On August 1st, the Center for Medicare and Medicaid Services (CMS) announced that the Severe Sepsis and Septic Shock Early Management Bundle, known as SEP-1, would officially be adopted into its Value-Based Purchasing (VBP) program, starting in 2024. The SEP-1 measure, introduced by CMS in 2015, consists of a bundle of evidence-based interventions that healthcare providers are expected to perform within a specific timeframe for patients suspected of having sepsis. These interventions include various components such as blood cultures, administration of antibiotics, measurement of lactate levels and fluid resuscitation. The recent inclusion of SEP-1 in CMS’ VBP program means that that there will be financial penalties for hospitals that perform poorly on SEP-1, while high performance can result in payment bonuses.

END SEPSIS’ Response to the SEP-1 Development

Sepsis remains a tragically ignored condition in the United States, despite the breathtaking rates of mortality and morbidity. As such, any policies or interventions that focus attention on sepsis are certainly welcomed by our organization and we applaud CMS for its recognition of the importance of improving sepsis care.

However, the SEP-1 measure is both problematic and controversial  and much more can and must be done in order to achieve real change in sepsis outcomes in this country. As strong proponents of New York State’s mandatory sepsis protocols, named Rory’s Regulations, we strongly suggest that several of the components that make Rory’s Regulations so successful at lowering mortality rates are included under an expanded SEP-1.  The differences between Rory’s Regulations and the CMS guidelines are major and important, leading us to believe that CMS guidelines could be greatly improved in order to facilitate positive patient outcomes.

Here are a few of the most important differences between Rory’s Regulations and the CMS guidelines:

1. While Rory’s Regulations cover all patients suspected of having sepsis, including pediatric patients, CMS guidelines exclude many patient groups, including children and transfer patients.

2. Rory’s Regulations require all relevant hospital staff to be trained in sepsis diagnosis and treatment; SEP-1 does not.

3. Rory’s Regulations require each hospital to develop their own set of evidence-based written protocols overseen by the Chief Medical Officer; CMS requires adherence and reporting on a single set of measures for all hospitals.

4. While all hospitals in New York State are required to implement approved sepsis protocols, reviewed by the Department of Health, studies show SEP-1 compliance is highly variable across hospitals, with an average of 50% bundle compliance.

5. Rory’s Regulations require the public reporting of outcomes by hospitals, including mortality rates; SEP-1 guidelines gather data on whether the SEP-1 process is being implemented-not on whether patients live or die.

6. It is important to note that while the SEP-1 measure and its impact remain controversial in hospitals, the data yielded thus far from Rory’sRegulations have clearly shown their effectiveness:

• In their first 30 months of implementation, sepsis protocols in New York State reduced the odds of dying for adult sepsis patients by 21%
• Sepsis mortality for pediatric patients was reduced by 40% when protocols were correctly administered

We strongly recommend that CMS look to the New York sepsis protocols model, in which clear protocols are developed, hospitals are held accountable, and data is collected and analyzed to improve care and reduce sepsis mortality. We hope that the components will be examined as a means of improving the impact of SEP-1.

Download our Take Action Sepsis Protocols Page Here:

https://www.endsepsis.org/wp-content/uploads/2020/06/TOOLKIT-FAQ.pdf