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Proposed Sepsis-Reporting Rules Could Lead to Overtreatment

Doctors dispute CMS definition

New federal reporting requirements for treating hospitalized sepsis patients are drawing both praise and criticism from physicians who treat the condition, according to an article in MedPage Today.

The reporting requirements, which will be implemented in October by the Centers for Medicare & Medicaid Services (CMS), define severe sepsis as "a suspected source of clinical infection, 2 or more manifestations of systemic infection (SIRS criteria), and the presence of sepsis-induced organ dysfunction." Septic shock is defined as having severe sepsis "and ... sepsis-induced hypoperfusion persisting despite adequate fluid resuscitation, or lactate >4 mmol/L."

Providers are expected to treat these patients as follows:


  • Measure lactate levels

  • Obtain blood cultures prior to antibiotics

  • Administer broad-spectrum antibiotics

  • Administer 30 mL/kg crystalloid for hypotension or lactate ≥ 4 mmol/L

  • Apply vasopressors (for hypotension that does not respond to initial fluid resuscitation to maintain a mean arterial pressure of 65 or greater)

  • In the event of persistent arterial hypotension despite volume resuscitation (septic shock) or initial lactate ≥ 4 mmol/L (36 mg/dL), measure central venous pressure and central venous oxygen saturation

  • Remeasure lactate if initial lactate is elevated

The measure calls for both severe sepsis and septic shock patients to receive the first three procedures within their first 3 hours of care, and for septic shock patients to receive the last four procedures within 6 hours.

The National Quality Forum (NQF), which vetted the measure for CMS, noted that sepsis continues to be a major problem at many hospitals. “The national bill for sepsis [associated with] pneumonia grew twice as fast as the overall growth in hospital charges –– about a 180% increase from 1997 to 2005, accounting for over $54 billion per year,” the NQF wrote. “When combined with pneumonia, sepsis is the 3rd largest consumer of Medicare, 4th largest consumer of Medicaid, and 5th largest consumer of private insurance financial resources and total hospital days.”

But according to a blog post by Scott Weingart, MD, an emergency physician at the State University of New York at Stony Brook, the main problem with the new measure is that “they have re-dubbed severe sepsis to be something very different than we are used to or have read in any of the major sepsis studies... [It is] pretty unacceptable to hold every hospital in the U.S. accountable to an arbitrary definition that has not been tested in large-scale trials.”

For instance, Weingart wrote, the definition doesn’t specify that the organ dysfunction must be thought to be due to infection. “I am sure they will say, ‘We have the line “sepsis-induced” in there,’ but unfortunately the measure itself doesn’t list your clinical feelings anywhere as an exclusion –– so that would be bunk.”

Officials at Henry Ford Hospital in Detroit, where the sepsis measure was developed over a 20-year period, defended the measure’s broad reach, noting that mortality from severe sepsis and septic shock was more than 40% nationally at the start of the measure’s development.

In addition to treating people for sepsis who may not actually have it, focusing all this attention on sepsis patients will naturally mean that doctors will have less time to spend with other patients, Weingart said. “We don’t have a 20% reserve that’s waiting for this measure to come. Something we’re already doing has to be done less well in order to do better at something else... I think if people thought of that every time they wrote a measure, we’d be a lot better off.”

Sources: Medpage Today; August 19, 2015; and National Quality Forum; January 5, 2015.

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