{"id":"F2024L00215","name":"Statement of Principles concerning myocarditis (Balance of Probabilities) (No. 18 of 2024)","slug":"statement-of-principles-concerning-myocarditis-balance-of-probabilities-no-18-of-2024","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":442288,"registerId":"F2024L00215-fast-fetch-1775957340107","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Statement of Principles concerning myocarditis (Balance of Probabilities) (No. 18 of 2024)","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\n---\n\n?xml version=\"1.0\" encoding=\"utf-8\" standalone=\"no\"?>\n\n![RMA Australian Government Coat of Arms](image.001.jpeg)\n\n \n\nStatement of Principles\n\nconcerning\n\nMYOCARDITIS  (Balance of Probabilities)\n\n(No. 18 of 2024)\n\nThe Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(3) of the Veterans' Entitlements Act 1986.\n\n \n\nDated                                           22 February 2024\n\n \n\n \n\n \n\n \n\n \n\n| The Common Seal of the  Repatriation Medical Authority  was affixed to this instrument  at the direction of:<br> |\n| --- |\n| <br> <br>Professor Terence Campbell AM<br>Chairperson<br> |\n\n\n \n\n   \n\n\nContents\n\n1 Name\n\n2 Commencement\n\n3 Authority\n\n4 Application\n\n5 Definitions\n\n6 Kind of injury, disease or death to which this Statement of Principles relates\n\n7 Basis for determining the factors\n\n8 Factors that must exist\n\n9 Relationship to service\n\n10 Factors referring to an injury or disease covered by another Statement of Principles\n\nSchedule 1 - Dictionary\n\n1 Definitions\n\n \n\n\n\n\n1               Name\n\nThis is the Statement of Principles concerning myocarditis (Balance of Probabilities) (No. 18 of 2024).\n\n2               Commencement\n\n              This instrument commences on 26 March 2024.\n\n3               Authority\n\nThis instrument is made under subsection 196B(3) of the Veterans' Entitlements Act 1986.\n\n4               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\n5               Definitions\n\nThe terms defined in the Schedule 1 - Dictionary have the meaning given when used in this instrument.\n\n6               Kind of injury, disease or death to which this Statement of Principles relates\n\n(1)          This Statement of Principles is about myocarditis and death from myocarditis.\n\nMeaning of myocarditis\n\n(2)          For the purposes of this Statement of Principles, myocarditis:\n\n(a)          means an inflammation of the heart muscle (myocardium); and\n\n(b)          excludes inflammation associated with coronary artery disease.\n\n(3)          While myocarditis attracts ICD‑10‑AM codes I40, I41, I01.2, I09.0, I51.4, in applying this Statement of Principles the meaning of myocarditis 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 myocarditis\n\n(5)          For the purposes of this Statement of Principles, myocarditis, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's myocarditis.\n\nNote: terminal event is defined in the Schedule 1 – Dictionary.\n\n7               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 myocarditis and death from myocarditis can be related to relevant service rendered by veterans or members of the Forces under the VEA, or members under the MRCA.\n\nNote: MRCA, relevant service and VEA are defined in the Schedule 1 – Dictionary.\n\n8               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, myocarditis or death from myocarditis is connected with the circumstances of a person's relevant service:\n\n(1)          undergoing a course of radiotherapy for cancer, where the heart was in the field of radiation, before clinical onset or clinical worsening;\n\n(2)           having a myocardial infection at the time of clinical onset or clinical worsening;\n\n(3)           having a systemic viral infection within the 4 weeks before clinical onset or clinical worsening;\n\n(4)          being infected with human immunodeficiency virus before clinical onset or clinical worsening;\n\n(5)           having tuberculosis before clinical onset or clinical worsening;\n\n(6)          having acute rheumatic fever at the time of clinical onset or clinical worsening;\n\n(7)          having one of the following vasculitides:\n\n(a)          Behcet disease;\n\n(b)          eosinophilic granulomatosis with polyangiitis (Churg Strauss syndrome);\n\n(c)          giant cell (temporal) arteritis;\n\n(d)          granulomatosis with polyangiitis (Wegener granulomatosis);\n\n(e)          Kawasaki disease;\n\n(f)           polyarteritis nodosa; or\n\n(g)          Takayasu arteritis;\n\nat the time of clinical onset or clinical worsening;\n\n(8)          having one of the following systemic inflammatory diseases:\n\n(a)          antiphospholipid syndrome;\n\n(b)          coeliac disease;\n\n(c)          dermatomyositis;\n\n(d)          Graves disease;\n\n(e)          Hashimoto disease;\n\n(f)           inflammatory bowel disease;\n\n(g)          polymyositis;\n\n(h)          rheumatoid arthritis;\n\n(i)            scleroderma (progressive systemic sclerosis);\n\n(j)            Sjögren syndrome; or\n\n(k)          systemic lupus erythematosus;\n\nat the time of clinical onset or clinical worsening;\n\n(9)          having myasthenia gravis at the time of or before clinical onset or clinical worsening;\n\n(10)      having cardiac graft acute cellular rejection at the time of clinical onset;\n\n(11)      having a haematopoietic stem cell transplant within the 4 years before clinical onset or clinical worsening;\n\n(12)       having a phaeochromocytoma or thymoma at the time of clinical onset or clinical worsening;\n\n(13)      being treated with one of the following medications within the 3 months before clinical onset or clinical worsening:\n\n(a)          alkylating agents including cyclophosphamide;\n\n(b)          anthracyclines including doxorubicin, daunorubicin, idarubicin, epirubicin and mitoxantrone;\n\n(c)          antibiotics including penicillin, cephalosporins, tetracyclines, sulphonamides, isoniazid, and streptomycin;\n\n(d)          carbamazepine;\n\n(e)          diuretics including furosemide and thiazides;\n\n(f)           fluoropyrimidines including 5-fluorouracil and capecitabine;\n\n(g)          immune checkpoint inhibitors including atezolizumab, avelumab, cemiplimab, dostarlimab, durvalumab, ipilimumab, nivolumab, pembrolizumab, relatilimab, retifanlimab, and tremelimumab;\n\n(h)          mesalazine (5-aminosalicylic acid);\n\n(i)            methyl dopa;\n\n(j)            phenytoin;\n\n(k)          quetiapine;\n\n(l)            tumour necrosis factor alpha antagonists including infliximab;\n\n(14)       being treated with clozapine within the 2 years before clinical onset or clinical worsening;\n\n(15)      taking a medication for at least 7 days which is associated in the individual with the clinical onset of myocarditis during medication therapy; and which is associated with:\n\n(a)          an increase in the symptoms and signs of myocarditis during drug therapy; and\n\n(b)          cessation of the symptoms and signs of myocarditis within weeks of discontinuing drug therapy;\n\n(16)      having a COVID-19 mRNA vaccine within the 4 weeks before clinical onset or clinical worsening;\n\n(17)      having smallpox vaccine within the 4 weeks before clinical onset or clinical worsening;\n\n(18)      using cocaine within the 3 months before clinical onset or clinical worsening;\n\n(19)       being envenomated by a scorpion, wasp, hornet, bee, spider of the Latrodectus spp. (including red back spider, katipo spider and black widow spider) within the 24 hours before clinical onset;\n\n(20)      being envenomated by a brown recluse spider (Loxosceles reclusa) within the one week before clinical onset;\n\n(21)      ingesting wild mushrooms or toadstools within the 7 days before clinical onset;\n\n(22)      having organophosphate poisoning or paraphenylene diamine poisoning at the time of clinical onset or clinical worsening;\n\n(23)      having chronic lead poisoning at the time of clinical onset or clinical worsening;\n\n(24)       having an alcohol use disorder at the time of clinical onset or clinical worsening;\n\n(25)      inability to obtain appropriate clinical management for myocarditis before clinical worsening.\n\n9               Relationship to service\n\n(1)          The existence in a person of any factor referred to in section 8, must be related to the relevant service rendered by the person.\n\n(2)          The clinical worsening aspects of factors set out in subsection 8 apply only to material contribution to, or aggravation of, myocarditis where the person's myocarditis was suffered or contracted before or during (but did not arise out of) the person's relevant service.\n\n10           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 8 applies in relation to a person; and\n\n(2)          that factor refers to an injury or disease in respect of which a Statement of Principles has been determined under subsection 196B(3) of the VEA;\n\nthen the factors in that Statement of Principles apply in accordance with the terms of that Statement of Principles as in force from time to time.\n\n \n\n \n\nSchedule 1 - Dictionary  \n\nNote:               See Section 5\n\n1               Definitions\n\nIn this instrument:\n\n                             MRCA means the Military Rehabilitation and Compensation Act 2004.\n\n                               myocarditis—see subsection 6(2).\n\n                             relevant service means:\n\n(a)          eligible war service (other than operational service) under the VEA;\n\n(b)          defence service (other than hazardous service and British nuclear test defence service) under the VEA; or\n\n(c)          peacetime service under the MRCA.\n\nNote: MRCA and VEA are defined in the Schedule 1 - Dictionary.             \n\n                             terminal event means the proximate or ultimate cause of death and includes the following:\n\n(a)           pneumonia;\n\n(b)           respiratory failure;\n\n(c)           cardiac arrest;\n\n(d)           circulatory failure; or\n\n(e)           cessation of brain function.\n\n                             VEA means the Veterans' Entitlements Act 1986.\n\n \n\n \n","sortOrder":0}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"This instrument maintains the standard scope of Repatriation Medical Authority Statements of Principles. It follows the established template for determining service-connected diseases under the VEA and MRCA, with no expansion beyond the traditional framework of listing specific causal factors for a single condition. The inclusion of contemporary factors (COVID-19 vaccines, immune checkpoint inhibitors) reflects updates to medical knowledge rather than scope creep."},"complexity_factors":["25 distinct causal factors with varying timeframes (24 hours to 4 years)","Multiple nested lists of specific diseases, medications, and substances (e.g., 7 vasculitides, 11 systemic inflammatory diseases, 12 medication classes)","Cross-references to other Statements of Principles for conditions mentioned in the factors","Dual application structure — covers both clinical onset AND clinical worsening, with different rules for each","Specific medical coding reference (ICD-10-AM Tenth Edition) with ISBN and effective date","Conditional logic in factor 15 requiring three cumulative elements (7 days use, symptom increase during therapy, cessation after discontinuation)","Exclusion clause in definition (coronary artery disease excluded from myocarditis definition)"],"plain_english_summary":"This Statement of Principles sets the medical test for when myocarditis (or death from it) is presumed related to Australian military service: claims succeed on the balance of probabilities and 25 specified medical factors create a rebuttable presumption of service connection. It applies to veterans and current/former defence members claiming under the VEA or MRCA for non-operational service. Notably it includes COVID‑19 mRNA vaccines and modern cancer immunotherapies among the listed factors."},"flash_summary":{"complexity_score":5,"scope_assessment":{"changed":false,"description":"The instrument sets the scope to myocarditis and death from myocarditis for claims under section 120B of the VEA or section 339 of the MRCA (s 4, s 6). It defines myocarditis narrowly (excluding coronary artery disease) and prescribes the factors and timing that must be present (s 6, s 8). The text does not indicate an expansion or contraction relative to an earlier stated intent within this instrument."},"complexity_factors":["Long enumerated list of discrete medical, toxicological, infectious and treatment-related factors (s 8) — many specific diseases, drugs and exposures increase evidentiary complexity.","Multiple temporal thresholds that condition causation (s 8: e.g. 24 hours, 7 days, 4 weeks, 3 months, 2 years, 4 years) requiring precise timing evidence.","Distinction between clinical onset and clinical worsening and limiting of 'worsening' to pre-existing myocarditis (s 9(2)), which affects burden of proof and case framing.","Cross-references to other Statements of Principles where a listed factor is itself covered elsewhere (s 10) — requires checking other instruments.","Legal application limited to claims under specified statutory provisions (s 4) and reliance on RMA's view of 'balance of probabilities' based on medical‑scientific evidence (s 7).","Use of ICD-10-AM codes for classification but an independent definitional override in the instrument (s 6(2)–(4)) creating potential coding vs. definition mismatches.","Broad, open-ended factor (inability to obtain appropriate clinical management) (s 8(25)) that is factual and system-dependent, increasing factual inquiry.","Some items require specialist clinical interpretation (e.g. graft rejection, vasculitides, autoimmune diseases, vaccine timing) imposing medical-evidence and expert-report costs."],"plain_english_summary":"This Statement of Principles defines myocarditis (and death from it) and lists the medical exposures, illnesses, treatments and timing windows that must exist for myocarditis to be accepted as related to a person’s eligible military or peacetime service under the VEA or MRCA. It affects veterans and serving members making claims by setting the evidentiary criteria decision-makers will apply when deciding entitlement to benefits."},"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"}},"importantCases":[],"_links":{"self":"/api/acts/statement-of-principles-concerning-myocarditis-balance-of-probabilities-no-18-of-2024","history":"/api/acts/statement-of-principles-concerning-myocarditis-balance-of-probabilities-no-18-of-2024/history","analysis":"/api/acts/statement-of-principles-concerning-myocarditis-balance-of-probabilities-no-18-of-2024/analysis","conflicts":"/api/acts/statement-of-principles-concerning-myocarditis-balance-of-probabilities-no-18-of-2024/conflicts","importantCases":"/api/acts/statement-of-principles-concerning-myocarditis-balance-of-probabilities-no-18-of-2024/important-cases","documents":"/api/acts/statement-of-principles-concerning-myocarditis-balance-of-probabilities-no-18-of-2024/documents"}}