Statement of Principles concerning aortic stenosis (Reasonable Hypothesis) (No. 13 of 2022)

This instrument, the Statement of Principles concerning aortic stenosis (Reasonable Hypothesis) (No. 13 of 2022), is a legislative determination made by the Repatriation Medical Authority under subsection 196B(2) of the Veterans' Entitlements Act 1986 (VEA). It replaces the earlier Statement of Principles No. 21 of 2013 on the same condition. Its mechanical effect is to specify the factors that must exist before a reasonable hypothesis can be raised connecting a person's aortic stenosis, or death from aortic stenosis, with the circumstances of their relevant service. Relevant service includes operational, peacekeeping, hazardous and British nuclear test defence service under the VEA, and warlike and non-warlike service under the Military Rehabilitation and Compensation Act 2004 (MRCA). The instrument applies to claims under section 120A of the VEA or section 338 of the MRCA. It does not create a new category of injury or disease; it merely operationalises the standard of proof known as 'reasonable hypothesis' by listing medical and service-related factors that, if present, are considered sufficient to raise such a hypothesis. The instrument also defines the condition narrowly: it means obstruction of blood flow across the aortic valve due to thickening and calcification, and it expressly excludes aortic stenosis from rheumatic heart disease, congenital stenosis of the aortic valve, and obstructions due to supravalvular or subvalvular narrowing. The definition is anchored to ICD-10-AM codes I35.0 and I35.2, but the meaning in subsection 7(2) governs. For death claims, the instrument includes death from a terminal event contributed to by the person's aortic stenosis, with 'terminal event' being defined in the dictionary to include pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function.

The central concept is the 'reasonable hypothesis' standard of proof. Under section 120A of the VEA, the Repatriation Medical Authority is empowered to determine Statements of Principles that set out the factors that must exist before a reasonable hypothesis can be said to connect a disease or injury to a person's service. This instrument is one such determination. The standard itself is not defined in the instrument but is well established in case law: a hypothesis is reasonable if it is not fanciful, is supported by sound medical-scientific evidence, and is consistent with the known facts. The instrument does not raise the hypothesis; it merely prescribes which factors, if present, will satisfy the legal test. The factors are listed in section 9 and are divided into two groups: those for the 'clinical onset' of aortic stenosis (factors 1 to 12) and those for the 'clinical worsening' of aortic stenosis (factors 13 to 27). Clinical onset and clinical worsening are not defined in the instrument but are concepts applied by decision-makers: onset refers to the first appearance of the condition; worsening refers to a material aggravation of an existing condition. Factor 27 is notable: 'inability to obtain appropriate clinical management for aortic stenosis'. This is a catch-all that does not require a specific prior medical condition but rather a systemic or service-related failure to provide treatment. The instrument also establishes that any factor must be 'related to the relevant service rendered by the person' (section 10(1)). For the worsening factors, they apply only to material contribution to or aggravation of aortic stenosis where the condition was suffered or contracted before or during (but did not arise out of) the person's relevant service (section 10(2)). The dictionary defines key medical and exposure terms: chronic kidney disease is defined by glomerular filtration rate, albuminuria, renal damage evidence, or kidney transplant; dyslipidaemia is defined by specific lipid thresholds or regular drug therapy; being overweight or obese is defined by BMI of 25 or greater (or waist circumference thresholds); one pack-year equals smoking 20 cigarettes per day for a year or equivalent; cumulative equivalent dose of ionising radiation is defined by reference to the ARPANSA guide. The factor for smoking requires at least 10 pack-years and, if ceased, onset or worsening must have occurred within 20 years of cessation. The factor for ionising radiation has a threshold of 0.5 sievert cumulative equivalent dose to the heart. The factor for therapeutic radiation for cancer applies if the heart was in the field of radiation. The pregnancy factor (25) applies only within six weeks before clinical worsening. The surgery factor (26) applies only to symptomatic or severe aortic stenosis and within 30 days before clinical worsening, with severe aortic stenosis defined by maximum aortic velocity of at least 4 m/s, mean pressure gradient of at least 40 mmHg, or aortic valve area of 1.0 cm² or less.

The primary individuals affected by this instrument are veterans, members of the Peacekeeping Forces, and members of the Forces under the VEA, as well as members under the MRCA, who have or have had aortic stenosis and who lodge a claim for compensation or a pension for that condition. Also affected are the dependants of such persons who claim in relation to death from aortic stenosis. The instrument directly binds the decision-makers who assess claims: the Repatriation Commission (for VEA claims) and the Military Rehabilitation and Compensation Commission (for MRCA claims). These bodies must apply the Statement of Principles as a mandatory step in determining whether a reasonable hypothesis exists. The Australian Administrative Appeals Tribunal and the Federal Court, on review, must also apply this instrument. Medical professionals providing evidence in support of claims are affected insofar as they must understand the specific definitions employed, such as the thresholds for dyslipidaemia, chronic kidney disease, and being overweight or obese. The instrument also affects medical advisers within the Department of Veterans' Affairs and the Repatriation Medical Authority itself, who rely on these factors to evaluate claims consistently. Applicants and their representatives (lawyers, advocates from ex-service organisations) must carefully align evidence with the factors listed. For example, a claimant who has smoked but ceased more than 20 years before onset will not satisfy factor 8(b). A person who has infective endocarditis must prove it occurred before the clinical onset of aortic stenosis. The instrument imposes a compliance burden on claimants: they must produce medical records confirming the specific laboratory values or diagnoses at the relevant time. The instrument has no direct effect on the general public or on health providers outside the veterans' compensation system, but its definitions of conditions like dyslipidaemia and obesity may be referenced in other contexts. The concentrated costs fall on claimants who must navigate a complex set of technical criteria; the diffuse benefit is that the instrument provides legal certainty and consistency in decision-making, reducing arbitrary outcomes. However, the specificity of the definitions may operate to deny claims where the available medical evidence does not precisely match the thresholds, even if the underlying relationship between service and condition is plausible.

The instrument does not impose duties directly on individuals; rather, it sets out the legal framework within which rights to compensation are determined. The key right for a claimant is to have their claim assessed against these factors: if the claimant can show that at least one factor in section 9 exists and that factor is related to their relevant service, then a reasonable hypothesis is raised, and the claimant is entitled to the benefit of the reasonable hypothesis standard of proof. This is a significant right because the reasonable hypothesis standard is lower than the civil standard of proof (balance of probabilities). The duty of the decision-maker is to apply the Statement of Principles strictly: they must not accept a hypothesis that relies on a factor not listed unless that factor is derived from another applicable Statement of Principles via section 11 (which cross-references factors that refer to an injury or disease covered by another SoP). The instrument also imposes an obligation on the decision-maker to treat the defined medical terms precisely. For instance, 'dyslipidaemia' is defined by five alternative criteria, including the regular administration of drug therapy to normalise lipid levels. A claimant who has dyslipidaemia diagnosed but whose lipid values are not recorded at the specific thresholds may still satisfy the definition if they are on drug therapy. The claimant has the duty to present evidence that meets these definitions, not merely a doctor's general diagnosis. The instrument creates no private rights of action outside the compensation system. The right to rely on a factor is contingent on the factor being 'related to the relevant service rendered by the person' (section 10). This requires a causal or worsening link between the service itself and the factor. For example, infective endocarditis could be related to service if the person contracted the infection during service. The instrument does not define 'related to'; that is a question of law and fact for the claim decision. The factor for inability to obtain appropriate clinical management (factor 27) imposes a duty on the decision-maker to consider whether the inability was due to service circumstances (e.g., lack of access to medical care while deployed). This factor is broad but may also be difficult for claimants to prove, especially if they are now able to access care.

This instrument is not penal in nature. It does not create offences or prescribe fines or imprisonment. Its enforcement mechanism is the claims adjudication process: if a claim is refused because the claimant cannot satisfy any of the factors, the claimant may seek internal review and then appeal to the Administrative Appeals Tribunal and the Federal Court. The penalty, from the claimant's perspective, is the denial of pension or compensation for aortic stenosis. For the decision-maker, failure to apply the instrument correctly may lead to the decision being set aside on review. The Repatriation Medical Authority is not itself subject to enforcement; its determinations are legislative instruments and can be disallowed by Parliament (though the timing and procedure for disallowance of SoPs is a distinct issue). There is a potential for the Commonwealth to seek recovery of overpaid compensation if a claim based on a reasonable hypothesis is later found to be unsupported by the facts, but that is a remedy under the administering Acts rather than this instrument. The instrument does not confer any enforcement powers on any body. Its practical enforcement lies in the power of the Federal Court to quash decisions that fail to apply the instrument correctly. The instrument also indirectly affects the enforcement of other legal obligations: for example, if a factor is met because of a service-related injury (like infective endocarditis), that injury may itself be compensable under another Statement of Principles, and the claimant may be entitled to compensation for both conditions. The absence of penalties means the instrument functions purely as a gatekeeper for entitlement. This is typical of Statements of Principles: they standardise medical evidence but leave adjudication to the Commission. The cost of non-compliance for the government is that it may pay compensation in cases where the hypothesis is later found to be weak; the cost for the claimant of non-compliance (i.e., failing to meet a factor) is the loss of compensation. There is no provision for penalties against medical practitioners who provide inaccurate evidence, but the general law of fraud applies.

This instrument is made under the VEA, specifically subsection 196B(2). It operates within the broader framework of Part XIA of the VEA (Statements of Principles). It interacts with section 120A of the VEA, which requires the application of a reasonable hypothesis standard unless a Statement of Principles exists. Section 120A(3) provides that if the Repatriation Medical Authority has determined a Statement of Principles, a claim cannot be determined to be war-caused unless the material fits the factors. Therefore this instrument supplants any earlier judicial or tribunal interpretations that might have accepted a broader range of factors. It also interacts with the MRCA via section 338 of that Act, which imports the same Statement of Principles regime. The instrument expressly repeals the earlier 2013 SoP on aortic stenosis, which is now superseded. Section 11 provides that if a factor in section 9 refers to an injury or disease covered by another Statement of Principles (e.g., infective endocarditis, hypertension, dyslipidaemia, chronic kidney disease), then the factors in that other SoP apply as in force from time to time, in accordance with that SoP. This creates a cross-referencing system: a claimant relying on, say, factor (4) (having hypertension before clinical onset) may need to satisfy the definition of hypertension in the relevant Statement of Principles for hypertension, even though that term is not defined in this aortic stenosis SoP. That cross-reference may change over time as other SoPs are amended, without amendment to this instrument. The instrument also interacts with the VEA definitions of 'veteran', 'member of the Forces', and 'relevant service', which incorporate various categories of service. The definitions of 'being overweight or obese' and 'BMI' are standard across many SoPs, ensuring consistency. The instrument does not override or conflict with the Therapeutic Goods Administration or medical standards; it simply adopts medical classifications. There is no interaction with state workers' compensation laws, as the VEA and MRCA are federal schemes. However, if a person also has rights under the Military Rehabilitation and Compensation Act 2004 for a different condition, the determination of aortic stenosis under this SoP may affect the overall assessment of impairment points. The instrument also interacts with the Social Security Act 1991 only indirectly, as any VEA pension may affect social security payments. The instrument does not amend any other legislation; it is subordinate to the VEA and MRCA.

This instrument is a replacement SoP. It repeals the Statement of Principles concerning aortic stenosis No. 21 of 2013 (F2013L00718), which was made under subsections 196B(2) and (8) of the VEA. The new instrument is dated 24 December 2021 and commences on 31 January 2022. The Repatriation Medical Authority reviews Statements of Principles periodically as medical knowledge evolves. The predecessor SoP had been in force for approximately nine years. The amendment history of the 2013 SoP itself is not detailed in this instrument. The Authority is required by section 196E of the VEA to review SoPs at least every three years, but the decision to issue a new SoP may be driven by new evidence or refinement of factor definitions. This instrument does not include a transitional provision for claims already being processed under the 2013 SoP. However, section 4 repeals the old instrument, meaning that from commencement date, any claim not yet determined must be assessed under the new SoP. The practical effect is that a person who had a claim lodged before 31 January 2022 but not finalised will have their claim assessed against the new factors. The 2013 SoP had different definitions and factors; for instance, the threshold for smoking pack-years may have been different, or the inclusion of factors like being overweight or obese may have been defined differently. The new SoP adds some new factors: factor (11) primary hyperparathyroidism and factor (12) Paget's disease of bone were not in the 2013 version (or may have been added). The pregnancy factor (25) and surgery factor (26) are also additions or refinements. The cumulative equivalent dose factor (9) and (21) now have a threshold of 0.5 sievert, which may have been lower or absent before. The instrument does not explain the reasons for the changes; that would be found in the Authority's explanatory statement, which is not part of this legislation. The amendment history is therefore significant for practitioners: old case law interpreting the 2013 SoP is of limited precedential value, especially where definitions changed.

The instrument itself does not mention any litigation, and Statements of Principles are legislative instruments, not court decisions. However, the predecessor SoP (No. 21 of 2013) was litigated in the Administrative Appeals Tribunal and the Federal Court on numerous occasions. While those cases are not binding on the new SoP in the same way, they interpret the structure of the SoP regime and the meaning of 'reasonable hypothesis'. Key cases have addressed the concept of 'clinical onset' and 'clinical worsening', the evidentiary requirements for factors like smoking, and the application of the 'related to service' requirement. The new SoP may generate its own litigation on the interpretation of new terms like 'primary hyperparathyroidism' and 'Paget's disease of bone' in the context of veterans' claims. The factor for 'inability to obtain appropriate clinical management' has been a recurring source of litigation under other SoPs, and it will likely be contested here as well. The definition of 'severe aortic stenosis' (for factor 26) will also likely be litigated to clarify whether it is diagnostic at the time of surgery or at the time of worsening. The instrument's exclusion of congenital and rheumatic stenosis will continue to be a point of dispute: if a claimant has both calcific aortic stenosis and a history of rheumatic fever, the decision-maker must determine whether the stenosis is truly within the scope of the SoP or excluded. The cross-reference provision (section 11) has also been the subject of litigation to determine whether a claimant must satisfy the factors of the referenced SoP or merely the definition of the condition. The ebb and flow of Federal Court decisions on the VEA's 'reasonable hypothesis' standard will also affect how this instrument is applied, including the High Court's guidance on the approach to Statements of Principles. Practitioners should be aware that reliance on case law from the old SoP may mislead if the definitions have changed. The instrument is too recent to have its own litigation history, but the pattern of challenges to SoPs suggests that the new factors will be tested within a few years.

Several provisions in this instrument are likely to trip up unwary claimants or advocates. First, the exclusion of rheumatic heart disease (subsection 7(2)(b)(i)): if a person's aortic stenosis is due to rheumatic fever, the claim does not fall under this SoP at all, and the person may need to rely on a different SoP (e.g., for rheumatic heart disease) or the general provisions of the VEA. This is a blunt exclusion that may catch people who have both calcific and rheumatic changes. Second, the smoking factor (8) requires both a minimum of 10 pack-years and, if cessation occurred, that the clinical onset or worsening occurred within 20 years of cessation. A person who smoked 20 pack-years but quit 25 years before onset fails the factor entirely. The definition of pack-years uses 20 cigarettes per day as the baseline; careful calculation is required. Third, the factor for ionising radiation (9) has a threshold of 0.5 sievert cumulative equivalent dose to the heart, calculated using a specific ARPANSA guide. The guide itself is not reproduced, and a claimant must obtain a detailed radiation dose reconstruction, which is costly and not always available for military exposures. Fourth, the pregnancy factor (25) applies only to clinical worsening, not onset, and only within six weeks before worsening. A pregnant veteran who develops aortic stenosis during pregnancy cannot rely on that factor for the initial condition. Fifth, the surgery factor (26) is limited to symptomatic or severe aortic stenosis and to surgery requiring a general, spinal, or epidural anaesthetic within 30 days before worsening. Routine dental surgery under local anaesthetic does not qualify. The definition of 'severe aortic stenosis' uses three alternative criteria, and a person may not satisfy the definition if their velocity is 3.9 m/s but valve area is 1.1 cm². Sixth, the cross-reference mechanism (section 11) means that a factor like 'having hypertension' (factor 4 or 16) requires the claimant to satisfy the definition of hypertension in whichever Statement of Principles currently covers hypertension. If the hypertension SoP is amended, the definition may change without notice. Seventh, the instrument uses 'clinical worsening' but does not define it. The Administrative Appeals Tribunal has often required a material worsening documented by objective evidence. A transient increase in symptoms may not suffice. Eighth, the factor for 'inability to obtain appropriate clinical management' (27) is extremely broad but also vague. The decision-maker will need evidence that management was unavailable or inappropriate and that this inability contributed to the worsening. It is not enough to show poor management; it must be inability. Ninth, the definition of 'being overweight or obese' uses waist circumference thresholds that differ by sex (94 cm for males, 80 cm for females) plus a BMI alternative of 25 or greater. A person with a BMI of 27 but a waist circumference of 90 cm (male) still qualifies because the definition is disjunctive. Tenth, the instrument has no sunset clause or review trigger; it remains in force until repealed. Tenth, the instrument applies to claims under both VEA and MRCA, but the definitions of 'relevant service' differ slightly. A person must ensure their service type fits the defined categories; for example, British nuclear test defence service is included under VEA but not MRCA.

For a claimant, compliance means gathering evidence that establishes at least one of the 27 factors and demonstrates that the factor is related to their relevant service. The first step is to obtain a diagnosis of aortic stenosis that meets the definition in subsection 7(2) , i.e., obstruction due to thickening and calcification, not due to rheumatic, congenital, or other obstructions. The diagnosis should be confirmed by echocardiography showing a maximum aortic velocity of at least 2 m/s (or other evidence of a significant pressure gradient). For death claims, a link to aortic stenosis must be shown, with the terminal event being contributed to by the condition. The second step is to identify which factor (or factors) may apply. Medical records must be obtained to prove the existence of conditions like infective endocarditis, systemic autoimmune connective tissue disease, hypertension, dyslipidaemia, diabetes mellitus, chronic kidney disease, primary hyperparathyroidism, Paget's disease of bone, or pregnancy. For smoking, the claimant needs a detailed smoking history including start/end dates and average consumption, plus evidence that the aortic stenosis onset or worsening occurred within 20 years of cessation. For ionising radiation, a reconstruction report from ARPANSA or a qualified health physicist is needed to prove a cumulative equivalent dose of at least 0.5 Sv to the heart. For therapeutic radiation, a treatment summary showing the heart was in the field is essential. For being overweight or obese, height, weight, and waist measurements must be documented for at least 5 years within the 20 years before onset or worsening. For surgery, the anaesthetic record must show general, spinal, or epidural anaesthetic, and if the surgery was within 30 days of worsening, a pre-surgery echocardiogram must demonstrate that the aortic stenosis was symptomatic or severe. For inability to obtain appropriate clinical management, evidence of service-related barriers to care (e.g., deployment to a remote area, lack of access to cardiology services, misdiagnosis due to resource constraints) is required. The third step is to establish that the factor is related to the person's relevant service. This may require service records showing exposure, medical treatment during service, or a causal connection. For example, infective endocarditis may be related to service if the person had dental surgery on a naval vessel. Hypertension may be related to service if the person had a service-related kidney injury. The claimant should also ensure that for worsening factors (13-27), the aortic stenosis was pre-existing and the worsening is material. The decision-maker will apply the instrument strictly; therefore, all medical evidence must use the definitions in the dictionary. For example, a doctor's note stating 'dyslipidaemia' without specifying the lipid values or drug therapy may not meet the definition. Compliance burden is high: the cost of obtaining specialist reports, radiation dose reconstructions, and detailed smoking histories can be significant. The claimant should engage an experienced veterans' advocate or lawyer who understands the SoP regime. The timing of the factor relative to clinical onset or worsening is critical; event dates must be precise. The instrument allows for reliance on multiple factors, so claimants should identify all potentially applicable factors. There is no penalty for claiming under a factor that later fails, but the claim may be delayed. The best practice is to assemble a comprehensive dossier that addresses the definition of aortic stenosis, the chosen factor(s), and the relationship to service. Regular review of any amendments to cross-referenced SoPs is also necessary because the definition of hypertension, chronic kidney disease, or other conditions may change without a change to this SoP.