Statement of Principles concerning fibromuscular dysplasia (Balance of Probabilities) (No. 82 of 2025)

The instrument revolves around a small set of technical concepts given operative definitions in the body and the Schedule. Core concepts are fibromuscular dysplasia, death from fibromuscular dysplasia, relevant service, one pack-year, clinical onset/clinical worsening, terminal event, and the statutory basis for the SoP (VEA s 196B(3)). The Schedule supplies key definitional detail that drives application.

Fibromuscular dysplasia is defined by clinical-pathological features rather than by ICD code. The SoP states that while FMD attracts ICD‑10‑AM code I77.3, the operative meaning for the SoP is the descriptive definition in subsection 7(2). That definition requires the disease to be non‑atherosclerotic, non‑inflammatory, segmental and involving musculature of arterial walls producing stenosis of small- and medium-sized arteries and either warranting treatment or producing certain clinical manifestations such as occlusion, aneurysm, dissection, or ischaemia to an organ. The definition expressly excludes carotid web (s 7(2)-(3)).

Death from FMD is framed as death from a terminal event or condition that was contributed to by the person’s FMD. Terminal event is defined in the Schedule and includes proximate or ultimate causes of death such as pneumonia, respiratory failure, cardiac arrest, circulatory failure and cessation of brain function (s 7(4); Schedule definitions).

Causal factors are set out in section 9. Two discrete categories are listed as “factors that must exist” before, on the balance of probabilities, a connection to relevant service is made: a smoking exposure criterion and an access-to-care/management failure criterion. The smoking criterion is quantified: having smoked at least 10 pack-years before clinical onset or clinical worsening (s 9(1)). The pack-year concept is defined in the Schedule and includes a formula and an equivalence table, including a numeric equivalence for smoking tobacco by weight (7,300 grams per pack-year) and a unit conversion for pipe tobacco and cigars (Schedule).

The clinical worsening aspect is an operational limitation. Section 10(2) specifies that the “clinical worsening” part of the factors applies only to material contribution to, or aggravation of, FMD where the person’s FMD was suffered or contracted before or during (but did not arise out of) the person’s relevant service. In plain terms, the factor that refers to clinical worsening is not available where the disease arose out of service; it applies only where the disease pre-dated, or began during, service and then materially worsened in relation to service.

The SoP also contains a mechanism for interactions with other SoPs: where a factor refers to an injury or disease covered by another SoP determined under s 196B(3) of the VEA, that other SoP applies as in force from time to time (s 11). This preserves a modular approach to medical causation rules and allows cross-SoP dependencies.

Finally, the instrument clarifies its statutory footing: it is made under subsection 196B(3) of the VEA (s 3), applies to claims to which s 120B of the VEA or s 339 of the MRCA applies (s 5), and repeals the earlier FMD SoP (No. 80 of 2016) (s 4). The ICD-10-AM reference is tied to a specific edition for coding context (Tenth Edition, effective 1 July 2017) but the SoP insists the textual definition governs (s 7(3)).

This SoP primarily affects three cohorts: claimants (veterans or members of the Forces) making or pursuing claims under the VEA or MRCA provisions cited, decision-makers and medical advisers in the Department or Tribunal applying the SoP to those claims, and treating clinicians or record-keepers whose documentation will be relied upon to establish the factors set out in the SoP.

Claimants: The instrument applies to claims to which section 120B of the VEA or section 339 of the MRCA applies (s 5). That means veterans or members seeking an operational or non‑operational service nexus for fibromuscular dysplasia or death from FMD will be subject to this SoP when medical causation is assessed under the statutory processes referenced. It is the presence or absence of the factors in s 9, and their relationship to relevant service under s 10, that the Authority has determined must exist, on the balance of probabilities, before a causal link to service can be accepted.

Decision-makers and administrative reviewers: Decision-makers implementing the VEA and MRCA who are required to consider whether a condition is connected with service will use this SoP as the medical-scientific statement informing causation assessment. The instrument is made under s 196B(3), which is the statutory mechanism for the Repatriation Medical Authority to make SoPs; the SoP is an input to determinations under the cited claim provisions (s 3, s 5). Where a factor references another disease or injury that in turn is governed by a separate SoP, decision-makers must apply that other SoP as in force (s 11), potentially involving cross-referencing multiple SoPs.

Clinicians and record-keepers: The SoP imposes de facto evidentiary requirements. Claimants will need to produce clinical records that fit the SoP’s definition of FMD (non-atherosclerotic, etc.), documentation of clinical onset and any clinical worsening, and evidence supporting either the smoking threshold (pack-year calculation) or inability to obtain appropriate clinical management before clinical worsening (s 7(2); s 9; Schedule). Clinicians’ diagnostic wording and dating of events will therefore directly affect claim outcomes.

Third parties and systems: Insurers, compensation coordinators and administrative officers in veteran support organisations will also be affected insofar as they must assist claimants in compiling relevant records or advising on the SoP’s requirements. The SoP repeals a previous SoP (No. 80 of 2016) (s 4), so claims assessed under the earlier instrument may be reassessed or interpreted differently depending on whether the new instrument’s provisions change the presence or weight of factors.

Who pays: The instrument itself does not prescribe payments. Rather, it shapes the medical causation threshold that determines whether statutory benefits under the VEA or MRCA may be payable. Financial consequences therefore fall upon the entities responsible for benefit payment under those Acts, contingent upon decisions that use this SoP in the causation assessment.

This SoP is not phrased as imposing duties and creating rights in the form of obligations or entitlements directly enforceable by private action; instead it sets the medical criteria decision-makers must have regard to when determining whether FMD or death from FMD is connected with relevant service for claims under the VEA or MRCA (see ss 3, 5). The operative legal effects create indirect duties on administrative actors and practical requirements for claimants, clinicians and records custodians.

Duties on decision-makers: The Repatriation Medical Authority has determined the SoP under its statutory power (s 3). Decision-makers who are required to assess causation for claims to which s 120B of the VEA or s 339 of the MRCA apply will need to have regard to the SoP’s factors when applying the balance of probabilities test. The instrument sets out that at least one of the factors in s 9 must exist before a causative connection is established on the balance of probabilities. The duty, therefore, is to determine whether those factors exist and whether they are related to relevant service in accordance with s 10.

Rights of claimants: The SoP does not itself confer an entitlement to benefits. However, a claimant has an interest in demonstrating that one or more of the SoP factors are present and related to relevant service. The SoP provides a defined list of what will be accepted as medically significant for causation: a smoking history of at least 10 pack-years before clinical onset or worsening, or inability to obtain appropriate clinical management before clinical worsening (s 9). Claimants can rely upon these defined factors when assembling evidence and presenting claims.

Obligations on clinicians and record-keepers: To support a finding under the SoP, clinicians must document the diagnosis and date of clinical onset and any clinical worsening, and provide detail about the nature of the disease that corresponds to the SoP’s definition (s 7(2)). If a claimant asserts inability to obtain appropriate clinical management, medical and administrative records that document attempts at, or denial of, care will be relevant. The Schedule supplies the method for pack-year calculation; clinicians or forensic experts may be asked to apply that formula or to provide evidence about equivalences for different tobacco products (Schedule).

Interaction with other SoPs and obligations to cross-apply: Section 11 imposes an operational obligation on decision-makers to apply any referenced SoP that covers a disease or injury referred to in s 9, “in accordance with the terms of that Statement of Principles as in force from time to time.” This creates a procedural duty to keep current with the terms of other SoPs and to apply them when a factor depends on a separate medical finding.

Administrative discretion and procedural obligations: The SoP leaves medical judgment about whether a factor is established to decision-makers and medical assessors within their statutory duties under the VEA and MRCA frameworks. The SoP does not specify evidentiary standards beyond the balance of probabilities; therefore administrative processes (requests for further medical evidence, independent medical examinations) and statutory review rights under the VEA and MRCA will determine how the SoP is operationalised in particular cases. The instrument therefore imposes an indirect procedural duty on administrative decision-makers to resolve factual disputes about onset, pack-year exposure, and access to care.

The Statement of Principles instrument contains no criminal penalties, civil fines, or regulatory sanctions. It is an administrative medical‑scientific statement produced under subsection 196B(3) of the VEA, intended to be used in the assessment of claims under specified provisions of the VEA and MRCA (see ss 3, 5). The instrument itself does not create enforcement mechanisms or penalty clauses.

Enforcement in practice occurs through the statutory claim processes under the VEA and MRCA. The SoP informs determinations about whether fibromuscular dysplasia or death from FMD is connected with relevant service so that decision-makers can apply the statutory test for entitlements. Remedies or consequences (such as the grant or refusal of benefits, reconsideration processes, administrative review or merits review) derive from the VEA and MRCA and their procedural regimes rather than from this SoP. The SoP specifies the medical factors to be considered; it does not prescribe the procedures for review, judicial oversight, or administrative penalties. Those procedural and remedial mechanisms are located in the principal Acts to which the SoP applies (s 5).

Because the instrument does not itself create penalties, there is no enforcement body named within it to impose sanctions for non-compliance with the SoP. The Repatriation Medical Authority produced the statement under its legislative function, and it will be used by decision-makers exercising statutory powers under the VEA and MRCA; enforcement of obligations or imposition of adverse consequences will therefore be effected through those decision-making functions and the statutory appeal or review routes in the principal Acts.

The absence of penalties in the instrument means that compliance is operational: parties either present evidence sufficient to satisfy the SoP factors on the balance of probabilities or they do not. Any disputes about interpretation or application of the SoP will be resolved via the claim processes, and ultimately by the review mechanisms that govern determinations under the VEA and MRCA. The SoP itself contains no enforcement timeline, sanction schedule, or compliance-failure consequences.

The SoP is an instrument made under s 196B(3) of the VEA and explicitly links to particular claim provisions in the VEA and MRCA. Section 5 states that the instrument “applies to a claim to which section 120B of the VEA or section 339 of the MRCA applies.” Those cross‑references determine the statutory context in which the SoP is used: it supplies medical causation criteria for decisions under those provisions. The SoP therefore functions as an evidentiary or decision-guiding instrument within the statutory decision-making frameworks of the VEA and MRCA.

Interaction with other Statements of Principles: Section 11 provides a specific interaction rule. If a factor referred to in section 9 applies in relation to a person, and that factor refers to an injury or disease which itself is covered by another SoP under s 196B(3) of the VEA, then the factors in that other SoP apply “in accordance with the terms of that Statement of Principles as in force from time to time.” This creates a hierarchy where individual SoPs can reference and depend on other SoPs, and it requires decision-makers to apply the current terms of the referenced SoP when a factor depends on another medical condition. The practical effect is that medical causation assessments may require cross-referencing multiple SoPs and keeping current with any amendments to those instruments.

ICD-10-AM reference: The SoP points to ICD‑10‑AM code I77.3 as the code associated with FMD but then clarifies that the operative meaning of FMD for the SoP is that provided in subsection 7(2). It further specifies which edition of ICD‑10‑AM is being referenced (Tenth Edition, effective 1 July 2017) (s 7(3)). This means coding can be used for classification but the textual clinical definition governs causation determinations. Decision-makers should therefore rely on the textual, clinical definition rather than code alone.

Repeal of earlier instrument: The SoP expressly repeals the Statement of Principles concerning fibromuscular dysplasia (No. 80 of 2016) (s 4). This alters the corpus of SoPs and can change how claims are assessed going forward. Decision-makers must therefore apply the new instrument from its commencement date (24 November 2025) and not the repealed 2016 instrument.

Relationship to the VEA and MRCA: The SoP operates within the statutory framework of those Acts. It does not amend the VEA or MRCA; rather it produces medical-scientific guidance that decision-makers use when applying statutory tests for causation (see ss 3 and 5). Any interaction with other laws (for example, privacy, evidentiary rules, or administrative law principles) will arise through the application of the VEA and MRCA decision processes rather than through provisions of the SoP itself. The SoP’s definitions (for example, of relevant service and terminal event) incorporate and replicate certain statutory terms (see Schedule: definitions of relevant service, MRCA and VEA).

Practical implication for claim processes: Because the SoP establishes discrete factors and defines key terms (such as pack-year and terminal event), it affects evidence-gathering, medical reporting, and the assessment of temporal relationships between disease onset/worsening and periods of relevant service. Where a factor depends on another medical condition, the decision-maker must consult the other SoP as in force, which can create multi-instrument dependency across the SoP corpus (s 11).

This instrument replaces and repeals a prior Statement of Principles concerning fibromuscular dysplasia (Balance of Probabilities) (No. 80 of 2016) (Federal Register of Legislation No. F2016L01683) (s 4). The current instrument is dated 24 October 2025 and commences on 24 November 2025 (heading plus s 2). It is made under the statutory authority stated (subsection 196B(3) of the VEA) (s 3).

The instrument also references a particular edition of ICD‑10‑AM for coding context (Tenth Edition, effective 1 July 2017) (s 7(3)), which indicates that the textual definition was drafted with that coding edition in mind. No other amendments, transitional arrangements, savings, or grandfathering provisions are stated in the instrument text. The repeal clause is express and absolute: the prior SoP is repealed rather than amended or partially retained (s 4).

There are no further amendment entries or schedules in the instrument that provide a history of incremental changes, and the instrument does not itself contain a provision preserving decisions previously made under the repealed 2016 SoP. The absence of a transitional clause in the text means that the administrative application of the repeal and the commencement date will govern how claims in progress are treated; administrative practice under the VEA and MRCA (outside this SoP text) will determine whether earlier decisions are revisited or remain in force.

Because the instrument is a stand-alone SoP replacing a prior SoP, users should take the following concrete points from the amendment history present in the text: the Repatriation Medical Authority updated its Statement of Principles in 2025, the previous instrument from 2016 is expressly repealed, and the new instrument takes effect from the listed commencement date (s 2, s 4). Any legal or administrative effects that arise from the change (for example, reassessment of claims) will flow from the statutory claim processes, not from transitional language within this instrument, because such language does not appear in the text provided.

The instrument itself contains no references to litigation, and it does not state any judicial or tribunal decisions addressing it. The text does not list cases, past determinations, or judicial interpretations, and it contains no discussion of litigation. Therefore, the instrument as provided supplies no primary litigation history to cite.

In practice, where statutory causation rules are codified in Statements of Principles, disputes about the application or interpretation of those rules can give rise to administrative review or litigation under the processes established by the VEA and MRCA; however, the text of this SoP does not indicate any completed or pending litigation. The SoP does not include a provision describing how it has been interpreted by courts or tribunals, nor does it mention judicial review or precedent.

Because the instrument functions as medical‑scientific guidance for administrative decision-making, the likely venues for contestation would be internal reconsideration, merits review bodies and judicial review processes under the VEA or MRCA frameworks. The instrument does not supply any record of such proceedings. Users should therefore treat this section as noting the absence of litigation material within the instrument itself and should consult decision registers, tribunal records or court databases for any case law that post-dates the SoP’s commencement if they require an account of how the SoP has been applied or challenged in adversarial or review settings. That search is outside the scope of the instrument text provided.

Several features of the SoP create potential interpretive and evidentiary pitfalls for claimants and decision-makers. These are concrete mechanics derived from the instrument text that can determine claim outcomes.

Definition-focused constraints: The operative definition of fibromuscular dysplasia is textual and specific (s 7(2)). Although the SoP notes the ICD‑10‑AM code I77.3, it explicitly instructs that the meaning for application is the textual definition in subsection 7(2) (s 7(3)). Consequently, a diagnosis that merely cites an ICD code without aligning clinical descriptions to the SoP’s non-atherosclerotic, non-inflammatory, segmental disease requirement, and the listed clinical manifestations, may be insufficient. The SoP also excludes carotid web, so any diagnosis that is carotid web must be distinguished from FMD under this SoP (s 7(2)).

Temporal and causal nuance for clinical worsening: The factors in s 9 require smoking exposure “before clinical onset or clinical worsening” and inability to obtain appropriate clinical management “before clinical worsening.” The SoP’s s 10(2) introduces a limit: the clinical worsening aspect applies only where the person’s FMD was suffered or contracted before or during (but did not arise out of) relevant service. This means that if FMD “arose out of” service, the clinical worsening route to causation through inability to obtain care will not apply. Users must be precise in establishing the temporal sequence of disease onset, any worsening events, and the dates of service to determine which limbs of the SoP can be invoked (ss 9-10).

Quantified smoking threshold and calculation specifics: The smoking factor is not open-ended; it requires at least 10 pack-years before clinical onset or worsening (s 9(1)). The Schedule gives a precise conversion method and sets an equivalence of 7,300 grams of smoking tobacco per pack-year and treats 1 gram of tobacco as a cigarette-equivalent for pipe tobacco and cigars (Schedule). Failure to use the Schedule’s specified calculation or lacking documentary evidence to substantiate the smoking history may undermine a claimant’s ability to meet this factor.

“Unable to obtain appropriate clinical management” is open to interpretation: The SoP lists inability to obtain appropriate clinical management as a qualifying factor (s 9(2)). The instrument does not define “appropriate clinical management” or provide thresholds for what constitutes inability to obtain it. This leaves room for evidentiary and interpretive disputes about whether, for example, geographic access, resource constraints, clinician refusal, diagnostic delay, or system-level failings meet the test. Claimants ought to document attempts to obtain care, dates, communications and any institutional or clinician responses to substantiate this factor.

Cross-reference dependence: Where a factor refers to a disease covered by another SoP, the other SoP applies “as in force from time to time” (s 11). This creates a moving target; if a referenced SoP is later amended, its terms as amended will govern the factor. Decision-makers must therefore ensure they are applying the current version of any referenced SoP.

Relevance of service and exclusions in “relevant service”: The Schedule defines “relevant service” in specific terms (eligible war service other than operational service under the VEA, defence service excluding hazardous service and British nuclear test defence service under the VEA, or peacetime service under the MRCA). The Schedule’s definition therefore excludes certain categories of service from the “relevant service” rubric. Users must map a person’s service category to the Schedule definition to determine whether the SoP can be applied (Schedule: definition of relevant service).

No direct transitional clauses: The instrument repeals the 2016 SoP but contains no transitional rules. This absence creates potential procedural uncertainty for claims in flight at the time of repeal and commencement; administrative practice under the VEA and MRCA will determine how previously assessed claims are handled in light of the new SoP (s 4).

Death causation chain: Death from FMD is interpreted as death from a terminal event or condition contributed to by FMD (s 7(4)). The Schedule enumerates examples of terminal events. Establishing that a terminal event was “contributed to” by FMD will require medical evidence linking the disease to the proximate events that caused death; mere contemporaneous presence of FMD without medical linkage may be insufficient.

Evidence quality and balance of probabilities: The SoP sets the medical factors that must exist on a balance of probabilities. The instrument does not prescribe evidentiary modalities (for example, admissible documents, expert reports, or specific diagnostic tests). Claimants and medical advisers must therefore anticipate that decision-makers will rely on standard administrative-evidence processes and medical opinion to determine whether the SoP’s factors are satisfied.

For claimants, practitioners and decision-makers, compliance with the SoP is evidentiary and procedural: gather, present and assess records in ways that map directly to the SoP’s defined elements. The following practical steps flow from the instrument text.

1. Establish the diagnosis against the SoP’s textual definition (s 7(2)-(3)).

• Obtain and collate clinical records that document the pathology and clinical manifestations described in subsection 7(2): evidence that the arterial disease is non‑atherosclerotic, non‑inflammatory and segmental; which arteries are affected; and whether the disease produces stenosis and one of the listed manifestations (occlusion, aneurysm, dissection, or organ ischaemia).
• Explicitly exclude carotid web where relevant, or document diagnostic distinction from carotid web, because the SoP excludes carotid web (s 7(2)).

2. Document clinical onset and any clinical worsening, with dates (ss 9, 10).

• Provide dated medical entries, imaging reports, procedure notes, and specialist letters that record the first clinical signs and any episodes of clinical deterioration.
• Because several factors hinge on whether a smoking exposure or lack-of-care occurred before “clinical onset or clinical worsening,” precise dating is essential (s 9).

3. Demonstrate smoking exposure consistent with the Schedule’s pack-year definition (s 9(1); Schedule).

• Compile a detailed smoking history showing cigarettes per day and the number of years smoked.
• Convert histories involving alternative tobacco products into pack-years using the Schedule’s equivalences (one pack-year = 20 cigarettes/day for one year; 7,300 grams of smoking tobacco = one pack-year; 1 gram of pipe tobacco or cigars = one cigarette equivalent).
• Where self-reported history is the only source, corroborate with contemporaneous notes, employment medicals, or other records if possible, because the SoP requires at least 10 pack-years before onset/worsening.

4. If relying on inability to obtain appropriate clinical management, assemble documentary proof (s 9(2)).

• Gather correspondence showing attempts to access care (referrals, appointment bookings, cancelled appointments), records of treatment denial, wait-list information, geographic access constraints, or records showing lack of available specialist services.
• Obtain treating clinician statements explaining the clinical management that would have been appropriate, why it was not available, and how the absence of management related temporally to clinical worsening.

5. Establish relationship to relevant service and apply temporal rules (s 10).

• Map the person’s service record to the Schedule’s definition of relevant service to confirm eligibility (Schedule: definition of relevant service).
• Demonstrate how the factor(s) relied upon are related to service: for the smoking factor, show the smoking exposure pre-dated clinical onset/worsening and that the exposure is related to the period of relevant service where necessary; for the inability-to-obtain-treatment factor where clinical worsening is the avenue used, confirm that the disease was suffered or contracted before or during, but did not arise out of, relevant service, because s 10(2) limits the clinical-worsening aspect to those circumstances.

6. Be attentive to cross-SoP references (s 11).

• If any factor in s 9 refers to an injury or disease governed by another SoP, identify and apply the current version of that SoP. Decision-makers must ensure they are using “the terms of that Statement of Principles as in force from time to time.”

7. For death claims, link terminal events to FMD (s 7(4); Schedule).

• Assemble medical records and a cause-of-death narrative that explain how the FMD contributed to the terminal event (for example, dissection leading to circulatory failure). Provide expert medical opinions if necessary to connect FMD to the proximate cause of death.

8. Use clear medical opinion evidence where matters are technical or contested.

• Where the SoP requires interpretation (for example, whether clinical management was “appropriate,” whether a smoking history meets the pack-year threshold, or whether FMD’s features meet the textual definition), obtain expert opinions that directly address the SoP elements, including dates, mechanism and causal linkage.

9. Decision-makers should apply the SoP textually and document reasoning.

• When making determinations under the VEA or MRCA provisions referenced, decision-makers should cite the specific SoP provisions relied upon (for example, s 7(2) for diagnosis, s 9(1) for smoking factor) and record why particular evidence does or does not meet the SoP’s criteria.

10. Anticipate and prepare for evidence gaps.

• The SoP does not supply definitions for some terms (for example, “appropriate clinical management”) and leaves interpretive questions to medical judgment. Where records are incomplete, parties should expect requests for further evidence, independent medical examinations, or clinical expert reports. Provide as much contemporaneous evidence as possible to avoid adverse inferences based on absence of proof.

Administrative practice note: Because the instrument repeals the prior 2016 SoP (s 4) and provides no transitional clauses, verify whether existing claims in process are to be determined under the new instrument as of the commencement date (24 November 2025) or under the prior SoP, as administrative practice under the VEA and MRCA may provide operational guidance on that point. Decision-makers should make and record clear choices about which SoP applies to particular claim files.

In short, compliance is achieved by aligning documentary and expert medical evidence to the narrow, listed elements of the SoP and by paying careful attention to timing, the Schedule’s pack‑year calculation, and the specific limits on the clinical-worsening route to causation.