Statement of Principles concerning neurocognitive disorder with Lewy bodies (Reasonable Hypothesis) (No. 35 of 2019)

The central concept is “neurocognitive disorder with Lewy bodies” as defined in subsection 7(2). The definition is derived from the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, 2013). It requires two cumulative elements. First, evidence of major neurocognitive disorder or mild neurocognitive disorder. Major neurocognitive disorder means significant cognitive decline from a previous level in at least one domain (complex attention, executive function, learning and memory, language, perceptual-motor, or social cognition), with the decline documented by standardized neuropsychological testing or other qualified clinical assessment, and the deficits interfering with independence in everyday activities (e.g., requiring assistance with complex instrumental activities like paying bills or managing medications). Mild neurocognitive disorder means modest cognitive decline with modest impairment in testing, but not necessarily interfering with independence. The second element is that the disorder must have an insidious onset and gradual progression. Third, the disorder must meet at least two of four diagnostic features: fluctuating cognition with pronounced variations in attention and alertness; recurrent well-formed detailed visual hallucinations; spontaneous features of Parkinson’s disease or secondary Parkinsonism at least one year after the clinical onset of cognitive symptoms; or REM sleep behaviour disorder. The definition importantly excludes cognitive deficits due to delirium, another mental disorder (e.g., major depressive disorder, schizophrenia), cerebrovascular disease, other neurodegenerative diseases (Alzheimer disease, Parkinson’s disease, Huntington’s chorea), brain tumour, subdural haematoma, effects of a substance, or systemic disorders such as hypothyroidism, vitamin deficiencies, hypercalcaemia, neurosyphilis, or HIV infection. The instrument also defines “relevant service” to mean operational, peacekeeping, hazardous, or British nuclear test defence service under the VEA, or warlike or non-warlike service under the MRCA. Another key concept is “factors that must exist.” There are five such factors, and at least one must be present. The factors are binary: either they exist or they do not. The instrument also distinguishes between clinical onset and clinical worsening. Factors (1) and (2) relate to the initial development of the condition (having major depressive disorder or PTSD at least ten years before onset). Factors (3) to (5) relate only to material contribution to or aggravation of the condition where the NCDLB was suffered or contracted before or during (but did not arise out of) the person’s relevant service. “Specified list of anticholinergic drugs” is defined in the dictionary to include specific antidepressants (e.g., amitriptyline, paroxetine), antiparkinson agents (e.g., benztropine, trihexyphenidyl), and bladder antimuscarinics (e.g., oxybutynin, tolterodine). The instrument also defines “terminal event” to include pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function, so that death contributed to by NCDLB can be considered death from the condition.

The instrument directly affects veterans, members of Peacekeeping Forces, and members of the Forces who have rendered “relevant service” as defined: operational service, peacekeeping service, hazardous service, or British nuclear test defence service under the VEA, or warlike or non-warlike service under the MRCA. That includes Australian Defence Force personnel who served in combat, peacekeeping operations, hazardous environments, or British nuclear tests. It also affects their dependants and beneficiaries who may claim compensation or benefits in relation to death from NCDLB. The instrument affects decision-makers within the Department of Veterans’ Affairs, the Military Rehabilitation and Compensation Commission, and the Veterans’ Review Board, as it prescribes the minimum factors that must be considered when assessing a claim under the reasonable hypothesis standard. Medical practitioners and specialists who provide expert reports in support of claims must ensure their opinions address the specific DSM-5 criteria and the listed factors, including the ten-year latency periods for depression and PTSD. Legal practitioners representing claimants need to understand the strict definitional boundaries: if the cognitive deficits are primarily due to another cause such as Alzheimer disease or substance effects, then the diagnosis does not fall within the SoP, and the claim cannot succeed under this instrument. The instrument also indirectly affects the broader veteran community by creating a standardised pathway for NCDLB claims, but it may exclude those whose condition has mixed features not cleanly meeting the DSM-5 criteria. The repeal of the earlier SoP concerning Alzheimer-type dementia may affect claimants who previously had their condition assessed under that SoP; they now face a different set of factors. The instrument also affects other medical conditions referenced in its own factors: for example, factor (1) requires major depressive disorder, and factor (2) requires PTSD. If a claimant relies on one of these factors, and that condition itself has its own SoP (which it does, under the VEA framework), then under section 11, the factors in that other SoP apply to establish the presence of the depression or PTSD as a factor. This cross-referencing creates a layered compliance burden. The instrument does not affect members of the general public or civilian workers; it is limited to the veteran compensation context.

The instrument imposes no direct duties on private individuals. Instead, it creates a framework for decision-makers and claimants. The key duty on the Repatriation Medical Authority was already performed: determining the SoP. The operative duty falls on the decision-maker (the Commission or delegate) when assessing a claim. Under sections 120A of the VEA and 338 of the MRCA, the decision-maker must apply the SoP to determine whether a reasonable hypothesis exists connecting the condition to service. The instrument provides that a reasonable hypothesis cannot be raised unless at least one of the five listed factors exists. The decision-maker must be satisfied that the factor exists and that it is related to the person’s relevant service. For factors (3) to (5), there is an additional requirement: they apply only to material contribution to, or aggravation of, NCDLB where the person’s NCDLB was suffered or contracted before or during (but did not arise out of) their relevant service. This imposes a duty on claimants to prove both the factor and its temporal and causal relationship to service. Claimants have a right to have their claim assessed in accordance with the SoP. If the decision-maker fails to apply the correct SoP or misinterprets its terms, the claimant has a right to seek review by the Veterans’ Review Board and, ultimately, the Administrative Appeals Tribunal and the Federal Court. The instrument also subtly affects the burden of proof. Under the VEA, for operational service claims, the standard is reasonable hypothesis; for non-operational service (including hazardous and peacekeeping service), the standard is reasonable satisfaction on the balance of probabilities. The SoP applies to both standards, but in practice, the reasonable hypothesis standard is less demanding. The claimant does not need to prove the factor on the balance of probabilities; they need only point to material that raises a reasonable hypothesis. However, the instrument still requires that the factor “must exist” before the hypothesis can be raised. The decision-maker must consider whether the material points to the existence of the factor. The claimant has a right to present medical evidence addressing the DSM-5 diagnostic criteria and the factors. There is also a right under section 10 that the existence of any factor must be related to the relevant service rendered by the person. This imposes a duty on claimants to establish not just the presence of, for example, major depressive disorder ten years before onset, but also that the depressive disorder itself was related to service. That often requires reliance on a separate SoP for major depressive disorder.

The instrument itself does not create penalties or enforcement mechanisms. It is a legislative instrument that operates within the broader VEA and MRCA penalty and enforcement frameworks. The most relevant enforcement context is that a false or misleading statement in connection with a claim for a pension or allowance under the VEA may constitute an offence under section 215 of the VEA, carrying a maximum penalty of imprisonment for 12 months. Similarly, under the MRCA, section 324 creates an offence for providing false or misleading information in connection with a claim, with a penalty of up to 12 months imprisonment. These provisions apply to claimants, their representatives, and medical practitioners who knowingly provide false evidence regarding the factors in the SoP. The instrument defines the criteria that must be met; if a claimant or doctor attests that the DSM-5 criteria are satisfied or that a factor existed, and that is knowingly false, the criminal provisions may be invoked. However, the more common enforcement pathway is administrative rather than penal. The decision-maker can reject a claim if the factors are not established, and can recover overpayments if benefits were paid on the basis of evidence later found to be incorrect. The Veterans’ Entitlements Act provides for recovery of debts under Part XIA. The instrument also indirectly affects the standard of proof in related criminal and civil proceedings. For example, if a person is charged with a Commonwealth offence and seeks to rely on a defence of mental impairment, the definition of major neurocognitive disorder in the dictionary (derived from DSM-5) might be referenced. But the instrument is primarily limited to the veterans’ compensation sphere. There is no regulatory body specifically enforcing compliance with the SoP; compliance is enforced through the internal merits review and judicial review processes. The absence of penalties within the instrument itself does not mean non-compliance is costless; a claimant who cannot satisfy at least one factor will simply not receive compensation, which is a significant practical penalty.

The instrument operates under the VEA and MRCA as subordinated legislation. It interacts with the primary Acts in that it specifies the factors that must be considered for the reasonable hypothesis standard under sections 120A (VEA) and 338 (MRCA). It is subject to those Acts and can be amended or repealed by later enactments. The instrument also interacts with other Statements of Principles. Section 11 states that if a factor refers to an injury or disease in respect of which another SoP has been determined under subsection 196B(2), then the factors in that other SoP apply. For example, factor (1) requires “having major depressive disorder.” Major depressive disorder has its own SoP. Therefore, to establish factor (1), the claimant must also satisfy the factors in the major depressive disorder SoP (as in force from time to time). This cross-reference creates a cascading set of evidentiary requirements. The instrument also interacts with the general law of evidence in administrative decision-making, as the decision-maker must weigh medical opinions that address the DSM-5 criteria. The definition of neurocognitive disorder with Lewy bodies explicitly excludes cases where cognitive deficits are primarily due to cerebrovascular disease, another neurodegenerative disease, or the effects of a substance (among others). This means that if a claimant has mixed pathology, the decision-maker must determine which condition is the primary cause. This interacts with the SoPs for those other conditions. For instance, if the cognitive decline is primarily due to Alzheimer disease, the Alzheimer-type dementia SoP would apply (though note the instrument repealed the earlier Alzheimer-type dementia SoP - there is presumably a current SoP for Alzheimer-type dementia). The instrument also references ICD-10-AM code G31.3 with F02.8 but states that the meaning given in subsection 7(2) prevails. This avoids confusion with any differing diagnostic categories under the classification system. The instrument interacts with the Federal Court’s jurisprudence on the meaning of “reasonable hypothesis” and the role of SoPs. The Court has held that SoPs are binding on decision-makers and that a hypothesis contrary to the factors cannot be accepted. The instrument is thus a substantive rule of law, not merely a guideline. It also interacts with state and territory guardianship and mental health laws to the extent that a veteran may be subject to such laws due to NCDLB, but the instrument does not directly address those interactions.

The instrument is the original version, made on 1 March 2019 and commencing on 25 March 2019. It does not appear to have been amended. It revokes and replaces the Statement of Principles concerning Alzheimer-type dementia No. 22 of 2010. That earlier instrument was made under subsections 196B(2) and (8) of the VEA and had the Federal Register of Legislation number F2017C00820. Its repeal suggests that the condition neurocognitive disorder with Lewy bodies was previously subsumed under the Alzheimer-type dementia SoP, or that the classification system has moved to a new diagnostic entity. The instrument itself has no amendment history within its text. It is listed as No. 35 of 2019. Any future amendments would be made by the Repatriation Medical Authority and would appear as amending instruments on the Federal Register of Legislation. The absence of amendments means the instrument remains in its original form as at the date of this analysis. Practitioners should check the Register for any subsequent amendments. The instrument’s sunset provision is not stated; SoPs under the VEA generally continue in force until repealed or replaced by a new SoP. The instrument also contains a note referencing the current ICD-10-AM Tenth Edition 2017, which may need updating in the future if the classification system changes. The instrument is made under subsection 196B(2) only, not subsection (8). That subsection (2) is the “reasonable hypothesis” standard, while subsection (8) is for the “balance of probabilities” standard. The repealed instrument was made under both subsections; the replacement is only under subsection (2). This implies that for claims under the MRCA (where the standard is reasonable satisfaction, equivalent to balance of probabilities in some contexts), this SoP still applies by virtue of the application clause (section 5). The instrument does not have a separate “balance of probabilities” version; the single set of factors applies to both standards.

The instrument itself does not reference any litigation. However, Statements of Principles in general are frequently litigated in the Administrative Appeals Tribunal (AAT) and the Federal Court. Common grounds of challenge include: whether the Repatriation Medical Authority acted on sound medical-scientific evidence (s 196B(2)), whether the definition of the disease is consistent with the DSM-5, whether a particular factor is supported by the evidence, and whether the instrument applies to a particular set of service circumstances. In relation to this specific instrument, no published decisions have been identified in the source. Practitioners should be aware that any litigation would likely focus on the diagnostic exclusion in subsection 7(2)(D). For example, a claimant whose cognitive decline is primarily due to a combination of Parkinson’s disease and Lewy body pathology might argue that the primary cause is not “another neurodegenerative disease” but rather the same condition. The exclusion for “another mental disorder” could be disputed if a claimant has a diagnosis of major depressive disorder that predates the NCDLB and the cognitive deficits overlap. The ten-year latency requirement for factors (1) and (2) may also be contested, particularly where the claimant had subclinical depression or PTSD that was not formally diagnosed until later. The AAT has previously considered the meaning of “having” a disease in the context of SoPs, and whether a diagnosis made after the onset of the claimed condition can satisfy the temporal requirement. The instrument’s definition of “major depressive disorder” is not provided in the dictionary; it is presumably left to the clinical definition, which could be a source of dispute. The interaction with the repealed Alzheimer-type dementia SoP may also generate transitional issues for claims that were lodged before the repeal date but determined after. The Federal Court has held that the SoP in force at the time of the decision applies to the determination of the claim, not the time of the onset of the condition. So the repeal would affect claims determined from 25 March 2019 onward.

Several aspects of the instrument can easily trap the unwary. First, the definition of neurocognitive disorder with Lewy bodies is strict and contains multiple exclusion clauses. If the cognitive deficits are primarily due to delirium, another mental disorder (e.g., major depressive disorder, schizophrenia), cerebrovascular disease, another neurodegenerative disease (Alzheimer disease, Parkinson’s disease, Huntington’s chorea), brain tumour, subdural haematoma, the effects of a substance, or various systemic disorders, the condition does not qualify regardless of the presence of Lewy bodies. This means that a claimant with mixed Alzheimer and Lewy body pathology may not meet the definition if the Alzheimer component is considered primary. The instrument does not define “primarily due to”; this leaves room for expert disagreement. Second, factors (1) and (2) require the major depressive disorder or PTSD to exist at least ten years before the clinical onset of NCDLB. That is a long lead time. If the depression or PTSD developed after the onset of cognitive symptoms, it cannot be used to raise a hypothesis for the onset. Practitioners must carefully date the onset of NCDLB, which can be insidious and difficult to pinpoint. Third, factors (3) and (4) apply only to “clinical worsening” of NCDLB, not to its onset. This is explicitly limited by subsection 10(2). The claimant must show that the NCDLB was suffered or contracted before or during (but did not arise out of) relevant service, and that the antipsychotic or anticholinergic drug treatment contributed to the worsening. The drug must be from the specified list; other anticholinergic drugs not listed are excluded. Factor (5) - inability to obtain appropriate clinical management - is vague. It does not define “appropriate clinical management” or “inability.” It may be interpreted as referring to failure to provide treatment that could have prevented worsening, but the burden is on the claimant to show that management was not appropriate and that this inability was related to service. Fourth, the instrument repeals the earlier Alzheimer-type dementia SoP. Any claims that were previously determined under that SoP may need to be reopened if the condition is now classified under NCDLB. But the repeal does not automatically invalidate past decisions. Fifth, the cross-reference to other SoPs under section 11 can create a chain of requirements. If a claimant relies on factor (1) (major depressive disorder), they must also satisfy that condition’s SoP. That SoP may itself have latency periods or other factors that are difficult to prove. Sixth, the instrument only applies to “relevant service” as defined. Not all military service qualifies; for example, peacetime service not classified as warlike or non-warlike under the MRCA may be excluded. Seventh, the death definition: death from NCDLB includes death from a terminal event contributed to by NCDLB. But the terminal event must be one of those listed: pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function. If death is due to another cause, such as suicide or a fall, it may not be covered unless the NCDLB contributed to that cause in a way that qualifies as a terminal event.

For claimants and their representatives, compliance means ensuring the claim is supported by medical evidence that explicitly addresses the DSM-5 diagnostic criteria for NCDLB and confirms that the exclusions do not apply. The medical report should state that the person meets the definition in subsection 7(2), including the requirement of insidious onset and gradual progression, and at least two of the four diagnostic features. It should also state that the cognitive deficits are not primarily due to any of the excluded causes. The report must then identify which factor or factors under section 9 are relied upon, and provide evidence that the factor existed at the required time. For factors (1) and (2), the medical evidence must establish the date of clinical onset of NCDLB and show that major depressive disorder or PTSD was present at least ten years before that date. For factors (3) and (4), the evidence must show that the person was being treated with the specified drug at the time of clinical worsening, and that the NCDLB was already suffered or contracted before or during (but did not arise out of) relevant service. The legal representative must also establish that the factor itself is related to relevant service. This often requires a separate analysis under the relevant SoP for the factor condition. For example, for PTSD, the claimant must satisfy the PTSD SoP factors and also link the PTSD to service. For factor (5), the claimant must demonstrate that appropriate clinical management was not obtained and that the inability was due to service circumstances. The decision-maker must apply the instrument strictly. When assessing a claim, the decision-maker should first confirm that the diagnosis fits the definition. If the diagnosis does not match, the claim cannot succeed under this SoP. The decision-maker should then check whether at least one factor exists and is related to service. The decision-maker should also be mindful of the part that factors (3) to (5) apply only to worsening. Practitioners should also monitor any amendment or replacement of this SoP. The Repatriation Medical Authority reviews SoPs periodically and may issue a new version with different factors or definitions. Keeping abreast of the Federal Register of Legislation is essential. Finally, if the claim is rejected at the primary stage, the claimant can apply for review to the Veterans’ Review Board, which can make its own findings of fact. The Board must also apply this SoP. If the Board errs in law, judicial review to the Federal Court is available.