024 indicated that hospitals which used electronic screening systems had fewer sepsis deaths than those using traditional techniques, like the CMS SEP-1 bundle.

The research team called for more studies to investigate and determine the best way to treat patients with suspected sepsis that results in the fewest deaths possible.

CMS Sepsis Treatment Rules

Sepsis is a serious and often life-threatening condition in hospitals, making early and accurate identification critical. Since sepsis can rapidly worsen, SEP-1 guidelines require specific treatments to be administered as soon as the condition is suspected. 

SEP-1 was implemented by the CMS in October 2015 as a pay-for-reporting measure. The bundle requires all patients with possible sepsis or septic shock to have lactate or blood cultures drawn and be given broad-spectrum antibiotics and intravenous fluids. All requirements must be adhered to in the first three hours.

Several medical organizations, including the Infectious Disease Society of America and the American College of Emergency Physicians, have raised concerns that the SEP-1 bundle pressures doctors to treat patients for sepsis even when the diagnosis is uncertain. Since many serious conditions can mimic early signs of sepsis, critics warn that the guidelines may lead to unnecessary treatments and the overuse of antibiotics. 

However, in 2023, the CMS issued a final rule indicating hospitals will be incentivized to comply with the SEP-1 bundle.