Pearls and Pitfalls: CMS and Sepsis

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The Pre-brief

In the decades since Dr. Rivers’ famous exposition of Early Goal-Directed Therapy (EGDT) in 2001, bundled care in sepsis has transformed quite a bit (1). A far cry from the PA catheters and dobutamine originally involved with these bundles, now the majority of US centers use SEP-1 criteria and bundles to comply with the Centers for Medicare and Medicaid Services (CMS) core metric. It should be noted that this article does not seek to describe whether this is a good or bad thing…just to help folks navigate some of the ins, outs, and misconceptions about what the government is really asking us to do.

Pitfall/ Misconception #1: The government reviews every sepsis case at my hospital. They are watching me right now!

No, CMS is not spying on every sepsis patient in the hospital, and it doesn’t even review most cases. Usually one of several private entities pairs up with a hospital (examples include Premier and Vizient), and they select 20% of all cases at random with discharge diagnoses consistent with “sepsis, severe sepsis, or septic shock.” Those cases are then reviewed by a hospital committee for compliance with the 2012 Surviving Sepsis Campaign SEP-1 bundle recommendations (2). 

Pearl #1: Bundled care according to the SSC is time-sensitive, but CMS calculates “time zero” for sepsis in a very specific way. I guarantee it’s not how you would do it. 

Nearly every piece of big data (prospective or otherwise) has shown that bundled care delivered in a timely fashion really does save lives (3). Even the folks who hold up PROMISE or ARISE as “disproving” EGDT as a valid practice (a topic for a different day) should be ready to admit that delays in antibiotics and early identification of septic patients are important (4). Broadly speaking, CMS states that timely sepsis care involves the satisfaction of the 3 and 6 hour bundle after the start of sepsis or “time zero” (Table 1). However, CMS doesn’t “start the clock” the same way you probably do (5).  Here’s how it happens:

Step 1: Once a case is selected for review, it goes to a chart abstractor in your hospital to comb through the notes, vitals, and labs. Who abstracts this chart and how thorough they are really matters. They will be looking for a discrete “time zero” for sepsis.

Step 2: An abstractor will look for 3 things to overlap within a window of 6 hours:

  • 2 or more SIRS criteria (Table 2)
  • A dated and timed note from a physician or mid-level provider that states the patient may have an infection/ sepsis
  • Lab or physical exam evidence of organ failure (Table 3)

The order in which these three things occur does not matter. 

Step 3: The abstractor will look for clarifying statements in provider notes. This includes:

  • Any note that specifically states the patient has “severe sepsis” or “septic shock”
  • Any note that specifically addresses reasons for organ failure NOT being from sepsis

Step 4: The abstractor will take the latest occurring criteria (from step 2) as sepsis “time zero.” There are several exceptions to this when certain phrases are found in the chart, however:

  • If a provider (MD/DO/APP) states that the patient “had sepsis on arrival,” then time zero auto-defaults to the exact time the patient arrives on the inpatient unit. 
  • If a provider states the patient had sepsis “upon triage,” then time zero auto-defaults to the time of ED arrival/ triage. 
  • If a provider note states that the patient has septic shock or severe sepsis, the abstractor will take the timestamp on the note as time zero. 

Example 1:

11:30- patient arrives in ED triage

11:40- patient’s HR =105 and RR is 25 (2 SIRS criteria)

12:00- patient is roomed in the ED

12:20- ED provider examines patient and starts a note (timestamp = 12:20)

13:30- CXR reveals infiltrate

15:45- Lactic acid returns at 2.5 mmol/dL (organ failure)

16:00- ED physician orders blood cultures, CTX, and admit order

19:00- ED physician signs note, with her Assessment and Plan stating that the patient had “severe sepsis”

When was time zero?

According to CMS, the physician note states that the patient has “severe sepsis” at 12:20, which becomes time-zero. To be compliant with the 3-hour bundle, the patient must receive blood cultures, have a lactic acid measured and receive abx within 3 hours of time-zero. 

Since time-zero = 12:20, but the patient did not actually get abx until, after 16:00, the case would fail arbitration and be ruled as “non-compliant.” The case would be ruled as inappropriate care. 

Example 2:

11:30- patient arrives in ED triage

11:40- patient’s HR =105 and RR is 25 (2 SIRS criteria)

12:00- patient is roomed in the ED

12:20- ED provider examines patient and starts a note (timestamp = 12:20)

13:30- CXR reveals infiltrate

15:45- Lactic acid returns at 2.5 mmol/dL (organ failure)

16:00- ED physician orders blood cultures, CTX, and admit order

19:00- ED physician signs note, with her Assessment and Plan stating that the patient had “community-acquired pneumonia.”

When was time zero?

According to CMS, the physician note specifies infection at 12:20 and 2 SIRS criteria are present at 11:40. However, it’s not until 15:45 that a lactic acid results at 2.5 mmol/dL. Since these 3 things occur within 6 hours of each other, the onset of sepsis time-zero defaults to the latest of these three things: lactic acid elevation at 15:45. Given that the patient got cultures, lactic acid, and abx 30 minutes after time-zero, the case would be ruled “compliant.”

Unfortunately, the CMS SEP-1 Core measure is an “all or none” pass/fail system. Example 1 gets no credit at all for managing the case appropriately whereas Example 2 gets all the glory of being “compliant.”

Table 1: Bundle Elements of the SEP-1 Bundle According to CMS * Hypotension here is defined to be 2 separate readings of MAP <65, SBP 40 mmHg from baseline BP.
Table 2: SIRS Criteria. CMS requires ≥2 of these criteria to be present to “start the clock.”
Table 3. Organ Failures. CMS requires at least one organ failure to be present to “start the clock.” If the provider note addresses abnormal values as related to pre-existing/ non-contributory circumstances, abstractors will not use that organ system. *Lactic Acid levels >4 qualify a patient to be treated for septic shock with an IV fluid bolus.

Pitfall #2: Most “non-compliant” cases are actually for dumb reasons. 

While it’s true that blood cultures, antibiotics, and lactic acid measurement really is important for the early identification and treatment of sepsis, most CMS SEP-1 “fall outs” actually occur for reasons that are highly technical and not really patient-centered (eg. the examples above). It’s also the case that repeat lactic acid labs commonly get canceled or forgotten, which is a key metric followed in the 6-hour bundle. It’s also true that, after controlling for case severity, most SEP-1 fallouts do not seem to have much worse mortality than do SEP-1 compliant cases (6). Again, we are not saying the game is fair; we are saying that if you lose the game that your institution might not look too favorably on it. The best solution here likely involves order-sets and reflex orders (not unlike a troponin) that takes the brain-power out of canceling labs or re-ordering things. 

Pearl #2: You do not have to flood your patients with fluid to succeed in the CMS metric.

There are 2 misconceptions when it comes to CMS and fluids in sepsis: (1) that fluids are harmful, and (2) that CMS does not allow you any way out of giving fluids.  

1: Fluids are OK for the most part, most of the time:

As far as big data goes, the 30 ml/kg fluid bolus seems pretty safe. In Seymour’s large survey of the New York State Database, it was pretty clear that the SEP-1 fluid bolus was uniformly well tolerated and did not contribute to death or adverse outcomes (3). In a separate study in the Keiser Permanente system, a large survey of sepsis cases found improved outcomes who received an initial 30 ml/kg bolus, especially when they had a history of CHF or end-stage renal disease (7). A very recent study also looked at patients in septic shock, which suggested that an association between vasopressor dose and mortality was only present when patients had not received an initial 1-2L of fluid to begin their resuscitation (8). That does not mean that a provider should surrender their autonomy when it comes to fluids…it just means that a fluid bolus upfront for most septic patients will not harm them. 

2: You can get out of flooding your patient. Just talk about it in your note. 

CMS has built in a few different ways you can minimize fluid administration in the setting of hypotension or lactic acidosis. 

  1. Remember, you only have to administer fluid if you believe their hypotension is new or if you think their lactate level >4 mmol/dL is indeed from sepsis. If the patient runs low, say that in your note. If they had a seizure or have liver failure and have a lactate of 5 at baseline, say that. Once you document the alternate cause, you are off the hook. 
  2. You can include pre-hospital fluids as well as the fluid used to deliver medications (like abx). Just document it. 
  3. You are allowed to reduce your 30 ml/kg IVF dose by 10% (in other words, if you write for 2L and they weigh 70kg, that’s ok). 
  4. You are allowed to dose your 30 ml/kg IVF dose based on ideal body weight if they are obese (BMI >30). You just have to document it. This is actually in line with evolving evidence and existing trials (9).
  5. If you really feel that giving fluid will be harmful or risky (for instance, end-stage CHF that you are not sure has sepsis AND they are a DNR/ DNI), you can document a conversation with the patient/ proxy. 

The Debrief

We are going to be doing a few more of these “Pearls and Pitfalls” for surviving CMS Sepsis measures. Again, these pieces are more about how to navigate and anticipate CMS case adjudication rather than ask the question of whether or not they should be done. Examples like the ones mentioned only scratch the surface of the headaches these core measures inflict, but unfortunately, the US government is not going to change this any time soon. Since the metrics are publicly reported and may soon be tied to hospital reimbursement or penalties, they also can’t simply be shrugged off. That said, there are ways through the nonsense so that you can BOTH get credit for doing the right thing AND provide good care to patients with sepsis.

References

  1. Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. 
  2. Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb SA, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including the Pediatric Subgroup. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med. 2013 Feb;41(2):580-637.
  3. Seymour CW, Gesten F, Prescott HC, Friedrich ME, Iwashyna TJ, Phillips GS, Lemeshow S, Osborn T, Terry KM, Levy MM. Time to Treatment and Mortality during Mandated Emergency Care for Sepsis. N Engl J Med. 2017 Jun 8;376(23):2235-2244.
  4. Angus DC, Barnato AE, Bell D, Bellomo R, Chong CR, Coats TJ, Davies A, Delaney A, Harrison DA, Holdgate A, Howe B, Huang DT, Iwashyna T, Kellum JA, Peake SL, Pike F, Reade MC, Rowan KM, Singer M, Webb SA, Weissfeld LA, Yealy DM, Young JD. A systematic review and meta-analysis of early goal-directed therapy for septic shock: the ARISE, ProCESS and ProMISe Investigators. Intensive Care Med. 2015 Sep;41(9):1549-60. 
  5. Sepsis CMS guidelines December 2018 update. https://www.qualityreportingcenter.com/globalassets/iqr_resources/032219/iqr_qa-transcript_sepv5.5a_vfinal508.pdf
  6. Rhee C, Filbin MR, Massaro AF, Bulger AL, McEachern D, Tobin KA, Kitch BT, Thurlo-Walsh B, Kadar A, Koffman A, Pande A, Hamad Y, Warren DK, Jones TM, O’Brien C, Anderson DJ, Wang R, Klompas M; Centers for Disease Control and Prevention (CDC) Prevention Epicenters Program. Compliance With the National SEP-1 Quality Measure and Association With Sepsis Outcomes: A Multicenter Retrospective Cohort Study. Crit Care Med. 2018 Oct;46(10):1585-1591.
  7. Liu VX, Morehouse JW, Marelich GP, Soule J, Russell T, Skeath M, Adams C, Escobar GJ, Whippy A. Multicenter Implementation of a Treatment Bundle for Patients with Sepsis and Intermediate Lactate Values. Am J Respir Crit Care Med. 2016 Jun 1;193(11):1264-70.
  8. Roberts RJ, Miano TA, Hammond DA, Patel GP, Chen JT, Phillips KM, Lopez N, Kashani K, Qadir N, Cairns CB, Mathews K, Park P, Khan A, Gilmore JF, Brown ART, Tsuei B, Handzel M, Chang AL, Duggal A, Lanspa M, Herbert JT, Martinez A, Tonna J, Ammar MA, Nazer LH, Heavner M, Pender E, Chambers L, Kenes MT, Kaufman D, Downey A, Brown B, Chaykosky D, Wolff A, Smith M, Nault K, Gong MN, Sevransky JE, Lat I; Observation of VariatiOn in fLUids adMinistEred in shock-CHaracterizAtion of vaSoprEssor Requirements in Shock (VOLUME-CHASERS) Study Group and SCCM Discovery Network. Evaluation of Vasopressor Exposure and Mortality in Patients With Septic Shock. Crit Care Med. 2020 Oct;48(10):1445-1453. 
  9. Taylor SP, Karvetski CH, Templin MA, Heffner AC, Taylor BT. Initial fluid resuscitation following adjusted body weight dosing is associated with improved mortality in obese patients with suspected septic shock. J Crit Care. 2018 Feb;43:7-12. doi: 10.1016/j.jcrc.2017.08.025. Epub 2017 Aug 15. PMID: 28823951.

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