Q&A: Changes to SEP-1 sepsis management bundle spark concern among experts
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Key takeaways:
- SEP-1 is the CMS Severe Sepsis/Septic Shock Management Bundle
- CMS is planning to transition SEP-1 from a pay-for-reporting measure to a pay-for-performance measure.
In 2015, the CMS introduced the Severe Sepsis/Septic Shock Management Bundle, or SEP-1, as an all-or-nothing, pay-for-reporting measure.
Now, changes are being made to SEP-1 to make it a pay-for-performance measure by incorporating it into the Hospital Value-Based Purchasing Program.
In a position paper penned by experts from the Infectious Diseases Society of America, American College of Emergency Physicians, Pediatric Infectious Diseases Society, Society for Healthcare Epidemiology of America, Society of Hospital Medicine and Society of Infectious Disease Pharmacists voiced concerns with this change.
For example, multiple studies indicate that SEP-1 implementation was associated with increased broad-spectrum antibiotic use, lactate measurements and aggressive fluid resuscitation for patients with suspected sepsis but not with decreased mortality rates, they wrote. Because of this, the experts recommend retiring SEP-1 rather than using it in a payment model and shifting instead to new sepsis metrics that focus on patient outcomes.
Healio spoke with Chanu Rhee, MD, MPH, FIDSA, associate professor of population medicine at Harvard Medical School and an infectious disease and critical care physician and associate hospital epidemiologist at Brigham and Women's Hospital, about SEP-1, concerns with the upcoming change and what recommendations he and colleagues have for sepsis care.
Healio: What is SEP-1?
Rhee: SEP-1 is the CMS Severe Sepsis/Septic Shock Management Bundle. It is a quality measure that consists of a series of diagnostic and therapeutic interventions that clinicians are expected to perform within the first hours of identifying patients with sepsis. Specifically, the SEP-1 3-hour bundle requires clinicians to measure a lactate level, draw blood cultures, administer broad-spectrum antibiotics, and infuse 30 cc/kg or more of IV crystalloids (if hypotension or lactic acidosis is present) within 3 hours of meeting CMS’s time zero definition for sepsis. The 6-hour bundle requires clinicians to repeat lactate measurements if the initial lactate is elevated, and to initiate vasopressors and document a repeat volume and perfusion assessment for patients with septic shock. SEP-1 was implemented by CMS in 2015 as a pay-for-reporting measure. Bundle compliance is “all or nothing,” meaning that clinicians must perform all elements of the bundle for their hospitals to get credit. Hospitals’ SEP-1 compliance rates have been publicly available on CMS’ Hospital Compare website since 2018.
Healio: What is the upcoming change?
Rhee: CMS is now planning to transition SEP-1 from a pay-for-reporting measure to a pay-for-performance measure by incorporating it into the Hospital Value-Based Purchasing Program beginning in fiscal year 2026. This directly ties hospital reimbursements with SEP-1 compliance rates, significantly raising the stakes associated with bundle compliance.
Healio: What are the concerns about it?
Rhee: Since SEP-1 was first implemented, there has been considerable controversy regarding the strength of evidence supporting its bundle elements, whether bundle compliance improves outcomes and whether there are unintended consequences that offset its potential benefits. Many bundle elements have only weak or no evidence to support their benefit, particularly the requirement for 30 cc/kg of fluids and serial lactate measurements. Observational studies also support the importance of immediate antibiotic administration in patients with septic shock, but the data are much weaker for sepsis without shock. Studies that show an association between bundle compliance and improved outcomes are observational in nature and prone to confounding.
More broadly, a major concern with the measure is that it may pressure clinicians to act very quickly in all settings in which sepsis may be present, regardless of illness severity, and even when there is considerable uncertainty about the presence of sepsis. This is important because the signs of sepsis are nonspecific and there is no gold standard diagnostic test. As a result, up to a third or more of patients treated for possible bacterial sepsis are later found to have viral or noninfectious etiologies for their syndromes. This has made many experts concerned that the pressure created by SEP-1 has increased premature and unnecessary antibiotic prescribing.
Indeed, in the past several years, several large rigorous time-series analyses have been published that shed light into the real-world impact of SEP-1 across hundreds of U.S. hospitals. These studies collectively indicate that SEP-1 implementation in 2015 was associated with increased broad-spectrum antibiotic use, as well as increased lactate measurements and aggressive fluid resuscitation for patients with suspected sepsis, but not with decreased sepsis mortality rates. Continued focus on SEP-1 risks further diverting attention and resources from more effective measures and comprehensive sepsis care, and this will likely be magnified as SEP-1 transitions from pay-for-reporting to pay-for-performance.
Healio: What does the paper recommend?
Rhee: In this multidisciplinary position paper by IDSA, American College of Emergency Physicians, Pediatric Infectious Diseases Society, Society for Healthcare Epidemiology of America, Society of Hospital Medicine, and Society of Infectious Disease Pharmacists, we recommend retiring SEP-1 rather than using it in a payment model and shifting to new sepsis metrics that focus on patient outcomes. This will encourage hospitals to pay more attention to the full breadth of sepsis care rather than the same limited set of processes in the SEP-1 bundle that do not clearly improve outcomes. This is critical because there are many opportunities to improve the care of patients with sepsis that span the early hours of presentation through their entire hospitalization and even after discharge. Examples include speeding identification of causative pathogens and antibiotic susceptibilities, implementing processes to facilitate timely source control, optimizing antimicrobial dosing and administration regimens, encouraging timely antimicrobial de-escalation, minimizing sedation and delirium, using lung protective ventilation for patients requiring mechanical ventilation, preventing hospital-acquired infections, preventing pressure injuries and improving rehabilitation programs.
To their credit, CMS has recognized this need and has been working on developing a community-onset sepsis 30-day mortality electronic clinical quality measure (eCQM) that is an important step in this direction. We support the eCQM but make recommendations in the paper to improve on the draft specifications that were released by CMS in 2022, including removing systemic inflammatory response syndrome (SIRS) criteria from the definition of sepsis and avoiding the use of diagnosis codes for infection and sepsis. These changes will help to streamline implementation, decrease variability between hospitals, maintain vigilance for patients with sepsis but without SIRS, and avoid promoting antibiotic use in uninfected patients with SIRS. We further advocate for CMS to harmonize the eCQM with CDC’s Adult Sepsis Event surveillance metric to promote unity in federal measures, decrease reporting burden for hospitals, and facilitate shared prevention initiatives.
Healio: What is the clinical take home message of this paper?
Rhee: CMS has brought welcome attention to sepsis, but SEP-1 itself has not catalyzed better clinical outcomes. Increasing focus on SEP-1 by transitioning it to a pay-for-performance measure risks further diverting attention and resources from more effective measures, preventing hospitals from focusing more comprehensively on improving sepsis care and exacerbating unnecessary broad-spectrum antibiotic use. We believe it is time to retire SEP-1 rather than use it in a payment model and shift instead to new sepsis metrics that focus on patient outcomes. CMS’s planned eCQM sepsis mortality measure is an important step in that direction, and we offer several recommendations to improve on its draft specifications. These steps will result in a more robust measure that will encourage hospitals to pay more attention to the full breadth of sepsis care, stimulate new innovations in diagnosis and treatment, and ultimately bring us closer to our shared goal of improving outcomes for patients.
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