Date amended:
External
Statements of Principles
Current RMA Instruments

Reasonable Hypothesis SOP

9 of 2026

Balance of Probabilities SOP

10 of 2026
Changes from previous Instruments
 
ICD Coding
  • ICD-10-AM Codes: B16, B18.0, B18.1
Brief description

Hepatitis B is an infection of the liver caused by the hepatitis B virus (HBV). The infection results in hepatic inflammation and may present as an acute or chronic illness. Acute infection may cause fever, fatigue, nausea, abdominal discomfort, or jaundice. Chronic infection- defined as infection persisting for at least six months- may be asymptomatic or associated with ongoing hepatic inflammation and, over time, fibrosis. 

This SOP covers acute symptomatic hepatitis B infection and chronic hepatitis B infection (symptomatic or asymptomatic). It does not cover individuals who have a transient, subclinical (symptoms are absent or not noticeable) acute infection that resolves without progression to chronic disease. 

Confirming the diagnosis

Diagnosis of hepatitis B infection requires laboratory confirmation of hepatitis B serological or nucleic acid markers. 

Acute hepatitis B infection:

Acute infection must be accompanied by a clinical illness consistent with acute viral hepatitis, together with laboratory evidence of acute HBV infection. 

  • Positive serology for acute infection:
    • HBsAg positive
    • Anti-HBc positive
    • IgM anti-HBc positive
    • Anti-HBs negative

Chronic hepatitis B infection:

Chronic infection is confirmed when HBV infection persists for at least six months, supported by repeated laboratory testing. 

  • Positive serology for chronic infection:
    • HBsAg positive
    • Anti-HBc positive
    • IgM anti-HBc negative
    • Anti- HBs negative
Additional diagnoses covered by SOP
  • Chronic inactive HBV infection ("carrier state")
  • Chronic active HBV infection
  • Acute hepatitis B evolving into chronic hepatitis B
Conditions not covered by SOP
  • Hepatitis A *
  • Hepatitis C *
  • Hepatitis D *
  • Hepatitis E *
  • Subclinical acute hepatitis B infection that does not progress to chronic hepatitis B infection

* Another SOP applies

Clinical onset

For acute hepatitis B infection, clinical onset is the earliest time at which symptoms of acute viral hepatitis- such as fever, tiredness, loss of appetite, nausea, vomiting, abdominal discomfort or jaundice- first appeared, subsequently confirmed to be due to HBV infection. 

For chronic hepatitis B diagnosed without a recognised acute symptomatic phase, clinical onset is the date on which HBV infection was first confirmed by pathology testing. Laboratory testing confirmation usually occurs after the clinical onset. 

Clinical worsening

Clinical worsening refers to deterioration beyond the expected natural course of HBV infection. This includes:

  • progression from acute to chronic hepatitis B infection
  • reactivation of previously inactive chronic infection
  • a flare-up of chronic hepatitis B with rising viral activity or hepatic inflammation

Management depends on disease phase and severity. Antiviral therapy may reduce viral replication and the risk of long-term complications. Assessment by an infectious diseases physician or hepatologist/gastroenterologist is recommended when considering whether true clinical worsening has occurred.