{"id":"F2022L01120","name":"Statement of Principles concerning steatohepatitis (Reasonable Hypothesis) (No. 86 of 2022)","slug":"statement-of-principles-concerning-steatohepatitis-reasonable-hypothesis-no-86-of-2022","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":441495,"registerId":"F2022L01120-fast-fetch-1775956780940","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Statement of Principles concerning steatohepatitis (Reasonable Hypothesis) (No. 86 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 (Reasonable Hypothesis)\n\n(No. 86 of 2022)\n\nThe Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(2) 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\n\n (Reasonable Hypothesis) (No. 86 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(2) of the Veterans' Entitlements Act 1986.\n\n4 Repeal\n\nThe Statement of Principles concerning steatohepatitis No. 79 of 2013 (Federal Register of Legislation No. F2013L01898) made under subsection 196B(2) of the VEA is repealed.\n\n5 Application\n\nThis instrument applies to a claim to which section 120A of the VEA or section 338 of the Military Rehabilitation and Compensation Act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\nThe Repatriation Medical Authority is of the view that there is sound medical‑scientific evidence that indicates that steatohepatitis and death from steatohepatitis can be related to relevant service rendered by veterans, members of Peacekeeping Forces, 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 as a minimum exist before it can be said that a reasonable hypothesis has been raised connecting steatohepatitis or death from steatohepatitis with the circumstances of a person's relevant service:\n\n(1) having hypertension before the clinical onset of steatohepatitis;\n\n(2) having diabetes mellitus at the time of the clinical onset of steatohepatitis;\n\n(3) being obese at the time of the clinical onset of steatohepatitis;\n\nNote: being obese is defined in the Schedule 1 – Dictionary.\n\n(4) 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(5) undergoing jejunoileal bypass surgery before the clinical onset of steatohepatitis;\n\n(6) receiving total parenteral nutrition for at least 3 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(7) having dyslipidaemia at the time of the clinical onset of steatohepatitis;\n\nNote: dyslipidaemia is defined in the Schedule 1 – Dictionary.\n\n(8) for males, consuming at least 55 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 10 grams of alcohol per standard alcoholic drink.\n\n(9) for females, consuming at least 30 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(10) having hyperuricaemia at the time of the clinical onset of steatohepatitis;\n\nNote: hyperuricaemia is defined in the Schedule 1 – Dictionary.\n\n(11) taking irinotecan for at least the 30 days before the clinical onset of steatohepatitis;\n\n(12) 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(13) 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(14) 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(14) 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(2) 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 hyperuricaemia means a serum uric acid level of at least 0.40 mmo/L.\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) operational service under the VEA;\n\n(b) peacekeeping service under the VEA;\n\n(c) hazardous service under the VEA;\n\n(d) British nuclear test defence service under the VEA;\n\n(e) warlike service under the MRCA; or\n\n(f) non-warlike 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(12)\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":{"complexity_score":4,"scope_assessment":{"changed":true,"description":"This instrument repeals the earlier Statement of Principles (No. 79 of 2013) and replaces it with a new set of criteria. The text itself does not quantify how the substantive coverage differs from the 2013 instrument; it therefore establishes a new operative Statement but does not, within this document alone, detail the specific scope changes between versions (see section 4)."},"complexity_factors":["Medical thresholds and objective definitions are detailed (BMI and waist circumference cutoffs; dyslipidaemia numeric limits; hyperuricaemia threshold) — Schedule 1.","Multiple temporal requirements for exposures and events (eg. 30 days for certain drugs, 3 months TPN within 1 year, 18 months for rapid weight‑loss link) — section 9(4),(6),(11)-(13).","Sex‑specific alcohol exposure thresholds (males 55 kg, females 30 kg alcohol in any 5‑year period) requiring calculation to Australian standard drinks — section 9(8)-(9).","Enumerated list of specified drugs that trigger the test if they cannot be ceased/substituted, plus criteria for rechallenge‑type causation — Schedule 2; section 9(12)-(13).","Interaction and potential overlap with other Statements of Principles requires cross‑reference where a factor is covered elsewhere — section 11.","Requirement that any listed factor be related to the person’s relevant service shifts evidentiary burden to link clinical facts to service history — section 10(1).","Exclusions of particular liver diseases (eg. haemochromatosis, Wilson’s disease) narrow scope and require differential diagnosis — section 7(2)(c).","Operational application limited to claims under specific statutes (VEA/MRCA) and replaces a prior Statement, so administrative transition and interpretation matter (commencement, repeal) — sections 2,4,5."],"plain_english_summary":"This Statement of Principles sets the medical criteria the Repatriation Medical Authority uses to decide when steatohepatitis (including alcoholic and non‑alcoholic forms, with specified exclusions) can be reasonably linked to a veteran’s or service member’s service for claims under the VEA and MRCA. It lists required risk factors, drug exposures, timing thresholds and precise clinical definitions that must be met to raise a “reasonable hypothesis” that service contributed to the condition."},"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"This is a standard periodic update of a Repatriation Medical Authority Statement of Principles. It replaces the 2013 version (No. 79 of 2013) but maintains the same fundamental scope: establishing medical criteria for linking steatohepatitis to military service. The structure and purpose remain consistent with the original intent under subsection 196B(2) of the VEA."},"complexity_factors":["Multiple defined terms in Schedule 1 (8 definitions including nested definitions like 'being obese' which itself references BMI)","Precise quantitative thresholds throughout (e.g., '55 kilograms of alcohol within any 5 year period', 'BMI of 30 or greater', '0.40 mmol/L' for uric acid)","Cross-referencing structure: factors in section 9 point to definitions in Schedule 1 and drug list in Schedule 2","Conditional logic in section 9(13) requiring both development AND redevelopment of disease on drug rechallenge","Gender-specific provisions (factors 8 and 9 for alcohol consumption; waist circumference definitions for obesity)","Interaction with other legislation: references to VEA and MRCA service types, and incorporates other Statements of Principles by reference in section 11"],"plain_english_summary":"This instrument updates the 2013 guidance on when steatohepatitis (fatty liver with inflammation) or death from it can be accepted as service-related, listing 14 medical risk factors that, if linked to service, create a “reasonable hypothesis” of causation. It affects veterans and current or former defence members claiming under the Veterans' Entitlements Act 1986 or the Military Rehabilitation and Compensation Act 2004. It matters because the reasonable‑hypothesis test lowers the evidentiary threshold for acceptance."},"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"}},"importantCases":[],"_links":{"self":"/api/acts/statement-of-principles-concerning-steatohepatitis-reasonable-hypothesis-no-86-of-2022","history":"/api/acts/statement-of-principles-concerning-steatohepatitis-reasonable-hypothesis-no-86-of-2022/history","analysis":"/api/acts/statement-of-principles-concerning-steatohepatitis-reasonable-hypothesis-no-86-of-2022/analysis","conflicts":"/api/acts/statement-of-principles-concerning-steatohepatitis-reasonable-hypothesis-no-86-of-2022/conflicts","importantCases":"/api/acts/statement-of-principles-concerning-steatohepatitis-reasonable-hypothesis-no-86-of-2022/important-cases","documents":"/api/acts/statement-of-principles-concerning-steatohepatitis-reasonable-hypothesis-no-86-of-2022/documents"}}