Beginning July 1, 2021, United Healthcare (“UHC”) will begin reviewing Medicare Advantage and commercial claims for sepsis-related treatment on a pre-payment basis and post-payment basis. Previously, UHC only reviewed sepsis-related claims on a post-payment basis. Payer policy changes, such as this, can have a lasting impact on a hospital system’s revenue cycle and it’s important to be knowledgeable about updates, changes, and potential repercussions.
This article includes an overview of UHC’s sepsis-related treatment clinical review, procedural arguments against the application of Sepsis-3 criteria, and revenue cycle mitigation steps to tackle denials and boost appeal resolution for sepsis-related claims.
UHC Clinical Review Overview
UHC will conduct patient medical records reviews to validate the presence of sepsis under the Sepsis-3 guidelines adopted by UHC. When a review is deemed necessary, UHC will send a letter to the provider requesting more information, associated instructions, and the deadline for requested records. Interestingly, UHC has not specified whether services will be denied or adjusted, or whether a corrected claim will be needed should UHC find that sepsis was not validated.
Clinical Criteria for Sepsis-3
The UHC policy cites the adoption of the Third International Consensus definition for sepsis and sepsis shock (“Sepsis-3”). The Sepsis-3 definition offers a higher bar than the previous version, including Systemic Inflammatory Response Syndrome (SIRS) criteria, which has been adopted by CMS. The Sepsis-3 definition states, “Sepsis should be defined as life-threatening organ dysfunction caused by a dysregulated host response to infection [suspected or confirmed].” 1
Utilizing the clinical definition, Sepsis-3 indicates:
“Organ dysfunction can be represented by an increase in Sequential [Sepsis-related] Organ Failure Assessment (SOFA) score of 2 points or more, which is associated with an in-hospital mortality greater than 10%. Septic shock should be 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. Patients with septic shock can be clinically identified by the 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/dL0 in the absence of hypovolemia.” 2
As noted previously, the Third International Sepsis Consensus Definitions (Sepsis-3) requires an acute change of more than 2 sepsis-related organ dysfunction assessments (SOFA) and known or suspected infection. The clinical indicators used to identify patients with sepsis include:
- Respiratory Rate >=22/min
- Altered mental state
- Systolic blood pressure <=100 mmHg
- Lactate level > 2 mmol/L
- Fever >100.4 F
- Heart Rate > 90 bpm
SOFA looks at 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.
Ultimately, the Sepsis-3 definition structure does not clearly identify patients in the early stages of sepsis where rapid resuscitation provides the greatest patient benefit and improves survival. This places hospitals in a difficult position as cases of “sepsis” without organ dysfunction can progress to severe sepsis with organ dysfunction or septic shock. The Sepsis-3 definition fails to recognize this very scenario and therefore, does not appear to contemplate the imperatives of early recognition, detection, and treatment of sepsis.
Procedural Arguments Against the Application of Sepsis-3 Criteria
Since many healthcare providers have not adopted Sepsis-3 criteria, there is bound to be an influx of sepsis clinical validation denials when the pre-payment audits begin. CMS has published a response, indicating that, “the existing sepsis definitions, including the use of SIRS criteria, have been instrumental in training clinicians and nurses on how to best identify patients in the early stages of sepsis.”
Furthermore, “the Sepsis-3 definition structure does not clearly identify patients in the early stages of sepsis where rapid resuscitation provides the greatest patient benefit and improves survival. A change to the existing definition could disrupt the 15-year trend toward further reduction in sepsis mortality.”
As CMS is the largest payer of healthcare services in the country, the CMS guidelines can be used to establish “generally accepted medical practices.” Additional arguments providers should contemplate when arguing against the application of Sepsis-3:
- Authors of Sepsis-3 continue to report that this criterion is not an ideal screening tool.
- SIRS has been operationalized and led to a proven reduction in mortality.
- Sepsis-3 criteria are not routinely measured outside the critical care environment; thus, it is nearly impossible to operationalize the identification of septic patients at the earliest possible time.
- Sepsis-3 criteria have been specifically rejected by:
- The America College of Chest Physicians
- The American College of Emergency Physicians; and
- The Infectious Disease Society of America
Arguments can also be made against a retro-active diagnosis by a Non-Treating Physician:
- Diagnosing a patient’s condition is solely the responsibility of the provider. Only the physician, or other qualified healthcare practitioners legally accountable for establishing the patient’s diagnosis, can ‘diagnose’ the patient. 3
- Sepsis-3 definitions are inconsistent with ICD-10-CM Official Guidelines for Coding and Reporting (OCG). OCG clearly distinguishes between sepsis with organ dysfunction and sepsis without organ dysfunction. If hospitals begin reporting only cases of sepsis with organ dysfunction and no cases of sepsis without organ dysfunction, it will disrupt all processes related to coding, reimbursement, and oversight on sepsis.
Hospitals should consider drafting template appeals that cite each hospital’s own accepted clinical criteria and resources that support those criteria for those commonly denied diagnoses codes flagged by payers for clinical validation reviews.
Impact on Hospital Revenue Cycle & Mitigation Steps
Implementation of the UHC policy will have a negative impact on hospitals. First, hospitals will experience an increased influx of clinical validation denials for sepsis. Second, in the event UHC finds sepsis is not present, UHC has not indicated whether they will (i.) adjust and reduce reimbursement or (ii.) deny the claim outright with a request for a complete corrected claim.
Hospitals will have a significant financial decision on their hands:
- If UHC denies claims outright with a corrected claim requested, and a hospital complies, they rescind their ability to fight the sepsis denial.
- If the hospital refuses to comply with the submission of a corrected claim because they intend to fight the sepsis denial, they could lose out on all reimbursement from the patient stay.
To mitigate the impact of UHC’s new policy, hospitals should explore the following:
- Review and adopt internal clinical criteria as an organization for commonly denied and high visibility diagnosis codes. Work with various departments internally to assist in developing and reviewing such criteria (Nutrition department, Nephrology, etc.).
- Review your state’s ability to appeal clinical validation denials to an Independent Review entity (“IRE”) or agency.
- Utilize technology to send alerts when certain clinical criteria are found in the record. For example, a sepsis alert might deploy when patient temperature > 101 and respiratory rate > 22.
- Utilize technology to track clinical validation denials by diagnosis and glean financial impact to determine next steps and to utilize during contract negotiations.
- Review the hospital’s managed care contracts with the legal and compliance departments and create a matrix that cites to various applicable provisions related to DRG validations and audits. During contract negotiations, contemplate negotiating for the adoption of specific agreed-upon criteria for each diagnosis.
To learn more about UHC’s new pre-payment review policy for sepsis clinical validations, please reach out to us at email@example.com.
1 See Singer M, Deutschman CS, Seymour C, et al. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016; 315:801-10. [PMID: 26903338] doi:10.1001/jama.2016.0287.
3 ICD-10-CM Official Guidelines for Coding Reporting FY 2019, Section II. Selection of Principal Diagnosis.