The newly proposed Sepsis-3 definition has been the subject of great controversy and consternation since its publication in The Journal of the American Medical Association (JAMA) on February 22, 2016. That controversial definition discarded the concept of SIRS as the basis for defining sepsis and eliminated the distinction between sepsis and severe sepsis.

Now JAMA has just published a letter in the July 26 issue submitted by three physician representatives of CMS announcing that CMS will not change the sepsis definitions used in its SEP-1 sepsis management inpatient quality measure implemented October 1, 2015. The definitions used in the SEP-1 measure, which CMS described as "widespread and understood", rely on sepsis as SIRS due to an infection and severe sepsis as sepsis with acute organ dysfunction.

CMS pointed out that clinical practice measures require "extensive real-world field testing to assess reliability, usability, and feasibility", and that "the SEP-1 measure underwent more than eight years of development and critical review" and is supported by a large body of clinical evidence.

While welcoming "new research and innovative thinking", the letter emphasized that "prior to changing the widespread and understood definitions used in SEP-1, rigorous clinical investigation will be required..."

Other reservations concerning the proposed Sepsis-3 definitions expressed by CMS in the letter included the potential for delayed diagnosis of sepsis, a disruption of a "15-year trend toward further reduction in sepsis mortality", and impeding ongoing quality improvement efforts.

The CMS letter expresses the same concerns voiced by the healthcare community at large since the new Sepsis-3 proposed definitions were first published. Many other letters from across the country and the world were also published by JAMA together with the CMS response expressing concerns that focused on potential flaws in methods and statistical analysis and the need for prospective studies to substantiate the "real-world" clinical validity of the new Sepsis-3 definitions. CMS will continue to track further research that the new "proposed definitions will inspire."

References:

1. CMS JAMA editorial letter  (requires membership for purchase).
2. Fact Sheet SEP-1: Early Management Bundle, Severe Sepsis/Septic Shock.
3. NQF Sepsis #0500 - Severe Sepsis and Septic Shock Management Bundle, pages 20-21.

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