{"id":"F2022L00909","name":"Statement of Principles concerning dermatomyositis (Reasonable Hypothesis) (No. 70 of 2022)","slug":"statement-of-principles-concerning-dermatomyositis-reasonable-hypothesis-no-70-of-2022","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":441446,"registerId":"F2022L00909-fast-fetch-1775956736231","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Statement of Principles concerning dermatomyositis (Reasonable Hypothesis) (No. 70 of 2022)","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\nmeta-generator: Aspose.Words for .NET 22.10.0\n---\n\n?xml version=\"1.0\" encoding=\"utf-8\" standalone=\"no\"?>\n\n\n\n \n\nStatement of Principles\n\nconcerning\n\nDERMATOMYOSITIS (Reasonable Hypothesis)\n\n(No. 70 of 2022)\n\nThe Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(2) of the Veterans' Entitlements Act 1986.\n\n \n\nDated 24 June 2022\n\n \n\n \n\n \n\n \n\n \n\n| The Common Seal of the Repatriation Medical Authority was affixed to this instrument at the direction of:
|\n| --- |\n|
Professor Terence Campbell AM
Chairperson
|\n\n\n \n\n \n\n\nContents\n\n1 Name\n\n2 Commencement\n\n3 Authority\n\n4 Repeal\n\n5 Application\n\n6 Definitions\n\n7 Kind of injury, disease or death to which this Statement of Principles relates\n\n8 Basis for determining the factors\n\n9 Factors that must exist\n\n10 Relationship to service\n\n11 Factors referring to an injury or disease covered by another Statement of Principles\n\nSchedule 1 - Dictionary\n\n1 Definitions\n\n \n\n\n\n\n1 Name\n\nThis is the Statement of Principles concerning dermatomyositis (Reasonable Hypothesis) (No. 70 of 2022).\n\n2 Commencement\n\n This instrument commences on 25 July 2022.\n\n3 Authority\n\nThis instrument is made under subsection 196B(2) of the Veterans' Entitlements Act 1986.\n\n4 Repeal\n\nThe Statement of Principles concerning dermatomyositis No. 9 of 2014 (Federal Register of Legislation No. F2014L00008) made under subsection 196B(2) of the VEA is repealed.\n\n5 Application\n\nThis instrument applies to a claim to which section 120A of the VEA or section 338 of the Military Rehabilitation and Compensation Act 2004 applies.\n\n6 Definitions\n\nThe terms defined in the Schedule 1 - Dictionary have the meaning given when used in this instrument.\n\n7 Kind of injury, disease or death to which this Statement of Principles relates\n\n(1) This Statement of Principles is about dermatomyositis and death from dermatomyositis.\n\nMeaning of dermatomyositis\n\n(2) For the purposes of this Statement of Principles, dermatomyositis:\n\n(a) means a chronic inflammatory disease characterised by inflammatory skin changes, usually accompanied by progressive and symmetric skeletal muscle weakness; and\n\n(b) includes amyopathic dermatomyositis.\n\nNote 1: Typical skin changes include a heliotrope rash, and red or violet, sometimes scaly, slightly raised papules that erupt on the finger joints or other bony extremities (Gottron papules). Typical muscle disease involves progressive and symmetrical weakness of the limb-girdle muscles, with or without dysphagia and respiratory muscle weakness.\n\nNote 2: The diagnosis may be confirmed by elevation of serum levels of muscle-associated enzymes, biopsy, imaging or the presence of myositis-associated antibodies.\n\n \n\nNote 3: Amyopathic dermatomyositis is a variant of dermatomyositis that is characterised by the typical skin rash but without muscle abnormalities. Clinically, amyopathic dermatomyositis may be hypomyopathic, with no objective weakness but with evidence of subclinical muscle involvement on testing, or amyopathic, with no evidence of muscle involvement on examination or testing.\n\nDeath from dermatomyositis\n\n(3) For the purposes of this Statement of Principles, dermatomyositis, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's dermatomyositis.\n\nNote: terminal event is defined in the Schedule 1 – Dictionary.\n\n8 Basis for determining the factors\n\nThe Repatriation Medical Authority is of the view that there is sound medical‑scientific evidence that indicates that dermatomyositis and death from dermatomyositis can be related to relevant service rendered by veterans, members of Peacekeeping Forces, or members of the Forces under the VEA, or members under the MRCA.\n\nNote: MRCA, relevant service and VEA are defined in the Schedule 1 – Dictionary.\n\n9 Factors that must exist\n\nAt least one of the following factors must as a minimum exist before it can be said that a reasonable hypothesis has been raised connecting dermatomyositis or death from dermatomyositis with the circumstances of a person's relevant service:\n\n(1) taking a drug from the specified list of drugs for at least the 4 weeks before the clinical onset of dermatomyositis;\n\nNote: specified list of drugs is defined in the Schedule 1 – Dictionary.\n\n(2) taking hydroxyurea for at least the 6 months before the clinical onset of dermatomyositis;\n\n(3) taking an immune checkpoint inhibitor or interferon alfa within the 1 year before the clinical onset of dermatomyositis;\n\nNote: Examples of immune checkpoint inhibitors include ipilimumab, nivolumab, pembrolizumab and tremelimumab.\n\n(4) taking a drug which is associated in the individual with the clinical onset of dermatomyositis during drug therapy and either:\n\n(a) the improvement of dermatomyositis within 2 months of discontinuing or tapering drug therapy; or\n\n(b) the redevelopment of dermatomyositis on rechallenge with the same drug; and\n\nwhere taking the drug continued for at least the 7 days before the clinical onset of dermatomyositis;\n\n(5) having a malignant neoplasm, other than non-melanotic malignant neoplasm of the skin, within 5 years of the clinical onset of dermatomyositis;\n\n(6) taking a drug from the specified list of drugs for at least the 4 weeks before the clinical worsening of dermatomyositis;\n\nNote: specified list of drugs is defined in the Schedule 1 – Dictionary.\n\n(7) taking hydroxyurea for at least the 6 months before the clinical worsening of dermatomyositis;\n\n(8) taking an immune checkpoint inhibitor or interferon alfa within the 1 year before the clinical worsening of dermatomyositis;\n\nNote: Examples of immune checkpoint inhibitors include ipilimumab, nivolumab, pembrolizumab and tremelimumab.\n\n(9) taking a drug which is associated in the individual with:\n\n(a) the clinical worsening of dermatomyositis during drug therapy; and\n\n(b) the improvement of dermatomyositis within 2 months of discontinuing or tapering drug therapy; and\n\nwhere taking the drug continued for at least the 7 days before the clinical worsening of dermatomyositis;\n\n(10) having a malignant neoplasm, other than non-melanotic malignant neoplasm of the skin, within 5 years of the clinical worsening of dermatomyositis;\n\n(11) inability to obtain appropriate clinical management for dermatomyositis.\n\n10 Relationship to service\n\n(1) The existence in a person of any factor referred to in section 9, must be related to the relevant service rendered by the person.\n\n(2) The factors set out in subsections 9(6) to 9(11) apply only to material contribution to, or aggravation of, dermatomyositis where the person's dermatomyositis was suffered or contracted before or during (but did not arise out of) the person's relevant service.\n\n11 Factors referring to an injury or disease covered by another Statement of Principles\n\nIn this Statement of Principles:\n\n(1) if a factor referred to in section 9 applies in relation to a person; and\n\n(2) that factor refers to an injury or disease in respect of which a Statement of Principles has been determined under subsection 196B(2) of the VEA;\n\nthen the factors in that Statement of Principles apply in accordance with the terms of that Statement of Principles as in force from time to time.\n\n \n\n \n\nSchedule 1 - Dictionary \n\nNote: See Section 6\n\n1 Definitions\n\nIn this instrument:\n\n dermatomyositis—see subsection 7(2).\n\n MRCA means the Military Rehabilitation and Compensation Act 2004.\n\n relevant service means:\n\n(a) operational service under the VEA;\n\n(b) peacekeeping service under the VEA;\n\n(c) hazardous service under the VEA;\n\n(d) British nuclear test defence service under the VEA;\n\n(e) warlike service under the MRCA; or\n\n(f) non-warlike service under the MRCA.\n\nNote: MRCA and VEA are also defined in the Schedule 1 - Dictionary.\n\n specified list of drugs means:\n\n(a) 5-fluorouracil;\n\n(b) capecitabine;\n\n(c) D-penicillamine;\n\n(d) statins;\n\n(e) trastuzumab; or\n\n(f) tumour necrosis factor-alpha inhibitors.\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":{"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"},"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 replaces the 2014 version with updated medical factors (particularly expanded drug lists including modern immune checkpoint inhibitors), but remains focused on its original purpose: establishing medical-scientific bases for connecting dermatomyositis to veterans' service. No significant scope creep detected."},"complexity_factors":["Moderate cross-referencing between the main body and Schedule 1 (Dictionary) for defined terms","Dual application framework — applies to two different Acts (VEA and MRCA) with different service definitions","Conditional logic in section 9 with 11 distinct factors, some containing nested sub-conditions (e.g., factor 9(4) requires both association with drug AND improvement/discontinuation OR rechallenge)","Temporal requirements specified for multiple factors (4 weeks, 6 months, 1 year, 5 years, 7 days, 2 months)","Section 10 contains important limitations — factors 6-11 only apply to aggravation of pre-existing conditions, not initial onset","Section 11 creates dynamic incorporation of other Statements of Principles by reference","Medical terminology requiring specialist knowledge (amyopathic dermatomyositis, immune checkpoint inhibitors, heliotrope rash, Gottron papules)","Specific drug lists and examples embedded in notes and definitions"],"plain_english_summary":"This Statement of Principles sets the medical-scientific rules for linking dermatomyositis—a rare autoimmune disease causing skin rashes and muscle weakness—to Australian Defence service, replacing the 2014 version and applying to claims under the Veterans’ Entitlements Act and the Military Rehabilitation and Compensation Act. It guides decisions about entitlement by identifying service‑related factors (drugs, cancer, treatment access) and uses the “reasonable hypothesis” test so affected ADF members, veterans, peacekeepers and families can seek compensation."},"flash_summary":{"complexity_score":5,"scope_assessment":{"changed":true,"description":"This instrument expressly repeals the 2014 Statement of Principles for dermatomyositis (s4) and replaces it with updated criteria. It sets out specific factors and timing rules (s9), definitions (s7, Schedule 1) and cross‑references to other SOPs (s11). The instrument therefore alters the governing criteria for linking dermatomyositis to service; the text itself does not quantify how these criteria differ substantively from the 2014 instrument."},"complexity_factors":["Technical medical definitions and variants (dermatomyositis, amyopathic dermatomyositis) requiring clinical evidence (s7(2)–(3)).","Multiple temporal thresholds and exposure-duration rules for onset and worsening (e.g. 4 weeks, 6 months, 1 year, 7 days) creating conditional logic that must be matched to clinical timelines (s9(1)–(4), (6)–(9)).","Specified list of implicated drugs and named examples (5‑fluorouracil, capecitabine, statins, TNF‑alpha inhibitors, trastuzumab, D‑penicillamine) requires pharmacological assessment (Schedule 1).","Inclusion of immune checkpoint inhibitors and interferon alfa with illustrative examples increases reliance on up‑to‑date tumour‑therapy knowledge (s9(3), (8)).","Distinct treatments for causation versus material contribution/aggravation and rules about pre‑existing disease introduce legal-medical distinctions (s10(2)).","Interplay with other Statements of Principles means cross-referencing and applying other SOP criteria where factors overlap (s11).","Evidentiary features tied to clinical response (improvement within 2 months of stopping, rechallenge, or clinical worsening) impose specific clinical-record burdens on claimants and clinicians (s9(4), (9)).","Applicability and administrative impact: instrument replaces prior SOP (repeal) and applies to VEA/MRCA claims, affecting decision procedures and claim preparation (s2–5, Schedule 1).","Discretion and implementation risk: medical judgement required to apply 'reasonable hypothesis' standard and to relate listed factors to the person’s relevant service (s8–10)."],"plain_english_summary":"This Statement of Principles sets the medical criteria used to link dermatomyositis (including death from it) to a person’s relevant military service for claims under the VEA and MRCA. It replaces the 2014 Statement and commenced on 25 July 2022.\n\nIt lists specific triggers — certain drugs and drug classes, immune therapies, recent malignancy, and failures of clinical management with defined timing thresholds — that, if shown and related to service, raise a reasonable hypothesis for service connection."}},"importantCases":[],"_links":{"self":"/api/acts/statement-of-principles-concerning-dermatomyositis-reasonable-hypothesis-no-70-of-2022","history":"/api/acts/statement-of-principles-concerning-dermatomyositis-reasonable-hypothesis-no-70-of-2022/history","analysis":"/api/acts/statement-of-principles-concerning-dermatomyositis-reasonable-hypothesis-no-70-of-2022/analysis","conflicts":"/api/acts/statement-of-principles-concerning-dermatomyositis-reasonable-hypothesis-no-70-of-2022/conflicts","importantCases":"/api/acts/statement-of-principles-concerning-dermatomyositis-reasonable-hypothesis-no-70-of-2022/important-cases","documents":"/api/acts/statement-of-principles-concerning-dermatomyositis-reasonable-hypothesis-no-70-of-2022/documents"}}