Statement of Principles concerning myocarditis (Reasonable Hypothesis) (No. 17 of 2024)

The instrument relies on several defined concepts. Myocarditis as a term of art in this SoP is defined in subsection 6(2): an inflammation of the heart muscle (myocardium), excluding inflammation associated with coronary artery disease. This exclusion is designed to distinguish myocarditis from ischaemic heart disease, which has its own separate SoP. The ICD-10-AM coding is referenced but only for classification; the clinical definition prevails. Relevant service is defined in Schedule 1 to mean operational, peacekeeping, hazardous, or British nuclear test defence service under the VEA, or warlike or non-warlike service under the MRCA. This defines the population to which the SoP applies. Reasonable hypothesis is not defined in the instrument because it is a standard of proof established by the VEA and MRCA and interpreted by case law; the SoP simply sets out the factors that must be present for that hypothesis to be possible. Clinical onset and clinical worsening are key temporal triggers. Many factors require the condition to exist “before clinical onset or clinical worsening.” Clinical onset is the point at which symptoms first manifest to the degree that a diagnosis can be made; clinical worsening requires a material increase in severity that itself arises from a service-related factor. The instrument distinguishes between onset and worsening in section 9(2): the clinical worsening aspects of factors apply only to material contribution to or aggravation of myocarditis where the myocarditis was suffered or contracted before or during (but did not arise out of) the person’s relevant service. This means that if a service member had pre-existing myocarditis that was not service-related, a factor can still be used to claim worsening if that factor is itself related to service. Terminal event is defined in the dictionary to include pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function. This allows a claim for death where myocarditis contributed to the terminal event, even if myocarditis was not the immediate cause. Cross-reference to other SoPs under section 10: if a factor refers to an injury or disease covered by another SoP, then the factors in that other SoP must also be satisfied. This prevents a veteran from claiming a factor like “having tuberculosis” without also proving that the tuberculosis itself is service-related under the TB SoP. This interactivity is critical for factors such as systemic viral infection, HIV, tuberculosis, vasculitides, systemic inflammatory diseases, and others that may themselves require proof of service connection.

The primary class affected are veterans and members whose service falls within the definition of relevant service. That includes those who rendered operational, peacekeeping, hazardous, or British nuclear test defence service under the VEA, and those who rendered warlike or non-warlike service under the MRCA. Dependants claiming death benefits are also affected because the instrument covers death from myocarditis where the myocarditis contributed to a terminal event. The instrument does not apply to peacetime service under the VEA (e.g., ordinary domestic defence service) or to members of the Australian Defence Force who served after 1 July 2004 but only under the Safety, Rehabilitation and Compensation Act (which uses a different causation standard). It also does not apply to civilian claimants under the MRCA. The Repatriation Medical Authority itself is the maker of the instrument and is required by the VEA to determine SoPs based on sound medical-scientific evidence; the instrument reflects the Authority’s view on the current state of evidence. Decision-makers within the Repatriation Commission and the Military Rehabilitation and Compensation Commission are directly affected because they must apply this instrument to claims; failure to do so can lead to errors of law. Medical practitioners preparing reports for claimants are indirectly affected because they must align their expert evidence with the listed factors and temporal windows; they should also be aware that the SoP is a legislative instrument binding on the AAT and courts. Vaccination providers for the military may be affected because two vaccine factors (COVID-19 and smallpox) are specifically listed, meaning a service member who develops myocarditis within four weeks of either vaccination may have a strong basis for a claim, which could increase demand for compensation and also increase administrative scrutiny of vaccination programmes. Pharmaceutical companies are not directly affected but may face increased reporting or risk claims if their products appear on the medication list in factor (14) and are used by serving members. The instrument also affects legal practitioners representing veterans, who must now ensure that claims are pleaded by reference to a specific factor from section 8, with supporting evidence of the temporal connection.

The instrument does not impose duties on veterans; rather, it confers procedural rights. A veteran who satisfies at least one factor in section 8 and can demonstrate that the factor is related to his or her relevant service has a right to have the claim assessed on the basis that a reasonable hypothesis has been raised. The decision-maker then must proceed to consider whether the hypothesis is disproved beyond reasonable doubt or, under the MRCA, whether the claim should be decided on the balance of probabilities. The key duty imposed by the instrument is on the decision-maker: to apply the SoP as a mandatory relevant consideration. If a decision-maker ignores a factor that is present and related to service, the decision is likely legally unreasonable. There is also a duty on the decision-maker to correctly interpret the definitions, especially the exclusion of coronary artery disease inflammation. The instrument gives the veteran the right to rely on any listed factor, including those that involve treatments or medical conditions that may themselves be contentious (e.g., drug therapy, vaccines, envenomation, poisoning). The existence of the factor is a question of fact, but the instrument provides the framework. Section 9 imposes a duty of causation in both directions: the factor must be related to service. That requires the veteran to prove not just that they had a systemic viral infection within four weeks, but that the infection was related to service. That may be easy if the infection occurred while deployed to a region with high prevalence, but difficult if the infection was acquired on leave. The instrument also gives the decision-maker a duty, under section 10, to look up other SoPs when a factor refers to another injury or disease. For example, factor (7) lists vasculitides such as Kawasaki disease. To rely on that factor, the veteran must have had Kawasaki disease. But if Kawasaki disease itself is covered by a separate SoP (as a medical condition), the decision-maker must also apply that SoP to determine if the Kawasaki disease is service-related. That multi-step analysis can create administrative burden. The right to rely on clinical worsening (section 9(2)) is narrower than for onset: the worsening must be materially contributed to by a factor that is service-related, but only if the myocarditis itself did not arise out of service. That prevents double counting but may be tricky in practice.

This instrument does not itself create penalties. It is a medical causation standard, not a prohibitory or regulatory instrument. However, the enforceability of the instrument lies through the claims system. If a decision-maker fails to apply the correct SoP or misapplies its factors, the veteran has a right to seek review first by the Veterans’ Review Board or MRCC Review Board, then by the Administrative Appeals Tribunal, and ultimately by the Federal Court on a question of law. The instrument does not impose fines or criminal liability for non-compliance. That said, there are provisions in the parent acts that apply to fraudulent claims: making a false statement or providing false or misleading evidence in support of a claim for pension can attract penalties under sections 218 and 219 of the VEA (up to 12 months imprisonment or fines). Those penalties apply irrespective of the SoP. The instrument indirectly affects enforcement by narrowing the scope of legitimate claims. If a veteran cannot point to a factor in section 8, the claim cannot succeed at the reasonable hypothesis stage, so any attempt to proceed would likely be futile; but that is not a penalty, it is a threshold. The Repatriation Medical Authority is not an enforcement body; it only determines the SoPs. The Authority does not investigate individual claims. Compliance with the instrument is ensured through the internal review and tribunal processes. There is no specific penalty for the Authority if it makes a SoP that is later found to be based on insufficient medical evidence, because the VEA gives the Authority wide discretion on what constitutes sound medical-scientific evidence. The only remedy is that a claimant may argue the SoP is invalid, but that would require a challenge to the instrument itself in the Federal Court. No penalties attach to the medical experts who give evidence, though they risk professional disciplinary action if they knowingly provide false evidence. Overall, the enforcement mechanism is the same as for any veterans’ entitlement decision: the instrument is mandatory and enforceable through the hierarchy of administrative review.

This SoP operates under the VEA and MRCA. It is a legislative instrument made under subsection 196B(2) of the VEA. It sits within a complex web of related instruments. For claims under the VEA, the standard of proof is set in section 120 of that Act, with section 120A requiring that a SoP be applied where one exists for the injury or disease. This SoP is such an instrument. It interacts with the definition of “relevant service” in the dictionary, which cross-references service types defined in the VEA and MRCA. There is also an interaction with the Safety, Rehabilitation and Compensation Act 1988 (SRCA) for members who served before 1 July 2004 but are not covered by the VEA or MRCA - though this SoP may not apply directly to SRCA claims, the SRCA does not have a SoP regime. The instrument interacts with other SoPs through section 10. For example, factor (5) requires having tuberculosis before clinical onset of myocarditis. Tuberculosis is itself a condition covered by a SoP. To rely on factor (5), the veteran must satisfy the tuberculosis SoP as well. Similarly, factor (4) (HIV), factor (7) (various vasculitides), factor (8) (systemic inflammatory diseases) all likely refer to conditions covered by other SoPs. That means multiple SoPs must be considered in sequence, increasing the complexity and cost of claims. The instrument also interacts with the ICD-10-AM coding system, referenced in subsection 6(4). While the code is not binding for diagnosis, the reference makes the coding system incorporated by reference as at a specific edition (Tenth Edition, effective 1 July 2017). That means any changes to the coding system after that date are not incorporated unless the SoP is amended. This can create inconsistency between clinical coding and the SoP definition. The instrument also interacts with state and territory workers’ compensation schemes only indirectly: a veteran may be able to claim under both systems, but compensation paid under one may be offset against the other. The instrument does not interact with common law negligence claims against vaccine manufacturers or doctors; those are separate and the SoP is not evidence in such proceedings. However, the fact that the RMA found “sound medical-scientific evidence” linking COVID-19 vaccine to myocarditis (factor 17) may be cited in civil litigation, though the instrument was not intended for that purpose. Finally, the instrument interacts with the Administrative Appeals Tribunal Act 1975 for review purposes, and with the Federal Court of Australia Act 1976 for judicial review.

The instrument is a new determination made on 22 February 2024, commencing 26 March 2024. The instrument does not state that it revokes any previous SoPs. Under section 196B of the VEA, the Repatriation Medical Authority is empowered to revoke or amend SoPs from time to time. It is normal practice for a new SoP to revoke the previous one on the same condition. However, this instrument is silent on revocation. That may mean either that no previous myocarditis SoP existed, or that the revocation clause was omitted by oversight. A search of the Federal Register of Legislation would clarify. Without that external search, we must rely on the source alone. The instrument contains no amendment schedule, no savings provisions, and no transitional provisions. This suggests it is the first SoP for myocarditis under the current legislative framework, or that the previous SoP was revoked separately. The absence of a revocation clause is unusual if a prior SoP existed, because the VEA requires that only one SoP be in force for a particular kind of injury or disease. If there is a pre-existing SoP that is not revoked, there could be a conflict, but the instrument’s commencement date would likely override by implication. The reader should check the Federal Register of Legislation for any pre-existing myocarditis SoPs. The instrument also does not mention any amendments to the dictionary or factors after its making; it is as at 26 March 2024. The Australian Government has no amendment history available within the instrument itself. For research purposes, one should note the instrument number (No. 17 of 2024) and the year, which suggests it is part of a series of SoPs issued in 2024. The Repatriation Medical Authority issues many SoPs each year, and they are each standalone. There is no cross-reference to previous versions. If a claim relates to a period before 26 March 2024, the law will generally apply the SoP that was in force at the time of the decision, subject to any transitional provisions in the VEA. It is possible that a previous SoP applied for periods before the 26 March 2024. Practitioners should confirm which SoP applied at the relevant time. The instrument does not provide a date of effect for the factors themselves; the factors are not retrospective in the sense that they define a reasonable hypothesis for claims made now, even if the clinical onset occurred many years earlier. The key date is the date of the claim or the date of determination.

The instrument is new as of 2024; there can be no litigation specifically concerning its interpretation yet. However, the instrument will inevitably be the subject of administrative and judicial review in the future. The more relevant litigation history concerns the reasonable hypothesis standard and other SoPs generally. The source itself contains no case names. Therefore, we cannot rely on any specific cases. We note that courts have frequently considered whether the Repatriation Medical Authority has properly exercised its discretion in determining factors, and whether a factor is based on sound medical-scientific evidence. Challenges to SoPs often focus on whether the Authority considered all relevant evidence and whether a factor is too restrictive. There may also be litigation on the meaning of “clinical onset” and “clinical worsening” in relation to specific factors. The temporal windows (e.g., “within 4 weeks” for viral infection or vaccine) are likely to be contested. For example, what is the precise moment of clinical onset? Is it the date of first symptoms or date of diagnosis? The instrument does not define clinical onset, so existing case law on that concept will apply. Another area likely to generate disputes is the exclusion of inflammation associated with coronary artery disease. A veteran with coronary artery disease who develops myocarditis may argue that the inflammation is not associated, triggering a fact-finding exercise. The term “associated” is ambiguous. If a veteran has concurrent coronary artery disease, the decision-maker must determine whether the inflammation is caused by the coronary artery disease or is independent. That will require expert medical evidence. The cross-reference mechanism in section 10 will also likely be litigated, especially when a factor refers to a disease that itself has a SoP that is difficult to satisfy. For example, factor (7) includes “Kawasaki disease”. If the veteran had Kawasaki disease but cannot satisfy the Kawasaki disease SoP, can they still rely on the myocarditis factor? The instrument seems to say no: the Kawasaki disease must itself be service-related. That could be a gateway that blocks otherwise valid myocarditis claims. The Federal Court may be asked to interpret the interaction. Overall, while no specific litigation has occurred yet, the instrument is ripe for legal challenge on the adequacy of some factors (e.g., factor (16) which requires medication that is “associated in the individual” with onset - this is an idiosyncratic test that is hard to prove without rechallenge). The lack of a specific factor for other vaccines (e.g., influenza) may also be challenged if new evidence emerges.

Several aspects of the instrument can trap the unwary. First, the definition of myocarditis in subsection 6(2) excludes inflammation associated with coronary artery disease. A claimant with both conditions may have difficulty if the inflammation is attributable to ischaemia. The decision-maker may argue that the myocarditis is not “myocarditis” for SoP purposes. Second, the temporal windows are strict: many factors require existence “within the 4 weeks before clinical onset” (systemic viral infection, COVID-19 vaccine, smallpox vaccine) or “within 3 months” (drugs, cocaine). Missing these windows by even a day can defeat the claim, even if medical science suggests a longer incubation period. Third, factor (16) (“taking a medication for at least 7 days which is associated in the individual with the clinical onset ... and cessation of symptoms within weeks of discontinuing”) is notoriously difficult to prove because it requires a de-challenge/re-challenge profile that is rarely documented in clinical records. Fourth, the inability to obtain appropriate clinical management (factor 26) applies only to clinical worsening, and only if the inability is related to service. A veteran who simply had poor medical care in civilian life cannot rely on this factor. Fifth, the cross-reference trap: to rely on factor (5) (tuberculosis) or factor (4) (HIV), the veteran must also satisfy the separate SoP for that condition, which may be even more stringent. This can create a cascading burden of proof. Sixth, clinical worsening claims under section 9(2) are limited: they only apply if the myocarditis was suffered or contracted before or during service but did not arise out of service. That requires careful parsing: if the myocarditis arose out of service, you cannot claim worsening under this SoP (though you might claim onset under a different factor). Seventh, the instrument does not list myocarditis from non-COVID-19 vaccines (e.g., influenza, hepatitis). That may be a deliberate omission based on current evidence, but it means a claimant who develops myocarditis after another vaccine cannot rely on a specific factor and must try to fit under systemic viral infection (if the vaccine caused an infection) or other factors, which may be impossible. Eighth, envenomation factors (20 and 21) are very narrow: they specify particular spiders and a 24-hour or one-week window. A bite from an unidentified spider or a different species will not qualify. Ninth, factor (14) lists many medications but does not include all medications that have case reports of myocarditis (e.g., certain antipsychotics other than clozapine). Clozapine is separately listed with a 2-year window (15). Other antipsychotics are not listed, so a veteran on olanzapine cannot use factor (14) unless it falls under another subcategory. Tenth, the factor for alcohol use disorder (25) requires the disorder to exist at the time of clinical onset. A history of past alcohol abuse that resolved before onset does not qualify.

For legal practitioners representing veterans, compliance means ensuring that every claim for myocarditis identifies at least one factor from section 8 that applies to the claimant, supported by medical evidence that the factor existed within the relevant temporal window and that the factor is related to service. The easiest factors to prove are those involving vaccines or infections acquired during overseas service. For example, if a veteran developed myocarditis within four weeks of a COVID-19 vaccination that was administered as part of a military requirement, factor (17) is clearly met, and the relationship to service is straightforward because the vaccination was mandated or offered in a military context. For other factors, such as autoimmune diseases, the veteran must first prove that the autoimmune disease itself is service-related (e.g., through a different SoP) or that it existed independently but is not the cause of the myocarditis. Medical reports should explicitly state the date of clinical onset, the date of the factor (e.g., date of vaccination, date of viral infection symptoms), and confirm that the temporal relationship matches the instrument’s requirements. For treatment-related factors, the report should confirm the medication name, dosage, and start/stop dates. For factor (16), the report should describe the individual’s symptom course and the de-challenge response if available. Decision-makers must carefully consider each factor claimed and ensure that the definition of myocarditis is not incorrectly narrowed by reference to ICD codes alone. If the clinical records show a diagnosis of “myocarditis” but also note coronary artery disease, the decision-maker must determine whether the inflammation is associated with the CAD. If it is, the claim cannot succeed under this SoP. Decision-makers should also check whether any factor requires cross-reference to another SoP. For example, if factor (7)(g) (Takayasu arteritis) is claimed, the decision-maker must locate the SoP for Takayasu arteritis and confirm that the veteran satisfies its factors. Medical evidence for the underlying condition should be obtained. Legal practitioners should request that medical experts address the specific wording of the factor to reduce ambiguity. For death claims, the report must show that myocarditis contributed to a terminal event listed in the dictionary, and that at least one factor existed before death and was related to service. The instrument does not require that the factor directly caused death; only that it contributed to a terminal event such as cardiac arrest or respiratory failure. Compliance also requires staying up to date with amendments. The instrument may be revoked or amended in future. The Repatriation Medical Authority reviews SoPs periodically, so practitioners should check the Federal Register of Legislation for the current version. For internal policy compliance within the Department of Veterans’ Affairs, decision-makers should use this SoP as the sole reference for assessing reasonable hypothesis for myocarditis, and should not apply any instrument that has been superseded. Training should be provided to claims officers on the exclusion of coronary artery disease and the cross-reference mechanism. Medical advisors to the Commission should develop standardised templates that map the factors to common clinical scenarios to streamline processing. Overall, the most effective compliance strategy is thorough documentation at the time of diagnosis: recording vaccination dates, infection history, medication lists, and the absence of coronary artery disease can greatly simplify later claims.