Statement of Principles concerning cerebrovascular accident (stroke) (Reasonable Hypothesis) (No. 45 of 2024)

This instrument is a Statement of Principles (SoP) issued by the Repatriation Medical Authority under subsection 196B(2) of the Veterans' Entitlements Act 1986 (VEA) (see s 3). It sets out the medical and factual factors that, if present and linked to a person’s relevant service, are sufficient to raise a reasonable hypothesis connecting cerebrovascular accident (stroke) or death from cerebrovascular accident (stroke) with that service (see s 8 and s 9). The SoP replaces the earlier Statement of Principles concerning cerebrovascular accident No. 65 of 2015 by express repeal (s 4), is dated 21 June 2024 and commences on 23 July 2024 (ss 1-2, 4).

Mechanically, the instrument does three main things. First, it defines the condition that it covers. Subsection 7(2) gives the operative meaning of “cerebrovascular accident (stroke)”, stating it means a sudden loss of brain function due to brain ischaemia or intracerebral haemorrhage, and explicitly includes transient ischaemic attack, ischaemic stroke and intracerebral haemorrhage while excluding “silent stroke”, subarachnoid, subdural and extradural haemorrhages (s 7(2)(a)-(c)). The SoP also treats death from a terminal event or condition contributed to by a person’s cerebrovascular accident as included (s 7(5)). Although ICD‑10‑AM codes are listed (s 7(3)-(4)), the statutory text makes clear the definition in s 7(2) controls application.

Second, the instrument lists the factors which, as a minimum, must exist for a reasonable hypothesis to be raised (s 9). Section 9 is an enumerated list: at least one listed factor must be present. The list is extensive and heterogeneous. It covers pre-existing medical conditions and physiological states (for example hypertension within 10 years before clinical onset, diabetes mellitus at clinical onset, chronic kidney disease), acute precipitating events and infections (for example certain brain infections within 4 weeks, SARS‑CoV‑2 within 3 months), exposures and behaviours (for example quantified alcohol consumption, smoking thresholds, sedentary behaviour or specific amounts of second‑hand smoke), recent procedures and therapies (for example cardiac surgery, anticoagulant therapy, thrombolytics, certain cancer therapies), and specified psychosocial stressors (category 1A, 1B and 2 stressors) among many others (s 9). Several items are limited to brain ischaemia or intracerebral haemorrhage only, with different thresholds and time windows provided (see many entries in s 9).

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RMA Australian Government Coat of Arms

Statement of Principles

concerning

CEREBROVASCULAR ACCIDENT (STROKE) (Reasonable Hypothesis)

(No. 45 of 2024)

The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(2) of the Veterans' Entitlements Act 1986.

Dated 21 June 2024.

<br> <br> <br> <br> <br> <br>Professor Terence Campbell AM<br>Chairperson<br>by and on behalf of <br>The Repatriation Medical Authority<br>

Contents

1 Name

2 Commencement

3 Authority

4 Repeal

5 Application

6 Definitions

7 Kind of injury, disease or death to which this Statement of Principles relates

8 Basis for determining the factors

9 Factors that must exist

10 Relationship to service

11 Factors referring to an injury or disease covered by another Statement of Principles

Schedule 1 - Dictionary

1 Definitions

1 Name

This is the Statement of Principles concerning cerebrovascular accident (stroke) (Reasonable Hypothesis) (No. 45 of 2024).

2 Commencement

This instrument commences on 23 July 2024.

3 Authority

This instrument is made under subsection 196B(2) of the Veterans' Entitlements Act 1986.

4 Repeal

The Statement of Principles concerning cerebrovascular accident No. 65 of 2015 (Federal Register of Legislation No. F2015L00652) made under subsections 196B(2) and (8) of the VEA is repealed.

5 Application

This instrument applies to a claim to which section 120A of the VEA or section 338 of the Military Rehabilitation and Compensation Act 2004 applies.

6 Definitions

The terms defined in the Schedule 1 - Dictionary have the meaning given when used in this instrument.

7 Kind of injury, disease or death to which this Statement of Principles relates

(1) This Statement of Principles is about cerebrovascular accident (stroke) and death from cerebrovascular accident (stroke).

Meaning of cerebrovascular accident (stroke)

(2) For the purposes of this Statement of Principles, cerebrovascular accident (stroke):

(a) means a sudden loss of brain function due to brain ischaemia or intracerebral haemorrhage; and

(b) includes:

(i) transient ischaemic attack;

(ii) ischaemic stroke; and

(iii) intracerebral haemorrhage; and

(i) subclinical or asymptomatic cerebrovascular disease identified by neuroimaging ("silent stroke");

(ii) subarachnoid haemorrhage;

(iii) subdural haemorrhage; and

(iv) extradural haemorrhage.

Note: brain ischaemia and intracerebral haemorrhage are defined in the Schedule 1 - Dictionary.

(3) While cerebrovascular accident (stroke) attracts ICD‑10‑AM codes I61, I63, I64, G45.0, G45.1, G45.2, G45.8, G45.9 or G46, in applying this Statement of Principles the meaning of cerebrovascular accident (stroke) is that given in subsection (2).

(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.

Death from cerebrovascular accident (stroke)

(5) For the purposes of this Statement of Principles, cerebrovascular accident (stroke), in relation to a person, includes death from a terminal event or condition that was contributed to by the person's cerebrovascular accident (stroke).

Note: terminal event is defined in the Schedule 1 – Dictionary.

8 Basis for determining the factors

The Repatriation Medical Authority is of the view that there is sound medical-scientific evidence that indicates that cerebrovascular accident (stroke) and death from cerebrovascular accident (stroke) 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.

Note: MRCA, relevant service and VEA are defined in the Schedule 1 – Dictionary.

9 Factors that must exist

At least one of the following factors must as a minimum exist before it can be said that a reasonable hypothesis has been raised connecting cerebrovascular accident (stroke) or death from cerebrovascular accident (stroke) with the circumstances of a person's relevant service:

(1) having hypertension within the 10 years before clinical onset;

(2) having a hypertensive emergency or crisis at the time of clinical onset;

Note: hypertensive emergency or crisis is defined in the Schedule 1 - Dictionary.

(3) inability to undertake any physical activity greater than three METs for at least 5 years within the 20 years before clinical onset;

Note: MET is defined in the Schedule 1 - Dictionary.

(4) consuming alcohol in an amount of at least 250 grams per week, for at least the 1 year before clinical onset;

(5) for brain ischaemia only, binge drinking 300 grams of alcohol within the 7 days before clinical onset;

(6) for intra-cerebral haemorrhage only, binge drinking:

(a) 90 grams of alcohol within the 24 hours; or

(b) 180 grams of alcohol within the 7 days;

before clinical onset;

(7) having one of the following brain infections within the 4 weeks before clinical onset:

(a) cerebral abscess;

(b) cerebral helminthic infection (cysticercosis, schistosomiasis, sparganosis);

(d) encephalitis;

(e) infectious vasculitis;

(f) intracerebral fungal infection (aspergillosis, coccidioidomycosis, Cryptococcus, histoplasmosis or mucormycosis);

(g) meningitis (syphilis, tuberculosis, fungal, bacterial, viral);

(h) neurosyphilis; or

(i) tuberculosis;

(8) having a Varicella-zoster virus infection, involving the brain, within the 1 year before clinical onset;

(9) having infection with human immunodeficiency virus before clinical onset;

(10) having one of the following systemic inflammatory disorders causing cerebral vasculitis at the time of clinical onset:

(a) ankylosing spondylitis;

(b) dermatomyositis;

(d) polymyositis;

(e) psoriatic arthritis;

(f) rheumatoid arthritis;

(g) systemic sclerosis (scleroderma);

(h) Sjögren syndrome; or

(i) systemic lupus erythematosus.

(11) having gout at the time of clinical onset;

(12) having one of the following vasculitides at the time of clinical onset:

(a) antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis;

(b) Behcet disease;

(d) giant cell (temporal) arteritis;

(e) granulomatosis with polyangiitis (Wegener granulomatosis);

(f) Immunoglobulin A vasculitis (Henoch-Schönlein purpura);

(g) microscopic polyangiitis;

(h) neurosarcoidosis;

(i) mucocutaneous lymph node syndrome (Kawasaki disease);

(j) primary angiitis of the central nervous system;

(k) polyarteritis nodosa;

(l) Takayasu arteritis; or

(m) thromboangiitis obliterans (Buerger disease);

(13) having one of the following vessel disorders at the time of clinical onset:

(a) atheroma of the penetrating arteries that arise from the vertebral artery, the basilar artery, the middle cerebral artery stem, and the arteries of the circle of Willis;

(b) cerebral amyloid angiopathy;

(d) cerebral venous thrombosis;

(e) Moyamoya disease or Moyamoya syndrome;

(f) Susac syndrome (retinocochleocerebral vasculopathy); or

(g) Sneddon syndrome;

(14) having thrombotic thrombocytopaenic purpura, sickle cell disorder or vaccine-induced thrombotic thrombocytopaenia at the time of clinical onset;

(15) being pregnant within the 6 weeks before clinical onset;

(16) using one or more of the following drugs within the 72 hours before clinical onset:

(a) amphetamines and amphetamine-type substances, excluding methylphenidate;

(b) anabolic-androgenic steroids;

(d) D-lysergic acid diethylamide (LSD);

(e) opioids, including heroin;

(f) marijuana;

(g) phencyclidine (angel dust);

(17) taking a selective serotonin reuptake inhibitor or another serotonergic drug for at least 2 weeks, within the 4 weeks before clinical onset;

(18) taking an overdose of one or more serotonergic drugs, within the 4 weeks before clinical onset;

(19) taking a non-topical, non-steroidal, anti-inflammatory drug, excluding aspirin, for a continuous period of at least 30 days before clinical onset, where the last dose of the drug was taken within the 7 days before clinical onset;

Note: non-steroidal, anti-inflammatory drug is defined in the Schedule 1 - Dictionary.

(20) having heat stroke at the time of clinical onset;

Note: heat stroke is defined in the Schedule 1 - Dictionary.

(21) being envenomated by a snake, scorpion, box jellyfish, bee, hornet or wasp within the 5 days before clinical onset;

(22) having active migraine at the time of clinical onset;

Note: active migraine is defined in the Schedule 1 - Dictionary.

(23) having diabetes mellitus at the time of clinical onset;

(24) having one of the following cardiac conditions with potential to give rise to a cerebral embolus within the 4 weeks before clinical onset:

(a) a prosthetic mitral or aortic valve;

(b) acute myocardial infarction;

(d) atrial septal aneurysm;

(e) calcification of the mitral or aortic valve;

(f) cardiac hydatid cysts;

(g) cardiomyopathy;

(h) congestive cardiac failure;

(i) endocarditis;

(j) ischaemic, valvular, arrhythmogenic and hypertensive cardiomyopathy;

(k) Lambl excrescences of the mitral or aortic valve;

(l) left atrial aneurysm or dilatation;

(m) left ventricular aneurysm;

(n) left ventricular dyskinesia;

(o) mitral valve prolapse;

(p) primary or secondary cardiac tumours;

(q) regurgitation of the mitral or aortic valve;

(r) rheumatic heart disease;

(s) sick sinus syndrome;

(t) stenosis of the mitral or aortic valve;

(u) thrombus within the left atrium or left ventricle; or

(v) valvulitis of the mitral or aortic valve;

(25) having one of the following non-cardiac causes of cerebral arterial embolism at the time of the clinical onset:

(a) aortic arch atherosclerosis;

(b) decompression sickness;

(d) pulmonary barotrauma;

(e) severe bone trauma;

(f) thrombus formation within the pulmonary vein, or arteries supplying the affected area of the brain;

(26) having a deep vein thrombosis or venous air embolism with one of the following anatomical defects at the time of clinical onset:

(a) atrial septal defect;

(b) patent foramen ovale;

(d) ventricular septal defect.

Note: Examples of circumstances where venous air embolism may occur include air bubble echocardiogram, sclerotherapy for varicose veins or removal of a central venous catheter.

(27) undergoing one of the following procedures within the 4 weeks before clinical onset:

(a) cardiac surgery or cardiac catheterisation;

(b) catheterisation of or injection into the arteries supplying the brain;

(c) major surgical procedure involving general or regional anaesthesia, including orthopaedic surgery or neurosurgery; or

(d) surgery involving the arteries supplying the brain, including carotid endarterectomy;

(28) having septicaemia or an infection requiring admission to hospital within the 3 months before clinical onset;

(29) having an injury or illness requiring admission to an intensive care unit or artificial ventilation, within the 3 months before clinical onset;

(30) having a malignant neoplasm, excluding non-melanotic malignant neoplasm of the skin, within the 1 year before clinical onset;

(31) having cirrhosis of the liver or chronic liver disease at the time of clinical onset;

(32) having chronic kidney disease before clinical onset;

Note: chronic kidney disease is defined in the Schedule 1 – Dictionary.

(33) experiencing a moderate to severe traumatic brain injury within the 1 year before clinical onset;

(34) being obese for at least 5 years within the 15 years before clinical onset;

Note: being obese is defined in the Schedule 1 – Dictionary.

(35) for males, having a waist to hip circumference ratio exceeding 1.0 for at least 5 years within the 15 years before clinical onset;

(36) for females, having a waist to hip circumference ratio exceeding 0.9 for at least 5 years within the 15 years before clinical onset;

(37) for intracerebral haemorrhage only, being underweight for at least 5 years within the 10 years before clinical onset;

Note: being underweight is defined in the Schedule 1 - Dictionary.

(38) having symptomatic inflammatory bowel disease within the ten years before clinical onset;

(39) having clinically significant depressive disorder within the 2 years before clinical onset;

Note: clinically significant is defined in the Schedule 1 – Dictionary.

(40) experiencing a category 1A stressor within the 4 weeks before clinical onset;

Note: category 1A stressor is defined in the Schedule 1 – Dictionary.

(41) experiencing a category 1B stressor within the 4 weeks before clinical onset;

Note: category 1B stressor is defined in the Schedule 1 – Dictionary.

(42) experiencing a category 2 stressor within the one year before clinical onset;

Note 1: A category 2 stressor can arise in a variety of circumstances connected with service. Such circumstances can arise during the course of service, as a result of separation from service and the conditions associated with that separation, and in the transition to civilian life in the years following separation.

Note 2: category 2 stressor is defined in the Schedule 1 - Dictionary.

(43) having panic disorder at the time of clinical onset;

(44) having phobic anxiety with panic attack at the time of clinical onset;

(45) having clinically significant posttraumatic stress disorder within the 1 year before clinical onset;

Note: clinically significant is defined in the Schedule 1 – Dictionary.

(46) having clinically significant adjustment disorder within the 1 year before clinical onset;

Note: clinically significant is defined in the Schedule 1 – Dictionary.

(47) having clinically significant anxiety disorder within the 1 year before clinical onset;

Note: clinically significant is defined in the Schedule 1 – Dictionary.

(48) having clinically significant schizophrenia within the 1 year before clinical onset;

Note: clinically significant is defined in the Schedule 1 – Dictionary.

(49) having clinically significant bipolar disorder within 1 year before clinical onset;

Note: clinically significant is defined in the Schedule 1 – Dictionary.

(50) having periodontitis for at least the 2 years before clinical onset;

(51) an inability to consume an average of at least 100 grams per day of vegetables or fruits, for at least the 1 year before clinical onset;

(52) consuming an average daily intake of at least 12 grams (200 millimoles) per day of salt (sodium chloride) for at least the 6 months before clinical onset;

(53) having infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within the 3 months before clinical onset;

Note: SARS-CoV-2 is the virus which causes coronavirus disease 2019 (COVID-19).

(54) for brain ischaemia only, where smoking has not ceased before clinical onset:

(a) smoking an average of at least 1 cigarette per day, or the equivalent thereof in other tobacco products, for at least the one year before clinical onset; or

(b) smoking at least one half of one pack-year before clinical onset;

Note: one pack-year is defined in the Schedule 1 - Dictionary.

(55) for intracerebral haemorrhage only, where smoking has not ceased before clinical onset:

(a) smoking an average of at least 5 cigarettes per day, or the equivalent thereof in other tobacco products, for at least the 1 year before clinical onset; or

(b) smoking at least one pack-year before clinical onset;

Note: one pack-year is defined in the Schedule 1 - Dictionary.

(56) for brain ischaemia only, where smoking has ceased before clinical onset:

(a) smoking at least one pack-year but less than 5 pack-years, before clinical onset, and clinical onset has occurred within 10 years of smoking cessation; or

(b) smoking at least 5 pack-years but less than 10 pack-years, before clinical onset, and clinical onset occurred within 20 years of smoking cessation; or

Note: one pack-year is defined in the Schedule 1 - Dictionary.

(57) for intracerebral haemorrhage only, where smoking has ceased before the clinical onset of cerebrovascular accident:

(a) smoking at least one pack-year but less than 10 pack-years before the clinical onset of cerebrovascular accident, and the clinical onset of cerebrovascular accident has occurred within 10 years of smoking cessation; or

(b) smoking at least 10 pack-years before clinical onset, and the clinical onset occurred within 20 years of smoking cessation;

Note: one pack-year is defined in the Schedule 1 - Dictionary.

(58) having been exposed to second-hand smoke:

(a) for at least 5,000 hours before clinical onset; and

(b) where the last exposure to second-hand smoke occurred within the 5 years before clinical onset;

Note: exposed to second-hand smoke is defined in the Schedule 1 – Dictionary.

(59) for brain ischaemia only, having dyslipidaemia within the 20 years before clinical onset;

Note: dyslipidaemia is defined in the Schedule 1 - Dictionary.

(60) having an upper respiratory tract infection, including sinusitis, within the 4 weeks before clinical onset;

(61) for brain ischaemia only, being treated with intravenous immunoglobulin within the 72 hours before clinical onset;

(62) for brain ischaemia only, taking combined oral or non-oral estrogen-progestogen contraception for a continuous period of at least 21 days, within the 4 weeks before clinical onset;

(63) for brain ischaemia only, taking hormone replacement therapy for a continuous period of at least 21 days within the 5 years before clinical onset;

Note: hormone replacement therapy is defined in the Schedule 1 - Dictionary.

(64) for brain ischaemia only, taking tamoxifen for a continuous period of at least the 21 days before clinical onset;

(65) for brain ischaemia only, having carotid artery disease, or occlusion or stenosis of the vertebral artery, basilar artery, aortic arch or ascending aorta due to atherosclerosis, fibromuscular dysplasia, dissection or other pathological process involving that artery, at the time of clinical onset;

(66) for brain ischaemia only, having a subarachnoid haemorrhage within the 2 weeks before clinical onset;

(67) for brain ischaemia only, having one of the following hypercoagulable states at the time of the clinical onset:

(a) acquired activated protein C resistance;

(b) acquired antithrombin III deficiency;

(d) acquired protein C deficiency;

(e) acquired protein S deficiency;

(f) antiphospholipid antibody syndrome;

(g) aplastic anaemia;

(h) disseminated intravascular coagulation;

(i) haemolytic uraemic syndrome;

(j) heparin-induced thrombocytopaenia;

(k) hyperfibrinogenaemia;

(l) hyperproteinaemia;

(m) hyperviscosity syndrome;

(n) chronic idiopathic thrombocytopaenic purpura or immune thrombocytopaenia;

(o) myeloma;

(p) myeloproliferative disease;

(q) nephrotic syndrome;

(r) paroxysmal nocturnal haemoglobinuria; or

(s) thrombocytosis;

(68) for brain ischaemia only, experiencing an acute hypotensive episode within the 24 hours before clinical onset;

Note: acute hypotensive episode is defined in the Schedule 1 - Dictionary.

(69) having sleep apnoea at the time of clinical onset;

(70) undergoing a course of therapeutic radiation for cancer, where the head, neck or mediastinum was in the field of radiation, before clinical onset;

(71) having received a cumulative equivalent dose of at least 0.5 sievert of ionising radiation to the head, neck or mediastinum before clinical onset;

Note: cumulative equivalent dose is defined in the Schedule 1 - Dictionary.

(72) for brain ischaemia only, having hyperhomocysteinaemia at the time of clinical onset;

(73) for brain ischaemia only, having one of the following traumatic injuries to the neck or the base of the skull within the 4 weeks before clinical onset:

(a) a non-penetrating injury, involving extension, rotation, hyperflexion or compression of the neck;

(b) an injury resulting in fracture or dislocation of the cervical spine;

(d) foreign body penetration or blunt injury of an artery within the head, neck or chest;

(74) for brain ischaemia only, inhaling polluted air, for a cumulative period of at least 100 hours, within the 7 days before clinical onset;

Note: polluted air is defined in the Schedule 1 – Dictionary.

(75) inhaling chronically polluted air for at least 1000 hours, within the 5 years before clinical onset;

Note: chronically polluted air is defined in the Schedule 1 – Dictionary.

(76) for intracerebral haemorrhage only, undergoing anticoagulant therapy within the 30 days before clinical onset;

Note: anticoagulant therapy is defined in the Schedule 1 – Dictionary.

(77) for intracerebral haemorrhage only, taking one of the following antiplatelet drugs on at least 3 days per week for a continuous period of at least 4 weeks before clinical onset, where the last dose was taken no more than 30 days before clinical onset:

(a) aspirin;

(b) clopidogrel;

(d) ticagrelor;

(e) dipyridamole; or

(f) ticlopidine;

(78) for intracerebral haemorrhage only, undergoing thrombolytic (fibrinolytic) therapy within the 7 days before clinical onset;

Note: thrombolytic (fibrinolytic) therapy is defined in the Schedule 1 - Dictionary.

(79) for intracerebral haemorrhage only, having one of the following disorders at the time of clinical onset:

(a) aplastic anaemia;

(b) idiopathic thrombocytopaenic purpura or immune thrombocytopaenia;

(d) essential thrombocythaemia;

(e) Hodgkin lymphoma;

(f) inherited or acquired coagulation protein disorder, including haemophilia;

(g) leukaemia;

(h) myeloma;

(i) non-Hodgkin lymphoma;

(j) post-transfusion purpura;

(k) qualitative platelet defects associated with coagulation defect;

(l) thrombocytopaenia; or

(m) vitamin K deficiency;

(80) for intracerebral haemorrhage only, bleeding of one of the following intracerebral space occupying lesions at the time of clinical onset:

(a) abscess;

(b) cyst;

(d) tuberculoma;

(81) for intracerebral haemorrhage only, bleeding from a cerebral aneurysm or a cerebral vascular malformation at the time of clinical onset;

(82) being sedentary for a cumulative total of at least 10 hours per day on more days than not for at least the 5 years before clinical onset;

Note: being sedentary is defined in the Schedule 1 - Dictionary.

(83) taking one of the following anti-androgen medications for at least the 6 months before clinical onset:

(a) androgen receptor blockers, including cyproterone acetate, flutamide and bicalutamide;

(b) gonadotrophin releasing hormone agonists, including goserelin and leuprorelin; or

(84) having bilateral orchiectomy before clinical onset;

(85) for brain ischaemia only, having compression of the carotid, vertebral, basilar or cerebral artery at the time of clinical onset;

Note: Examples of a mass or structure that can cause compression include osteophytes associated with cervical spondylosis (especially with rotation of the neck beyond 45 degrees), an abscess, haematoma or neoplasm in the neck.

(86) taking an antipsychotic drug on more days than not for at least one week, within the 6 months before clinical onset;

(87) taking tibolone for a continuous period of at least 21 days within the 2 months before clinical onset;

(88) taking a systemic vascular endothelial growth factor (VEGF) inhibitor or monthly intra-vitreous injections of a VEGF inhibitor within the 4 months before clinical;

Note: Vascular endothelial growth factor (VEGF) inhibitors include monoclonal antibodies, such as bevacizumab; fusion molecules such as aflibercept; and tyrosine kinase inhibitors, such as axitinib, cabozantinib, lenvatinib, nintedanib, pazopanib, sorafenib, sunitinib and vandetanib. Systemic VEGF inhibitors are used in the treatment of several cancers, and other indications such as interstitial lung disease. Intra-vitreous injections of VEGF inhibitors (such as aflibercept, bevacizumab, ranibizumab) are used mostly in the treatment of age-related macular degeneration, macular oedema due to diabetes mellitus or retinal vein occlusion and choroidal neovascularisation.

(89) taking alemtuzumab within the 30 days before clinical onset;

Note: Alemtuzumab is usually used for treatment of multiple sclerosis or chronic lymphocytic leukaemia.

(90) taking ponatinib on more days than not for 2 weeks within the 30 days before clinical onset;

Note: Ponatinib is usually used for treatment of chronic myeloid leukaemia or acute lymphoblastic leukaemia.

(91) taking a thalidomide analogue within the 30 days before clinical onset;

Note: a thalidomide analogue includes thalidomide, lenalidomide and pomalidomide and are used in the treatment of multiple myeloma, myelodysplastic syndrome, mantle cell lymphoma and erythema nodosum leprosum.

(92) inability to obtain appropriate clinical management for cerebrovascular accident (stroke) prior to clinical worsening.

10 Relationship to service

(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.

(2) The factor set out in subsection 9(92) applies only to material contribution to, or aggravation of, cerebrovascular accident (stroke) where the person's cerebrovascular accident (stroke) was suffered or contracted before or during (but did not arise out of) the person's relevant service.

11 Factors referring to an injury or disease covered by another Statement of Principles

In this Statement of Principles:

(1) if a factor referred to in section 9 applies in relation to a person; and

(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;

then 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.

Schedule 1 - Dictionary

Note: See Section 6

1 Definitions

In this instrument:

active migraine means having at least one migraine headache per year.

acute hypotensive episode means a sudden drop in blood pressure of a sufficient degree to cause cerebral hypoperfusion.

anticoagulant therapy means therapeutic administration of a pharmacological agent which suppresses, delays or attenuates blood coagulation, including heparin, warfarin, dicumarol, or direct oral anticoagulants (such as dabigatran, apixaban, rivaroxaban), but excludes antiplatelet therapy.

being obese means having a Body Mass Index (BMI) of 30 or greater.

Note: BMI is defined in the Schedule 1 - Dictionary.

being sedentary means waking behaviour characterised by an average energy expenditure of 1.5 METs or less while in a sitting or reclining posture.

Note: MET is defined in the Schedule 1 - Dictionary.

being underweight means having a Body Mass Index (BMI) of 18.5 or less;

Note: BMI is also defined in the Schedule 1 – Dictionary

BMI means W/H2 where:

(a) W is the person’s weight in kilograms; and

(b) H is the person’s height in metres.

brain ischaemia means a reduction or interruption of blood supply to an area of the cerebrum, diencephalon, brain stem or cerebellum, leading to dysfunction of the brain tissue in that area.

category 1A stressor means one of the following severe traumatic events:

(a) experiencing a life-threatening event;

(b) being subject to a serious physical attack or assault including rape and sexual molestation; or

category 1B stressor means one of the following severe traumatic events:

(a) killing or maiming a person;

(b) being a witness to a person being killed or critically injured;

(d) participating in the clearance of a corpse or a critically injured casualty; or

(e) viewing a corpse or a critically injured casualty as a witness.

Note: corpse and witness are defined in the Schedule 1 – Dictionary.

category 2 stressor means one of the following negative life events, the effects of which are chronic in nature and cause the person to feel on-going distress, concern or worry:

(a) being socially isolated and unable to maintain friendships or family relationships, due to physical location, ethnicity, sexuality, disability, or medical or psychiatric illness;

(b) experiencing a problem with a long-term relationship including the break-up of a close personal relationship, the need for marital or relationship counselling, marital separation, or divorce;

(c) having concerns in the work or school environment including on-going disharmony with fellow work or school colleagues, perceived lack of social support within the work or school environment, perceived lack of control over tasks performed and stressful workloads, or experiencing bullying in the workplace or school environment;

(d) experiencing serious legal issues including being detained or held in custody, on-going involvement with the police concerning violations of the law, or court appearances associated with personal legal problems;

(e) having severe financial hardship including loss of employment, long periods of unemployment, foreclosure on a property, or bankruptcy; or

(f) having a family member or close friend experience a major deterioration in their health.

cerebrovascular accident (stroke)-see subsection 7(2).

chronically polluted air means air with average annual concentrations of particulate matter with an aerodynamic diameter of < 2.5 µm (PM2.5) exceeding 30 µg/m3 or particulate matter with an aerodynamic diameter < 10 µm (PM10) exceeding 150 µg/m3.

chronic kidney disease means:

(a) having a glomerular filtration rate of less than 60 ml/min/1.73 m2 for at least 3 months;

(b) having albuminuria with an albumin to creatinine ratio of at least 3 milligrams/millimole for at least 3 months;

(c) having kidney damage, as evidenced by renal biopsy, imaging studies, urinary sediment abnormalities or other markers of abnormal renal function; or

(d) having had a kidney transplant.

clinically significant means sufficient to warrant ongoing management which may involve regular visits (for example, at least monthly) to a psychiatrist, counsellor or general practitioner.

Note: To warrant ongoing management does not require that any actual management was received or given for the condition.

corpse means the human remains or body parts of one or more persons who have met a violent or horrific death.

Note: Examples of a violent or horrific death may include death due to suicide, gunshot, improvised explosive devices, natural and technological disasters, terrorist attacks or motor vehicle accidents. Seeing a closed body bag or viewing a body in an open-casket coffin are excluded from this definition.

cumulative equivalent dose means the total dose of ionising radiation received by the particular organ or tissue. The formula used to calculate the cumulative equivalent dose allows doses from multiple types of ionising radiation to be combined, by accounting for their differing biological effect. The unit of equivalent dose is the sievert. For the purposes of this Statement of Principles, the calculation of cumulative equivalent dose excludes doses received from normal background radiation, but includes therapeutic radiation, diagnostic radiation, cosmic radiation at high altitude, radiation from occupation-related sources and radiation from nuclear explosions or accidents.

dyslipidaemia means persistently abnormal blood lipid levels, diagnosed by a medical practitioner and evidenced by:

(a) a serum high density lipoprotein cholesterol level less than 1.0 mmol/L;

(b) a serum low density lipoprotein level greater than 4.0 mmol/L;

(d) a total serum cholesterol level greater than 5.5 mmol/L;

exposed to second-hand smoke means having been in an enclosed space and inhaling smoke from burning tobacco products or smoke that has been exhaled by another person who is smoking.

heat stroke means central nervous system and multiple organ dysfunction from complications of hyperthermia.

hormone replacement therapy means administration of estrogen preparations often in combination with progestogen, usually to offset a hormone deficiency following surgically induced or naturally occurring menopause.

hypertensive emergency or crisis, also known as malignant hypertension, means a sudden and severe increase in blood pressure to a diastolic blood pressure greater than or equal to 110 mm Hg or a systolic blood pressure greater than or equal to 180 mm Hg, or of a sufficient degree to cause acute impairment to one or more organ systems.

intracerebral haemorrhage means bleeding within the ventricles or parenchyma of the cerebrum, diencephalon, brain stem or cerebellum, including haemorrhagic transformation of cerebral ischaemia.

MET means a unit of measurement of the level of physical exertion. 1 MET = 3.5 ml of oxygen/kg of body weight per minute, or 1.0 kcal/kg of body weight per hour, or resting metabolic rate.

MRCA means the Military Rehabilitation and Compensation Act 2004.

non-steroidal, anti-inflammatory drug means any of a large chemically heterogeneous group of drugs that inhibit cyclooxygenase activity, resulting in decreased synthesis of prostaglandin and thromboxane precursors from arachidonic acid. In addition to anti-inflammatory actions, they have analgesic, antipyretic, and platelet inhibitory actions.

one 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.

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.

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.

polluted air means air with 24 hour average concentrations of:

(a) particulate matter with an aerodynamic diameter of less than 2.5 micrometres (PM2.5), exceeding 50 micrograms of cubic metre; or

(b) particulate matter with an aerodynamic diameter of less than 10 micrometres (PM10), exceeding 150 micrograms per cubic metre.

relevant service means:

(a) operational service under the VEA;

(b) peacekeeping service under the VEA;

(d) British nuclear test defence service under the VEA;

(e) warlike service under the MRCA; or

(f) non-warlike service under the MRCA.

Note: MRCA and VEA are defined in the Schedule 1 - Dictionary.

terminal event means the proximate or ultimate cause of death and includes the following:

(a) pneumonia;

(b) respiratory failure;

(d) circulatory failure; or

(e) cessation of brain function.

thrombolytic (fibrinolytic) therapy means therapeutic administration of a pharmacological agent in order to dissolve a thrombus, retard fibrin deposition on established thrombi or prevent the formation of new thrombi, and includes agents such as streptokinase, urokinase, tissue plasminogen activator, prourokinase, acyl-SK-plasminogen, anistreplase, alteplase, defibrotide, duteplase, lanoteplase, monteplase, nasaruplase, saruplase, staphylokinase or reteplase;

VEA means the Veterans' Entitlements Act 1986.

witness means a person who experiences an incident at the time it occurs and can give direct evidence of it. This excludes persons exposed only to public broadcasting or mass media coverage of the incident.

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Statement of Principles

concerning

CEREBROVASCULAR ACCIDENT (STROKE) (Reasonable Hypothesis)

(No. 45 of 2024)

The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(2) of the Veterans' Entitlements Act 1986.

Dated 21 June 2024.

<br> <br> <br> <br> <br> <br>Professor Terence Campbell AM<br>Chairperson<br>by and on behalf of <br>The Repatriation Medical Authority<br>

Contents

1 Name

2 Commencement

3 Authority

4 Repeal

5 Application

6 Definitions

7 Kind of injury, disease or death to which this Statement of Principles relates

8 Basis for determining the factors

9 Factors that must exist

10 Relationship to service

11 Factors referring to an injury or disease covered by another Statement of Principles

Schedule 1 - Dictionary

1 Definitions

1 Name

This is the Statement of Principles concerning cerebrovascular accident (stroke) (Reasonable Hypothesis) (No. 45 of 2024).

2 Commencement

This instrument commences on 23 July 2024.

3 Authority

This instrument is made under subsection 196B(2) of the Veterans' Entitlements Act 1986.

4 Repeal

The Statement of Principles concerning cerebrovascular accident No. 65 of 2015 (Federal Register of Legislation No. F2015L00652) made under subsections 196B(2) and (8) of the VEA is repealed.

5 Application

This instrument applies to a claim to which section 120A of the VEA or section 338 of the Military Rehabilitation and Compensation Act 2004 applies.

6 Definitions

The terms defined in the Schedule 1 - Dictionary have the meaning given when used in this instrument.

The statutory instrument rests on a set of core concepts that structure its operation. The leading concept is the “reasonable hypothesis” threshold for causation in the veterans’ compensation context. Section 9 prescribes the fact patterns that, if shown to exist and related to relevant service, constitute at least the minimum necessary for a reasonable hypothesis to be raised connecting cerebrovascular accident (stroke) or death from it to service (s 9). The Repatriation Medical Authority states its view that there is “sound medical‑scientific evidence” linking stroke and death from stroke to relevant service; this is the evidentiary posture underpinning the list of factors (s 8). The instrument therefore functions as an evidentiary template: it enumerates qualifying factors and sets temporal and quantitative thresholds for many of them.

Definitional control is another main concept. The instrument does not rely solely on external classification systems. Although it cites ICD‑10‑AM codes as attracting stroke codes (s 7(3)-(4)), it expressly provides the operative definition of cerebrovascular accident in subsection 7(2). That definition identifies the causal mechanisms (brain ischaemia or intracerebral haemorrhage) and specifies inclusions and exclusions (for example excluding subarachnoid haemorrhage and “silent stroke”). The Schedule supplements that with technical definitions (for example “brain ischaemia”, “intracerebral haemorrhage”, and “hypertensive emergency or crisis”), and measurement units such as MET and BMI (Schedule 1).

Temporal windows and dose thresholds are central. Many factors are qualified by precise time limits relative to clinical onset, for example infections within 4 weeks (s 9(7)), Varicella‑zoster virus within 1 year (s 9(8)), SARS‑CoV‑2 within 3 months (s 9(53)), or exposure to certain drugs within 72 hours (s 9(16)) or 4 weeks (s 9(17)-(18)). Quantitative thresholds are specified for behaviours and exposures: alcohol consumption measured in grams per week, binges defined by specific grams within set periods (s 9(4)-(6)), smoking measured in cigarettes per day or pack‑years (s 9(54)-(57)), salt intake in grams per day (s 9(52)), and hours of second‑hand smoke exposure (s 9(58)). For obesity and body composition the SoP uses BMI and waist‑to‑hip ratios and sets persistence requirements (for example obese for at least 5 years within the 15 years before clinical onset (s 9(34)-(36)); Schedule 1 defines BMI and the waist‑to‑hip thresholds).

Heterogeneity of causal pathways is built into the list. The factors include direct vascular pathology (for example atheroma, cerebral amyloid angiopathy, Moyamoya, cerebral venous thrombosis at s 9(13)), systemic conditions that increase thrombosis or bleeding risk (for example hypercoagulable states in s 9(67), anticoagulant therapy in s 9(76), disorders associated with intracerebral haemorrhage in s 9(79)), procedural risks (for example cardiac surgery or catheterisation in s 9(27)), trauma and iatrogenic causes (for example traumatic neck injury at s 9(73), venous air embolism with congenital defects at s 9(26)), and environmental risks (for example polluted air exposure with defined PM2.5/PM10 thresholds in Schedule 1 and hours of exposure at s 9(74)-(75)). The list also includes psychosocial stressors (categories 1A, 1B and 2 defined in Schedule 1 and included at s 9(40)-(42)) as potential precipitants.

Cross‑SoP interaction is another structured concept. Section 11 provides that where a factor in s 9 refers to an injury or disease covered by another SoP, then the factors in that other SoP apply according to its terms as in force. This creates an incorporation mechanism and requires decision‑makers and practitioners to consult multiple SoPs where cross‑references arise (s 11).

Finally, the instrument distinguishes conditions by subtype. Many factors are qualified to apply only to brain ischaemia or only to intracerebral haemorrhage (see s 9 where numerous items are prefaced “for brain ischaemia only” or “for intracerebral haemorrhage only”). This bifurcation reflects that certain exposures, treatments or pathologies present differential causal relevance to ischaemic versus haemorrhagic events; mechanically the SoP requires the correct subtype to be established for the relevant factor to operate.

All of these concepts are anchored in the Schedule’s definitions and the express temporal and quantitative thresholds in s 9, which together determine the boundaries of what may raise a reasonable hypothesis linking stroke to relevant service (s 7-9; Schedule 1).

The instrument applies to particular classes of claimants and decision‑makers. Its application clause states that the SoP applies to a claim to which section 120A of the VEA or section 338 of the MRCA applies (s 5). Those references identify the statutory claims processes for veterans, members of Peacekeeping Forces, and members of the Forces covered by the VEA and MRCA. The Schedule defines “relevant service” to include operational, peacekeeping, hazardous and British nuclear test defence service under the VEA and warlike or non‑warlike service under the MRCA (Schedule 1, definition of relevant service). In practical effect, claimants who are veterans or former members of the Forces seeking entitlements tied to cerebrovascular accident (stroke) will be directly affected because adjudicators will apply this SoP in deciding whether a reasonable hypothesis of service connection is established (s 5, s 9).

Decision-makers within the Department of Veterans’ Affairs and tribunals that hear appeals of administrative decisions will be affected because they must apply the SoP as the medical‑scientific framework that supports causation findings under the VEA and MRCA. The instrument itself is made under s 196B(2) of the VEA by the Repatriation Medical Authority (s 3), and the Authority’s view that there is sound medical‑scientific evidence underpins the list of factors (s 8). Medical practitioners preparing reports and treating clinicians providing records will be affected because the SoP specifies precise clinical and temporal thresholds that reports should address to establish the existence (or absence) of listed factors (see s 9 and Schedule 1).

The instrument can also affect claims management and record‑keeping practices at hospitals and defence health services, because many factors require documentation that is commonly held in acute hospital records, procedure notes, imaging reports, prescription and medication records, occupational exposure logs and service records. For example, several factors are tied to surgical procedures, administration of specific drugs, radiation doses or ICU admissions within specified time windows (s 9(27), s 9(61), s 9(71), s 9(29)). The SoP therefore creates practical evidentiary expectations for claimants and clinicians.

Stakeholders in legal practice and advocacy are affected because the SoP determines the threshold for a reasonable hypothesis. Legal advisers preparing claims or appeals must marshal evidence mapped to the SoP’s enumerated factors and the Schedule’s definitions; they must also be alert to the cross‑reference rule in s 11 where other SoPs cover co‑existing conditions. Finally, the repeal provision (s 4) affects any claimant or decision‑maker who had relied on the previous 2015 SoP, because the new instrument replaces it as of commencement (s 2, s 4).

The instrument does not on its face create new statutory rights or novel penalties. It is an evidentiary standard for administrative decisions under the VEA and MRCA. The parties who “pay” in the operational sense are the administrators of the scheme who must apply the SoP and claimants who must marshal evidence against the enumerated thresholds; the parties who “decide” are those administrative decision‑makers applying the SoP together with the Repatriation Medical Authority which made the instrument (s 3, s 5, s 9-11).

The SoP establishes a framework of duties and evidentiary expectations rather than prescriptive procedural commands. The principal duty imposed by the instrument is procedural and evidentiary: a claimant who wishes to establish that cerebrovascular accident (stroke) or death from it is connected to relevant service must show, as a minimum, that at least one of the enumerated factors in section 9 existed and that that factor is related to the person’s relevant service (s 9; s 10(1)). The instrument does not state how evidence is to be presented, but the detailed thresholds and temporal windows in s 9 imply duties on claimants and their advisers to obtain clinical, laboratory and service records that establish the presence and timing of a listed factor.

Decision‑makers charged with assessing claims under section 120A of the VEA or section 338 of the MRCA must apply this SoP as the medical‑scientific basis for drawing a reasonable hypothesis as to service connection, insofar as those claims fall within the SoP’s application (s 5; s 8). The Repatriation Medical Authority expresses the view that sound medical‑scientific evidence supports the connections listed (s 8); the duty on decision‑makers is to treat the SoP as the specified medical standard in claims covered by the referenced statutory provisions.

There is an incorporation duty concerning other SoPs. Section 11 provides that where a factor in s 9 refers to an injury or disease covered by another SoP determined under subsection 196B(2) of the VEA, the factors in that other SoP “apply in accordance with the terms of that Statement of Principles as in force from time to time.” This places a duty on decision‑makers and practitioners to identify and refer to other SoPs when factors overlap, and to apply the other SoP’s terms as current. For example, if a factor in s 9 refers to a condition that itself is governed by another SoP, that other instrument’s factors and temporal definitions will form part of the analytical chain.

The SoP sets rights in a limited sense: claimants have the right to have their claims judged against this SoP for the relevant statutory provisions. The instrument does not specify procedural rights such as disclosure or review rights; those remain governed by the VEA, the MRCA and administrative law. There is no positive obligation in the SoP that compels third parties to produce documents; however, the practical effect is that claimants will need to seek records that prove presence and timing of listed factors to vindicate their rights under the VEA/MRCA.

The Schedule clarifies interpretive rights and limits in some places. Notably, the definition of “clinically significant” (Schedule 1) states that the condition must be “sufficient to warrant ongoing management” but also expressly notes that ongoing management need not actually have been provided. That affects the claimant’s burden on some psychiatric and chronic conditions included in s 9 (for example PTSD, anxiety disorders, depressive disorder, schizophrenia and bipolar disorder at various temporal thresholds listed in s 9(39), s 9(45)-(49)). Practitioners and decision‑makers must apply that definition when assessing those factors.

There is a narrowly framed right in s 7(5): death from cerebrovascular accident (stroke) is included where the death was from a terminal event or condition that the person’s stroke contributed to. The Schedule defines “terminal event” and lists examples (Schedule 1: terminal event). This creates an evidentiary obligation to show the causal contribution of stroke to the terminal event where death is claimed.

Finally, s 10(2) places a specific limitation on the application of s 9(92), the inability to obtain appropriate clinical management. That factor applies only where the stroke was suffered or contracted before or during (but did not arise out of) the person’s relevant service. This creates a duty to demonstrate the temporal relationship between the stroke and the service period in that particular sub‑case.

In sum, the instrument imposes duties of proof and cross‑instrument awareness on claimants and decision‑makers, and clarifies certain interpretive rights (for example the Schedule’s note on “clinically significant”). The SoP does not create stand‑alone administrative procedures, penalties or other statutory entitlements beyond shaping the causal standard for relevant claims.

The Statement of Principles is an administrative medical instrument and contains no penal provisions or criminal offences. The text is focused on definitions, enumerated factors and their temporal and quantitative thresholds; it does not create enforcement mechanisms, fines, or sanctions within the instrument itself. The instrument’s legal operation is to supply the medical‑scientific foundation for adjudication of claims under the VEA and MRCA (s 3, s 5, s 8). Enforcement, in the ordinary sense of adjudicating compliance or imposing penalties, is the responsibility of the statutory decision‑making apparatus created by the VEA and MRCA, not of the SoP instrument. The SoP therefore functions as guidance that administrative decision‑makers apply when determining whether the “reasonable hypothesis” threshold is met for a claim.

Where the SoP is applied, administrative consequences follow from the decision under the VEA or MRCA rather than from the SoP itself. If a decision‑maker finds that a qualifying factor exists and is related to relevant service such that a reasonable hypothesis is raised, that factual finding feeds into the statutory criteria for entitlement in the relevant Acts. Conversely, failure to establish any of the listed factors (or inability to link a factor to relevant service) will tend to leave the claimant unable to establish a reasonable hypothesis and therefore may result in claim refusal under the statutory claims regime. Those outcomes are administrative and statutory, not criminal, and the SoP does not prescribe a particular remedy beyond serving as the evidentiary benchmark.

The instrument provides no procedural enforcement details or compliance inspections. It does not lay down investigative powers, subpoena powers or sanctions for non‑production of evidence. Those procedural tools, if relevant, derive from the VEA/MRCA and general administrative law processes, none of which are set out in this instrument. Similarly, there are no specific penalties for misrepresentation in relation to meeting a factor; any consequences for fraudulent representations would arise under general law or the statutory frameworks governing veterans’ entitlements rather than from the SoP text itself.

The Schedule and the instrument make clear that definitions and thresholds must be applied in assessing claims. Any contention about application or interpretation of the SoP would be resolved through the administrative decision process and, where appropriate, by judicial review or merits review avenues available under the VEA and MRCA. The instrument contains no list of administrative remedies or enforcement steps specific to its application, and contains no separate enforcement regime.

The SoP is tightly framed to operate within the VEA and MRCA statutory contexts. Its authority is expressly drawn from subsection 196B(2) of the VEA (s 3), and section 5 states it applies to claims under section 120A of the VEA or section 338 of the MRCA. The Schedule defines “VEA” and “MRCA” and defines “relevant service” by cross‑reference to the service categories in those Acts (Schedule 1). Thus, the instrument is an ancillary medical instrument whose legal effect is mediated through the substantive statutes governing veterans’ entitlements and military rehabilitation and compensation.

Section 11 creates an express mechanism for interaction with other Statements of Principles determined under subsection 196B(2) of the VEA. If a factor in s 9 refers to an injury or disease covered by another SoP, then the factors in that other SoP apply “in accordance with the terms of that Statement of Principles as in force from time to time” (s 11). This cross‑SoP incorporation means that multiple SoPs may need to be consulted and applied in tandem, and that changes to other SoPs (amendments) will affect how referenced factors are applied. The instrument therefore forms part of a network of SoPs rather than operating in isolation.

The SoP references an external clinical classification system, ICD‑10‑AM, by listing codes associated with cerebrovascular accident at subsection 7(3) and defining the edition referenced (Tenth Edition, effective date 1 July 2017) at subsection 7(4). However, the SoP makes it explicit that the meaning of “cerebrovascular accident (stroke)” for the purposes of the instrument is the statutory definition in s 7(2) and not merely the ICD code list (s 7(3)). This means that while decision‑makers may use ICD codes as ancillary information, the statutory definition controls.

Several factors require measurement or thresholds that intersect with other legal or regulatory regimes. For example, the Schedule’s definitions of “chronically polluted air” and “polluted air” reference particulate concentrations (PM2.5 and PM10) with specific microgram per cubic metre thresholds (Schedule 1). These environmental measures may be sourced from or validated by environmental law or regulatory monitoring data, but the instrument itself does not set out how those data are to be obtained or by whom. Similarly, the cumulative equivalent dose of ionising radiation is defined in the Schedule in terms that would normally implicate records governed by radiation safety and occupational health frameworks (Schedule 1, cumulative equivalent dose). The SoP does not prescribe which agencies produce radiation dose records; it simply requires a claimant to establish the cumulative dose where that factor is invoked (s 9(71)).

Where a factor references a prescribed therapy or drug (for example thrombolytics, anticoagulants, VEGF inhibitors, alemtuzumab, ponatinib, thalidomide analogues), the SoP relies on clinical usage and product names as markers. These interactions may require references to pharmaceutical records and medical prescribing law or hospital pharmacy records. The SoP does not itself regulate prescribing or hospital practice; it requires evidence of exposure to those agents within the time windows specified (s 9(61), (76), (88)-(91)).

Finally, the SoP’s cross‑references to psychosocial stressors (category 1A, 1B, 2) create an intersection between medical causation and factual determinations about exposure to traumatic events. The Schedule defines “corpse”, “witness” and various categories of stressor (Schedule 1 definitions for category stressors). Determinations about those stressors will require evidence from service records, witness statements and incident reports held under the VEA/MRCA administrative frameworks. The SoP therefore interfaces with other aspects of veteran‑related administrative law and record systems rather than creating novel cross‑agency powers.

In sum, the SoP functions as a medical‑scientific Appendix to the VEA/MRCA claims regime and interacts with other SoPs, classification systems and record‑keeping regimes. It does not displace or duplicate substantive provisions of other laws, but it requires the use of evidence that may be sourced from environmental, occupational, medical and military record systems.

This instrument expressly repeals the Statement of Principles concerning cerebrovascular accident No. 65 of 2015 (Federal Register of Legislation No. F2015L00652), which was made under subsections 196B(2) and (8) of the VEA (s 4). The new Statement of Principles is identified as No. 45 of 2024 and is dated 21 June 2024 (front matter). It commences on 23 July 2024 (s 2). The instrument is made under subsection 196B(2) of the VEA (s 3), which is the statutory power under which the Repatriation Medical Authority determines SoPs.

The instrument does not record any prior amendments to itself because it is a new SoP that replaces the 2015 instrument. The text contains no schedules of transitional provisions, savings clauses or grandfathering provisions expressly preserving determinations made under the prior SoP. The single express amendment event recorded in the instrument is the repeal of the 2015 SoP (s 4). The instrument does not set out an amendment schedule or a process for future amendment; by statutory design, SoPs are updated from time to time by the Repatriation Medical Authority under the VEA’s subsection 196B(2), so future amendments would likely be recorded in later instruments made under that subsection.

For practitioners tracking the evolution of medical causation criteria, the material change is that the 2015 SoP is rescinded and replaced by this list of factors and definitions. The instrument does not annex a comparison table between the old and new lists; therefore users must compare the two instruments directly if they wish to identify substantive additions, deletions or rewordings relative to the 2015 version. The commencement date is explicit (23 July 2024), so claims determined after that date (subject to the transitional provisions of the VEA/MRCA and administrative practice) will be assessed against the new SoP.

The Schedule contains several definitional clarifications and notes (for example clarifying that “clinically significant” does not require actual treatment), which may represent substantive interpretive changes relative to prior instruments; however, the new instrument is the operative legal text as of its commencement. There is no amendment history in the instrument itself beyond the repeal of the 2015 SoP.

The instrument as provided contains no citations of cases and records no litigation history. It is a standard Statement of Principles format document: a determinate list of medical factors and technical definitions determined by the Repatriation Medical Authority under subsection 196B(2) of the VEA (s 3, s 9). There are no judicial decisions, tribunal determinations or other litigation events referenced within the text.

That silence in the instrument does not mean litigation is impossible or improbable in practice; the SoP will be engaged in administrative determinations under the VEA and MRCA and may, as a functional matter, be the subject of merits review or judicial review in particular claims. However, any such litigation history is outside the content of this instrument and therefore not recorded in the text provided. Users seeking adjudicative precedent that interprets or applies this particular SoP will need to search tribunal and court databases for decisions post‑commencement that expressly cite the No. 45 of 2024 Statement of Principles.

If litigation occurs, the issues likely to attract adjudication would include interpretation of definitional terms in the Schedule (for example how to apply the “clinically significant” note, or how to calculate pack‑years and whether documentation meets the thresholds), the correct mapping of a claimant’s clinical event to the ischaemic versus haemorrhagic categories (given several factors apply only to one subtype), the temporal application of the specified windows, and the operation of s 11 where cross‑references to other SoPs arise. But none of those hypothetical case types are cited in the instrument itself. The instrument does not list decisions applying or construing it, and gives no litigation narrative.

Practitioners and claimants therefore should be aware that at the time the instrument comes into force, there is no litigation history recorded within it; case law developing around its application will need to be monitored separately through tribunals and courts.

This SoP contains numerous operational and evidentiary traps for the unwary. First, many items require precise temporal alignment: the factor must exist within a strictly defined period “before clinical onset” or “at the time of clinical onset” for a particular stroke subtype. Examples include infections within 4 weeks (s 9(7)), Varicella‑zoster brain infection within 1 year (s 9(8)), drug use within 72 hours (s 9(16)), thrombolytic therapy within 7 days (s 9(78)), or receiving systemic VEGF inhibitors within 4 months (s 9(88)). Failure to document the exact timing against the clinical onset date may mean a potentially relevant factor cannot be accepted as meeting the stated threshold.

Second, the instrument frequently distinguishes between brain ischaemia and intracerebral haemorrhage, allocating different factors, quantities and time windows to each. Several factors are qualified “for brain ischaemia only” or “for intracerebral haemorrhage only” (see multiple entries in s 9). A claimant’s treating records thus must establish the subtype of stroke with adequate diagnostic detail; relying on an ICD code alone may be insufficient because s 7(2) provides a statutory definition and s 7(3) states that, in applying the SoP, the meaning given in s 7(2) controls despite ICD‑10‑AM codes being relevant.

Third, the instrument relies heavily on quantified behavioural thresholds that can be hard to prove. Examples include alcohol consumption thresholds measured in grams per week or within days (s 9(4)-(6)), salt intake in grams per day over six months (s 9(52)), pack‑year calculations for smoking with cessation windows (s 9(54)-(57)), and a requirement to demonstrate exposure to second‑hand smoke for at least 5,000 hours with the last exposure within five years (s 9(58)). Proving these quantities and durations will typically require contemporaneous clinical records, employment and housing histories, or credible witness statements; the SoP does not specify acceptable forms of proof.

Fourth, some definitions in the Schedule depart from intuitive evidentiary requirements. For example, “clinically significant” is defined as “sufficient to warrant ongoing management” and the Note makes clear that ongoing management need not actually have been received (Schedule 1). That reduces the evidentiary requirement in one sense but raises an interpretive issue about the standard to be applied in the absence of treatment: a decision‑maker must be satisfied that the condition was of that degree even if the person did not receive care.

Fifth, cross‑SoP links create complexity. Section 11 dictates that where a factor refers to an injury or disease covered by another SoP, that other SoP applies “as in force from time to time.” Practically this means a claimant may need to identify and satisfy multiple SoPs simultaneously. Failure to recognise the need to consult the relevant other SoP may lead to misframing of evidence or missed factors.

Sixth, the instrument contains items that require specialist technical data (for example cumulative equivalent radiation dose at least 0.5 sievert to head, neck or mediastinum (s 9(71)), or environmental particulate concentrations that meet the Schedule’s PM2.5/PM10 thresholds (s 9(74)-(75) and Schedule 1)). Those data typically reside with regulatory bodies, occupational health units or hospital radiation records. The SoP does not specify provenance of such data; claimants must secure them from third parties.

Seventh, some factors are situational and fact‑intensive, such as the definition of category 1A/1B/2 stressors (Schedule 1) and the Schedule’s restricted definitions of “corpse” and “witness”. The Schedule’s examples narrow what counts for certain stressors (for instance, seeing a closed body bag or televised images is excluded from “corpse”). Claimants relying on stressor items must map their factual narrative tightly to the Schedule’s prescribed categories.

Eighth, certain items are framed negatively or are limited by service timing. The inability to obtain appropriate clinical management factor at s 9(92) only applies where the stroke was suffered or contracted before or during relevant service and did not arise out of the person’s relevant service (s 10(2)). That specialised limitation can be overlooked and is an unusual application constraint.

Ninth, the instrument lists many clinical disorders and therapies by name (for example specific chemotherapy agents, immunomodulators and antipsychotics at s 9(83), (86)-(91)). Practitioners must ensure drug names and classes are consistently identified with the SoP wording; imprecise drug descriptions may fail to meet the stated factor.

Finally, there is the general “at least one factor” formulation in s 9: only one listed factor needs to be shown as a minimum to raise a reasonable hypothesis. This can be a double‑edged sword. On one hand, a clearly documented single qualifying factor may be sufficient for the threshold; on the other, if the available evidence is spread across several non‑qualifying or borderline items, nothing may meet the narrow thresholds. The SoP therefore drives a binary evidentiary test in many cases that requires precise, often quantitative proof.

Users must therefore map evidence to the exact wording and temporal windows in the instrument, and be alert to the Schedule’s definitions which materially affect interpretation. The instrument’s granular lists and thresholds are a source of both opportunity and risk depending on the quality and specificity of available records.

Compliance in this context is about assembling, documenting and presenting the evidence necessary for decision‑makers to find that at least one factor in s 9 existed and was related to the person’s relevant service (s 9; s 10). Below are concrete, source‑grounded steps and evidential categories that claimants, treating clinicians and advisers should attend to, anchored to the instrument’s requirements.

Establish the clinical onset and stroke subtype precisely

Obtain clinical notes, emergency department records, inpatient summaries, neurology consults and neuroimaging reports to confirm the date and clinical onset and to classify the event as brain ischaemia or intracerebral haemorrhage as per s 7(2) and Schedule 1 definitions (brain ischaemia, intracerebral haemorrhage). The SoP frequently conditions factors on the subtype and on the date of clinical onset.

Map available factors to section 9 with attention to timing and quantity

For each factor asserted under s 9, identify the temporal window applicable (for example within 72 hours, 4 weeks, 3 months, 1 year, 5 years, 10 years) and extract supporting records that place the factor inside that window. Many items are time‑bound; documentation must show occurrence within the specified interval.
For quantifiable exposures (alcohol grams, salt grams, cigarettes per day, pack‑years, hours of second‑hand smoke, BMI duration, waist‑to‑hip ratio duration), collate contemporaneous medical records, hospital nutrition notes, occupational exposure records, pharmacy dispensing histories, and documented histories from treating clinicians that quantify consumption or measurements. The Schedule defines units such as MET and pack‑year that must be applied (Schedule 1).

Medical and hospital evidence

For infections, septicemia, ICU admission, cardiac conditions, surgical procedures, transfusions, thrombolytic therapy, anticoagulant therapy, or receipt of specified drugs, obtain procedure notes, operation records, pharmacy charts, ICU summaries and discharge summaries specifying dates and agents. Section 9 includes many items that require confirming a procedure or therapy within short windows (for example s 9(27), s 9(61), s 9(76)-(78), s 9(88)-(91)).
For thrombophilia, hypercoagulable states and haematological disorders, include laboratory results and consultant haematology reports indicating diagnosis and timing (s 9(67), s 9(79)).

Service records and linkage to relevant service

Obtain service records, postings and deployment histories that show the timing and nature of relevant service, consistent with the Schedule’s definition of relevant service. Establish the causal or temporal link required by s 10(1). Where invoking s 9(92) inability to obtain appropriate clinical management, ensure the stroke occurred before or during service (but did not arise out of it) to meet s 10(2), and gather evidence of healthcare access issues (referrals, local facility limitations, evacuation policies, contemporaneous correspondence).

Environmental and occupational exposure data

For factors referencing polluted air or radiation dose, obtain monitoring data, occupational exposure logs, radiation records and dosimetry where relevant. The Schedule defines “polluted air” and “chronically polluted air” with specific particulate thresholds (Schedule 1), and cumulative equivalent dose is defined with a sievert threshold for radiation (s 9(71); Schedule 1). Secure authoritative data from employers, environmental agencies or hospital radiation safety units.

Psychosocial stressors and psychiatric conditions

For category 1A/1B/2 stressors, obtain incident reports, witness statements, service investigation reports and contemporaneous clinical notes that map the event to the Schedule’s categories (Schedule 1 definitions). For “clinically significant” psychiatric disorders, supply clinical notes that show the condition warranted ongoing management even if actual ongoing treatment did not occur, per the Schedule’s note on “clinically significant” (Schedule 1).

Lifestyle and anthropometric evidence

For obesity, underweight, sedentary behaviour and metabolic risk factors, obtain recorded BMI trajectories, weight charts, GP notes, allied health records and employment medicals documenting duration and timing as required by s 9 and Schedule 1 (for example obesity for at least 5 years within the 15 years before clinical onset at s 9(34)).

Drug exposure and pharmacology

For alleged exposure to drugs specified in s 9 (for example SSRIs, antipsychotics, VEGF inhibitors, alemtuzumab, ponatinib, thalidomide analogues), obtain pharmacy dispensing records, specialist clinic notes and treatment summaries with dates sufficient to show the duration and last dose timing required by the SoP.

Cross‑SoP factors and references

Where a factor in s 9 refers to an injury or disease governed by another SoP, identify that other SoP and obtain evidence to meet its criteria as “in force from time to time” (s 11). Ensure integrated evidence packages address both instruments’ requirements.

Record clarity on exclusion categories

The SoP excludes certain haemorrhages (subarachnoid, subdural, extradural) from its definition of cerebrovascular accident (s 7(2)(c)). Ensure diagnostic differentiation is clear in records to avoid misapplication.

Prepare a structured medico‑legal narrative

Draft a clinician letter or medico‑legal report that addresses each relevant s 9 factor point by point, cites the Schedule definitions where relevant (for example “clinically significant” or “pack‑year”), and links the specific factor to the service history per s 10. Where only one factor needs to be shown (s 9), focus on the strongest documented factor and explain how it meets the instrument’s quantitative and temporal thresholds.

Anticipate evidentiary weaknesses

Where precise quantitative or timing data are absent, consider alternative corroborative evidence such as contemporaneous statements, workplace records, or hospital triage notes that can place an exposure close to the required window. Be mindful that absence of precise proof may mean the minimum threshold is not satisfied.

Monitor amendment and cross‑reference changes

Because s 11 incorporates other SoPs “as in force from time to time”, compliance requires periodic checking of related SoPs for updates that might alter factors or interpretation.

These steps are grounded in the instrument’s own wording: the SoP specifies the condition (s 7), the factors and their timing (s 9), the service linkage requirement (s 10) and the Schedule definitions that materially affect interpretation. Compliance is therefore documentary and analytic: assemble contemporaneous clinical, procedural, pharmaceutical, service, occupational and environmental records; map them to the SoP’s precise thresholds; and prepare a clinician’s narrative that ties the factor to service in the terms the instrument requires.

Statement of Principles concerning cerebrovascular accident (stroke) (Reasonable Hypothesis) (No. 45 of 2024)

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