After considering feedback from physicians in emergency departments and hospitals, the Centers for Medicare & Medicaid Services (CMS) has opted to delay implementation of its sepsis quality measure. The chart-abstracted quality measure “Early Management Bundle for Severe Sepsis and Septic Shock” was scheduled to take effect Jan. 1, 2015, for the FY 2017 Inpatient Quality Reporting Program payment determinations.
ACEP played an active role in the successful efforts to delay implementation of the sepsis measure. Here is an excerpt from a letter ACEP President Alexander Rosenau, DO, CPE, FACEP, sent to CMS Administrator and Chief Operating Officer Marilyn Tavenner in June.
CMS … proposes the addition of NQF [National Quality Forum] #0500: Early Management Bundle for Severe Sepsis and Septic Shock, which mandates the invasive monitoring of CVP [central venous pressure] and ScVO2 [central venous oxygen saturation] via central line. With nearly two-thirds of all admitted septic patients presenting to the ED, and with the clear time sensitivity that exists between recognition, treatment, and outcomes, our members are on the “front lines” to save lives from this frequently fatal disease and promote the highest quality of sepsis care. Importantly, mortality is significantly reduced for septic patients who present to the ED compared to those who are admitted directly to the ICU or other inpatient floors, due to the timely, high quality care treatment they receive.1 ACEP appreciates that CMS verified this in the proposed rule by citing research performed by the Agency for Healthcare Research and Quality (AHRQ) Healthcare Cost and Utilization Project (HCUP), which determined that patients admitted through the ED had a 17 percent lower likelihood of dying from sepsis than when directly admitted.2
As previously stated by ACEP in public comments to CMS, although early intervention does reduce mortality, not all elements of the composite 2012 NQF #0500 meet the criteria of being evidence-based. Specifically, we refer to the measurement of CVP and/or central oxygen saturation, both requiring placement of a central venous catheter. ACEP continues to have grave concerns about requiring the use of invasive monitoring of central venous pressure and oxygenation levels in patients with severe sepsis or septic shock, when less invasive methods of monitoring intravascular volume are equally effective.
On March 18, 2014, the Protocolized Care for Early Septic Shock (ProCESS) trial published its findings in the New England Journal of Medicine. The ProCESS Investigators published a large multi-center randomized trial of protocol-based care for early septic shock to address whether better outcomes would be realized using an invasive approach with central line and central venous oxygenation monitoring as compared to usual care or protocolized care without invasive monitoring. In the two non-invasive arms of the trial, it was left up to the clinician to decide whether a central venous catheter was necessary. In all three arms of the study, the cornerstones of sepsis management, including early recognition, antibiotics, and resuscitation were maintained. The ProCESS trial results showed no difference in the primary mortality outcome after enrolling 1,341 patients, having the power to detect a 6–7 percent difference in 60-day mortality for any reason as the primary outcome.3 In addition, there were no differences in 90-day mortality, one year mortality, or the need for organ support.3 The ProCESS trial is more powerful than the seminal Rivers trial4 from over a decade ago and reflects a change in basic care with respect to lactate clearance, blood cultures, antibiotics, fluids and vasopressors.