The 2017 Surviving Sepsis Campaign (SSC) guidelines, published in the March 2017 issue of Critical Care Medicine, announced the Campaign's adoption of the Sepsis-3 definition of sepsis as “life-threatening organ dysfunction caused by a dysregulated host response to infection,” discarding the Sepsis-2 definition of sepsis, systemic inflammatory response syndrome (SIRS) due to infection, which had been used by the SSC since 2002.
As discussed in recent issues of this column, Sepsis-3, published in JAMA last year, represents a radical departure from the prior sepsis definitions established in 1991 (Sepsis-1) and 2001 (Sepsis-2).The Sepsis-3 consensus definition makes no distinction between sepsis and the condition described by Sepsis-2 as severe sepsis (that is, sepsis with acute organ dysfunction). Sepsis and severe sepsis would therefore be synonymous terms, and Sepsis-3 makes the point that “severe” sepsis would be redundant; there are only sepsis and septic shock. Sepsis-3 defines organ dysfunction as an increase in the total Sequential [Sepsis-related] Organ Failure Assessment (SOFA) score of 2 points or more from baseline.
The SSC definitions and guidelines are the authoritative clinical source for the diagnosis and management of severe sepsis, but adopting the Sepsis-3 definition leaves several practical and operational difficulties, particularly for proper documentation. The ICD-10-CM classification and official CMS coding guidelines still define sepsis as SIRS due to an infection and suggest several acute organ dysfunction criteria for severe sepsis that are not all-inclusive. Coders will have difficulty correctly and compliantly assigning codes for sepsis and severe sepsis when physicians use only the Sepsis-3 definitions.
Of major concern pertinent to quality measures is the CMS Hospital Inpatient Quality Reporting (IQR) severe sepsis management measure (called SEP-1), which is abstracted by hospitals' quality departments. SEP-1 does not utilize Sepsis-3 but rather defines severe sepsis as SIRS due to infection with acute organ dysfunction. SIRS is defined as two or more of four criteria: temperature, leukocytosis, tachycardia, and tachypnea.
The SEP-1 measure also defines acute organ dysfunction much differently than SOFA, with criteria including systolic blood pressure <90 mm Hg or mean arterial pressure <70 mm Hg; creatinine level >2.0 mg/dL or urine output <0.5 mL/kg/h for more than two hours; bilirubin level >2 mg/dL; platelet count <100,000 cells/mm3; international normalized ratio >1.5 or an activated partial thromboplastin time >60 s; and a lactate level >2 mmol/L.
If physicians do not follow these SEP-1 definitions, a deficiency in the quality of care for severe sepsis management could be reported to the CDC and CMS. Following only the Sepsis-3 definition may allow many sepsis cases to “fall through the cracks” for SEP-1 reporting.
However, recovery audit contractors will almost certainly adopt Sepsis-3 for clinical validation review of claims and reject the diagnosis of sepsis and severe sepsis based on Sepsis-2 as unsubstantiated, removing them from claims.
How should clinicians and coders respond? It's a complicated and confusing situation, and it remains to be seen how CMS will now react to the new SSC guidelines adopting the Sepsis-3 definition. In the meantime, hospital medical staff and leadership should be engaged and establish policies to deal with this complex challenge of reconciling authoritative SSC clinical guidelines with the CMS quality reporting imperative.
If physicians use only Sepsis-3 definitions and SOFA to identify and manage severe sepsis, deficiencies in the CMS IQR SEP-1 quality reporting will occur. If Sepsis-2 definitions are used exclusively, the result will be deficiencies in the clinically authoritative SSC diagnostic and management standards. Perhaps both Sepsis-2 and Sepsis-3 need to be used to diagnose and treat severe sepsis until this daunting dilemma is resolved.