The Sepsis Confusion: Sepsis-2 or Sepsis-3?

It has been used to deny payment by some payers. The remedy? Accurate Documentation.

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Sepsis is a life-threatening reaction of the body to infection. It can cause enormous damage, and it frequently causes death. In fact, according to the CDC, at least 1.7 million adults develop sepsis each year, and nearly 270,000 Americans die each year from it.

There has been controversy over how to define sepsis, because there is no blood test or x-ray that diagnoses sepsis. In fact, sepsis can be the “great imitator,” initially manifesting as many other conditions. As a critical care specialist, I see sepsis almost every day of my professional life, and I have been touched by it personally: my daughter died of septic shock nearly ten years ago.

And so, how do you define sepsis? For many years, sepsis was defined as known or suspected infection plus two or more SIRS criteria. SIRS stands from the “Systemic Inflammatory Response Syndrome.” SIRS is actually a very long list of conditions, but typically, many define SIRS as the following:

  1. Fever (>38.0°C) or Hypothermia (< 36.0°C)
  2. Tachycardia (>90 beats/minute)
  3. Tachypnea (>20 breaths/minute)
  4. Leukocytosis (>12K ) or Leukopenia (<4K)

So, technically, if I have a cold with a fever and a heart rate of 100, which is a very normal response, I meet the criteria for sepsis. Most, if not all, clinicians, however, would not admit me to the ICU to treat my cold (I hope).

The Centers for Medicare and Medicaid Services (CMS) defines sepsis this way: infection + SIRS, known as Sepsis-2. And so, a person who comes to the hospital from a nursing home with a urinary tract infection and has a fever, elevated heart rate, and an elevated WBC count, he or she can be diagnosed with sepsis. And, according to both CMS and Sepsis-2, they would be correct.

In 2016, the critical care world was thrust into controversy when the definition was changed. According to the new consensus definition — based on real research — sepsis became defined as “life-threatening organ dysfunction caused by a dysregulated host response to infection.”

To make things further confusing, the new sepsis definitions introduced the SOFA (Sequential Organ Failure Assessment) score. This is not a diagnostic tool for sepsis. Rather, it is a scoring system to grade the severity of organ dysfunction in the setting of infection. It includes parameters for oxygenation, platelet count, Glasgow Coma Scale, bilirubin, degree of hypotension, and serum creatinine level. The worse the organ dysfunction, the higher the SOFA score. The new definition says that, if a patient has known or suspected infection with a change in SOFA score of > 2, they are “septic” and have a higher risk for mortality (it is assumed that a normal, healthy patient has a baseline SOFA score of 0).

And so, that same patient with a UTI, fever, and high WBC count — under the new definition, called Sepsis-3 — would not be classified as having sepsis. And, of course, some commercial payers started denying payment for inpatient admissions of those patients who were diagnosed with “sepsis” under the old Sepsis-2 definition. I know this, because I have written a bunch of appeals in this regard.

In fact, according to the RACmonitor website, United Healthcare announced it would start using Sepsis-3 as its “official definition” of sepsis as of January 1 of this year:

As first reported last October by RACmonitor, UHC announced in a monthly bulletin that as of Jan. 1, 2019, the giant insurer would be using Sepsis-3 to determine if a diagnosis of sepsis is clinically validated. Ronald Hirsch, MD, in reporting the story for RACmonitor, said that UHC would use the “Sequential (sepsis-related) Organ Failure Assessment (SOFA) score to determine if sepsis is present.” Hirsch quoted UHC as saying that patients with septic shock “can be clinically identified by a vasopressor requirement to maintain a mean arterial pressure of 65 mm Hg or greater and serum lactate level greater than 2 mmol/L (>18 mg/dL).”

This caused a backlash in the state of New York, which mandates sepsis care by law and uses Sepsis-2 as its “official” definition. The Healthcare Association of New York “strongly opposed” this planned change in the definition by UHC. And, as of this week, UHC backed down:

The Healthcare Association of New York (HANY) told providers Tuesday that the Empire State that it will not use the UnitedHealthcare (UHC) Sepsis-3 criteria when reviewing claims to validate sepsis for payment. New York state law defines sepsis with systemic inflammatory response syndrome (SIRS) criteria, otherwise known as Sepsis-2.

Tuesday’s announcement by HANY follows a news release from the Greater New York Healthcare Association (GNYHA) that said the group “strongly opposed UHC’s misguided proposed policy, which would have negatively impacted hospital quality improvement efforts and significantly reduced hospital reimbursement for sepsis cases.”

GNYHA confirmed that UHC had written to both the New York State Department of Health (DOH) and the New York State Department of Financial Services (DFS), stating that it would not implement Sepsis-3 criteria in the state of New York.

In defending its use of Sepsis-3 in general, UHC, in its letter to New York health officials, cited the endorsement of the new definition by 31 medical societies and providers, noting that it “provides the most clinically relevant definition of sepsis, a topic of considerable debate.”

It is interesting to me that this report didn’t say that UHC would not implement Sepsis-3 criteria in general. It just said they would not implement Sepsis-3 in New York. It remains to be seen what will happen with sepsis denials in other states across the country, by UHC and other commercial payers.

When this new sepsis definition was announced, I was like, “Duh…we know that is what sepsis is.” Yet, as this whole incident with UHC shows, it has caused a considerable amount of confusion. And, UHC is correct when it said that Sepsis-3 “provides the most clinically relevant definition of sepsis.”

Still, and this is what the guidelines don’t cover, there are some patients who — while not technically septic according to the new definition — we know in our guts are septic. For example, let’s say a patient who is on chemotherapy comes to the hospital with fever and tachycardia (fast heart rate), but all of the other labs and tests are normal. Most, if not all, clinicians would treat that patient aggressively, with IV fluids and IV antibiotics. I suspect many, if not most, clinicians would diagnose that person with “sepsis.”

But, technically, that patient would not fit the criteria for sepsis according to the new definition. And, it is possible, that the patient’s insurance company may deny payment for the inpatient admission after the fact, citing Sepsis-3 as the basis for the denial. And, technically, the insurance company will be correct. What to do about this?

Here is where documentation is the key (of course I HAD to go there…). Proper documentation is so important, especially these days with the increased scrutiny by insurance companies and regulatory agencies of the work which we clinicians provide.

For the patient above — on chemotherapy that comes in with a fever and high heart rate — it would behoove any clinician to be much more detailed in their documentation. For instance, one should write in the record:

While technically this patient does not meet Sepsis-3 criteria, this is a patient on chemotherapy, which places him at great risk for infection, and infection in the setting of immunosuppression from the chemotherapy can cause life-threatening sepsis. His presentation with fever and tachycardia, even though all other studies are normal, makes me suspect infection. As such, I am starting aggressive IV fluid therapy and IV antibiotics. I will also need to closely monitor this patient for signs and symptoms of clinical worsening, and for this reason, the patient is not safe for discharge from the ED. He needs admission — as an inpatient — for further care and monitoring as his risk for adverse outcome is extremely high. He will likely need care well beyond a normal and reasonable period of observation.

Is that a mouthful? Absolutely. Will it take more time to write (or type, or dictate) that paragraph into the record? Absolutely. Is it time well-spent? Absolutely.

Not only does that paragraph above clearly articulate the clinical concern — what your “gut” tells you — but it would be a very strong defense if the case was later denied by an insurance company (not that this case would be denied, but I am using it as an example). If I was given this case to write an appeal or do a Peer-to-Peer discussion, this paragraph would greatly strengthen my argument.

Sepsis can be a major clinical conundrum, and that is why there is so much confusion and controversy over how to precisely define what sepsis is. I am not advocating that we abandon being clinicians and start diagnosing sepsis based on strict criteria. What I am advocating, however, is that when a diagnosis of sepsis is in “our guts,” we take the extra time to document what we are thinking and why a particular patient, while not “ticking all the boxes” for sepsis, may very well have sepsis. It can make all the difference, and it may even help avoid the painstaking process of appealing a denial after the fact.

The opinions expressed in this post are my own and do not reflect those of my employer or the organizations with which I am affiliated.

NY Times featured Pulmonary and Critical Care Specialist | Physician Leader | Author and Blogger | His latest book is “Code Blue,” a medical thriller.

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