Ask The Appeal Experts
By Nina Youngstrom
When Erica Remer, M.D., was a young physician, the way she knew a patient with an infection had sepsis was “you walked into the room and got the sinking feeling the person would die from this infection.” As she got older, more formal protocols for diagnosing sepsis were developed, notably Sepsis-2, and more recently, Sepsis-3, which mandated the presence of organ dysfunction. But they’re more than clinical tools to help detect sepsis. The tug of war between Sepsis-2 and Sepsis-3 is at the heart of Medicare Advantage and other payer claim denials. The plans may downcode MS-DRGs unless patients have all the hallmarks of Sepsis-3, which some hospitals and physicians feel leaves too many cases out. They may stick with Sep-2, although there is movement toward Sep-3, experts say.
Remer thinks the payers are right for a change, although Sepsis-3 is more restrictive. “The sine qua non of sepsis is organ dysfunction,” she said.
But it’s a complicated and expensive picture because sepsis is probably the top diagnosis of clinical validation, said Denise Wilson, senior vice president of PayerWatch in Towson, Maryland. “Sep-3 made it a lot easier for the payers to pick that as a target.” The downcoding driven by Sepsis-3 continues to be “a pervasive problem” nationally, said Jolene Calla, vice president of health care finance and insurance at the Hospital and Healthsystem Association of Pennsylvania (HAP). She said the protocol was never meant to be a basis for payment.
Sepsis-2 is defined by the presence of systemic inflammatory response syndrome (SIRS) plus infection, according to the Society of Critical Care Medicine’s (SCCM) 1991 consensus definition, known as Sepsis-1, which continued with its 2001 Sepsis-2 definition and remained through 2015. In 2016, SCCM’s Sepsis Definitions Task Force published Sepsis-3, which defines sepsis as “life-threatening organ dysfunction caused by a dysregulated host response to infection.” They recommended the use of sequential organ failure assessment (SOFA) scores to determine organ dysfunction.
“I see more physicians including the diagnosis of sepsis in the medical records when the clinical criteria meets Sep-3,” Wilson said. “There are still a lot of physicians who are diagnosing sepsis if it’s SIRS plus infection, but it’s swinging the other way.” She emphasized that when patients have SIRS plus infection, providers should consider and treat sepsis before it advances to organ dysfunction “but for billing and payment, payers are looking for Sepsis-3.”
Sepsis-3 makes sense to Remer. “I realized, when I use to walked into the patient’s room, the organ dysfunction was what I was picking up on,” like respiratory distress, said Remer, president of Erica Remer, MD, Inc. in Ohio. “It indicated to me they were sicker than the average person with the same underlying infection.”
However, none of these criteria are required (except in New York state, which mandates the use of Sepsis-2). “It’s the progression from any infection, so there’s no gold standard test for it,” Remer said. And that’s why some hospital experts are troubled by clinical validation and the way that MA plans and other commercial payers downcode claims when the medical records show the diagnosis is based on Sepsis-2.
“Sepsis is a hot mess,” said Stephanie Van Zandt, M.D., medical director of physician advisor services at a large health system in Florida. “We are getting blowback from the insurance companies because they want to do a validation based on the fact they don’t think there’s sepsis. They define it as only Sep-3, but we say there’s Sep-2. That’s where we start arguing about ICD-10. They say there’s only severe sepsis and septic shock.”
‘We Still Use the Same Resources to Treat It’
Any cases coded only as ICD-10 code A41.9 won’t be paid as sepsis, even though it’s the code for sepsis, unspecified organism, because the code tracks to Sepsis-2, Van Zandt said. The MA plans require R65.20 (severe sepsis) and R65.21 (severe sepsis with septic shock), which they say corresponds to Sepsis-3, Van Zandt explained. She said that’s a contrived reason for denials coming from third-party auditors hired by the payers. “We are using SIRS plus infection equals sepsis—that’s Sep-2,” Van Zandt said. “When we go to appeal it, they say clinically, it’s not sepsis, even though doctors coded it. Anything with A41.9 will get flagged,” she said. But the claims are flagged by coders, not clinicians, creating an inappropriate mix of clinical and DRG validations. “We appeal and don’t get a professional answer back,” she said.
Remer commented that “you can’t have A41.9 without the two other codes.”
Payers also flag inpatient claims for sepsis associated with a short hospital stay, Van Zandt said. “People feel you can’t be septic if you stayed a short period of time, so we are getting denied these cases” even when patients stay two midnights. That should change starting Jan. 1, when the 2024 rule on policy and technical changes to the MA program takes effect.[1] It requires MA plans to abide by traditional Medicare’s inpatient coverage criteria, including the two-midnight rule.
Van Zandt thinks the rule will help with MS-DRG payments patients with sepsis but predicts resistance from MA plans. “We still use the same resources to treat it,” she noted. The trigger goes off in the emergency department, the sepsis protocol takes effect, and “we still have to report it to CMS” under the inpatient quality reporting program (which is based on Sepsis-2). In fact, some physicians expressed concern in a 2021 CMS report that there might be missed opportunities to intervene early under Sepsis-3.[2]
“Since MA plans started using Sep-3 to deny and downcode sepsis claims, there has been pushback, mostly because Sep-3 is not universally accepted from a clinical perspective and CMS requires Sep-2 from a clinical perspective and rejected Sep-3 when asked about this,” Calla noted.
The MA rule and a recent administrative law judge (ALJ) opinion overturning a hospital’s malnutrition claim denials may empower hospitals in their appeals of clinical validation denials, whether it’s sepsis, malnutrition, respiratory failure or other diagnoses, said Richelle Marting, an attorney and coder in Olathe, Kansas.[3] The rule reinforced that MA plans “may only apply coverage criteria that are no more restrictive than Traditional Medicare coverage criteria found in NCDs, LCDs, and Medicare laws.” That means if MA plans are going to adopt criteria for diagnosing malnutrition, they must be based on widely used treatment guidelines or clinical literature and they have to be publicly accessible, she noted. In the malnutrition appeal, the ALJ called the criteria “nebulous” at best. The ALJ also gave considerable deference to physicians’ medical judgment as part of his decision to overturn Vidant Health’s audit findings and agreed that auditors “applied unpromulgated rules” in deciding the patients whose medical records were reviewed didn’t have severe malnutrition. Marting said the same logic applies to sepsis.
HAP Is Asking CMS for Clarity
In light of the MA rule, Calla thinks there’s an argument to be made that if CMS uses Sep-2, MA plans should do the same. “We have been talking to the American Hospital Association” and CMS regional office, which she said is “taking it to its policy team for further consideration. It would be helpful if regulators came out with clear guidance and put this to rest. This is something we hope to get clarity on. It’s causing a lot of frustration.”
Regardless of whether physicians and hospitals follow Sepsis-2 or Sepsis-3, “The only way to diagnose sepsis is by clinical judgment. You have SOFA and SIRS, but when push comes to shove, it’s clinical judgment,” Remer said. “If you think the patient has sepsis, you need to treat them aggressively and try to save their lives.”
As for the payers, good documentation is the best defense, Remer said. She recommends physicians use a macro in electronic health records that states “sepsis due to [infection] with acute sepsis-related organ dysfunction as evidenced by [organ dysfunction].” For example, if they document sepsis due to urinary tract infection with organ dysfunction as evidenced by acute kidney injury, encephalopathy and acute hypoxemia, “it’s hard for a payer to say, ‘we don’t really think this was sepsis,’” Remer explained. It accomplishes two things in terms of the physicians: “It makes the doctors think, ‘do I have the pieces and parts for sepsis?’ And it expresses it to the insurance company and other clinicians that this is how I’m synthesizing this patient’s hospital presentation.”
Is Sepsis 2.5 Project a Compromise?
There may be some compromises coming. The Sepsis 2.5 project could be one of them. According to the Society of Critical Care Magazine, “the Sepsis-2.5 project was a cooperative effort between a hospital system and a private payer to develop a community-based, literature-supported consensus definition for sepsis characterized by the presence of clinical illness, a source of infection, and evidence of organ dysfunction. This new definition (‘Sepsis-2.5’) has been instrumental in resolving provider-payer conflicts in defining clinical sepsis and reimbursing care.”[4]
The Centers for Disease Control and Prevention (CDC) also just announced Hospital Sepsis Program Core Elements: 2023, and “they are using the definition of Sepsis-3,” Remer noted.[5] Getting more people on board is a combination of physicians and their institutions “and it’s hard to change that trajectory.”
Contact Remer at eremer@icd10md.com, Van Zandt at stephanie.vanzandt@baycare.org, Wilson at dwilson@payerwatch.com and Marting at rmarting@richellemarting.com.
1 Medicare Program; Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly, 88 Fed. Reg. 22,120 (June 5, 2023), https://bit.ly/3CH7TmX.
2 Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, Summary of Sepsis Technical Expert Panel (TEP) Evaluation of Measures: Patient Safety Measure Development and Maintenance, May 25, 2021, version 2, https://go.cms.gov/44PzjCI.
3 Nina Youngstrom, “ALJ Overturns All Malnutrition Denials in Hospital Appeal; CMS Has ‘No Official Policy,’” Report on Medicare Compliance 32, no. 26 (July 24, 2023), https://bit.ly/3YjxEDB.
4 Howard Rodenberg et al., “Sepsis-2.5: Resolving Conflicts Between Payers and Providers,” Critical Care Explorations 5, no. 9 (September 2023), https://bit.ly/3Lou5qm.
5 Centers for Disease Control and Prevention, Hospital Sepsis Program: Core Elements: 2023, https://bit.ly/3PfyjC1.