“A victory for patients with severe sepsis and septic shock.” – Sepsis Alliance, August 2023
In August 2023, the Centers for Medicare & Medicaid Services (CMS) adopted the Severe Sepsis and Septic Shock Management Bundle (SEP-1) into the Hospital Value-Based Purchasing Program (VBP) for FY2024. The final rule will impact reimbursement to hospitals – in the form of incentives or penalties – in 2026, based on the performance period of January 1, 2024-December 31, 2024.
The Burning Platform
Though it can vary across types of hospitals, the average percentage of hospitals in compliance with the SEP-1 bundle is approximately 49%. With SEP-1 now a pay-for-performance measure, hospitals are held to rigorous performance standards and required to report their SEP-1 compliance metrics. The integration of SEP-1 into the VBP program is not just a regulatory checkbox; it’s a rallying cry for hospitals to improve sepsis care.
Sepsis, a life-threatening reaction to infection, is the leading cause of death among hospitalized patients, claiming the lives of at least 350,000 Americans each year. Based on current SEP-1 bundle compliance rates, current early warning systems and sepsis care protocols are insufficient to address this condition that impacts 1.7 million patients and is the leading cause of hospital readmissions, costing over $3.5 billion annually.
The Path to Change
Sepsis is not a new healthcare challenge. But fortunately, there are new ways to combat this life-threatening and costly infection response. AI-assisted diagnosis and prediction tools for sepsis are emerging solutions, complementary to existing early warning alert systems and sepsis care protocols.
An October 2024 article in JAMA reported on the FDA’s review and authorization of AI-enabled medical devices, highlighting Prenosis’ Sepsis ImmunoScore™ as an example of AI innovation successfully navigating the FDA’s stringent regulatory process.
Sepsis ImmunoScore is the first FDA-authorized AI diagnostic for sepsis. For early detection, this groundbreaking tool can play a pivotal role in SEP-1 compliance. By integrating routinely collected electronic medical record (EMR) data with protein biomarkers, including Procalcitonin (PCT) and C-reactive protein (CRP), Sepsis ImmunoScore can provide advanced warning of patients likely to become septic even before they meet the SEP-1 time zero criteria—the time at which the SEP-1 clock starts running. This advanced warning gives providers critical extra time to provide SEP-1 compliant care before the 3- and 6-hour deadlines. Sepsis ImmunoScore also provides a single, reliable measure of imminent sepsis risk that may be easier to interpret than monitoring the relatively complex SEP-1 time zero criteria.
Using tools like Sepsis ImmunoScore can assist providers in accurately diagnosing and coding for sepsis care. The downstream impact is improved SEP-1 bundle compliance, helping hospitals adequately capture the value of the care they are already providing.