New Study Questions the Effectiveness of CMS Sepsis Treatment Protocols

A new study has cast significant doubt on the effectiveness of a federally mandated hospital protocol designed to improve care and management of sepsis patients. The research, published in JAMA Network Open this week, indicates that adherence to the Centers for Medicare and Medicaid Services (CMS) Severe Sepsis and Septic Shock Management Bundle (SEP-1) does not necessarily correlate with improved patient outcomes.

The researchers found that patients treated in a noncompliant manner tended to be older, have multiple health issues, and present with more complex clinical conditions compared to those whose care adhered to the SEP-1 standards. After adjusting for these critical factors, the study concluded that compliance with the SEP-1 bundle did not demonstrate a relationship with reduced mortality rates, challenging earlier evidence that had supported the protocol's effectiveness.

This study follows a systematic review and meta-analysis published last month in the Annals of Internal Medicine, which also reported no substantial evidence linking SEP-1 compliance with decreased mortality rates.

Sepsis, a life-threatening condition that arises when the body's response to infection causes injury to its tissues and organs, affects more than 1.7 million Americans annually, resulting in approximately 250,000 deaths each year. To combat this medical crisis, CMS introduced the SEP-1 bundle in 2015, which mandates that medical professionals administer broad-spectrum antibiotics within three hours of suspected sepsis diagnosis, among other measures like rapid fluid infusion and blood culture tests.

Initially, implementation of SEP-1 was based on data suggesting that following its guidelines led to reduced mortality. However, in 2023, CMS shifted its focus from a pay-for-reporting system to a pay-for-performance model, promising financial incentives for hospitals that comply with the SEP-1 measures.

Lead author Dr. Chanu Rhee of the Harvard Pilgrim Health Care Institute remarked, 'The findings raise concerns that the decision to transition SEP-1 to a pay-for-performance measure may not lead to tangible improvements in sepsis survival rates.'

The study reviewed data from 590 adult sepsis patients treated over several years at four academic hospitals across Massachusetts, Iowa, and California. It sought to:

Study Objectives

1. Compare the clinical characteristics of patients receiving compliant versus noncompliant care. 2. Investigate the correlation between SEP-1 compliance and hospital mortality rates.

The results indicated a higher proportion of elderly patients (those over 65), individuals with diabetes, and those with multiple health complications in the noncompliant care group. Additionally, these patients demonstrated greater instances of septic shock, kidney dysfunction, and impaired mental status at the time of hospital admission.

Interestingly, when examining unadjusted mortality rates, compliant care was initially associated with lower death rates (11.9% for compliant versus 16.1% for noncompliant). However, once demographic and clinical complexities were factored in, this correlation dissipated entirely.

The researchers emphasized that noncompliance with protocols doesn’t necessarily indicate poor patient care. Instead, it may reflect the nuanced and multifaceted nature of sepsis and other concurrent medical conditions experienced by patients. This led to calls for a reassessment of the SEP-1 protocol to potentially phase it out in favor of strategies that concentrate on detailed, risk-adjusted outcome measures, allowing healthcare facilities to offer customized care based on specific patient needs.

'As we push to improve sepsis outcomes, we must look beyond standard admission bundles and focus on comprehensive strategies that address the entire spectrum of sepsis treatment,' stated Dr. Michael Klompas, senior author and faculty member at Harvard Medical School.

This new evidence prompts critical questions about the future of the SEP-1 bundle, as medical professionals and policymakers reconsider the best approach to improving sepsis care and outcomes.