Statement of Principles concerning peripheral artery disease (Reasonable Hypothesis) (No. 70 of 2020)

This instrument is a Statement of Principles (SoP) made by the Repatriation Medical Authority under subsection 196B(2) of the Veterans' Entitlements Act 1986 (the VEA) (see s3). It prescribes the medical definition of peripheral artery disease (PAD) for the purposes of veterans' claims, and it sets out the specific clinical and exposure factors that, if present and related to a person’s relevant service, are the minimum required to raise a reasonable hypothesis that PAD or death from PAD is connected to that service (see ss7 and 9). The instrument applies to claims to which section 120A of the VEA or section 338 of the Military Rehabilitation and Compensation Act 2004 applies (see s5). The SoP is therefore a rulebook for decision‑makers and medical reviewers who must determine whether a "reasonable hypothesis" exists in claims for service connection for PAD.

Mechanically, the SoP does three things. First, it defines the injury/disease: PAD is specified as atherosclerosis of one or more arteries of the upper or lower limbs causing partial or complete occlusion and either warranting medical treatment or giving specified clinical manifestations such as chronic limb ischaemia, critical limb ischaemia or exertional leg pain restricting walking (s7(2)). Second, it lists discrete factors that must exist, as a minimum, before a reasonable hypothesis may be said to be raised connecting PAD (or death from PAD) with relevant service; these factors cover risk conditions (for example, hypertension, diabetes, dyslipidaemia), behavioural exposures (smoking, second‑hand smoke, diet), occupational or medical exposures (ionising radiation, therapeutic radiation), medication exposure (nilotinib or ponatinib), functional limitations (inability to undertake activity greater than 3 METs) and service‑related access issues (inability to obtain appropriate clinical management) (s9). Third, it specifies temporal and causal rules governing which listed factors apply to claims for onset and which apply only to material contribution or aggravation where PAD pre‑existed service (s10).

The SoP is explicit about the normative operation of its textual definitions. It states that where PAD attracts an ICD‑10‑AM code (I70.2) that code is not the operative definition; the statutory definition in s7(2) controls (s7(3)). The Schedule contains the dictionary definitions and numerical thresholds used to operationalise many factors, including BMI cutoffs, what counts as one pack‑year of smoking, what constitutes exposure to second‑hand smoke, the MET unit, chronic kidney disease, dyslipidaemia thresholds, and the method for calculating cumulative equivalent dose of ionising radiation (Schedule 1). The instrument is a specialised evidentiary sieve: if at least one listed factor is present and is causally related to relevant service, a decision‑maker can be said to have a reasonable hypothesis that PAD or death from PAD is connected to that service (s9).

Authority and application are narrowly administrative. The Repatriation Medical Authority made the instrument under its statutory power; the instrument itself does not create offences or civil penalties, and it does not determine entitlement outcomes outside the statutory processes set out in the VEA and MRCA. The compilation and amendment history are recorded in the endnotes. The current compilation includes an amendment in 2022 refining the definition of "one pack‑year" (Endnotes 3 and 4).

The instrument turns a medical condition into a decision rule by specifying (a) what PAD means for VEA/MRCA purposes, (b) an enumerated set of contributory factors that, singly, suffice to “raise a reasonable hypothesis” of service connection, and (c) temporal and causal limits on when listed factors may be used to establish onset versus aggravation or material contribution.

Definition of PAD: Peripheral artery disease is defined for the instrument as atherosclerosis of one or more arteries of the upper or lower limbs causing partial or complete occlusion and having clinical significance either by warranting medical treatment or producing one or more listed clinical manifestations (chronic limb ischaemia, critical limb ischaemia, or exertional leg pain restricting walking) (s7(2)). The instrument clarifies that, while PAD is associated with ICD‑10‑AM code I70.2, the legal meaning for the SoP is the statutory text in s7(2) rather than the code (s7(3)-(4)).

Factor list as threshold for "reasonable hypothesis": Section 9 contains a discrete list of factors, each phrased so that the existence of at least one factor as a minimum is required before it can be said that a reasonable hypothesis exists connecting PAD or death from PAD with relevant service. The factors cover established cardiovascular risk factors (hypertension s9(1), diabetes s9(2), dyslipidaemia s9(4), obesity s9(3)), behavioural risks (active smoking and quantified pack‑years s9(5)-(6), second‑hand smoke exposure hours s9(7)-(8), dietary insufficiency s9(14), physical inactivity measured by MET inability s9(10)), clinical comorbidities (chronic kidney disease s9(11), hyperhomocysteinaemia s9(9), periodontitis s9(15), autoimmune disease s9(16)), certain medications (nilotinib or ponatinib s9(18)), radiation exposures (therapeutic radiation in the field s9(12), cumulative equivalent dose of at least 0.5 sievert to the affected artery s9(13)), mental health (clinically significant depressive disorder s9(17)), and a service‑related access factor (inability to obtain appropriate clinical management s9(37)). Many of these appear twice in respect of clinical onset and clinical worsening, with a separate block of factors (s9(19)-(36)) that apply only in material contribution/aggravation contexts.

Temporal and causal allocation: The instrument differentiates factors relevant to the clinical onset of PAD from those relevant to clinical worsening of PAD; for onset factors the existence must be before clinical onset, and for the material contribution/aggravation factors the text applies only where PAD was suffered or contracted before or during (but did not arise out of) the person’s relevant service (see s9 and s10(2)). Section 10(1) requires that any factor relied on must be related to the person’s relevant service.

Primary individuals affected are persons making claims under the VEA or MRCA for peripheral artery disease or death from peripheral artery disease, which will typically be veterans, former members of the Forces, members of Peacekeeping Forces, and, under the MRCA, members who rendered warlike or non‑warlike service (see the definition of relevant service in Schedule 1). The instrument applies to claims to which section 120A of the VEA or section 338 of the MRCA applies (s5), so claimants in those statutory processes are directly impacted.

Decision‑makers and medical assessors are materially affected. The Repatriation Medical Authority made the SoP (s3) and it is intended for use by decision‑makers within the Department of Veterans’ Affairs and by medical specialists who prepare reports for tribunals and administrative decision processes. The SoP changes the evidence landscape those decision‑makers rely on: it sets the minimal factual prerequisites that must be present before a reasonable hypothesis of service connection is established (s9). Medical practitioners will need to map clinical records and test results to the numeric and temporal thresholds in the Schedule. Where a factor relies on a diagnostic criterion listed in another Statement of Principles, the medical assessor must consult that SoP as required by s11.

Third parties with records or measurement responsibilities are implicated. For example, providers of radiation exposure records, employers (for records of second‑hand smoke exposure in enclosed spaces), GPs and hospital services (for BMI history, chronic kidney disease markers, lipid panels), psychiatrists and counsellors (for evidence on clinically significant depressive disorder), and dental practitioners (for periodontitis records) will be sources of evidence needed to meet the specified factors. The Schedule’s radiation definition requires use of a named ARPANSA guide for cumulative dose reconstruction, so agencies or contractors who perform dose reconstructions will be called on to follow that methodology (Schedule 1 cumulative equivalent dose).

Administrative processes and programmes that monitor veterans’ health will be affected because the SoP creates concrete measurement thresholds that generate claims. For instance, a record of BMI ≥30 persisting for five years within a 20 year window is a specific trigger (s9(3) and Schedule 1). Claims administrators will need to handle enquiries where one factor is narrowly met or where multiple factors interact. The SoP’s exposure thresholds for smoking and second‑hand smoke, in particular, mean that claimants’ historical lifestyle information and employment histories acquire administrative significance.

This instrument is not a statute that imposes criminal sanctions or direct civil duties; rather it prescribes evidentiary rules that decision‑makers must apply when deciding whether a reasonable hypothesis exists connecting PAD or death from PAD with relevant service. The principal duty imposed by the SoP is procedural and interpretive: decision‑makers deciding claims under the VEA or MRCA must treat the SoP definitions and factors as the minimum facts required to raise a reasonable hypothesis (s9). The Repatriation Medical Authority fulfils its statutory function by making the SoP under s196B(2) of the VEA (s3). That is the duty the instrument records.

For claimants the practical right is procedural: where a claimant can show the existence of at least one of the enumerated factors and relate it to relevant service, the decision‑maker can say a reasonable hypothesis has been raised (s9). The SoP specifies what counts as the claimant’s necessary evidentiary threshold. It does not convert the raising of a reasonable hypothesis into a guaranteed right to an entitlement. The entitlement determination and the steps that follow are governed by the VEA/MRCA frameworks referenced in s5 and in those Acts.

Medical assessors, clinicians and ancillary record‑holders have the duty to provide accurate and temporally precise records in order to satisfy the threshold. The Schedule’s definitions place particular evidential demands: for example, dyslipidaemia requires laboratory thresholds or regular drug therapy (Schedule 1). Chronic kidney disease requires evidence of abnormality present for at least three months (Schedule 1). BMI calculations are specified by formula in the Schedule. Smoking exposure is quantified by the one pack‑year concept and the instrument provides conversion guidance (Schedule 1). The radiation exposure factor requires application of a specified methodology for cumulative equivalent dose (Schedule 1).

Decision‑makers also have a duty to observe cross‑references. Section 11 mandates that if a factor refers to an injury or disease covered by another SoP, that other SoP’s factors apply according to its current terms. This creates an interpretive duty to consult other SoPs and apply their present terms.

Claimants have the procedural right that the SoP demands no proof of actual prior treatment for some conditions. For example, "clinically significant" depressive disorder is defined as sufficient to warrant ongoing management which may involve regular visits, and a note emphasises that to warrant ongoing management does not require that any actual management was received or given for the condition (Schedule 1 clinically significant definition). That is an explicit evidentiary easing for claimants who lacked treatment despite clinical need.

The Statement of Principles itself contains no penalty regime, fines or criminal sanctions. It is an administrative instrument that sets evidentiary and definitional standards for decision‑makers exercising statutory powers under the Veterans' Entitlements Act 1986 and the Military Rehabilitation and Compensation Act 2004. The SoP was made under subsection 196B(2) of the VEA (s3); it operates as an authoritative medical guidance document rather than a punitive statute.

Enforcement, to the extent relevant, occurs within the administrative decision processes of the VEA and MRCA. Section 5 specifies that the instrument applies to claims to which s120A of the VEA or s338 of the MRCA applies. Those statutory provisions and the broader statutory scheme of the VEA and MRCA govern how a finding that a reasonable hypothesis is raised affects subsequent administrative steps, entitlements and any review or appeal rights. The SoP determines whether the evidentiary threshold for a reasonable hypothesis exists, which then feeds into the statutory triggers and decision‑making processes established by the VEA and MRCA. The instrument itself does not lay out those downstream processes.

There are implementation and compliance enforcement implications in the sense that decision‑makers are required to apply the SoP when they assess whether a reasonable hypothesis exists. Administrative sanctions for non‑compliance with the VEA/MRCA procedural rules or for maladministration would be matters for the tribunal and judicial review processes established under the Acts, but the Statement contains no internal enforcement provisions.

Records and methodology expectations may create practical compliance obligations on third parties who supply evidence. For example, cumulative equivalent dose must be calculated in accordance with the ARPANSA methodology referenced in the Schedule 1 definition of cumulative equivalent dose. If a dose reconstruction is required, entities that perform this work will need to follow the named methodology in order for the radiation factor to be properly applied. However, the SoP prescribes methodology only as a component of the evidentiary standard; it does not itself create licensing, reporting or penalty obligations for those third parties.

Finally, the instrument cross‑references other Statements of Principles (s11). Where a factor refers to an injury or disease covered by another SoP, the other SoP applies as in force. Enforcement of those other SoPs, and any sanction regimes applicable under them or under the underlying Acts, will be governed by the instruments and Acts concerned, not by this SoP.

Direct statutory linkage: The SoP is made under the Repatriation Medical Authority’s power in subsection 196B(2) of the VEA (s3). It explicitly applies to claims to which s120A of the VEA or s338 of the MRCA applies (s5). That means the SoP functions within the administrative decision framework of those Acts and is used to establish whether a reasonable hypothesis exists when applying the statutory entitlements regime in the VEA and MRCA. The SoP does not itself alter entitlements; it supplies medical criteria that feed into entitlement decisions under those Acts.

Cross‑SoP interaction: Section 11 requires that where a factor in this SoP refers to an injury or disease that is the subject of another Statement of Principles under subsection 196B(2) of the VEA, the factors in that other SoP apply in accordance with its terms as in force from time to time. This creates a modular architecture where disease‑specific SoPs can be read together. Decision‑makers must therefore consult other relevant SoPs where there is overlap; for example, if the factor is chronic kidney disease and there is a separate SoP for chronic kidney disease, that separate SoP’s factors and definitions will apply as well.

Medical classification systems: The SoP explicitly notes the ICD‑10‑AM code I70.2 as the code generally associated with PAD but then states that the legal meaning for this instrument is the statutory definition in s7(2) rather than the code (s7(3)-(4)). The instrument therefore severs automatic dependence on ICD coding and instead uses its own statutory text and Schedule definitions as the controlling medical‑legal standard.

External standards and guides: The Schedule refers to a named ARPANSA guide for the calculation of cumulative equivalent dose for ionising radiation (Schedule 1 cumulative equivalent dose). The Schedule requires that dose be calculated "in accordance with the methodology set out in Guide to calculation of 'cumulative equivalent dose' ... Australian Radiation Protection and Nuclear Safety Agency, as in force on 2 August 2017" (Schedule 1). This ties an evidentiary factor to a technical external standard and requires decision‑makers and experts to follow that methodology for dose reconstruction. The inclusion of an external methodology means that changes to that guide or later editions may materially affect how the radiation factor is applied, although the Schedule fixes the guide's version as of 2 August 2017.

Evidentiary overlap with clinical standards: Several Schedule definitions are clinical thresholds that mirror accepted diagnostic criteria such as dyslipidaemia lipid cutoffs and GFR thresholds for kidney disease. Where these clinical thresholds are also used in other laws, clinical guidelines or professional standards, the SoP imports them as legal evidentiary thresholds without reference to broader clinical practice beyond what the Schedule specifies.

The compilation includes the legislative and amendment history recorded in the endnotes. The principal history recorded is:

• The original Statement of Principles concerning peripheral artery disease (Reasonable Hypothesis) was made as Determination No. 70 of 2020. It was registered 30 October 2020 and commenced on 30 November 2020 (Endnote 3, Legislation history table).

• A subsequent amending instrument, Veterans' Entitlements (Statements of Principles,definition of "one pack-year") Amendment Determination 2022 (No. 94 of 2022), was registered 26 August 2022 and commenced 19 September 2022 (Endnote 3). Endnote 4 records that this 2022 amendment amended notes to subsections 9(5), 9(6), 9(23), 9(24) and the Schedule 1 definition of one pack‑year.

The compilation date shown at the head of the instrument is 19 September 2022, and the compilation includes amendments up to Amendment Determination 2022 No. 94 of 2022 (as stated on the face of the instrument).

The endnotes include the usual compilation material: summary of amendments, abbreviation key, and a table noting how particular provisions were affected (Endnote 4 lists the specific provisions affected). The Schedule itself includes definitions that are substantive and were the focus of the 2022 amendment (the one pack‑year definition and related notes appear to have been refined).

Practical effect of the amendment history: Users must be careful to apply the version of the SoP in force at the relevant time for a claim. The SoP explicitly cross‑references external documents and other SoPs; because the 2022 amendment changed the smoking equivalence and related notes, claims depending on precise smoking exposure calculations will be affected by the amended definition. The endnotes identify which parts of the instrument were changed and provide the registration and commencement dates for those changes; decision‑makers and practitioners should consult the current instrument text and the endnote history to establish which version governs a claim.

No retrospective amendment or saving provisions are included in the SoP text itself. If there were any special application, saving or transitional provisions relevant to these amendments, the compilation says those would be recorded in the endnotes; none are shown in the main body. Practitioners should therefore check whether any separate commencement or transitional rules in the amendment instrument affect existing claims, by reference to the amending Determination and its registered details in the endnotes.

The compiled instrument and its endnotes do not record any litigation history. The SoP itself does not cite case law, and there are no cases referenced within the body of the instrument. The endnotes supplied with the compilation list the registration and amendment of the instrument but do not record judicial or tribunal decisions interpreting the SoP. Accordingly, from the text of this compilation there are no reported decisions identified as having interpreted or applied this particular Statement of Principles.

This absence, however, is a statement of what the compilation records. It does not necessarily mean that no tribunal or court has ever considered the SoP since enactment; it only means the compilation's endnotes do not list litigation. Practitioners should search administrative tribunal and court databases for any decisions that post‑date the compilation or that otherwise engage the SoP. Where decisions exist interpreting phrases such as "reasonable hypothesis", "clinical onset", "clinical worsening", or assessing the Schedule thresholds (for example, cumulative equivalent dose calculations using ARPANSA methodology, or pack‑year calculations), those decisions will be important precedent for how tribunals and courts treat the SoP in practice.

Given the SoP’s role as an evidentiary threshold in an administrative regime that produces many veterans’ claims, one should expect that tribunal or judicial review litigation could arise challenging whether decision‑makers correctly applied the SoP’s factors in particular cases. The compilation does not provide such decisions, so practitioners must obtain current case law from the relevant repositories.

The instrument is precise in places that are practically challenging. The following are concrete points of potential friction or misinterpretation drawn from the text.

1. Reasonable hypothesis is a low threshold but it is evidence‑based. Section 9 states that at least one of the listed factors must exist as a minimum before it can be said that a reasonable hypothesis has been raised. That is not a composite test requiring several factors, but the factor must still be shown to exist and to be related to relevant service under s10(1). Practitioners should not assume multiple factors are required; a single qualifying factor suffices to meet the SoP’s minimum hurdle.

2. Distinction between onset and aggravation material is important and can be missed. Subsections 9(1)-9(18) are framed for "before the clinical onset of peripheral artery disease", while subsections 9(19)-9(36) are framed for "before the clinical worsening of peripheral artery disease". Section 10(2) limits the latter block so that those factors apply only to material contribution to, or aggravation of, PAD where the PAD was suffered or contracted before or during (but did not arise out of) relevant service. That means if PAD arose out of service initially, those aggravation factors in s9(19)-(36) do not apply. Practitioners must map onset dates precisely to determine which block of factors can lawfully be invoked.

3. Temporal windows and durations are specific and sometimes long. For example, obesity must have been present for at least five years within the 20 years before clinical onset or worsening (s9(3), s9(21)). Periodontitis must have been present for at least two years before onset or worsening (s9(15), s9(33)). Depressive disorder requires at least five years before onset or worsening (s9(17), s9(35)). The Schedule defines clinically significant to include cases that warrant ongoing management even if no treatment was actually received (Schedule 1). This latter point can be an evidentiary advantage for claimants who had no treatment despite clinical need, but it also means that decision‑makers must evaluate the clinician’s judgement about whether ongoing management was warranted, not simply whether treatment occurred.

4. Smoking and second‑hand smoke thresholds have precise numeric rules and different rules depending on whether smoking has permanently ceased. For active smoking, a threshold of at least one pack‑year applies where smoking has not permanently ceased, but where smoking permanently ceased before clinical onset the threshold is higher or time‑bounded: at least five pack‑years, or at least one but less than five pack‑years if onset occurred within 20 years of cessation (s9(5)-(6) and s9(23)-(24)). The Schedule’s "one pack‑year" definition contains a weight‑based equivalence and an example; the 2022 amendment revised this definition. Second‑hand smoke thresholds are expressed in hours and vary depending on whether exposure has permanently ceased and how long since last exposure (s9(7)-(8), s9(25)-(26)). These time and quantity thresholds create a high evidentiary bar in some cases, and precise historical documentation will be required.

This section sets out practical steps, evidence types and decision‑making practices to align claims and assessments with the SoP’s thresholds. All citations below refer to sections of the Statement of Principles and the Schedule.

1. Identify the operative SoP and claim pathway. Confirm the claim falls under s120A of the VEA or s338 of the MRCA (s5) and therefore that this SoP applies. Check whether the PAD in question fits the statutory definition in s7(2) rather than relying solely on diagnostic coding.

2. Establish the timing of clinical onset and any clinical worsening. Map the precise dates of onset and any worsening events against the SoP’s temporal requirements. Many factors are expressly required to be present before the clinical onset or before clinical worsening (see s9(1)-(18) and s9(19)-(36)). Section 10(2) restricts the aggravation factors s9(19)-(36) so that they apply only where the person’s PAD was suffered or contracted before or during, but did not arise out of, relevant service. Therefore establish whether PAD "arose out of" service or was pre‑existing.

3. Gather medical records matching Schedule definitions. For factors such as hypertension, diabetes and dyslipidaemia, obtain contemporaneous GP or specialist records showing diagnosis and, where relevant, laboratory values. The Schedule defines dyslipidaemia by numeric thresholds or the regular administration of drug therapy to normalise blood lipid levels (Schedule 1 dyslipidaemia). Chronic kidney disease is defined by GFR <60 mL/min/1.73 m2 or other markers, and the Schedule requires three months’ duration (Schedule 1 chronic kidney disease). For BMI history, collect clinic or hospital notes, occupation health records or documented measurements; Schedule 1 defines BMI and being obese as BMI ≥30.

4. Document smoking and second‑hand smoke exposure using the Schedule method. Calculate pack‑years according to the Schedule 1 definition of one pack‑year and the example formula provided. For pipe tobacco and cigars, use the weight equivalence rules in Schedule 1 Note 1. Where smoking permanently ceased, apply the differing thresholds in ss9(6) and 9(24). For second‑hand smoke, obtain employment records, service postings, accommodation logs, witness statements or contemporaneous notes showing hours of exposure in enclosed spaces; the Schedule defines second‑hand smoke exposure and s9 sets hour thresholds.

5. For radiation‑related factors, commission dose reconstruction performed to the ARPANSA methodology named in Schedule 1. If a factor depends on a cumulative equivalent dose of at least 0.5 sievert to the affected artery (s9(13) and s9(31)), obtain a specialist report applying the ARPANSA guide referenced in Schedule 1. Ensure the report addresses the specific organ/tissue dose averaging rules and separates background radiation as the Schedule requires.