Statement of Principles concerning otitis media (Balance of Probabilities) (No. 63 of 2022)

The central concept is ‘otitis media’, defined in section 7(2) as an infective or inflammatory process within the middle ear. This definition expressly excludes cholesteatoma and isolated perforation of the tympanic membrane, meaning that a person presenting with those conditions alone cannot rely on this SoP. The instrument cross‑references ICD‑10‑AM codes H65, H66, or H67 (non‑supportative otitis media, suppurative otitis media, and otitis media in diseases classified elsewhere) but states that the definition in subsection 7(2) prevails for the SoP’s purposes (section 7(3)). This is a critical nuance: the clinical coding is a guide, not a substitute for the legal definition. ‘Clinical onset’ and ‘clinical worsening’ are not expressly defined in the SoP but are used throughout section 9. Clinical onset refers to the first occurrence of symptoms or signs sufficient to warrant a diagnosis; clinical worsening refers to a permanent increase in severity. The instrument distinguishes between factors that produce the initial disease and those that aggravate a pre‑existing condition (section 10(2)). A key concept is ‘relevant service’, defined in the Dictionary (Schedule 1) as: (a) eligible war service (other than operational service) under the VEA; (b) defence service (other than hazardous service and British nuclear test defence service) under the VEA; or (c) peacetime service under the MRCA. This definition excludes operational service, hazardous service, and British nuclear test defence service, which have their own SoP regimes (operational service uses the reasonable hypothesis standard under s 196B(2), not the balance of probabilities standard under s 196B(3)). Thus, this SoP applies only to non‑operational, non‑hazardous, and peacetime service. The ‘balance of probabilities’ standard means the decision‑maker must be satisfied that it is more probable than not that the factor is related to the service. The SoP includes a ‘terminal event’ definition (Schedule 1) listing pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function as proximate causes of death that may be linked to otitis media. This allows the instrument to cover death contributed to by otitis media even if the immediate cause is one of those terminal events (section 7(5)). The notion of ‘obstruction of the Eustachian tube’ is given a practical note (section 9, note to factor 2) describing usual symptoms and signs, which helps claimants and medical assessors understand what evidence is needed. The instrument also incorporates by reference other SoPs: if a factor in section 9 refers to an injury or disease covered by another SoP, then the factors in that other SoP apply (section 11). This creates a cross‑referencing mechanism that can expand the inquiry. For example, if a claimant has gastro‑oesophageal reflux disease (factor 10 or 22), the decision‑maker must also consider whether that condition is itself connected to service under its own SoP. The result is a layered causation analysis that can multiply the evidentiary burden.

The primary population affected by this SoP is veterans, members of the Forces, and members of the Australian Defence Force who have rendered ‘relevant service’ and who suffer from otitis media or die from it. Specifically, the instrument applies to persons who have: eligible war service (other than operational service) under the VEA, defence service (other than hazardous service and British nuclear test defence service) under the VEA, or peacetime service under the MRCA (Schedule 1). This excludes veterans with operational service (who would be assessed under the reasonable hypothesis standard) and those with hazardous or British nuclear test defence service. Consequently, a large cohort of veterans, including many with service in combat zones or on certain deployments, are not within the scope of this instrument. The SoP also affects the dependents or estate of such persons who make a claim for death from otitis media. Beyond claimants, the instrument directly impacts the decision‑makers: the Repatriation Commission, the Military Rehabilitation and Compensation Commission, and the Veterans’ Review Board and Administrative Appeals Tribunal when reviewing decisions. For legal practitioners and advocates, the SoP creates a structured framework for building a case; they must identify which factor applies, gather medical evidence within the specific time windows, and establish the relationship to service. Medical practitioners are affected insofar as they are asked to provide reports that address the exact wording of the SoP, such as whether an upper respiratory tract infection occurred within 14 days before clinical onset (factor 1), or whether a space‑occupying mass existed in the nasopharynx (factor 4). The instrument also imposes implicit costs on claimants: many factors require contemporaneous medical records (e.g. evidence of a ruptured tympanic membrane within three months before clinical worsening, factor 18), which may be difficult to obtain if the condition developed years after service. The RMA itself is a repeat player, updating the SoP as medical science evolves. The repeal of the 2014 SoP means that anyone with a claim pending on 25 July 2022 but not yet determined may be subject to the new factors and definitions, although transitional application depends on the claim’s date. The instrument does not directly affect the general public, but it does influence the allocation of public funds through the veteran compensation system. From an economic perspective, the SoP standardises the causal criteria, reducing discretion in individual decisions but potentially increasing the administrative cost of verifying compliance with tight temporal windows and specific medical definitions.

The SoP does not impose duties on private persons in the way a regulatory statute does, but it creates obligations for decision-makers under the VEA and MRCA. The central duty on the Repatriation Commission or the MRCC is to apply the SoP when determining whether otitis media is connected to relevant service on the balance of probabilities. This duty arises under section 120B of the VEA and section 339 of the MRCA, which require that a SoP determined under subsection 196B(3) be applied. The decision‑maker must accept that the condition is service‑related if at least one factor in section 9 exists and is related to the person’s service, unless the contrary is proved. Conversely, if no factor exists, the claim must be rejected. The instrument thus creates a right for claimants: the right to have their claim assessed against a predetermined set of medical factors rather than on an ad‑hoc medical opinion. This reduces arbitrariness but also limits the scope of arguments available. Claimants have the right to present evidence that one or more factors exist, and the decision‑maker must consider that evidence. The notes to several factors (e.g. the note for factor 2 listing symptoms and signs of Eustachian tube obstruction) provide guidance but are not legally binding; they assist in interpreting but do not expand the factors. The SoP also confers a right on claimants to rely on cross‑referenced SoPs under section 11: if a factor (e.g. ANCA‑associated vasculitis) is itself covered by another SoP, then the claimant may need to also establish that underlying condition as service‑related, but if they do, the factor is satisfied. This can be an advantage where the primary condition arises from a complex causal chain. The duty on the RMA is implicit: it must base the SoP on sound medical‑scientific evidence (section 8). The RMA declares that it has done so, and the instrument is not open to challenge on the merits of that evidence except through judicial review on narrow grounds. Claimants have no statutory right to challenge the content of the SoP itself, only its application to their case. There is also a duty on the decision‑maker to apply the correct standard of proof (balance of probabilities) and to take into account all relevant medical evidence. The instrument also preserves the ability to consider ‘inability to obtain appropriate clinical management’ (factor 25) as a factor for clinical worsening only, which gives some flexibility for cases where service‑related barriers to treatment aggravated the condition. Overall, the SoP functions as a rule‑based causation framework that both enables and constrains the rights of claimants to establish a service connection.

The SoP itself creates no penalties. It is an evidentiary instrument; enforcement occurs through the broader veterans’ entitlements and military compensation legislation. False or misleading claims made under the VEA or MRCA can attract civil or criminal penalties under those Acts, including recovery of overpaid benefits and prosecution for fraud. For example, section 205 of the VEA (as amended from time to time) provides for offences relating to false statements or documents in connection with claims. If a claimant or a medical practitioner knowingly provides false evidence to satisfy a factor under the SoP, they may face those penalties. However, the SoP does not itself reference any penalty provisions. Enforcement of the SoP’s application is indirect: a decision‑maker who incorrectly applies the SoP may have their decision set aside on review by the Veterans’ Review Board or the Administrative Appeals Tribunal, or by a court on judicial review. There is no fining mechanism for the RMA if the SoP is later found to be based on deficient science. The instrument’s repeal clause (section 4) ensures that the 2014 SoP no longer applies, but claims determined under the old SoP are not retroactively reopened. The practical enforcement risk for claimants is that if they fail to produce evidence meeting the factor’s exact temporal or medical criteria, their claim will be refused, and they must bear the costs of time, legal representation, and medical reports. This creates a compliance burden: to avoid rejection, claimants must assemble precise documentation. The SoP also operates as a gatekeeper for liability - the Commission cannot pay compensation unless the causal link is established under the SoP. In a broader sense, the SoP enforces cost control on the compensation system by limiting successful claims to those meeting the specified factors, which may exclude a subset of meritorious cases that do not fit the template. This can produce diffuse economic effects, as veterans who cannot prove the factor may instead rely on other provisions (e.g. inability to obtain appropriate clinical management) or seek alternative support.

This SoP is made under the VEA and also applies to claims under the MRCA as specified in section 5. It interacts directly with section 120B of the VEA and section 339 of the MRCA, which mandate the use of SoPs for determining causation. For operational service (VEA) or hazardous service (MRCA), a different SoP standard applies: under subsection 196B(2) of the VEA, the SoP is for reasonable hypothesis (i.e. it must not be unreasonable to hypothesise a causal connection), not balance of probabilities. This SoP (No. 63 of 2022) is specifically for the balance of probabilities standard, meaning it applies only to non‑operational / non‑hazardous service. The interaction is thus a jurisdictional divide. The instrument also cross‑references other SoPs via section 11: if a factor refers to a disease (e.g. tuberculosis, ANCA‑associated vasculitis, gastro‑oesophageal reflux disease) for which a SoP exists under subsection 196B(3), then the factors in that SoP apply in accordance with its terms as in force from time to time (section 11). This means the decision‑maker must potentially apply multiple SoPs for a single claim, each with its own temporal and definitional requirements. For example, if a veteran has otitis media and also has gastro‑oesophageal reflux disease (GORD) as a factor, they must also satisfy the GORD SoP to establish that the GORD is service‑related, which then satisfies the otitis media SoP. This creates a cascade of causation that can increase the evidentiary burden. The SoP also interacts with the general law of evidence and administrative decision‑making. The Veterans’ Entitlements Act and MRCA contain their own rules about burden of proof, onus, and consideration of medical evidence, and the SoP must be read in that context. Section 7(3) of the SoP references ICD‑10‑AM coding, but notes that the definition in the SoP takes precedence. This means that hospital discharge summaries or GP records using ICD codes may be misleading if the code includes a condition excluded by the SoP (e.g. cholesteatoma). The interaction with state‑based workers’ compensation or motor accident schemes is indirect; the SoP does not apply outside the federal military compensation system. However, in cases where a veteran also has a private claim, the SoP’s criteria might be used evidentially but are not binding outside VEA/MRCA.

This instrument, the Statement of Principles concerning otitis media (Balance of Probabilities) (No. 63 of 2022), is a standalone legislative instrument that replaces the earlier SoP No. 52 of 2014 (Federal Register of Legislation No. F2014L00484). Section 4 of the 2022 SoP expressly repeals the 2014 SoP. The 2022 SoP was made on 24 June 2022 under the Common Seal of the Repatriation Medical Authority and commenced on 25 July 2022 (section 2). It is the most current SoP for otitis media under the balance of probabilities standard. The 2014 SoP would have contained its own set of factors and definitions; the differences between the two are not specified in the text but likely reflect updated medical evidence and potentially a revised list of factors. For example, the 2022 SoP includes factors for ANCA‑associated vasculitis (factors 12 and 24) and for ascariasis or myiasis (factors 11 and 23), which may not have been present in the 2014 version. The explicit inclusion of notes for certain factors (e.g. nasopharyngeal masses, myiasis) is a drafting change that aids interpretation. The 2022 SoP also clarifies the meaning of otitis media to exclude cholesteatoma and isolated perforation, which may have been a point of ambiguity in the earlier version. The RMA’s practice is to review SoPs periodically, so this amendment history reflects a typical biennial or periodic review cycle. Users must be careful to apply the correct instrument by date of claim determination. For claims made before 25 July 2022 but not yet determined, the transitional provisions of the VEA or MRCA would apply; generally, the SoP in force at the time of the decision applies, not the one at the time of the claim or the onset of disease. The RMA has the power to further repeal or amend this SoP, and any future SoP will supersede this one. The instrument is registered on the Federal Register of Legislation and is publicly available.

The instrument itself does not mention any litigation history, and as a legislative determination made by the Repatriation Medical Authority under statutory authority, it is not subject to the same litigation report as a court decision. However, it is possible that previous SoPs for otitis media have been challenged in the Administrative Appeals Tribunal or in judicial review proceedings. Common grounds for challenge include whether the RMA properly based the factors on sound medical‑scientific evidence, whether the factor definitions are ambiguous or ultra vires, or whether the SoP was applied incorrectly to a particular claim. For example, under the 2014 SoP, a claimant might have argued that the definition of otitis media was unclear regarding cholesteatoma; the 2022 SoP resolves that explicitly. There is no known binding precedent that this instrument must overcome, but practitioners should be aware that the Federal Court has considered the legal effect of SoPs more generally. In cases such as Repatriation Commission v Deledio (1998) or more recent decisions, the High Court and Federal Court have articulated the stepped approach for applying SoPs. The SoP’s wording is drafted to conform to those judicial constructions. The instrument’s note‑based guidance (e.g. notes on Eustachian tube obstruction symptoms and signs) may be used in litigation to interpret the factor, but they are not part of the operative text. If a dispute arises over whether a particular condition falls within the SoP’s definition, the decision‑maker and ultimately the tribunal or court will need to construe the instrument according to standard principles of statutory interpretation, giving weight to the text, context, and purpose. The inclusion of the ICD‑10‑AM codes but with a disclaimer that the SoP definition prevails could be a source of litigation if a claimant’s medical records use a code that technically includes an excluded condition. For practitioners, the safety of this instrument is its specificity; litigation is more likely on factual questions (did the factor exist within the time window?) than on legal validity. Until a judicial decision directly addresses the 2022 SoP, the litigation history remains sparse.

Several provisions in this SoP create traps for unwary practitioners and claimants. The first major gotcha is the exclusion of cholesteatoma and isolated perforation of the tympanic membrane from the definition of otitis media (section 7(2)(b)). A claimant whose condition is coded as H65, H66, or H67 but who actually has cholesteatoma will not be covered by this SoP, and may need a different SoP or a general causation approach. The note to factor 7 (chronic perforation) clarifies that chronic perforation includes tympanostomy tubes (grommets), but ‘isolated perforation’ is excluded from the disease itself. This means that a perforation that is not linked to infection or inflammation might not qualify as otitis media. The second gotcha is the distinction between ‘clinical onset’ factors (factors 1‑12) and ‘clinical worsening’ factors (factors 13‑24 plus factor 25). A claimant must identify which is relevant: if they had otitis media before service and it worsened during service, they must show one of the worsening factors. The time windows for worsening are often identical to onset (e.g. within 14 days before clinical worsening for upper respiratory tract infection). But factor 25 (inability to obtain appropriate clinical management) applies only to clinical worsening, not onset. This asymmetry means a claimant with onset pre‑service who then suffers worsening due to lack of treatment can succeed, but a claimant whose onset occurs during service with no listed factor but who couldn’t get treatment cannot rely on factor 25 because it is not in the onset list. Third, the requirement in section 10(1) that any factor must be ‘related to the relevant service rendered by the person’. This is not a matter of mere existence of the factor; the factor itself must have been caused or contributed to by service. For example, having an upper respiratory tract infection within 14 days before onset is only helpful if that infection was related to service. Claimants must prove not just the factor, but the service connection of the factor. Fourth, the cross‑referencing in section 11 can backfire: if a factor (e.g. active tuberculosis) is itself covered by another SoP, the claimant must satisfy that SoP too. This multiplies the evidentiary gateposts. Fifth, the notes to several factors give examples (e.g. space‑occupying masses in the nasopharynx). These are non‑exhaustive, but a claimant might incorrectly assume only those examples count. Conversely, a condition not listed could still qualify if it fits the general term (e.g. ‘space‑occupying mass’). Sixth, the temporal windows are short: 14 days, 7 days, 3 months, or ‘at the time of’. These windows are strict. A claimant with a respiratory infection 20 days before onset cannot rely on factor 1. The onus is on the claimant to prove the exact timing. Seventh, the instrument only applies to ‘relevant service’ as defined. Many members of the Australian Defence Force with operational service are not covered; they would be assessed under a different SoP standard. Practitioners must verify the service type before using this SoP. Finally, the dictionary definition of ‘terminal event’ lists five specific causes of death. If a person dies from a cause not listed (e.g. renal failure) that is nevertheless contributed to by otitis media, death may not be covered unless the unlisted cause fits within ‘proximate or ultimate cause’ and the listed events are merely inclusive examples. The term ‘includes’ suggests the list is non‑exclusive, but the definition could be read narrowly. The risk is that a death that is directly due to sepsis from otitis media might not be covered unless sepsis leads to cardiac arrest or respiratory failure.

Because this SoP is an evidentiary instrument applied by decision‑makers, ‘compliance’ means that claimants and their representatives must ensure that the claim file contains enough evidence to satisfy at least one factor and to show that factor is related to relevant service. The process is not about obeying a rule but about proving a case. The first step is to identify whether the veteran or member has otitis media as defined. Obtain a medical diagnosis that confirms an infective or inflammatory process within the middle ear and that expressly excludes cholesteatoma and isolated perforation. A specialist ENT report is advisable. The report should reference ICD‑10‑AM coding only as a guide; the diagnosis must match the SoP definition. Second, determine whether the condition is a new onset or a worsening of a pre‑existing condition. This will dictate whether to use factors 1‑12 or 13‑25. If the veteran had otitis media before service and it became worse during service, focus on factors 13‑25. Third, identify which factor or factors are plausible. For each potential factor, gather medical records that demonstrate the factor’s existence and its precise timing relative to clinical onset or worsening. For example, for factor 1 (upper respiratory tract infection within 14 days before onset), obtain GP records of the infection and then a diagnosis of otitis media within that window. The records must show dates clearly. For factors that require underlying conditions (e.g. gastro‑oesophageal reflux disease, ANCA‑associated vasculitis), the claimant may need to establish that those conditions are themselves service‑related. This will likely require a separate assessment under their own SoPs. Representations should follow the reasoning in section 11, showing that the underlying condition satisfies its SoP. Fourth, establish the relationship of the factor to relevant service. This is the most difficult part. For instance, an upper respiratory tract infection acquired during service in barracks may be related to service if it arose from communal living, but a routine cold picked up while on leave may not. The decision‑maker will consider the temporal and circumstantial connection. Legal representatives should gather evidence of the service conditions that caused or contributed to the factor. Fifth, ensure the claim file includes a clear narrative linking each element. Use the notes in the SoP to frame the evidence, e.g. the note on Eustachian tube dysfunction symptoms can be used to corroborate factor 2. Sixth, if the claim is for death from otitis media, gather evidence that the terminal event (e.g. cardiac arrest, pneumonia) was contributed to by otitis media. A coronial report or medical opinion linking the infection to the terminal event is essential. Seventh, review the claim for any alternative pathways, such as inability to obtain appropriate clinical management (factor 25) if service‑related barriers to treatment (e.g. remote posting, lack of access to ENT specialty) led to worsening. This factor requires evidence that appropriate management was not available or accessible and that this caused or contributed to the worsening. Compliance also means avoiding common pitfalls: ensure the factor is not excluded (cholesteatoma), ensure the time window is met, ensure the service is ‘relevant service’ (non‑operational, non‑hazardous, peacetime). Practitioners should also check whether any other SoP applies (e.g. for sensorineural hearing loss or tinnitus) and consider whether the otitis media claim might be subsumed under a broader condition. Finally, if the claim is refused, the decision can be reviewed, and the SoP’s factors will be applied again. Keeping meticulous medical records and obtaining contemporaneous evidence significantly increases the chance of compliance with the SoP’s requirements.