Payers and Clinicians Should use Clinically Accepted Criteria when Diagnosing Sepsis

The accurate diagnosis of sepsis is not for DRG assignment.

There has been quite a bit of controversy stirred up by UnitedHealthcare (UHC) and its approach to sepsis, and since I am wrapping up a fascinating targeted sepsis project, I want to share what I have learned with you. I believe I can shed some light on the subject.

It is essential to acknowledge that the accurate diagnosis of sepsis is not for DRG assignment. It is not for increased reimbursement or improved quality metrics. Prompt diagnosis and treatment of sepsis is to improve the medical care and outcomes of patients.

The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) came out on Feb. 23, 2016. The new definition of sepsis was established as “life-threatening organ dysfunction caused by a dysregulated host response to infection.” The Sequential Organ Failure Assessment (SOFA) and qSOFA are tools designed to prognosticate mortality, but were not intended to be diagnostic. In fact, the consensus paper states that “sepsis is a syndrome without, at present, a validated criterion standard diagnostic test,” adding that “neither qSOFA nor SOFA is intended to be a standalone definition of sepsis. Failure to meet two or more qSOFA or SOFA criteria should not lead to a deferral of investigation or treatment of infection or delay in care.”

For a period of time, this wreaked havoc in the medical community, because there was a discrepancy between Sepsis-2 (set out in the Surviving Sepsis Campaign, or SSC, in 2001, superseding Sepsis-1, from 1991) and Sepsis-3 definitions. Sepsis-2 was “systemic inflammatory response syndrome (SIRS) plus a presumed or confirmed infection equals sepsis” definition. Hospitals were in a quandary as to how to counsel providers to diagnose sepsis. Early adopters wanted to use Sepsis-3; old practitioners were comfortable with and relied on SIRS to recognize sepsis.

The problem was that Sepsis-2 was misinterpreted and misunderstood. It was never intended that the general variable SIRS clinical indicators (temperature, heart rate, tachypnea) plus the inflammatory variable of abnormal WBC count were to be sufficient to diagnose sepsis (I will designate this subset of the greater set of SIRS variables as SIRS). Somewhere along the line, clinicians forgot that sepsis mandated that the patient was sick with a capital “S” from an infection, not just that they were tachycardic and febrile, with a bump in their white blood cell count. SIRS cast a wide net; providers were supposed to sort through the fish and toss the small fries back in the pond.

The other hitch was that there were always other SIRS clinical indicators, including hypotension, thrombocytopenia, hyperglycemia, ileus, and elevated creatinine. In fact, if you look at the table for diagnostic criteria for sepsis from SSC 2012 (Table 1), the list includes all the elements of the SOFA score.

If you have a fever and an appropriate tachycardia from streptococcal pharyngitis, but you are sitting on the bed laughing with your parents, you meet SIRS criteria, but you are not septic. If you are elderly, on beta blockers, and are hypoxic and encephalopathic from a systemic response to an infection, but can’t mount a white count or tachycardia, you are septic without meeting SIRS criteria.

The last puzzle piece is that the Centers for Medicare & Medicaid Services (CMS) established its own criteria for severe sepsis and septic shock diagnosis for the SEP-1 sepsis core measure bundle. These include SIRS plus one or more organ dysfunction criteria. It would serve everyone well to recall that criteria and clinical guidelines are good, but they do not supersede the clinician’s judgment.

UnitedHealthcare announced in October 2018 that it planned to transition to Sepsis-3 as of Jan. 1, 2019. I was delighted to hear this…until I read the entire announcement.

I am wholly supportive of payers utilizing current, clinically validated standards. In 2016, it was absurd for payers to be using the World Health Organization criteria for malnutrition from 1999. As medicine advances, so should clinicians and those who are judging clinical care.

It is desirable for payers to be transparent on the current criteria they are using. The gray period of sepsis (from Feb. 23, 2016 to Jan. 18, 2017, the period after Sepsis-3’s release, but before Sepsis-2 aligned its sepsis definition with Sepsis-3) allowed for payers to move the goalposts. If I used SIRS plus infection as my criteria, the payer denied on the basis of Sepsis-3. If I used organ dysfunction to justify the diagnosis, they would try to claim the patient didn’t meet SIRS criteria from Sepsis-2.

With the definition alignment and clinical acceptance by most clinical societies, including the Centers for Disease Control and Prevention (CDC), American College of Emergency Physicians, and the Society of Critical Care Medicine, sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. This is the definition we should be using. This is the definition payers should be using. UnitedHealthcare did right to embrace the definition.

But, and this is a big, capitalized “BUT,” SOFA is not meant to be the gold-standard diagnostic test for sepsis. This is the part of the UHC release that disturbs me. It states that “in clinical operation, the Sequential (Sepsis-related) Organ Failure Assessment (SOFA) score of two points or more, which is associated with an in-hospital mortality (rate of) >10 percent, should be used in defining sepsis.”

Most folks don’t realize it, but the bar for a positive SOFA score is pretty low. A pulse oximetry reading of 95 percent on room air scores a 1. A blood pressure of 98/55 is a MAP of 69 mm Hg (SOFA threshold of <70 mm Hg). A creatinine of 1.2 scores a 1, and that isn’t even out of normal range for a man.

Conversely, there are organ dysfunctions not found in SOFA. Type 2 myocardial infarction, ileus, critical illness myopathy or neuropathy, and liver dysfunction manifested by transaminitis without hyperbilirubinemia are all examples. If organ dysfunction is caused by a systemic response to the localized infection, sepsis is present. UHC may deny the diagnosis, but that won’t negate the clinical reality that the patient is septic. UHC should revise its policy.

Sepsis always has been and may always be (barring some amazing future discovery of a gold-standard laboratory test) a clinical diagnosis based on the clinician’s experience and judgment. The key to getting sepsis right is ensuring that providers recognize it and document it appropriately. Keep in mind that sepsis under the current definition is the condition formerly known as severe sepsis, and should be documented such that the code for severe sepsis (or septic shock) can be captured for all cases of sepsis.

This begs repeating. Integral to the definition of sepsis is now organ dysfunction. Sepsis with acute sepsis-related organ dysfunction is permitted by the coding guidelines to be coded with R65.20 (severe sepsis without septic shock), even without the provider documenting the qualifier “severe.”

So, what to do?

The crucial step is to make sure that your providers are recognizing sepsis. There is nothing wrong with SIRS being a screening tool. It just isn’t a diagnostic tool.

Here are my steps for sepsis success:

1. There is a documented infection, presumed or confirmed, and the patient is sicker than the average patient with just the underlying infection.

For illustration:

• It seems obvious, but a decubitus ulcer is not an infection. Having an infected decubitus ulcer (L08.9 plus decubitus specificity) is. There needs to be an infection for sepsis to exist, so providers must diagnose and document a presumed or confirmed infection.
• If you have pneumonia with significant hypoxemia, such that your SOFA score is 2, but you have no other systemic organ dysfunction, you meet the criteria for sepsis. The authors of Sepsis-3 intentionally did not exclude this scenario. However, auditors may try to deny the claim of sepsis on the basis that patients with pneumonia are expected to have hypoxemia and are not sicker than other patients with the condition.

2. There is organ dysfunction due to the infection/sepsis.
   1. Calculate SOFA, if possible. If positive, note it. If negative, explicitly acknowledge it and detail the organ dysfunction present.Although the SOFA score at this time is only 1 for hypoxemia, there is additional sepsis-related organ dysfunction of ileus with persistent vomiting and AKI (Cr 1.0, yesterday was 0.6).
   2. Use best-practice documentation of the organ dysfunction.
      1. Altered mental status – is it encephalopathy? Document individual components and total GCS.
      2. Hypoxemia – don’t just record the pulse ox level; draw a conclusion about it (don’t describe, ascribe!). Calculate the Carrico index (PaO2/FiO2). If there is acute hypoxic respiratory failure, document that.
      3. If there is not frank organ “failure,” explicitly use the word “dysfunction” (See transaminitis example above).
   3. Even if the organ dysfunction is of the organ involved in the infection (i.e., it isn’t of an organ or system distant from the localized infection), Sepsis-3 allows for the diagnosis of sepsis (see second bullet point under 1). Provider judgment is called into play for this, and the documentation should support the manifestations being in excess of expected.
3. The documentation is adequate such that the code for severe sepsis may be captured.
   1. This is my suggestion (make a macro):
      Sepsis due to (infection) with acute sepsis-related organ dysfunction as evidenced by (insert organ dysfunctions and clinical indicators here).
   2. You do not need to copy and paste all of the supporting narrative into each and every note, but diagnosis should be carried throughout the record.
   3.  This should be consistent by all providers caring for the patient.
   4.  Evolve, resolve, remove, recap. This should appear when diagnosed, be declared resolved when no longer present, and should reappear in the discharge summary.
4.  The core measures bundle should be performed on all patients with “sepsis, the condition formerly known as (and should be coded as) severe sepsis.” If you do not, you will fall out of core measures. This may give you pause to retrospectively query for sepsis, but if a provider missed the diagnosis, they should be educated. Remember, the goal is to save lives, not to pigeonhole encounters into a more favorable DRG.

Additional tips:

• Use uncertain diagnoses liberally. Better to document “possible sepsis” in the ED and rule it out than miss picking it up present on admission. It also impacts the mindset of subsequent providers improving medical care.
• The medical record should tell a coherent story. If a patient has sepsis, each provider should note it. They shouldn’t flip between “bacteremia” and “sepsis” diagnoses. The weekend coverage should either propagate, rule out, or resolve the diagnosis, not just drop it off the impression list.
• A patient either has sepsis (life-threatening organ dysfunction caused by a dysregulated host response to infection) or they do not, in terms of coding, and possibly clinically as well (I am leaving wiggle room for clinical judgment). There is no code for “impending” or “aborted” sepsis. If sepsis never evolved during the admission, no code is assigned for sepsis. If you averted sepsis by prompt, aggressive therapy, pat yourself on the back, but don’t code sepsis!

However, if your intuition is telling you that the patient is sicker than the average patient with the same underlying infection, you may be correct, and the patient does indeed have sepsis, not “impending sepsis.” Review the data again to see if there is organ dysfunction that you believe is from a systemic, dysregulated response to the infection. If so, document your support of the diagnosis, call it sepsis, and treat it.

Have providers avoid sepsis-adjacent phraseology like “sepsis syndrome,” “septic protocol started (without an explicit diagnosis of “sepsis”), “sepsis-like,” “met sepsis criteria,” etc.

• If payers deny clinical validity of sepsis because the SOFA criteria were not satisfied, but the patient had legitimate organ dysfunction and was sicker than the average patient with the underlying infection, appeal the denial. Use quotes from Sepsis-3 as your substantiation.

It is critical to recognize, diagnose, and treat sepsis. Providers and payers alike should respect the definition upon which experts have settled. The patient’s life may depend on it.

Program Note:

Listen to Dr. Remer every Tuesday on Talk Ten Tuesday, 10 a.m. ET.