{"id":"F2021L00214","name":"Statement of Principles concerning pulmonary thromboembolism (Balance of Probabilities) (No. 38 of 2021)","slug":"statement-of-principles-concerning-pulmonary-thromboembolism-balance-of-probabilities-no-38-of-2021","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":101324,"registerId":"commonwealth-F2021L00214-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Statement of Principles concerning pulmonary thromboembolism (Balance of Probabilities) (No. 38 of 2021)","content":"![Commonwealth Coat of Arms](image.001.png)\n\nStatement of Principles concerning pulmonary thromboembolism (Balance of Probabilities) (No. 38 of 2021)\n\nmade under subsection 196B(3) of the\n\nVeterans' Entitlements Act 1986\n\nCompilation No. 1\n\nCompilation date: 19 September 2022\n\nIncludes amendments up to: Veterans' Entitlements (Statements of Principles—definition of \"one pack-year\") Amendment Determination 2022 (No. 94 of 2022) (F2022L01128)\n\nThe day of commencement of this Amendment Determination is 19 September 2022.\n\nAbout this compilation\n\nThis compilation\n\nThis is a compilation of the Statement of Principles concerning pulmonary thromboembolism (Balance of Probabilities) (No. 38 of 2021) that shows the text of the law as amended and in force on 19 September 2022.\n\nThe notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.\n\nUncommenced amendments\n\nThe effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.\n\nApplication, saving and transitional provisions for provisions and amendments\n\nIf the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.\n\nModifications\n\nIf the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.\n\nSelf‑repealing provisions\n\nIf a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.\n\nContents\n\n1 Name\n\n3 Authority\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\nEndnotes\n\nEndnote 1—About the endnotes\n\nEndnote 2—Abbreviation key\n\nEndnote 3—Legislation history\n\nEndnote 4—Amendment history\n\n  \n\n1 Name\n\nThis is the Statement of Principles concerning pulmonary thromboembolism (Balance of Probabilities) (No. 38 of 2021).\n\n3 Authority\n\nThis instrument is made under subsection 196B(3) of the Veterans' Entitlements Act 1986.\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 pulmonary thromboembolism and death from pulmonary thromboembolism.\n\nMeaning of pulmonary thromboembolism\n\n(2) For the purposes of this Statement of Principles, pulmonary thromboembolism means obstruction of the pulmonary artery or one of its branches by a mass of clotted blood.\n\n(3) While pulmonary thromboembolism attracts ICD‑10‑AM code I26, in applying this Statement of Principles the meaning of pulmonary thromboembolism 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 pulmonary thromboembolism\n\n(5) For the purposes of this Statement of Principles, pulmonary thromboembolism, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's pulmonary thromboembolism.\n\n> Note: 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 pulmonary thromboembolism and death from pulmonary thromboembolism can be related to relevant service rendered by veterans or members of the Forces under the VEA, or members under the MRCA.\n\n> Note: 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, pulmonary thromboembolism or death from pulmonary thromboembolism is connected with the circumstances of a person's relevant service:\n\n(1) having a deep vein thrombosis within the three months before the clinical onset of pulmonary thromboembolism;\n\n(2) having superficial vein thrombosis within the six months before the clinical onset of pulmonary thromboembolism;\n\n(3) having acute myocardial infarction within the three months before the clinical onset of pulmonary thromboembolism;\n\n(4) having heart failure or a thrombus within the right atrium or right ventricle at the time of the clinical onset of pulmonary thromboembolism;\n\n(5) having a malignant neoplasm at the time of the clinical onset of pulmonary thromboembolism;\n\n(6) having an aneurysm of a vein in the deep venous system at the time of the clinical onset of pulmonary thromboembolism;\n\n(7) being overweight or obese at the time of the clinical onset of pulmonary thromboembolism;\n\n> Note: being overweight or obese is defined in the Schedule 1 - Dictionary.\n\n(8) having sleep apnoea at the time of the clinical onset of pulmonary thromboembolism;\n\n(9) being pregnant within the three months before the clinical onset of pulmonary thromboembolism;\n\n(10) having infection with human immunodeficiency virus or hepatitis C virus at the time of the clinical onset of pulmonary thromboembolism;\n\n(11) having infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within the three months before the clinical onset of pulmonary thromboembolism;\n\n> Note: SARS-CoV-2 is the virus which causes coronavirus disease 2019 (COVID-19).\n\n(12) having an autoimmune disease at the time of the clinical onset of pulmonary thromboembolism;\n\n> Note: Examples of autoimmune diseases that may cause pulmonary thromboembolism include rheumatoid arthritis, polymyositis and Sjögren syndrome.\n\n(13) having diabetes mellitus at the time of the clinical onset of pulmonary thromboembolism;\n\n(14) having a hypercoagulable state as specified at the time of the clinical onset of pulmonary thromboembolism;\n\n> Note: hypercoagulable state as specified is defined in the Schedule 1 - Dictionary.\n\n(15) having a kidney disease from the specified list of kidney diseases at the time of the clinical onset of pulmonary thromboembolism;\n\n> Note: specified list of kidney diseases is defined in the Schedule 1 - Dictionary.\n\n(16) having implantation of an intravenous device for a continuous period of at least 24 hours within the three months before the clinical onset of pulmonary thromboembolism;\n\n> Note: Examples of implanted devices include a central venous catheter, an indwelling cardiac pacemaker and defibrillator leads.\n\n(17) having surgery requiring a general, spinal or epidural anaesthetic within the six months before the clinical onset of pulmonary thromboembolism;\n\n(18) having an injury or illness as specified within the three months before the clinical onset of pulmonary thromboembolism;\n\n> Note: injury or illness as specified is defined in the Schedule 1 - Dictionary.\n\n(19) having restricted mobility for a continuous period of at least four hours within the four weeks before the clinical onset of pulmonary thromboembolism;\n\n> Note: Examples of situations in which restricted mobility can occur include travel by road, rail or air and physical restraint.\n\n(20) having a neurological disease that causes loss or impairment of motor function of a limb within the three months before the clinical onset of pulmonary thromboembolism;\n\n> Note: Examples of neurological diseases that cause loss or impairment of motor function of a limb include cerebrovascular accident, multiple sclerosis and motor neurone disease.\n\n(21) taking a drug from the specified list of drugs within the three months before the clinical onset of pulmonary thromboembolism;\n\n> Note: specified list of drugs is defined in the Schedule 1 - Dictionary.\n\n(22) taking combined estrogen-progestogen contraception or taking menopausal hormone therapy as an oral estrogen, or a non-oral estrogen combined with a progestogen, for a continuous period of at least four weeks, within the three months before the clinical onset of pulmonary thromboembolism;\n\n> Note: menopausal hormone therapy is defined in the Schedule 1 - Dictionary.\n\n(23) having smoked tobacco products:\n\n(a) in an amount of at least one pack-year before the clinical onset of pulmonary thromboembolism; or\n\n(b) in an amount of at least 10 cigarettes per day, or the equivalent thereof in other tobacco products, for a period of at least three months before the clinical onset of pulmonary thromboembolism; and\n\nif smoking has ceased before the clinical onset of pulmonary thromboembolism, then that onset occurred within six months of cessation;\n\n> Note: cigarettes per day, or the equivalent thereof in other tobacco products and one pack-year are defined in the Schedule 1 - Dictionary.\n\n(24) being at an altitude of at least 3,000 metres for a continuous period of at least five days within the three months before the clinical onset of pulmonary thromboembolism;\n\n(25) inability to obtain appropriate clinical management for pulmonary thromboembolism.\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(25) applies only to material contribution to, or aggravation of, pulmonary thromboembolism where the person's pulmonary thromboembolism 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\nSchedule 1 \\- Dictionary\n\nNote: See Section 6\n\n1 Definitions\n\nIn this instrument:\n\nabnormality of kidney structure or function means:\n\n(a) having a glomerular filtration rate of less than 60 mL/min/1.73 m2; or\n\n(b) having kidney damage, as evidenced by renal biopsy, imaging studies, albuminuria, urinary sediment abnormalities or other markers of abnormal renal function; or\n\n(c) having had a kidney transplant.\n\nacute kidney injury means:\n\n(a) having an increase in serum creatinine of at least 26.5 mol/L within a period of 48 hours; or\n\n(b) having an increase in serum creatinine of at least 1.5 times baseline levels, which has occurred within the previous seven days; or\n\n(c) having a urine volume of less than 0.5 mL/kg/h for six hours.\n\nbeing overweight or obese means having a Body Mass Index (BMI) of 25 or greater.\n\n> Note: BMI is also defined in the Schedule 1 - Dictionary.\n\nBMI 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\nchronic kidney disease means an abnormality of kidney structure or function that has been present for at least three months.\n\n> Note: abnormality of kidney structure or function is also defined in the Schedule 1 - Dictionary.\n\ncigarettes per day, or the equivalent thereof in other tobacco products means either:\n\n(a) cigarettes, pipe tobacco or cigars, alone or in any combination, where one tailor-made cigarette approximates one gram of tobacco; or\n\n(b) one gram of cigar, pipe or other smoking tobacco.\n\nhypercoagulable state as specified means:\n\n(a) antiphospholipid antibody syndrome;\n\n(b) cirrhosis of the liver;\n\n(c) Cushing syndrome;\n\n(d) disseminated intravascular coagulation;\n\n(e) heparin-induced thrombocytopaenia;\n\n(f) hyperthyroidism and thyrotoxicosis;\n\n(g) hypothyroidism;\n\n(h) inability to access anticoagulant treatment for an existing coagulation disorder;\n\n(i) thrombocytosis; or\n\n(j) venom-induced thrombosis.\n\ninjury or illness as specified means:\n\n(a) a limb, pelvic, rib or spinal fracture;\n\n(b) a moderate to severe traumatic brain injury;\n\n(c) a physical injury or illness requiring mechanical ventilation support or admission to an intensive care unit;\n\n(d) a spinal cord injury;\n\n(e) a tear, rupture or avulsion of a muscle, tendon or ligament in the lower limb;\n\n(f) a traumatic upper or lower limb amputation;\n\n(g) an injury requiring immobilisation of an upper or lower limb in a plaster cast or similar restraining or bracing device; or\n\n(h) any other injury or illness that causes significantly reduced mobility.\n\n> Note: traumatic upper or lower limb amputation is also defined in the Schedule 1 - Dictionary.\n\nmenopausal hormone therapy means administration of estrogen preparations often in combination with a progestogen to offset a hormone deficiency following surgically induced or naturally occurring menopause.\n\nMRCA means the Military Rehabilitation and Compensation Act 2004.\n\none pack-year means the amount of tobacco consumed in smoking 20 cigarettes per day for a period of 1 year, or an equivalent amount of tobacco products.\n\n> Note 1: An equivalent amount of tobacco products is 7,300 grams of smoking tobacco by weight, either in cigarettes, pipe tobacco or cigars, or a combination of same. For pipe tobacco, cigars or combinations of multiple tobacco types, 1 gram of tobacco is considered to be equal to one cigarette.\n\n> Note 2: Pack-years are calculated by dividing the number of cigarettes smoked per day by 20 and multiplying this number by the number of years the person has smoked. For example, smoking 10 cigarettes per day for 10 years is equal to 5 pack-years, and smoking 40 cigarettes per day for 10 years is equal to 20 pack-years.\n\npulmonary thromboembolism—see subsection 7(2).\n\nrelevant 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\n> Note: MRCA and VEA are also defined in the Schedule 1 - Dictionary.\n\nspecified list of drugs means:\n\n(a) anti-psychotic drugs;\n\n(b) chemotherapy for a malignant disease;\n\n(c) erythropoiesis-stimulating agents (including erythropoietin and darbepoietin);\n\n(d) intravenous thrombin or fibrin sealant;\n\n(e) lenalidomide;\n\n(f) selective estrogen receptor modulators (including tamoxifen); or\n\n(g) thalidomide.\n\nspecified list of kidney diseases means:\n\n(a) acute kidney injury;\n\n(b) chronic kidney disease; or\n\n(c) nephrotic syndrome.\n\n> Note: acute kidney injury and chronic kidney disease are also defined in the Schedule 1 - Dictionary.\n\nterminal 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\ntraumatic upper or lower limb amputation means loss of an upper or lower limb as a result of an accidental injury, including blast injury.\n\nVEA means the Veterans' Entitlements Act 1986.\n\n> Note: Endnotes\n\n> Note: Endnote 1—About the endnotes\n\nThe endnotes provide information about this compilation and the compiled law.\n\nThe following endnotes are included in every compilation:\n\nEndnote 1—About the endnotes\n\nEndnote 2—Abbreviation key\n\nEndnote 3—Legislation history\n\nEndnote 4—Amendment history\n\nAbbreviation key—Endnote 2\n\nThe abbreviation key sets out abbreviations that may be used in the endnotes.\n\nLegislation history and amendment history—Endnotes 3 and 4\n\nAmending laws are annotated in the legislation history and amendment history.\n\nThe legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.\n\nThe amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.\n\nMisdescribed amendments\n\nA misdescribed amendment is an amendment that does not accurately describe the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation “(md)” added to the details of the amendment included in the amendment history.\n\nIf a misdescribed amendment cannot be given effect as intended, the abbreviation “(md not incorp)” is added to the details of the amendment included in the amendment history.\n\n> Note: Endnote 2—Abbreviation key\n\n|                                                | o = order(s)                        |\n| ---------------------------------------------- | ----------------------------------- |\n| ad = added or inserted                         | Ord = Ordinance                     |\n| am = amended                                   | orig = original                     |\n| amdt = amendment                               | par = paragraph(s)/subparagraph(s)  |\n| c = clause(s)                                  | /sub‑subparagraph(s)                |\n| C[x] = Compilation No. x                       | pres = present                      |\n| Ch = Chapter(s)                                | prev = previous                     |\n| def = definition(s)                            | (prev…) = previously                |\n| Dict = Dictionary                              | Pt = Part(s)                        |\n| disallowed = disallowed by Parliament          | r = regulation(s)/rule(s)           |\n| Div = Division(s)                              |                                     |\n| exp = expires/expired or ceases/ceased to have | reloc = relocated                   |\n| effect                                         | renum = renumbered                  |\n| F = Federal Register of Legislation            | rep = repealed                      |\n| gaz = gazette                                  | rs = repealed and substituted       |\n| LA = Legislation Act 2003                      | s = section(s)/subsection(s)        |\n| LIA = Legislative Instruments Act 2003         | Sch = Schedule(s)                   |\n| (md) = misdescribed amendment can be given     | Sdiv = Subdivision(s)               |\n| effect                                         | SLI = Select Legislative Instrument |\n| (md not incorp) = misdescribed amendment       | SR = Statutory Rules                |\n| cannot be given effect                         | Sub‑Ch = Sub‑Chapter(s)             |\n| mod = modified/modification                    | SubPt = Subpart(s)                  |\n| No. = Number(s)                                | underlining = whole or part not     |\n|                                                | commenced or to be commenced        |\n\n> Note: Endnote 3—Legislation history\n\n| Name                                                                                                                          | Registration              | Commencement      | Application, saving and transitional provisions |\n| ----------------------------------------------------------------------------------------------------------------------------- | ------------------------- | ----------------- | ----------------------------------------------- |\n| Statement of Principles concerning pulmonary thromboembolism (Balance of Probabilities) (No. 38 of 2021)                      | 9 March 2021F2021L00214   | 5 April 2021      |                                                 |\n| Veterans' Entitlements (Statements of Principles—definition of \"one pack-year\") Amendment Determination 2022 (No. 94 of 2022) | 26 August 2022F2022L01128 | 19 September 2022 |                                                 |\n\n> Note: Endnote 4—Amendment history\n\n| Provision affected                             | How affected      |\n| ---------------------------------------------- | ----------------- |\n| Section 2……………….                               | rep LA s 48D      |\n| Section 4……………….                               | rep LA s 48C      |\n| Subsection 9(23) note...                       | rs No. 94 of 2022 |\n| Schedule 1 – Dictionary – one pack-year...…….. | rs No. 94 of 2022 |","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":"The instrument remains focused on its original purpose: establishing medical criteria for linking pulmonary thromboembolism to veterans' service. The 2022 amendment was technical—updating the definition of 'one pack-year' for smoking calculations—without expanding the scope beyond pulmonary thromboembolism or altering the fundamental claims framework."},"complexity_factors":["25 distinct medical factors with varying timeframes (ranging from 4 hours to 6 months before clinical onset)","Cross-referencing to other Statements of Principles for conditions mentioned as factors (section 11)","Schedule 1 contains 15 defined terms with nested definitions (e.g., 'chronic kidney disease' refers to 'abnormality of kidney structure or function')","Mathematical calculations required for smoking history (pack-years formula) and BMI","Specific medical coding references (ICD-10-AM) with edition and ISBN citations","Conditional logic in factor 9(23) regarding smoking cessation timing","Dual legislative framework application (VEA and MRCA with different service definitions)"],"plain_english_summary":"This Statement of Principles sets the medical criteria for deciding, on the balance of probabilities, whether a pulmonary thromboembolism (or death from it) is related to military service. It affects veterans and current/former defence members claiming under the Veterans' Entitlements Act 1986 or the Military Rehabilitation and Compensation Act 2004 for peacetime/non-operational service. The instrument lists 25 risk factors; claimants must show at least one factor existed and was related to service for a compensable link."},"flash_summary":{"complexity_score":5,"scope_assessment":{"changed":true,"description":"The instrument’s core scope — criteria for relating pulmonary thromboembolism to relevant service — remains, but a 2022 amendment clarified the definition/calculation of 'one pack‑year' and adjusted the note to subsection 9(23). The change is definitional (how smoking exposure is measured) rather than adding new categories of risk factors (see Sch.1 definition of one pack‑year; Endnotes 3–4; s.9(23))."},"complexity_factors":["Technical medical detail and specialised terminology (eg hypercoagulable states, thrombus) (see s.7(2), Sch.1)","Many discrete timing thresholds for risk factors (eg 3 months, 6 months, 4 weeks, 5 days) scattered through s.9","Numerous cross‑references to Schedule 1 definitions that must be applied (eg BMI, one pack‑year, specified drugs) (see s.6, Sch.1)","Interaction with other Statements of Principles where an identified factor refers to another determined condition (see s.11)","Measurement and evidentiary requirements (BMI calculation, pack‑years, diagnosis of infections or malignancy) that require clinical records","Legal causation standard is factual/probabilistic ('balance of probabilities') but applied to clinical constructs (see s.8)","Inclusion of ICD‑10‑AM code as a reference while adopting its own statutory definition of PTE (see s.7(3)–(4))","An amendment clarifying the definition of 'one pack‑year' affects how smoking exposure is quantified (see Sch.1; Endnotes 3–4)","Potential need for specialist clinical evidence to prove temporal relationships and causal contribution"],"plain_english_summary":"This Statement of Principles sets the medical criteria the Repatriation Medical Authority uses to decide if pulmonary thromboembolism (PTE) or death from PTE is connected to a veteran's relevant service for VEA/MRCA claims. It affects veterans and service members lodging compensation or rehabilitation claims by listing specific medical risk factors, timing windows and technical definitions (eg BMI, pack‑year, hypercoagulable states) that are used to establish causation on the balance of probabilities."}},"importantCases":[],"_links":{"self":"/api/acts/statement-of-principles-concerning-pulmonary-thromboembolism-balance-of-probabilities-no-38-of-2021","history":"/api/acts/statement-of-principles-concerning-pulmonary-thromboembolism-balance-of-probabilities-no-38-of-2021/history","analysis":"/api/acts/statement-of-principles-concerning-pulmonary-thromboembolism-balance-of-probabilities-no-38-of-2021/analysis","conflicts":"/api/acts/statement-of-principles-concerning-pulmonary-thromboembolism-balance-of-probabilities-no-38-of-2021/conflicts","importantCases":"/api/acts/statement-of-principles-concerning-pulmonary-thromboembolism-balance-of-probabilities-no-38-of-2021/important-cases","documents":"/api/acts/statement-of-principles-concerning-pulmonary-thromboembolism-balance-of-probabilities-no-38-of-2021/documents"}}