{"id":"F2024L00756","name":"Statement of Principles concerning malignant neoplasm of the bile duct (Balance of Probabilities) (No. 54 of 2024)","slug":"statement-of-principles-concerning-malignant-neoplasm-of-the-bile-duct-balance-of-probabilities-no-5","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":442451,"registerId":"F2024L00756-fast-fetch-1775957453622","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Statement of Principles concerning malignant neoplasm of the bile duct (Balance of Probabilities) (No. 54 of 2024)","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\n---\n\n?xml version=\"1.0\" encoding=\"utf-8\" standalone=\"no\"?>\n\n\n\n \n\nStatement of Principles\n\nconcerning\n\nMALIGNANT NEOPLASM OF THE BILE DUCT (Balance of Probabilities)\n\n(No. 54 of 2024)\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 21 June 2024.\n\n \n\n \n\n \n\n \n\n \n\n|
Professor Terence Campbell AM
Chairperson
by and on behalf of
The Repatriation Medical Authority
|\n| --- |\n| |\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 Definitions\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\n \n\n\n\n\n1 Name\n\nThis is the Statement of Principles concerning malignant neoplasm of the bile duct (Balance of Probabilities) (No. 54 of 2024).\n\n2 Commencement\n\n This instrument commences on 23 July 2024.\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 malignant neoplasm of the bile duct No. 70 of 2015 (Federal Register of Legislation No. F2015L00655) made under subsections 196B(3) and (8) of the VEA is repealed.\n\n5 Application\n\nThis instrument applies to a claim to which section 120B of the VEA or section 339 of the Military Rehabilitation and Compensation Act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 Definitions\n\nThe terms defined in the Schedule 1 - Dictionary have the meaning given when used in this instrument.\n\n7 Kind of injury, disease or death to which this Statement of Principles relates\n\n(1) This Statement of Principles is about malignant neoplasm of the bile duct and death from malignant neoplasm of the bile duct.\n\nMeaning of malignant neoplasm of the bile duct\n\n(2) For the purposes of this Statement of Principles, malignant neoplasm of the bile duct:\n\n(a) means a primary malignant neoplasm arising from the epithelial cells of the intrahepatic or extrahepatic bile ducts (including the ampulla of Vater and the cystic duct); and\n\n(b) includes:\n\n(i) cholangiocarcinoma;\n\n(ii) Klatskin tumour (hilar cholangiocarcinoma);\n\n(iii) squamous cell carcinoma of the bile duct;\n\n(iv) adenosquamous carcinoma of the bile duct;\n\n(v) undifferentiated carcinoma of the bile duct;\n\n(vi) lymphoepithelioma-like cholangiocarcinoma; and\n\n(vii) adenocarcinoma of ampulla of Vater; and\n\n(c) excludes:\n\n(i) soft tissue sarcoma;\n\n(ii) malignant neoplasm of the gallbladder;\n\n(iii) neuroendocrine carcinoma of the gallbladder;\n\n(iv) non-Hodgkin lymphoma; and\n\n(v) Hodgkin lymphoma.\n\n(3) While malignant neoplasm of the bile duct attracts ICD‑10‑AM code C22.1, C24.0 and C24.1, in applying this Statement of Principles the meaning of malignant neoplasm of the bile duct is that given in subsection (2).\n\n(4) For subsection (3), a reference to an ICD-10-AM code is a reference to the code assigned to a particular kind of injury or disease in The International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Australian Modification (ICD-10-AM), Tenth Edition, effective date of 1 July 2017, copyrighted by the Independent Hospital Pricing Authority, ISBN 978-1-76007-296-4.\n\nDeath from malignant neoplasm of the bile duct\n\n(5) For the purposes of this Statement of Principles, malignant neoplasm of the bile duct, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's malignant neoplasm of the bile duct.\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 malignant neoplasm of the bile duct and death from malignant neoplasm of the bile duct 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, malignant neoplasm of the bile duct or death from malignant neoplasm of the bile duct is connected with the circumstances of a person's relevant service:\n\n(1) having an infestation of the hepatobiliary tract with the liver flukes Clonorchis sinensis, Opisthorchis viverrini before clinical onset;\n\n(2) having primary sclerosing cholangitis before clinical onset;\n\n(3) having inflammatory bowel disease before clinical onset;\n\n(4) having cholelithiasis, choledocholithiasis or hepatolithiasis before the clinical onset of malignant neoplasm of the bile duct;\n\nNote: Cholelithiasis relates to the formation of stones in the gallbladder, choledocholithiasis relates to stones in the bile ducts, and hepatolithiasis relates to stones in the bile ducts inside the liver.\n\n(5) having had an injection of Thorotrast (thorium dioxide) before clinical onset;\n\n(6) having cirrhosis of the liver before clinical onset;\n\n(7) having chronic infection with the hepatitis B virus at the time of clinical onset;\n\nNote: chronic infection with hepatitis B virus is defined in the Schedule 1 – Dictionary.\n\n(8) having chronic infection with the hepatitis C virus at the time of clinical onset;\n\nNote: chronic infection with hepatitis C virus is defined in the Schedule 1 – Dictionary.\n\n(9) having diabetes mellitus for at least 5 years before clinical onset;\n\n(10) being obese for at least 10 years within the 20 years before clinical onset;\n\nNote: being obese is defined in the Schedule 1 – Dictionary.\n\n(11) undergoing solid organ transplantation excluding corneal transplant, at least 5 years before clinical onset;\n\n(12) having non-alcoholic fatty liver disease for at least 5 years within the 20 years before clinical onset;\n\n(13) consuming at least 640 kilograms of alcohol at least 5 years before clinical onset;\n\n(14) inhaling, ingesting or having cutaneous contact with 1,2-dichoropropane for at least 1,000 ppm-years at least 5 years before the clinical onset of malignant neoplasm of the bile duct;\n\nNote: ppm-years is defined in the Schedule 1 – Dictionary.\n\n(15) inability to obtain appropriate clinical management for malignant neoplasm of the bile duct before clinical worsening.\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(15) applies only to material contribution to, or aggravation of, malignant neoplasm of the bile duct where the person's malignant neoplasm of the bile duct 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\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 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 chronic infection with the hepatitis B virus means:\n\n infection with the hepatitis B virus resulting in a chronic infection of at least six months duration and which must be confirmed by laboratory testing for hepatitis B serological or nucleic acid markers, or both.\n\n chronic infection with the hepatitis C virus means:\n\n infection with the hepatitis C virus resulting in a chronic infection of at least six months duration and which must be confirmed by laboratory testing for hepatitis C serological or nucleic acid markers, or both.\n\n malignant neoplasm of the bile duct—see subsection 7(2).\n\n MRCA means the Military Rehabilitation and Compensation Act 2004.\n\n ppm-years means parts per million multiplied by years of exposure.\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 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 VEA means the Veterans' Entitlements Act 1986\n\n \n","sortOrder":0}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"This is a standard replacement of an existing Statement of Principles (repealing No. 70 of 2015). The scope remains tightly focused on establishing medical causation for a specific cancer in the veterans' compensation scheme. No expansion beyond the original purpose of determining service-related disability claims."},"complexity_factors":["Moderate cross-referencing: 9 defined terms in Schedule 1, with some terms (BMI, chronic infections) requiring mathematical or laboratory confirmation","Nested definitions: 'being obese' has three alternative tests (BMI ≥30, or gender-specific waist measurements)","Conditional logic with temporal requirements: 9 of the 15 factors include specific timeframes ('at least 5 years before', 'within the 20 years before', 'at the time of')","Exclusion clauses in disease definition: subsection 7(2) contains 7 inclusions and 5 specific exclusions for what counts as bile duct cancer","Dual statutory framework: instrument operates under both VEA and MRCA with slightly different service definitions","Chemical exposure calculation: factor 9(14) requires calculation of 'ppm-years' (parts per million × years), a technical exposure metric"],"plain_english_summary":"This instrument updates the medical test for bile duct cancer claims by defining the disease and setting the causation standard at the \"balance of probabilities.\" It identifies specific service‑related risk factors (infections, liver disease, metabolic and lifestyle risks, certain chemical and treatment exposures) that, if linked to service, can establish entitlement.\n\nIt applies to veterans and defence members seeking compensation under the Veterans' Entitlements Act 1986 or the Military Rehabilitation and Compensation Act 2004."},"flash_summary":{"complexity_score":5,"scope_assessment":{"changed":true,"description":"This instrument expressly repeals the prior Statement of Principles No. 70 of 2015 (section 4) and replaces it with a Statement that defines the covered disease, lists updated factors and numeric thresholds (section 7; section 9) and provides detailed definitions for key terms (Schedule 1). The practical scope change is that claim assessment will now be governed by the new enumerated factors, timing and quantitative measures (e.g. alcohol in kilograms, ppm‑years, specified durations for obesity and diabetes) and the conditional application of factor 15 (sections 9, 10; Schedule 1)."},"complexity_factors":["Multiple discrete medical and exposure factors with precise temporal thresholds must be shown (e.g. diabetes ≥5 years, obesity ≥10 years within 20 years, solid organ transplant ≥5 years) (section 9(9)-(12)).","Unusual quantitative exposure measures create evidentiary complexity: alcohol quantified as ≥640 kilograms consumed ≥5 years before onset (section 9(13)); chemical exposure measured in ppm‑years (≥1,000 ppm‑years for 1,2‑dichloropropane) (section 9(14); Schedule 1).","Laboratory confirmation required for chronic hepatitis B and C (≥6 months duration, serological or nucleic acid markers) increases documentary burden (Schedule 1 definitions).","Key clinical inclusions and exclusions are specified and displace simple ICD coding: the statutory definition lists included tumour types and excludes other neoplasms (section 7(2)-(4)).","Death from the condition is included if the cancer contributed to a terminal event or condition, expanding application to fatal outcomes (section 7(5); Schedule 1 terminal event).","Requirement that any listed factor be related to the person's relevant service introduces a causation linkage that decision‑makers must assess (section 10(1)).","Factor 15 (inability to obtain appropriate clinical management) only applies to material contribution or aggravation where the disease pre‑existed or was contracted before/during service — a conditional and procedural limitation (section 9(15); section 10(2)).","Interplay with other Statements: where a factor refers to another injury/disease covered by a different Statement of Principles, that other Statement governs evidentiary application (section 11).","Definitions in Schedule 1 (BMI formula, obesity cutoffs by sex/waist circumference, ppm‑years, chronic infection definitions) create technical measurement rules that must be applied consistently (Schedule 1).","Instrumental and procedural context: this Statement is made by the Repatriation Medical Authority under subsection 196B(3) and applies to claims under specified provisions of the VEA and MRCA, so decision‑making bodies will use these criteria when assessing claims (sections 3 and 5; section 8 sets the evidentiary standard as balance of probabilities).","Repeal of the 2015 Statement and replacement by this instrument requires practitioners to compare prior case histories against updated criteria (section 4)."],"plain_english_summary":"This instrument repeals the 2015 Statement and sets the medical criteria the Repatriation Medical Authority will use to decide, on the balance of probabilities, whether malignant neoplasm of the bile duct (including cholangiocarcinoma and related tumours) is connected with a veteran’s or service member’s relevant service. It lists specific pre‑existing diseases, exposures and duration/threshold tests that must be present for a claim and defines key terms (for example, obesity, chronic hepatitis and ppm‑years)."},"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-malignant-neoplasm-of-the-bile-duct-balance-of-probabilities-no-5","history":"/api/acts/statement-of-principles-concerning-malignant-neoplasm-of-the-bile-duct-balance-of-probabilities-no-5/history","analysis":"/api/acts/statement-of-principles-concerning-malignant-neoplasm-of-the-bile-duct-balance-of-probabilities-no-5/analysis","conflicts":"/api/acts/statement-of-principles-concerning-malignant-neoplasm-of-the-bile-duct-balance-of-probabilities-no-5/conflicts","importantCases":"/api/acts/statement-of-principles-concerning-malignant-neoplasm-of-the-bile-duct-balance-of-probabilities-no-5/important-cases","documents":"/api/acts/statement-of-principles-concerning-malignant-neoplasm-of-the-bile-duct-balance-of-probabilities-no-5/documents"}}