Q&A: Clinical validation of sepsis and clinical criteria

Q: Do you have any suggestions for when a clinical validation query is sent for sepsis asking for additional supporting documentation if ruled in? We are seeing providers rule sepsis in as a valid diagnosis, but they do not provide additional supporting documentation. We seem to be having a lot of queries that are answered like this so sepsis gets coded without supporting documentation.

A: This is an excellent question and one that you are not alone in as many CDI specialists have asked the same question. Before I discuss sepsis, let’s briefly look at the role of clinical validation and the False Claims Act (FCA).

Clinical validation is a process by which documentation is evaluated to ensure that the medical record demonstrates enough clinical support for all documented diagnoses as mandated by the FCA. If there is a lack of clinical support for sepsis within the documentation, a clinical validation query should be sent. Query choices should list sepsis as ruled out versus ruled in (because the provider is documenting sepsis), but the query choice should also ask the provider to provide additional clinical support within the medical record. Additional query choices that are supported by clinical indicators listed on the query should also be listed as appropriate. An important goal in CDI is to ensure that anyone reading the medical record after discharge will come to the same conclusion(s) as the provider(s).

The FCA, 31 U.S.C. §§ 3729 - 3733, is a federal statute housed within the Social Security Act, which ultimately prohibits billing for services that weren’t provided, including billing for medical services. To support that services were provided as billed, documentation must demonstrate that there is sufficient clinical support for all conditions listed on the final billing summary.

The 2011 RAC Statement of Work manual also supports this direction by the FCA as it states that “all conditions billed on the final bill submitted to CMS for payment must be clinically valid.” Therefore, the focus must be on the documentation and the strength of clinical support for any given condition that’s documented within the medical record.

Now let’s turn our attention to sepsis in particular. It is no secret that sepsis is the number one denied diagnosis in the nation. Additionally, based on the questions we receive regarding sepsis and clinical validation, it does not seem that in most cases, the denial rate for sepsis is improving. I believe, however, that there is something important for facilities and providers alike that is possibly overlooked which could be one of the reasons that providers are failing to offer additional documentation of supporting criteria for sepsis when requested on a clinical validation query.

According to the National Institutes of Health (NIH), “many symptoms associated with sepsis, such as fever and difficulty breathing, mimic or mask other conditions, making sepsis hard to diagnose in its early stages.”

Unfortunately, we often see the overuse of the diagnosis rather than a lack of use since most providers are fearful of missing the diagnosis because the result of not treating a case of potential sepsis could literally mean the death of the patient. Therefore, could one of the reasons for the lack of supporting clinical documentation be that a patient is treated prophylactically and there is perhaps no additional data to add?

The terms “prophylactic or empirical” do not imply a definitive diagnosis is being treated but rather the provider is treating the patient to prevent a diagnosis from occurring. According to Merriam-Webster dictionary, prophylactic means “guarding from or preventing the spread or occurrence of disease or infection.” Therefore, anyone who submits a clinical validation query for sepsis should consider the option of prophylactic or empiric treatment as a valid choice for those cases with little to no clinical support in the medical record.

Let’s look at a potential query example:

Dear Dr. Smith:

This 50-year-old female patient with a history of hypertension was admitted for sepsis due to pneumonia per the history and physical. Per the ED chief complaint, “the patient stated symptoms of shortness of breath, productive cough, lethargy, and a lack of PO intake brought the patient to the hospital.” Trended vital signs on admission were temperature 37.5-38.0, heart rate 84-92, respiratory rate 14-16, blood pressures range from 132/94 to 138/96, oxygen saturation levels trending at 94-97% on room air. Blood and sputum cultures are inconclusive for a specific microorganism. Procalcitonin was 0.03, Lactic acid 1.0. There is no evidence of a provider order for bilirubin or CRP to date for this encounter. In the ED, 500cc of NS was given as an IV fluid bolus which was followed by NS at 50cc/hr. Admission orders reveal Vancomycin 1gm IV q12 hrs. and Zosyn, 3.375mg IV q8hrs. for which the patient received according to the medication administration record.

Based on the above clinical criteria, do any of the following apply:

• Treating sepsis prophylactically

• Sepsis is a valid diagnosis—please provide additional supporting criteria in the progress notes

• Sepsis is ruled out, treating for pneumonia only

• Other, please specify

CDI specialists should discuss prophylactic treatment for sepsis with providers to determine how they view this scenario. If a provider is treating a patient prophylactically and selects this as an option on a clinical validation query, denial rates could reduce for facilities as conditions being treated prophylactically should not be coded. Also, collaborate with the coding professionals at your facility to discuss prophylactic treatment so everyone involved has the same understanding. Remember, accurate and consistent documentation is the cornerstone to overcome denial rates and that would also include when a provider is treating sepsis prophylactically.

Editor’s note: Dawn Valdez, RN, LNC, CCDS, CDIP, CRC, CDI education specialist at HCPro/ACDIS, which is based in Middleton, Massachusetts, answered this question. Contact her at dvaldez@hcpro.com.