{"id":"F2022L01121","name":"Statement of Principles concerning steatohepatitis (Balance of Probabilities) (No. 87 of 2022)","slug":"statement-of-principles-concerning-steatohepatitis-balance-of-probabilities-no-87-of-2022","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":441497,"registerId":"F2022L01121-fast-fetch-1775956780942","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Statement of Principles concerning steatohepatitis (Balance of Probabilities) (No. 87 of 2022)","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\nmeta-generator: Aspose.Words for .NET 22.10.0\n---\n\n?xml version=\"1.0\" encoding=\"utf-8\" standalone=\"no\"?>\n\n\n\n \n\nStatement of Principles\n\nconcerning\n\nSTEATOHEPATITIS (Balance of Probabilities)\n\n(No. 87 of 2022)\n\nThe Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(3) of the Veterans' Entitlements Act 1986.\n\n \n\nDated 23 August 2022.\n\n \n\n \n\n \n\n \n\n \n\n| The Common Seal of the Repatriation Medical Authority was affixed to this instrument at the direction of:
|\n| --- |\n|
Professor Terence Campbell AM
Chairperson
|\n\n\n \n\n \n\n\nContents\n\n1 Name\n\n2 Commencement\n\n3 Authority\n\n4 Repeal\n\n5 Application\n\n6 Schedules\n\n7 Kind of injury, disease or death to which this Statement of Principles relates\n\n8 Basis for determining the factors\n\n9 Factors that must exist\n\n10 Relationship to service\n\n11 Factors referring to an injury or disease covered by another Statement of Principles\n\nSchedule 1 - Dictionary\n\n1 Definitions\n\nSchedule 2 - Drugs\n\n1 Specified drugs\n\n \n\n\n\n\n1 Name\n\nThis is the Statement of Principles concerning steatohepatitis (Balance of Probabilities) (No. 87 of 2022).\n\n2 Commencement\n\n This instrument commences on 19 September 2022.\n\n3 Authority\n\nThis instrument is made under subsection 196B(3) of the Veterans' Entitlements Act 1986.\n\n4 Repeal\n\nThe Statement of Principles concerning steatohepatitis No. 80 of 2013 (Federal Register of Legislation No. F2013L01900) made under subsection 196B(3) of the VEA is repealed.\n\n5 Application\n\nThis instrument applies to a claim to which section 120B of the VEA or section 339 of the Military Rehabilitation and Compensation Act 2004 applies.\n\n6 Schedules\n\nAny item in a Schedule to this Instrument has effect according to its terms.\n\n7 Kind of injury, disease or death to which this Statement of Principles relates\n\n(1) This Statement of Principles is about steatohepatitis and death from steatohepatitis.\n\nMeaning of steatohepatitis\n\n(2) For the purposes of this Statement of Principles, steatohepatitis:\n\n(a) means the presence of fatty change and inflammation of the liver with hepatocyte injury, with or without fibrosis; and\n\n(b) includes alcoholic steatohepatitis and non-alcoholic steatohepatitis; and\n\n(c) excludes:\n\n(i) alpha-1 antitrypsin deficiency;\n\n(ii) biliary obstruction;\n\n(iii) haemochromatosis; and\n\n(iv) Wilson's disease.\n\nDeath from steatohepatitis\n\n(3) For the purposes of this Statement of Principles, steatohepatitis, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's steatohepatitis.\n\nNote: terminal event is defined in the Schedule 1 – Dictionary.\n\n8 Basis for determining the factors\n\nOn the sound medical‑scientific evidence available, the Repatriation Medical Authority is of the view that it is more probable than not that steatohepatitis and death from steatohepatitis can be related to relevant service rendered by veterans or members of the Forces under the VEA, or members under the MRCA.\n\nNote: MRCA, relevant service and VEA are defined in the Schedule 1 – Dictionary.\n\n9 Factors that must exist\n\nAt least one of the following factors must exist before it can be said that, on the balance of probabilities, steatohepatitis or death from steatohepatitis is connected with the circumstances of a person's relevant service:\n\n(1) having diabetes mellitus at the time of the clinical onset of steatohepatitis;\n\n(2) being obese at the time of the clinical onset of steatohepatitis;\n\nNote: being obese is defined in the Schedule 1 – Dictionary.\n\n(3) having rapid weight loss causing protein-calorie malnutrition within the 18 months before the clinical onset of steatohepatitis;\n\nNote: rapid weight loss is defined in the Schedule 1 – Dictionary.\n\n(4) undergoing jejunoileal bypass surgery before the clinical onset of steatohepatitis;\n\n(5) receiving total parenteral nutrition for at least 6 months within the 1 year before the clinical onset of steatohepatitis;\n\nNote: total parenteral nutrition is defined in the Schedule 1 – Dictionary.\n\n(6) having dyslipidaemia at the time of the clinical onset of steatohepatitis;\n\nNote: dyslipidaemia is defined in the Schedule 1 – Dictionary.\n\n(7) for males, consuming at least 75 kilograms of alcohol within any 5 year period before the clinical onset of steatohepatitis;\n\nNote: Alcohol consumption is calculated utilising the Australian Standard of ten grams of alcohol per standard alcoholic drink.\n\n(8) for females, consuming at least 40 kilograms of alcohol within any 5 year period before the clinical onset of steatohepatitis;\n\nNote: Alcohol consumption is calculated utilising the Australian Standard of ten grams of alcohol per standard alcoholic drink.\n\n(9) taking irinotecan for at least the 30 days before the clinical onset of steatohepatitis;\n\n(10) taking a drug specified in the Schedule 2 - Drugs of this Instrument, that cannot be ceased or substituted, for at least the 30 days before the clinical onset of steatohepatitis;\n\n(11) taking a drug that cannot be ceased or substituted and which is associated in the individual with:\n\n(a) the development of steatohepatitis within 30 days of first taking the drug; and\n\n(b) the redevelopment of steatohepatitis on rechallenge with the same drug;\n\n(12) inability to obtain appropriate clinical management for steatohepatitis.\n\n10 Relationship to service\n\n(1) The existence in a person of any factor referred to in section 9, must be related to the relevant service rendered by the person.\n\n(2) The factor set out in subsection 9(12) applies only to material contribution to, or aggravation of, steatohepatitis where the person's steatohepatitis was suffered or contracted before or during (but did not arise out of) the person's relevant service. \n\n11 Factors referring to an injury or disease covered by another Statement of Principles\n\nIn this Statement of Principles:\n\n(1) if a factor referred to in section 9 applies in relation to a person; and\n\n(2) that factor refers to an injury or disease in respect of which a Statement of Principles has been determined under subsection 196B(3) of the VEA;\n\nthen the factors in that Statement of Principles apply in accordance with the terms of that Statement of Principles as in force from time to time.\n\n \n\n \n\nSchedule 1 - Dictionary \n\nNote: See Section 6\n\n1 Definitions\n\nIn this instrument:\n\n being obese means:\n\n(a) having a Body Mass Index (BMI) of 30 or greater; or\n\n(b) for males, having a waist circumference exceeding 102 centimetres; or\n\n(c) for females, having a waist circumference exceeding 88 centimetres.\n\nNote: BMI is also defined in the Schedule 1 - Dictionary.\n\n BMI means W/H2 where:\n\n(a) W is the person's weight in kilograms; and\n\n(b) H is the person's height in metres.\n\n dyslipidaemia means persistently abnormal blood lipid levels, diagnosed by a medical practitioner and evidenced by:\n\n(a) a serum high density lipoprotein cholesterol level less than 1.0 mmol/L; or\n\n(b) a serum low density lipoprotein cholesterol level greater than 4.0 mmol/L; or\n\n(c) a serum triglyceride level greater than or equal to 2.0 mmol/L; or\n\n(d) a total serum cholesterol level greater than 5.5 mmol/L; or\n\n(e) the regular administration of drug therapy to normalise blood lipid levels.\n\n MRCA means the Military Rehabilitation and Compensation Act 2004.\n\n rapid weight loss means reduction of body mass by at least 20 percent, within a continuous period of no more than 6 months.\n\nNote: Situations which can be associated with rapid weight loss and protein-calorie malnutrition include anorexia nervosa, acute starvation and surgery causing significant diarrhoea or malabsorption (for example, extensive small bowel resection and pancreaticoduodenectomy).\n\n relevant service means:\n\n(a) eligible war service (other than operational service) under the VEA;\n\n(b) defence service (other than hazardous service and British nuclear test defence service) under the VEA; or\n\n(c) peacetime service under the MRCA.\n\nNote: MRCA and VEA are also defined in the Schedule 1 – Dictionary.\n\n steatohepatitis—see subsection 7(2).\n\n terminal event means the proximate or ultimate cause of death and includes the following:\n\n(a) pneumonia;\n\n(b) respiratory failure;\n\n(c) cardiac arrest;\n\n(d) circulatory failure; or\n\n(e) cessation of brain function.\n\n total parenteral nutrition means a total nutrient admixture providing calories, amino acids, electrolytes, fluids, minerals, trace elements and vitamins, by the intravenous route.\n\n VEA means the Veterans' Entitlements Act 1986.\n\n \n\n\n\n\nSchedule 2 - Drugs \n\nNote: See Section 6, Subsection 9(10)\n\n1 Specified drugs\n\n \n\n| amiodarone | 2. antiretroviral agents | 3. asparaginase |\n| --- | --- | --- |\n| 4. beta-blockers | 5. calcium channel blockers | 6. carbamazepine |\n| 7. cisplatin | 8. diethylamino-ethyoxyhexestrol | 9. diethylstilbestrol |\n| 10. estrogen | 11. fialuridine | 12. fluorouracil |\n| 13. glucocorticoids | 14. linezolid | 15. methotrexate |\n| 16. oxaliplatin | 17. pegaspargase | 18. perhexiline |\n| 19. raloxifene | 20. rifampicin | 21. tamoxifen |\n| 22. tetracycline antibiotics | 23. tianeptine | 24. toremifene |\n| 25. troglitazone | 26. valproate | |\n\n\n \n\n \n","sortOrder":0}],"analysis":{"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"},"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"This is a standard replacement Statement of Principles under the veterans' compensation scheme. It maintains the same scope as its 2013 predecessor and other SOPs — establishing medical causation criteria for a specific condition. The structure (factors, definitions, schedules) follows the established template for Repatriation Medical Authority instruments. No scope creep is evident; it remains tightly focused on steatohepatitis causation for compensation purposes."},"complexity_factors":["Multiple defined terms (8 definitions in Schedule 1 including nested definitions — 'being obese' refers to 'BMI' which has its own formula)","Gender-specific thresholds for alcohol consumption (factors 7 and 8) requiring calculation based on Australian Standard drink measurements","Time-bound conditions with varying windows (18 months for weight loss, 1 year for IV nutrition, 5 years for alcohol, 30 days for drugs)","Cross-referencing structure — factor 11 incorporates by reference other Statements of Principles for related conditions","Dual application framework covering both VEA and MRCA legislation with different service definitions","Specific exclusion list in section 7(2)(c) excluding four specific conditions from the definition","Conditional logic in factor 12 limiting its application to aggravation/pre-existing cases only"],"plain_english_summary":"This instrument updates the medical test for linking steatohepatitis to military service, replacing the 2013 guidance with current evidence and a specified set of 12 risk factors. It affects veterans and current/former defence members making claims under the Veterans' Entitlements Act 1986 or MRCA, applies the \"balance of probabilities\" standard, and matters because meeting these factors can establish service connection for compensation (including where the disease contributed to death)."},"flash_summary":{"complexity_score":5,"scope_assessment":{"changed":true,"description":"This instrument repeals and replaces the earlier Statement of Principles No. 80 of 2013 (s4). It applies to VEA and MRCA claims (s5) and clarifies/updates scope by: expressly including death from steatohepatitis (s7(3)); specifying numeric obesity and alcohol thresholds (s9(7)–(8); Sch1); adding drug‑use timing and rechallenge rules plus a specified drug list (s9(9)–(11); Schedule 2); and adding inability to obtain appropriate clinical management as a qualifying factor (s9(12))."},"complexity_factors":["Technical medical definitions and diagnostic thresholds (steatohepatitis definition in s7(2); dyslipidaemia and BMI definitions in Schedule 1)","Numeric cutoffs and time windows that affect causation (BMI/waist measures in Sch1; alcohol quantities and 5‑year window in s9(7)–(8); 30‑day, 6‑month and 18‑month windows in s9)","Drug‑related causal rules and an extensive specified drug list (use for ≥30 days, rechallenge criteria in s9(9)–(11); Schedule 2 drug list)","Requirement that any qualifying factor be related to the person’s relevant service and the defined scope of relevant service (s10(1); Schedule 1 relevant service definitions)","Inclusion of inability to obtain appropriate clinical management as a factor (s9(12)), which raises evidentiary and administrative assessment issues","Interplay with other Statements of Principles where factors overlap (s11), creating cross‑instrument dependency","Death inclusion via contribution to a terminal event (s7(3) and Schedule 1 terminal event definition), requiring proximate causation analysis","Repeal of the prior Statement and replacement effect (s4), requiring administrators and claimants to adapt to updated criteria"],"plain_english_summary":"This instrument sets the medical criteria the Repatriation Medical Authority uses to decide whether steatohepatitis (fatty‑liver inflammation) and deaths from it are connected to a veteran’s relevant service for VEA/MRCA claims. It replaces the 2013 Statement and commences 19 September 2022.\n\nIt lists specific, measurable risk factors and exposures—diabetes, obesity (BMI/waist measures), dyslipidaemia, defined alcohol thresholds, recent rapid weight loss or surgeries, prolonged total parenteral nutrition, use of listed drugs or irinotecan, and inability to obtain appropriate clinical management—and requires those factors to be related to the person’s relevant service (see s7–s9, Sch1–Sch2)."}},"importantCases":[],"_links":{"self":"/api/acts/statement-of-principles-concerning-steatohepatitis-balance-of-probabilities-no-87-of-2022","history":"/api/acts/statement-of-principles-concerning-steatohepatitis-balance-of-probabilities-no-87-of-2022/history","analysis":"/api/acts/statement-of-principles-concerning-steatohepatitis-balance-of-probabilities-no-87-of-2022/analysis","conflicts":"/api/acts/statement-of-principles-concerning-steatohepatitis-balance-of-probabilities-no-87-of-2022/conflicts","importantCases":"/api/acts/statement-of-principles-concerning-steatohepatitis-balance-of-probabilities-no-87-of-2022/important-cases","documents":"/api/acts/statement-of-principles-concerning-steatohepatitis-balance-of-probabilities-no-87-of-2022/documents"}}