{"id":"F2018L01179","name":"Statement of Principles concerning bronchiolitis obliterans organising pneumonia (Balance of Probabilities) (No. 80 of 2018)","slug":"statement-of-principles-concerning-bronchiolitis-obliterans-organising-pneumonia-balance-of-probabil","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":439737,"registerId":"F2018L01179-fast-fetch-1775955645405","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Statement of Principles concerning bronchiolitis obliterans organising pneumonia (Balance of Probabilities) (No. 80 of 2018)","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\nmeta-generator: Aspose.Words for .NET 20.2\n---\n\n?xml version=\"1.0\" encoding=\"utf-8\" standalone=\"no\"?>\n\n\n\n \n\nStatement of Principles\n\nconcerning\n\nBRONCHIOLITIS OBLITERANS ORGANISING PNEUMONIA (Balance of Probabilities)\n\n(No. 80 of 2018)\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 24 August 2018\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 Nicholas Saunders AO
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 bronchiolitis obliterans organising pneumonia (Balance of Probabilities) (No. 80 of 2018).\n\n2 Commencement\n\n This instrument commences on 24 September 2018.\n\n3 Authority\n\nThis instrument is made under subsection 196B(3) of the Veterans' Entitlements Act 1986.\n\n4 Repeal\n\nThe Statement of Principles concerning bronchiolitis obliterans organising pneumonia No. 63 of 2009 (Federal Register of Legislation No. F2009L03226) made under subsection 196B(3) of the VEA is repealed.\n\n5 Application\n\nThis instrument applies to a claim to which section 120B of the VEA or section 339 of the Military Rehabilitation and Compensation Act 2004 applies.\n\n6 Definitions\n\nThe terms defined in the Schedule 1 - Dictionary have the meaning given when used in this instrument.\n\n7 Kind of injury, disease or death to which this Statement of Principles relates\n\n(1) This Statement of Principles is about bronchiolitis obliterans organising pneumonia and death from bronchiolitis obliterans organising pneumonia.\n\nMeaning of bronchiolitis obliterans organising pneumonia\n\n(2) For the purposes of this Statement of Principles, bronchiolitis obliterans organising pneumonia:\n\n(a) means a histological pattern of organising pneumonia consisting of the patchy filling of alveoli, alveolar ducts and bronchioles by loose plugs of granulation tissue consisting of fibroblasts embedded in connective tissue, arising in response to lung injury and resulting in excessive proliferation of healing tissue, with:\n\n(i) respiratory symptoms; or\n\n(ii) other clinical evidence of pulmonary dysfunction; and\n\n(b) excludes:\n\n(i) organising pneumonia secondary to infectious pneumonia or acute respiratory distress syndrome;\n\n(ii) organising pneumonia that occurs in the presence of another interstitial lung disease and is not the dominant histological finding;\n\n(iii) organising pneumonia that occurs as a pulmonary manifestation of a systemic disease; and\n\n(iv) pulmonary inflammation that is confined to the bronchioles (obliterative bronchiolitis, proliferative bronchiolitis).\n\nNote 1: Bronchiolitis obliterans organising pneumonia ('BOOP') is also known as cryptogenic organising pneumonia.\n\nNote 2: Although the definition refers to a histological pattern, the diagnosis of bronchiolitis obliterans organising pneumonia can be made in patients with typical clinical and radiographic features without a lung biopsy being undertaken.\n\nDeath from bronchiolitis obliterans organising pneumonia\n\n(3) For the purposes of this Statement of Principles, bronchiolitis obliterans organising pneumonia, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's bronchiolitis obliterans organising pneumonia.\n\nNote: terminal event is defined in the Schedule 1 – Dictionary.\n\n8 Basis for determining the factors\n\nOn the sound medical‑scientific evidence available, the Repatriation Medical Authority is of the view that it is more probable than not that bronchiolitis obliterans organising pneumonia and death from bronchiolitis obliterans organising pneumonia can be related to relevant service rendered by veterans or members of the Forces under the VEA, or members under the MRCA.\n\nNote: MRCA, relevant service and VEA are defined in the Schedule 1 – Dictionary.\n\n9 Factors that must exist\n\nAt least one of the following factors must exist before it can be said that, on the balance of probabilities, bronchiolitis obliterans organising pneumonia or death from bronchiolitis obliterans organising pneumonia is connected with the circumstances of a person's relevant service:\n\n(1) taking a drug or a drug from a class of drugs from the specified list of drugs, at the time of the clinical onset of bronchiolitis obliterans organising pneumonia;\n\nNote: specified list of drugs is defined in the Schedule 1 - Dictionary. \n\n(2) being treated with a drug which is associated in the individual with the following:\n\n(a) the development of bronchiolitis obliterans organising pneumonia within six months of commencing drug therapy; and\n\n(b) the absence of bronchiolitis obliterans organising pneumonia prior to commencing drug therapy; and\n\n(c) clinical improvement within weeks of ceasing drug therapy; and\n\n(d) exclusion of other aetiologies for bronchiolitis obliterans organising pneumonia;\n\n(3) having a solid organ transplant, stem cell transplant or bone marrow transplant before the clinical onset of bronchiolitis obliterans organising pneumonia;\n\n(4) undergoing a course of therapeutic radiation for the treatment of malignant neoplasm of the breast within the two years before the clinical onset of bronchiolitis obliterans organising pneumonia;\n\n(5) having bronchial obstruction immediately adjacent to a focus of pulmonary organisation, at the time of the clinical onset of bronchiolitis obliterans organising pneumonia;\n\nNote: bronchial obstruction is defined in the Schedule 1 - Dictionary. \n\n(6) inhaling high concentrations of a substance with irritant properties, where:\n\n(a) the inhalation has resulted in signs and symptoms of acute damage to the lower respiratory tract within the 48 hours after the inhalation; and\n\n(b) the clinical onset of bronchiolitis obliterans organising pneumonia occurs within the 30 days following the inhalation of the substance;\n\n(7) inhaling sulphur mustard (mustard gas) resulting in signs and symptoms of acute damage to the lower respiratory tract within the 30 days before the clinical onset of bronchiolitis obliterans organising pneumonia;\n\n(8) having gastro-oesophageal reflux disease at the time of the clinical onset of bronchiolitis obliterans organising pneumonia;\n\n(9) taking a drug or a drug from a class of drugs from the specified list of drugs, at the time of the clinical worsening of bronchiolitis obliterans organising pneumonia;\n\nNote: specified list of drugs is defined in the Schedule 1 - Dictionary. \n\n(10) being treated with a drug which is associated in the individual with the following:\n\n(a) the worsening of bronchiolitis obliterans organising pneumonia within six months of commencing drug therapy; and\n\n(b) clinical improvement within weeks of ceasing drug therapy;\n\n(11) having a solid organ transplant, stem cell transplant or bone marrow transplant before the clinical worsening of bronchiolitis obliterans organising pneumonia;\n\n(12) undergoing a course of therapeutic radiation for the treatment of malignant neoplasm of the breast within the two years before the clinical worsening of bronchiolitis obliterans organising pneumonia;\n\n(13) having bronchial obstruction immediately adjacent to a focus of pulmonary organisation, at the time of the clinical worsening of bronchiolitis obliterans organising pneumonia;\n\nNote: bronchial obstruction is defined in the Schedule 1 - Dictionary. \n\n(14) inhaling high concentrations of a substance with irritant properties, where:\n\n(a) the inhalation has resulted in signs and symptoms of acute damage to the lower respiratory tract within the 48 hours after the inhalation; and\n\n(b) the clinical worsening of bronchiolitis obliterans organising pneumonia occurs within the 30 days following the inhalation of the substance;\n\n(15) inhaling sulphur mustard (mustard gas) resulting in signs and symptoms of acute damage to the lower respiratory tract within the 30 days before the clinical worsening of bronchiolitis obliterans organising pneumonia;\n\n(16) having gastro-oesophageal reflux disease at the time of the clinical worsening of bronchiolitis obliterans organising pneumonia;\n\n(17) inability to obtain appropriate clinical management for bronchiolitis obliterans organising pneumonia.\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(9) to 9(17) apply only to material contribution to, or aggravation of, bronchiolitis obliterans organising pneumonia where the person's bronchiolitis obliterans organising pneumonia was suffered or contracted before or during (but did not arise out of) the person's relevant service.\n\n11 Factors referring to an injury or disease covered by another Statement of Principles\n\nIn this Statement of Principles:\n\n(1) if a factor referred to in section 9 applies in relation to a person; and\n\n(2) that factor refers to an injury or disease in respect of which a Statement of Principles has been determined under subsection 196B(3) of the VEA;\n\nthen the factors in that Statement of Principles apply in accordance with the terms of that Statement of Principles as in force from time to time.\n\n \n\n \n\nSchedule 1 - Dictionary \n\nNote: See Section 6\n\n1 Definitions\n\nIn this instrument:\n\n bronchial obstruction means occlusion of the lumen of a bronchus or bronchiole due to an endogenous pathological process or structure, or from exogenous material, such as a foreign body.\n\n bronchiolitis obliterans organising pneumonia—see subsection 7(2).\n\n MRCA means the Military Rehabilitation and Compensation Act 2004.\n\n relevant service means:\n\n(a) eligible war service (other than operational service) under the VEA;\n\n(b) defence service (other than hazardous service and British nuclear test defence service) under the VEA; or\n\n(c) peacetime service under the MRCA.\n\nNote: MRCA and VEA are also defined in the Schedule 1 - Dictionary.\n\n specified list of drugs means:\n\n(a) amiodarone;\n\n(b) amphotericin B;\n\n(c) azathioprine;\n\n(d) beta-blockers;\n\n(e) bleomycin;\n\n(f) bucillamine;\n\n(g) busulphan;\n\n(h) carbamazepine;\n\n(i) cephalosporins;\n\n(j) chlorambucil;\n\n(k) cocaine;\n\n(l) cyclophosphamide;\n\n(m) cytosine arabinoside;\n\n(n) doxorubicin;\n\n(o) everolimus;\n\n(p) gold salts (aurothiopropanosulfonate);\n\n(q) interferons alpha, beta and gamma;\n\n(r) irinotecan;\n\n(s) L-tryptophan;\n\n(t) mecamylamine;\n\n(u) mesalamine;\n\n(v) methotrexate;\n\n(w) minocycline;\n\n(x) mitomycin-c;\n\n(y) nilutamide;\n\n(z) nitrofurantoin;\n\n(aa) oxaliplatin;\n\n(bb) penicillamine;\n\n(cc) phenytoin;\n\n(dd) risedronate;\n\n(ee) rituximab;\n\n(ff) sirolimus;\n\n(gg) sulfasalazine;\n\n(hh) tacrolimus;\n\n(ii) temozolomide;\n\n(jj) temsirolimus;\n\n(kk) thalidomide;\n\n(ll) ticlopidine; or\n\n(mm) trastuzumab.\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 is a standard replacement Statement of Principles under the Veterans' Entitlements Act framework. It maintains the established scope of determining service connection for a specific rare lung disease. The 2018 version updates medical evidence and drug lists but does not expand beyond the original purpose of providing compensation criteria for BOOP in the veterans' entitlements system."},"complexity_factors":["17 distinct causal factors with specific temporal requirements (e.g., 'within 6 months', 'within 30 days', 'within 2 years')","39 specific drugs listed in the defined term 'specified list of drugs'","Dual structure covering both clinical onset (factors 1-8) and clinical worsening (factors 9-17) with nearly parallel but not identical criteria","Nested conditional logic in factor 2 requiring four cumulative elements (timing, absence prior to therapy, improvement on cessation, and exclusion of other causes)","Cross-reference mechanism in section 11 allowing incorporation of other Statements of Principles by reference","Technical medical definitions requiring histological and clinical expertise (e.g., 'granulation tissue consisting of fibroblasts embedded in connective tissue')","Exclusion clauses in the disease definition (subsection 7(2)(b)) with four distinct carve-outs"],"plain_english_summary":"This instrument updates medical rules for deciding whether bronchiolitis obliterans organising pneumonia (BOOP) is service-related, replacing the 2009 version. It applies to veterans and current/former defence members claiming under the Veterans' Entitlements Act 1986 or the Military Rehabilitation and Compensation Act 2004 and uses the \"balance of probabilities\" test.\n\nA claim succeeds if at least one of 17 specified risk or causal factors is present (examples: certain drugs, transplants, radiation, inhaled irritants, GERD, or lack of appropriate treatment). It ensures access to benefits for service-related BOOP without absolute proof."},"flash_summary":{"complexity_score":4,"scope_assessment":{"changed":false,"description":"This instrument replaces the 2009 Statement of Principles (section 4) and updates the medical criteria for linking bronchiolitis obliterans organising pneumonia to relevant service. It retains the core statutory purpose — specifying medical factors that, if present and related to relevant service, establish connection on the balance of probabilities — and refines and restates those factors (for example by listing specific drugs, setting timing windows, and including inability to obtain appropriate clinical management). These are clarifications and updates rather than a material expansion of scope beyond the original purpose of setting medical criteria for service‑connection of BOOP."},"complexity_factors":["Clear structure with 11 sections plus a Dictionary (Schedule 1) — modest length","Single long defined list of specified drugs in Dictionary (about 39 listed items) that must be checked item-by-item","Multiple conditional factors with timing windows (e.g. 6 months from drug start; 30 days after inhalation; 48 hours for acute lower respiratory signs)","Paired clauses for both clinical onset and clinical worsening (sections 9(1)–9(8) and mirrored 9(9)–9(16)) doubling similar conditions","Cross-reference mechanism to other Statements of Principles (section 11) requiring reviewers to consult other instruments where factors reference other diseases","Limited number of defined terms (bronchial obstruction, terminal event, relevant service, specified list of drugs) — reduces but does not eliminate complexity","A subjective factor ('inability to obtain appropriate clinical management' in section 9(17)) which may require discretionary factual and evidentiary assessment","Exclusions and diagnostic nuance in definition of BOOP (section 7(2)) including allowance for clinical/radiographic diagnosis without biopsy"],"plain_english_summary":"**What this instrument does (mechanics first)**\n\n- This is a \"Statement of Principles\" made by the Repatriation Medical Authority under the Veterans' Entitlements Act. It replaces an earlier 2009 Statement (see section 4). (A Statement of Principles sets out medical findings and the factors that, if present, allow decision‑makers to say an injury or disease is connected with a veteran's service for claims under the VEA or MRCA.)\n- It commences on 24 September 2018 (section 2) and applies to claims under section 120B of the VEA or section 339 of the MRCA (section 5).\n- The instrument defines what is meant by bronchiolitis obliterans organising pneumonia (BOOP) for the purposes of claims (section 7(2)), explicitly allows diagnosis without a biopsy when clinical and radiographic features are typical (note to section 7(2)), and treats death that a BOOP contributed to as included (section 7(3)).\n- The Authority states its view that, on the available medical evidence, it is \"more probable than not\" that BOOP (and death from BOOP) can be related to relevant service (section 8). That is the legal standard used for linking disease to service in these SoPs.\n- The document then lists the specific factors that *must* exist for a decision‑maker to conclude, on the balance of probabilities, that BOOP is connected with service (section 9). At least one listed factor must be present. The listed factors include:\n - taking certain listed drugs at the time of clinical onset or at time of clinical worsening (sections 9(1) and 9(9) and the drug list in the Dictionary);\n - a pattern of drug-associated onset or worsening (timing within 6 months of starting the drug, improvement on stopping, exclusion of other causes) (sections 9(2) and 9(10));\n - having a solid organ, stem cell or bone marrow transplant before onset or worsening (sections 9(3) and 9(11));\n - therapeutic radiation to the breast within two years before onset or worsening (sections 9(4) and 9(12));\n - bronchial obstruction immediately adjacent to a focus of pulmonary organisation at onset or worsening (sections 9(5) and 9(13));\n - inhalation of a high concentration irritant with acute lower respiratory tract damage and onset/worsening within specified short windows (48 hours for acute damage signs, BOOP within 30 days) (sections 9(6) and 9(14));\n - inhalation of sulphur mustard producing acute lower respiratory tract damage within 30 days of onset/worsening (sections 9(7) and 9(15));\n - having gastro‑oesophageal reflux disease at the time of onset or worsening (sections 9(8) and 9(16)); and\n - inability to obtain appropriate clinical management for BOOP (section 9(17)).\n- Section 10 requires that whatever factor is relied on must be related to the person's \"relevant service\" (see Dictionary for the precise definition of relevant service). It also limits the application of factors 9(9)–9(17) to matters of material contribution or aggravation where the BOOP was suffered or contracted before or during (but did not arise out of) relevant service.\n- Section 11 provides that, where a listed factor in this SoP refers to an injury/disease covered by some other Statement of Principles, the rules in that other Statement apply.\n\n**Who is affected and why it matters**\n\n- Who is affected: veterans or current/former members of the Australian Defence Forces who lodge claims under the Veterans' Entitlements Act (VEA) or the Military Rehabilitation and Compensation Act (MRCA) alleging BOOP (or death from BOOP) related to their service.\n- Decision‑makers (DVA or the relevant decision body) use this instrument as the medical basis for linking BOOP to service. If a claimant establishes one of the listed factors and it can be related to \"relevant service,\" the statutory standard for connection (balance of probabilities) is satisfied under the terms of this SoP (sections 8 and 9).\n- Why it matters: the Statement reduces the evidentiary burden on claimants by identifying specific medical or exposure patterns that, if proved and linked to service, meet the legal test for service connection. That can affect entitlement to pensions, compensation or other benefits available under the VEA/MRCA.\n\n**Official purpose claim and a practical test of its effects**\n\n- The Authority's stated purpose is that, based on medical‑scientific evidence, BOOP can be linked to relevant service on the balance of probabilities (section 8). The instrument operationalises that claim by listing concrete causal or aggravating factors (section 9).\n- Costs and who pays: if connection is established under this SoP, benefits potentially payable under VEA/MRCA are funded from government programs administered by DVA. The instrument itself does not create new payments; it sets the medical rules decision‑makers use to assess claims.\n- Incentives and behaviour change: the Statement lowers the legal hurdle for claimants who can document one of the listed factors (for example, recorded use of a specified drug, a transplant, an inhalation exposure, or documented reflux). That creates incentives for thorough medical documentation of drug prescriptions, exposures and clinical course. It may also affect how service health records are compiled (sections 9 and Dictionary). It does not directly regulate private prescribing or non‑service medical practice, but documented exposures or treatment history are material to decisions.\n- Trade‑offs and opportunity costs: by providing specific presumptive links (especially where the listed factor is common or easy to document), the SoP transfers the evidentiary burden away from claimants proving general medical causation and towards proving the existence and service‑connection of a listed factor. This simplifies decision‑making in many cases but can increase fiscal exposure where exposures or treatments occurred in service.\n- Implementation and compliance risk: the practical application requires reliable medical records showing timing (onset/worsening relative to exposures/treatment and service), clinical features consistent with BOOP, and where relevant, evidence of improvement after stopping a drug (sections 7(2), 9(2), 9(10)). Some factors have narrow timing windows (e.g. six months from starting a drug; 30 days after inhalation), which can make proof sensitive to record quality. The inclusion of \"inability to obtain appropriate clinical management\" (section 9(17)) introduces a subjective element that will require adjudicators to assess access to care.\n- Bureaucratic discretion: the Repatriation Medical Authority prescribes the medical criteria; decision‑makers apply those criteria to each claim. Section 11 allows cross‑application of other Statements of Principles, so adjudication may involve checking multiple instruments in complex cases.\n\n**Concrete mechanisms — who decides, who pays, what changes**\n\n- Who decides: DVA decision‑makers (and those assessing MRCA claims) apply this SoP as the medical rule to determine service connection. The Repatriation Medical Authority sets the SoP (section 3).\n- Who pays: benefits and compensation, if granted under the VEA or MRCA, are paid under the respective Acts; this SoP is the evidentiary tool to establish eligibility.\n- What behaviour changes: claimants and clinicians are incentivised to document exposures, drug treatments, timing of symptom onset/worsening, biopsies or radiology, and responses to stopping medications; administrative record‑keeping of service exposures becomes more important for claims.\n\n**Implementation notes and practical points for claimants and advisers**\n\n- The drug list (Dictionary) is explicit and needs to be checked against a claimant's medication history.\n- The SoP recognises clinical diagnosis without biopsy in typical cases (note to section 7(2)), which matters where a biopsy was not taken.\n- Several factors require tight timing evidence (e.g. onset within 6 months of starting a drug, BOOP within 30 days of inhalation exposure), so contemporaneous clinical notes and service records will be important.\n\n(References: sections 2–11 and the Schedule 1 Dictionary.)"},"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-bronchiolitis-obliterans-organising-pneumonia-balance-of-probabil","history":"/api/acts/statement-of-principles-concerning-bronchiolitis-obliterans-organising-pneumonia-balance-of-probabil/history","analysis":"/api/acts/statement-of-principles-concerning-bronchiolitis-obliterans-organising-pneumonia-balance-of-probabil/analysis","conflicts":"/api/acts/statement-of-principles-concerning-bronchiolitis-obliterans-organising-pneumonia-balance-of-probabil/conflicts","importantCases":"/api/acts/statement-of-principles-concerning-bronchiolitis-obliterans-organising-pneumonia-balance-of-probabil/important-cases","documents":"/api/acts/statement-of-principles-concerning-bronchiolitis-obliterans-organising-pneumonia-balance-of-probabil/documents"}}