Research raises more questions about the benefits of the CMS sepsis bundle

Another study is asking questions about whether compliance with federal mandatory hospital protocols aimed at improving sepsis care and management is associated with better outcomes.

studyPublished this week Jama Network Open, Sepsis patients who received unintegrated care with the Centers for Medicare and Medicaid Services (CMS) Severe Septic Shock Management Bundle (SEP-1) are more likely to have more comorbidities and have more complex clinical symptoms than those who received obedient care. If these factors were explained, SEP-1 compliance was no longer associated with improved mortality.

This study is on the heel of a Systematic reviews and meta-analysisIt was released last month Internal medicine chronicles, It found no evidence that SEP-1 compliance was associated with improved mortality.

Sepsis occurs when the immune system overreacts to an infection, causing a series of events that can lead to tissue damage, organ failure, and death. More than 1.7 million Americans are treated for sepsis each year, with an estimated 250,000 deaths. Implemented by CMS in 2015, SEP-1 is a bundle of measures that involve the administration of broad spectral antibiotics to all patients with potential sepsis within 3 hours of recognition. Other elements of SEP-1 include rapid fluid injection, blood culture, lactic acid measurements, twin fluke devices for liquid-intangible hypotension, and reassessment of volume status.

SEP-1 was adopted based on evidence that bundle compliance was associated with lower mortality. In 2023, CMS announced that it would move SEP-1 from reporting to compensation payment measures. This means that hospitals will be rewarded for SEP-1 compliance.

However, the authors of the new study say the findings raise more questions about the benefits of mortality, raising the question of whether hospitals should be punished for not complying with a single size approach that does not improve outcomes and does not explain the complexity of patients with sepsis.

“The lack of association between SEP-1 compliance and mortality after adjusting for these factors raises concern that CMS' decision to move SEP-1 to performance payment measures will not catalyze any meaningful benefits in sepsis survival.” press release From the Institute.

“From protection to null”

For retrospective studies, a team of US researchers led by Rhee analyzed data on adult sepsis patients treated at four academic teaching hospitals in Massachusetts, Iowa and California from January 2019 to December 2022.

“Most of the previous studies on bundle compliance rely on management and/or electronic health records (EHR) data, limiting our ability to identify complex clinical factors that are not normally captured in structured areas (such as early-level infection among clinicians, difficult intravenous access, the need for urgent bedside procedures, competing non-infectious diagnosis, etc.). “Identifying these factors may highlight key barriers to timely sepsis care and help us to better understand the association between bundle compliance and outcomes.”

This study included 590 patients (median age, 65 years; 55.8% males), of which 335 (56.8%) received SEP-1 integrated care and 255 (43.2%) received non-integrated care. Regarding baseline clinical features, patients in the non-complex group were more likely to be over 65 years of age (55.7% vs. 47.2%, odds ratio [OR]1.41; 95% confidence interval [CI]1.01-1.95), diabetes (31.8% vs 21.5%; OR, 1.70; 95% CI, 1.17-2.46), and multiple comorbidities (38.8% vs 29.6%).

The lack of association between SEP-1 compliance and mortality after adjusting for these factors raises concern that CMS' decision to move SEP-1 to performance payment measures may not catalyze meaningful benefits in sepsis survival.

In the presentation, patients in the unconnected group had a higher incidence of septic shock (42.0% vs. 31.9%; OR, 1.54; 95% CI, 1.10-2.16), renal dysfunction (34.1% vs. 23.9%; OR, 1.65; 95% CI, 1.15-2.37), and 16.9%; 1.16; 95% CI, 1.02-2.62). They also found that more non-enzymatic presentations (53.3% vs. 36.1%; OR, 2.02; 95% CI, 1.45–2.82), impaired mental state (36.1% vs. 28.1%; or 1.45; 95% CI, 1.02–2.05), necessity for bedside treatment 3.21), acute concurrent non-communicable diseases (54.9% vs. 45.1%; OR, 1.48; 95% CI, 1.07–2.06), and non-infectious diseases (32.9% vs. 21.2%; OR, 1.82; 95% CI, 1.08–3.08).

In unadjusted mortality analysis, SEP-1 compliance was associated with a lower crude mortality compared to noncompliance violations (11.9% vs. 16.1%; OR, 0.60; 95% CI, 0.37-0.98). However, after consecutive adjustments for demographics and comorbidities, there were no statistically significant differences between groups (adjusted or [AOR]0.71; 95% CI, 0.42-1.18), source of infection (AOR, 0.71; 95% CI, 0.43-1.20), severity of the disease (AOR, 0.86; 95% CI, 0.50-1.49), and clinical markers of complexity (AOR, 1.08; 95% CI, 0.61-1.91).

“When adjusted for these confounding factors, many were only available through detailed medical record reviews, shifting estimates of the effect of SEP-1 compliance and mortality associations from protection to null,” the authors write.

Addressing the full scope of sepsis care

The authors state that there is room for improving SEP-1 bundle compliance rates, but findings indicate that violations do not imply that patients are receiving inadequate care, but that they can reflect the complexity of presentation of sepsis and the frequent presence of other acute conditions requiring simultaneous diagnosis and management.

They also note that discussions about the impact of SEP-1 are one of the reasons groups such as the American Infectious Diseases Association have Called in CMS We will abolish SEP-1 and move the focus to risk-adjusted outcome metrics to provide more flexibility to customize sepsis care.

“If you really want to improve your sepsis outcome, you need to move beyond the simple bunch of admission and focus on strategies that address the full scope of sepsis care,” says Michael Cronpas, MD, senior study author at Harvard Medical School.