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August 2016

Redefined Sepsis Affects Coding, Documentation
By Susan Chapman
For The Record
Vol. 28 No. 8 P. 10

Transitioning to the new definition touches virtually everyone across the health care continuum.

A leading cause of death in the United States, sepsis results in 750,000 fatalities each year. With annual treatment costs estimated to be $20 billion, sepsis tops the list of the most expensive conditions to treat. Because health care organizations have difficulty diagnosing the life-threatening complication in a timely way, individuals who develop the condition while in the hospital often experience treatment delays and subsequently poor outcomes.

The Society of Critical Care Medicine and the European Society of Intensive Care Medicine recently brought together a task force comprising experts in sepsis pathobiology, epidemiology, and clinical trials to generate new definitions and clinical criteria for sepsis and septic shock. International professional societies peer reviewed the group's findings before the definitions were finalized.

Since 2001, when the definitions for sepsis and septic shock were last amended, many advances have been made, which brought to light the need to reexamine those conditions and convene the task force. As reported in the communication "The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)," published in the February 23, 2016, issue of The Journal of the American Medical Association (JAMA), "Limitations of previous definitions included an excessive focus on inflammation, the misleading model that sepsis follows a continuum through severe sepsis to shock, and inadequate specificity and sensitivity of the systemic inflammatory response syndrome (SIRS) criteria. Multiple definitions and terminologies are currently in use for sepsis, septic shock, and organ dysfunction, leading to discrepancies in reported incidence and observed mortality."

In the previous SIRS model, patients were considered presenting with sepsis if they met two or more of the following criteria caused by infection:

• a body temperature greater than 100.4° F or less than 96.8° F;
• a heart rate greater than 90 beats/minute;
• a respiratory rate greater than 20 breaths/minute; and
• a white blood cell count greater than 12,000/mm3, less than 4,000/mm3, or greater than 0.5 K/uL bands.

The new recommendations, as reported in the JAMA article, are that "sepsis should be defined as a life-threatening organ dysfunction caused by dysregulated host response to infection," with septic shock being defined as "a subset of sepsis in which particularly profound circulatory, cellular, and metabolic abnormalities are associated with a greater risk of mortality than with sepsis alone." Additionally, based on the new definitions, the task force deemed the condition severe sepsis to be a redundant diagnosis.

Stephen Claypool, MD, medical director of clinical software solutions at Wolters Kluwer, believes one of the challenges associated with sepsis is the lack of a definitive diagnostic test. Instead, providers rely on the recommended criteria checklist. "It's a clinical diagnosis based on observation, infection, and how the patient is doing," he says. "But, for sepsis, survival is dramatically improved if it's caught and treated early with antibiotics and fluid. Under the old definition, when people had two SIRS abnormalities due to infection, they called it sepsis. However, other conditions also can cause SIRS. It's not isolated to just sepsis. Because of that, physicians have been reluctant to call SIRS-positive cases sepsis and, as a result, may not treat the condition in a timely fashion."

Claypool believes the sepsis-3 definition features criteria physicians can agree upon, which will help with documentation and incidence reporting. "One of the reasons for physicians pushing for the change has to do with the false-positives," he says. "The old definition was frequently incorrect. If electronic alerts were created with the old definition, it would result in false alerts in the EMR. With the new definition, when a patient meets criteria for sepsis, it will most often be an accurate case of sepsis without false-positives."

Impact on Coding
Because coders code based on what physicians document, the new definitions can present issues. "The description for sepsis with ICD coding is based upon the sepsis-2 definitions, not the new definition, so there are codes that represent sepsis based on SIRS criteria and severe sepsis for organ dysfunction," Claypool says. "If physicians write sepsis in the chart now using the new definition, it will correspond with the old definition's state of severe sepsis. So what should coders code? Should they code severe sepsis or sepsis? Some coding blogs advise coders to code sepsis by the new definition with severe sepsis based on organ dysfunction. But some coders may not code severe sepsis unless the physician explicitly writes 'severe.' This may lead to discrepancies in coding practice."

Roshan Shetty, MD, CCDS, CDIP, CCS, a physician advisor and vice president of clinical documentation improvement (CDI) services at Saince, believes the new sepsis and septic shock definitions create ambiguity between coding and clinical definitions. "The ICD-10 codes do not reflect what this new definition is stating," he says. "The new definition essentially eliminates the term 'severe sepsis.' Therefore, if you're going to use the new definitions, then you have to determine how to code them using the ICD-10 codes."

Kristi Repetto, BSN, CCDS, director of clinical documentation at Lee Memorial Health System in Fort Myers, Florida, disagrees. "We look to CMS [Centers for Medicare & Medicaid Services] for our coding guidelines. ICD-10 codes are not outdated as of yet, as CMS has not put anything out as a tool for the new ICD-10 codes or the sepsis bundling."

Judy Sturgeon, CCS, CCDS, clinical coding/reimbursement compliance manager at Harris Health System in Houston, clarifies that coders still need to know the same coding rules. "ICD-10 seems to have anticipated the new definition by removing the term SIRS from the presumption of sepsis: There must also be a clear diagnosis of sepsis in order to be reported as such," she says. "As more physicians embrace the new criteria, the effect on coding will be fewer reported cases of sepsis, but a greater percentage of those will be reported as severe sepsis. Hospital administrators will need to be aware that a shift in severity of illness or case mix index data may correspond to the new sepsis definition rather than to coding errors."

"Physicians didn't agree with the sepsis-2 definition, so they didn't use it," Claypool says. "Hospitals would try for years to have physicians use those definitions to help with coding and billing. But physicians would wait until the person was really ill before they would call the condition sepsis. A lot of problems over the last 15 years had to do with reporting. If physicians did call the condition sepsis, then that meant the hospital would have a high rate of sepsis.

"Now, some physicians will embrace the sepsis-3 definition while others will continue their pattern of diagnosis based on the sepsis-2 definition. Furthermore, since there will be inconsistencies in coding, there will be inconsistencies with coding that will cause billing and reporting problems. It will be difficult to compare sepsis rates from hospital to hospital and over time until there is uniformity across the country."

Claypool adds that some hospitals convinced physicians to document SIRS-positive patients as septic per the sepsis-2 definition even though they were only in a rule-out phase. Many of those patients ended up not having sepsis. "That meant that people were coded as sepsis even when they didn't have it," Claypool says. "With the new definition, when a physician documents sepsis, the patient will certainly have sepsis. However, this doesn't mean that SIRS-positive patients shouldn't be evaluated for sepsis. We may no longer label them as sepsis yet, but we should still start an evaluation and early treatment while we figure out if they have sepsis. We should label these patients as 'rule-out sepsis.'

"In this changing environment, we cannot forget early detection and treatment of ill patients," he continues. "It's fine to withhold diagnosing patients as sepsis until we're certain, based on sequential organ failure assessment (SOFA) definitions, but we cannot withhold treatment. It's fine to use the new definition of sepsis, but somebody needs to figure out how to code sepsis and code the rule-out stage."

Sturgeon adds, "It will be critical to document specifically when the patient's condition was, in fact, ruled out. Coding rules are language based, and if coders see a final diagnosis of 'rule out sepsis' it means this patient has possible sepsis. Consequently, if the chart still says 'rule out sepsis' at discharge with no further clarification in the chart, it can be coded as if it still exists."

Impact on CDI
Repetto says that although the new definitions have been reflected in core measures, the CDI team at Lee Memorial is not yet implementing any new strategies. "But, as I mentioned, we do require clear, defined rules from CMS to fall back on to make sure we're following their guidelines, and those have not been defined," she says.

"Just as they will coders, the new definitions will certainly affect CDI specialists," Shetty says. "It's going to be a challenge. The SIRS criteria came out about 15 years ago, and even today CDI specialists would query providers regarding SIRS. SIRS has fairly easy to remember criteria vs those of SOFA, which has six different criteria with scores ranging from 0 to 4. One of the biggest challenges for CDI departments will be educating providers."

Repetto believes updated guidelines from CMS will benefit coders and CDI staff "because CDI and the coding department always work hand in hand. Once new guidelines are provided and implemented, both areas will need to be educated on what those new rules and regulations are. That might mean we would have to update our query questions based on those guidelines and, most importantly, we would have to update the physicians once those regulations are updated."

She notes that whenever there are changes to CMS guidelines, the information gets disseminated into the system. "When we query under new guidelines, the goal is not to simply be sending questions—it's to help educate everyone and create smart tools that will benefit the organization in the long run," she explains.

Shetty and his team advise clients to set a standard for validating sepsis, determine when they plan to adopt the new definitions, and ascertain how documentation flow will evolve. "We advise our clients to work collaboratively among physician leadership, the CDI team, and HIM to develop facility-specific definitions and establish an in-house query policy for sepsis," he says. "For instance, SIRS is still a codable diagnosis in ICD-10; do you still want your CDI staff to query providers when SIRS is present? Facilities should also expect to review and adapt these policies as we get more coding guidance from the cooperating parties (AHIMA, CMS, the American Hospital Association, and the National Center for Health Statistics). This will be an evolving process, and CDI departments will need to work closely with physicians and medical staff in educating them on the new definitions and guidelines."

Quality Measure Reporting
Inpatient quality reporting must follow specifications and guidelines for each quality measure based on predetermined bundles. "What that means is when you have a patient with severe sepsis, for example, you have a protocol to follow, steps you need to take," Shetty explains. "You have to draw cultures and give antibiotics within three hours, for instance. If the new definition is what everyone is reporting, then quality measures and reporting will have to adjust as well. Maybe they just have to change the terminology from severe sepsis to sepsis. That is something that needs to be addressed. Guidance is needed from those quality programs. Abstractors will need to know what sepsis criteria to follow when reviewing documentation on hospital adherence of these measures."

Shetty also notes that many EMRs feature SIRS and sepsis alerts that let physicians know when a patient may be presenting with the conditions based on labs and vitals that follow the SIRS criteria. "Those alerts are just one of many components that will need to be evaluated as we move forward with sepsis-3," he says.

Claypool doesn't expect the new definition to change the act of reporting, but it still may cause headaches. "The impact is that there probably won't be an impact," Claypool argues. "The National Quality Forum measure is very clear: Hospitals will still have to expend energy according to the sepsis-2 definition and report to CMS. What will change is increased confusion for hospitals that grapple with two definitions. Physicians may use the new definitions, but the hospitals will use the old ones to report to CMS. They will have to go back to physicians to query what they meant in the record, which will be onerous and challenging for some facilities. Still, the reporting won't change … for now."

Other Efforts to Improve Outcomes
Because sepsis and septic shock are enormous health issues, physicians and researchers continue to study how best to treat the conditions. Part of that effort involves taking advantage of HIT. For example, Claypool and Sharad Manaktala, MD, PhD, recently implemented a sepsis improvement program at Huntsville Hospital in Alabama that utilized change management, an electronic surveillance system, and decision support delivered via a mobile application.

The researchers noted in their paper, "Evaluating the Impact of a Computerized Surveillance Algorithm and Decision Support System on Sepsis Mortality," published in the Journal of the American Medical Informatics Association, "The observed coding of sepsis diagnoses by ICD-9 coding in the study units was 116 cases per 100 hospital days during the control period, compared to 151 cases per 100 hospital days while the electronic sepsis surveillance system was in place. The sepsis-related mortality rate was 90 deaths per 1,000 cases of sepsis during the control period, compared to 42 deaths per 1,000 sepsis cases during the study phase, amounting to 53% fewer deaths per 1,000 cases after the electronic sepsis surveillance system was implemented."

At the conclusion of the study Manaktala and Claypool wrote, "We observed a significant improvement in sepsis-related quality metrics, including decreased mortality and decreased 30-day readmissions, using a triad of change management, electronic surveillance with highly sensitive and specific alerting rules, and decision support delivered to the point of care." The pair recommended the results be externally validated in larger, more varied patient populations.

"In my opinion, the early detection of sepsis, screening, and treatment is still really important," Claypool says. "We want to catch sepsis patients as early as possible and treat them. The definition may not matter as much as long as physicians are screening and treating patients early enough. What I propose in order to achieve that is that we still use the SIRS-based screening process—we don't need to call the condition sepsis, but treat patients as having sepsis and do the work-up for that. If it becomes life-threatening, then we can say definitively that they have sepsis and then rule out sepsis if they don't ever present with it."

Claypool notes that the same process is followed in emergency departments with suspected heart attacks. "We do a 'rule-out heart attack' when a person arrives with chest pain," he says. "We need to do the same with sepsis. It would be completely unacceptable to wait. The terms may change, but care and treatment should remain the same."

— Susan Chapman is a Los Angeles-based writer.