Statement of Principles concerning deep vein thrombosis (Reasonable Hypothesis) (No. 35 of 2021)

The instrument revolves around several discrete legal and medical concepts. The controlling statutory concept is the “reasonable hypothesis” standard as used in the VEA and MRCA claim processes; this Statement of Principles operationalises that standard for DVT by listing the medical and exposure factors that can raise the hypothesis (s 9). The document also distinguishes the medical concept of deep vein thrombosis from thromboses in certain named venous beds which are excluded (s 7(2)(b)). The instrument treats death from DVT as including death from a terminal event or condition that was contributed to by the person’s DVT (s 7(3) and Schedule 1 terminal event).

Key medical or exposure concepts are defined in the Schedule 1 - Dictionary (see s 6). Examples of defined items include BMI and the threshold for “being overweight or obese” (BMI 25 or greater), one pack-year and cigarettes per day equivalents, “exercise of the affected upper limb” limited to strenuous repetitive abduction activities, and “external compression of the affected vein” meaning an endogenous or exogenous structure compressing or occluding the vein. Several medical states are given precise enumerations: hypercoagulable state as specified lists antiphospholipid antibody syndrome, cirrhosis, Cushing syndrome and other named states; specified list of drugs enumerates antipsychotics, chemotherapy, erythropoiesis-stimulating agents, lenalidomide, tamoxifen and others (Schedule 1).

Temporal qualification is a central feature. Many factors have specific look‑back windows before the “clinical onset” of DVT: for example, superficial vein thrombosis within 12 months (s 9(1)); device implantation within six months (s 9(22)); surgery requiring general, spinal or epidural anaesthetic within six months (s 9(23)); pregnancy within three months (s 9(13)); infection with SARS‑CoV‑2 within three months (s 9(17)); exercise of an affected upper limb within seven days for upper limb DVT (s 9(4)). Others have duration thresholds, such as restricted mobility for a continuous period of at least four hours within eight weeks before clinical onset (s 9(25)). The instrument therefore combines presence, timing and duration criteria.

Finally, the instrument contains cross‑references to other Statements of Principles. If a factor in s 9 refers to an injury or disease that has its own Statement of Principles under s 196B(2) of the VEA, then the factors in that other Statement apply “in accordance with the terms of that Statement” as in force from time to time (s 11). The relationship of any factor to the person’s relevant service is separately required (s 10). Notably, factor 32 , “inability to obtain appropriate clinical management for deep vein thrombosis” , is limited by s 10(2) to matters of material contribution or aggravation where the DVT was suffered or contracted before or during, but did not arise out of, relevant service.

The instrument affects claimants, medical assessors, the Repatriation Medical Authority and the Department administering veterans’ entitlements because it prescribes the medical criteria used in assessing whether a “reasonable hypothesis” of service connection exists for DVT or death from DVT. By its application provision the instrument applies to “a claim to which section 120A of the VEA or section 338 of the MRCA applies” (s 5). Those cross‑references specify the statutory contexts in which the “reasonable hypothesis” test is used; practitioners should treat the Statement of Principles as the RMA’s determinative guidance for DVT in those statutory tests.

Who bears evidentiary burden in practice is not specified in the instrument, but the instrument’s operational effect is that claimants who want a reasonable hypothesis raised for DVT must adduce evidence that one or more of the factors in s 9 existed and that the factor is related to relevant service (s 9, s 10). The Schedule offers precise, sometimes numerical, definitions for contested facts: BMI 25 or greater counts as overweight or obese (Schedule 1), one pack-year is the amount of tobacco consumed in smoking 20 cigarettes per day for a year and gives the calculation method (Schedule 1). These numerical thresholds affect how claimants and clinicians compile and present evidence: weight and height measures to compute BMI, detailed smoking history to calculate pack-years, documentation of surgical dates and anaesthetic types, records of implanted devices and their durations, or travel history for altitude exposures.

Medical practitioners who provide expert opinion for claims need to address the specific factors and time windows in s 9 and use the Dictionary definitions, for example describing whether an upper limb activity involved abduction as defined for exercise (Schedule 1). The RMA, which prepared and adopted the Statement, is the authority that determined the sound medical‑scientific basis for the list (s 8). Administrators considering claims under the VEA/MRCA will apply the Statement’s factors and definitions when assessing whether the reasonable hypothesis threshold is met (s 5, s 9, s 10). Finally, other governments or insurers are not directly bound, but the instrument’s definitions and enumerations may be referred to in other contexts; the instrument itself is expressly tailored to veterans’ entitlements processes.

The instrument does not create criminal sanctions, fines, or duties in the ordinary legislative sense. Instead it creates administrative obligations and evidentiary reference points for parties involved in veterans’ entitlements claims. The primary operative duties are implicit: decision‑makers assessing whether a reasonable hypothesis has been met must apply the factors and definitions the RMA has set out (s 9, Schedule 1), and claimants must adduce evidence corresponding to those factors and definitions to establish they exist and are related to relevant service (s 10).

Rights created or affected are rights within the adjudicative process under the VEA and MRCA. For example, an applicant seeking recognition that DVT is related to their relevant service has the right to have a claim assessed against the RMA’s Statement of Principles for DVT (s 5 and s 8). Conversely, administrators have the right to require evidence that aligns to the instrument’s definitions; absence of such evidence may mean the reasonable hypothesis is not raised. Section 11 creates a procedural interactional duty: where a factor in s 9 refers to an injury or disease covered by another Statement of Principles, the factors in that other Statement “apply in accordance with the terms of that Statement” (s 11). That produces a duty on decision‑makers to consult and apply other relevant SOPs when factors cross‑refer.

The instrument places specific evidentiary contours on some medical facts. For example, the phrase “within the three months before the clinical onset” or “within six months before the clinical onset” sets a temporal duty to adduce evidence that the fact existed in the stated window (s 9). Schedule 1 supplies numeric definitions that constrain how evidence is examined, for example the BMI threshold (Schedule 1) and pack-year calculation method (Schedule 1). The instrument also defines certain conditions that, when present, can be treated as qualifying factors (for example, a specified list of hypercoagulable states). Practitioners and clinicians preparing reports must therefore address the specific definition labels used in the instrument.

Rights to administrative review, merits review, or judicial review are not mentioned in the instrument. Those rights, where available, will be found in the VEA or MRCA or in general administrative law, not in this instrument. The Statement itself is framed as an RMA determination of medical criteria (s 3, s 8); it does not specify operational appeals processes or remedies. In practice, an affected person’s rights to challenge a decision that applied this Statement will arise under the substantive Act and the general Commonwealth review framework.

The Statement of Principles instrument does not itself prescribe penalties, disciplinary sanctions, or criminal offences. It is a medical standards instrument made under subsection 196B(2) of the VEA (s 3). There are therefore no enforcement provisions in the instrument that impose penalties on individuals for non‑compliance with the Statement itself. The instrument’s operational force is administrative: it functions as the RMA’s medical determination that certain factors, if present and related to relevant service, raise a reasonable hypothesis for the purposes of claims under the VEA and MRCA (s 8, s 9).

Enforcement in the sense of application arises when decision‑makers in the veterans’ entitlements framework apply the Statement in adjudicating claims to which the specified statutory sections apply (s 5). The instrument supplies determinative criteria for adjudicators. If an adjudicator determines, on the evidence, that none of the s 9 factors exists or that any existing factor is unrelated to relevant service (s 10), the reasonable hypothesis will not be raised and administrative outcomes under the VEA or MRCA will follow. Those outcomes and any associated legal consequences or rights of review flow from the principal Acts, not from this instrument.

The instrument contains precise thresholds and definitions which produce enforcement‑like effects in administrative decision making. For example, the instrument requires that an implanted device in the affected vein be present “for a continuous period of at least 24 hours within the six months before the clinical onset” to qualify (s 9(22)). A claim lacking evidence of that discrete factual requirement can be rejected on that ground. The instrument also imposes timing limits, for example SARS‑CoV‑2 infection within three months before clinical onset (s 9(17)), which create strict temporal tests for evidence.

Because the instrument does not create offences, discipline, or fines, any challenge to how the Statement is applied will be by administrative or judicial review of a decision under the VEA or MRCA. Those appeal and review mechanisms are external to the Statement of Principles and are set out in the principal Acts and in administrative law. The instrument’s endnotes record amendments and registration details but do not add enforcement machinery (Endnotes).

The instrument is expressly made under subsection 196B(2) of the VEA (s 3) and expressly applies to claims to which s 120A of the VEA or s 338 of the MRCA applies (s 5). That anchors the Statement of Principles within the statutory claim framework of both the VEA and MRCA. The Statement is therefore not a freestanding entitlement instrument; it operates as the medical standard that is applied within the statutory tests for reasonable hypothesis under those Acts. Practitioners must therefore read this instrument together with the relevant provisions of the VEA and MRCA which prescribe the procedural and legal consequences of whether a reasonable hypothesis is raised.

Section 11 provides an internal cross‑instrument interaction rule: if a factor in s 9 refers to an injury or disease for which another Statement of Principles has been determined under subsection 196B(2) of the VEA, then the factors in that other Statement apply in accordance with its terms as in force from time to time (s 11). That creates a layered application model where this DVT Statement can import and defer to other Statements for the detailed medical characterisation of co‑morbid injuries or diseases. Practically, if a claimant’s DVT factor refers to, for example, a traumatic limb injury that has its own Statement, adjudicators must consult the other Statement’s factors and definitions.

The Dictionary in Schedule 1 contains numerous defined terms that will commonly require cross‑reference with other medical and statutory sources. For example, “active tuberculosis disease” is defined in the Schedule, and “hypercoagulable state as specified” enumerates multiple causes (Schedule 1). These definitions will be relied on in claims where coexistent disease or exposures are at issue. The pack‑year and cigarettes per day definitions in the Schedule provide a standardised conversion of smoking history. The instrument also explicitly excludes thromboses in certain venous beds (retinal veins, cerebral veins, pulmonary veins, hepatic vein, renal veins, portal vein, mesenteric veins) meaning those conditions fall outside this Statement and must, if relevant, be considered against other medical standards or other Statements if available (s 7(2)(b)).

The Statement has a formal amendment history recorded in the endnotes, indicating it is subject to legislative instrument procedures and can be varied; the most recent amendment in the compilation is the Veterans’ Entitlements (Statements of Principles,definition of “one pack-year”) Amendment Determination 2022 (No. 94 of 2022) which amended the one pack‑year definition and came into effect 19 September 2022 (Endnote 3 and 4). Lawyers and administrators must therefore ensure they are applying the current compilation of the Statement and its Dictionary definitions. Finally, though the Statement does not set procedural rules for appeals, its application will interact with the broader review and appeal pathways in the VEA and MRCA and with Commonwealth administrative law principles.

The compilation shows this Statement was registered on 10 March 2021 and commenced on 5 April 2021; it has since been amended by the Veterans’ Entitlements (Statements of Principles,definition of “one pack-year”) Amendment Determination 2022 (No. 94 of 2022) registered 26 August 2022 and commencing 19 September 2022 (Endnote 3). The endnotes and amendment history table record which provisions were affected by amendments. Specifically, Endnote 4 records that the Subsection 9(30) note and the Schedule 1 Dictionary definition of one pack-year were updated by the No. 94 of 2022 instrument. The compilation date shown is 19 September 2022 and states it includes amendments up to the F2022L01128 instrument (the No. 94 of 2022 amendment).

The document contains the standard compilation endnotes that explain how the text is presented and that uncommenced amendments, modifications by other laws, application, saving and transitional provisions and self‑repealing provisions may not be shown in the compiled text (the preamble paragraphs under “About this compilation”). The endnotes identify the amending instruments and provide commencement dates and registration numbers (Endnote 3). The amendment history table in Endnote 4 identifies specific provision-level changes and notes when a provision label was replaced or modified.

Practitioners should note the instrument’s compiled text includes the Schedule and defined terms as current at the compilation date. The instrument’s Note to endnotes states that details of uncommenced amendments or other modifications are available on the Legislation Register. Where operational decisions rely on a precise definition (for example, one pack‑year), it is essential to check whether any later determinations have altered that definition after the compilation date. The amendment record here identifies that methodological change to the pack‑year definition as the principal recent amendment.

The instrument’s structure and endnotes are consistent with other RMA Statements of Principles compiled under the Legislative Instruments Act framework. The compilation contains an Endnote 2 abbreviation key which practitioners can use to interpret how amendments are annotated. For research or litigation purposes, always check the legislation register and the current F‑numbered instrument text for the latest version, because the compiled version here warns that uncommenced or subsequently commenced amendments, or external modifications, might not be fully reflected in the compilation text.

This compilation contains no recorded litigation history for the Statement of Principles instrument itself. The text and endnotes do not refer to any judicial decisions, statutory challenges, or case law arising from this particular Statement. Endnote 3 lists the registration and commencement history of the instrument and its amending instrument, but does not include any entries of judicial review, declaratory relief or appeal decisions in respect of the instrument’s content.

The absence of litigation recorded within the instrument does not mean that decisions applying the Statement have not been the subject of administrative review or court proceedings, but any such proceedings would be recorded and reported separately in case law and administrative review records. This compilation does not purport to be a comprehensive guide to case law under the VEA or MRCA. Practitioners requiring complete litigation background should search the relevant case law databases and administrative review determinations concerning the VEA and MRCA reasonable hypothesis tests and the RMA’s Statements of Principles in general.

Where a claimant challenges an administrative decision that applied this Statement, the dispute would ordinarily proceed under the review and appeal mechanisms provided in the VEA or MRCA, and through general administrative law, rather than through a direct challenge to the Statement instrument itself. Because the Statement is a legislative instrument made under s 196B(2) of the VEA (s 3), challenges to its validity could in principle be pursued under judicial review grounds if procedural or jurisdictional defects were alleged, but the instrument and its endnotes do not record any such litigation. Practitioners preparing for litigation or review in this area should therefore treat this compilation as the text of the RMA’s DVT medical criteria as at the compilation date, and separately compile the administrative decisions and case law that apply those criteria in practice.

The instrument contains several details that commonly trip up practitioners if not read closely. First, the definition of DVT is restricted to the deep venous system and excludes named venous beds (s 7(2)(b)). That exclusion means documentation of a thrombosis in, for example, a pulmonary vein or cerebral vein does not fall within this Statement. Second, many factors have tight temporal windows or duration thresholds. For claim preparation, a clinician’s report must align to the instrument’s precise windows: superficial vein thrombosis is relevant only if it occurred within 12 months of clinical onset (s 9(1)); surgery and implanted devices are assessed on a six month look‑back (s 9(22)-(23)); SARS‑CoV‑2 infection within three months (s 9(17)); exercise of an affected upper limb only applies for upper limb DVT within seven days of onset (s 9(4)). Failure to provide evidence that meets those temporal tests can be decisive against a reasonable hypothesis.

Third, many terms are numerically defined in Schedule 1 and so evidence must be factual and measurable. Examples include “being overweight or obese” at BMI 25 or greater (Schedule 1), the pack‑year calculation method and the one pack‑year definition (Schedule 1 and Endnote 4 amendment), “exercise of the affected upper limb” narrowed to activities involving abduction (Schedule 1), and “device implanted” requiring continuous presence for at least 24 hours (s 9(22)). Smoking criteria in s 9(30) are two alternative routes: either one pack‑year prior to onset or at least 10 cigarettes per day for three months, with cessation within six months of onset still counting. Incorrectly computed pack-years or missing contemporaneous measures of weight/height will complicate claims.

Fourth, factor 32 , inability to obtain appropriate clinical management for DVT , has a limited application. Section 10(2) constrains that factor to material contribution to, or aggravation of, DVT where the DVT was suffered or contracted before or during (but did not arise out of) relevant service. That restriction is easily missed; the factor cannot be used as a general causative link for DVT arising out of service. Fifth, cross‑referencing with other Statements can change the analytical path. If a factor refers to an injury or disease with its own SOP, the other SOP’s factors apply as in force from time to time (s 11). Practitioners must identify overlapping SOPs and apply them together.

Sixth, the instrument’s Dictionary lists many named medical states as qualifying “hypercoagulable state as specified” or “specified list of drugs”. If an individual’s condition or medication is not expressly listed, the factor will not be met under that label even if clinically relevant. For example, certain newer drugs are not automatically included in the specified list and so a claimant would need to rely on another factor in s 9 or on a cross‑referenced SOP. Finally, the Statement’s compiled status and recent amendment to the pack‑year definition (Endnote 4) demonstrate that definitions can change; practitioners should confirm they are working with the current version when calculating smoking exposure or other thresholds.

For claimants and their advisers, compliance means preparing evidence that directly addresses the instrument’s factors, definitions and timing requirements. The first step is to map the claimant’s medical history and exposures to the s 9 factors, noting the precise look‑back windows and durations. For each factor relied upon, assemble contemporaneous medical records, imaging reports, operative notes, anaesthetic records, radiotherapy planning and field details, laboratory results (for example creatinine trends for kidney injury), infective disease testing or diagnosis dates (SARS‑CoV‑2, CMV, HIV, hepatitis C, active tuberculosis), and device insertion records identifying duration of implantation (s 9 and Schedule 1).

When relying on BMI, provide recorded weight and height measurements close in time to the clinical onset so a BMI calculation meets the instrument’s definition of “being overweight or obese” (Schedule 1). For smoking history, document daily cigarette counts and duration so pack‑years can be computed per the Schedule 1 method; if relying on the alternative threshold in s 9(30)(b), provide records that support at least a three month history of the stated daily consumption and evidence of cessation timing if relevant. For restricted mobility factor evidence, demonstrate continuous immobilisation for the required period (at least four hours within eight weeks before onset) and include travel records or detention/restraint records if relevant (s 9(25)).

Where a factor cross‑refers to another injury or disease with its own Statement, identify that Statement and ensure evidence responds to the terms of that Statement too (s 11). Where multiple factors might be present, provide clear linkage explaining timing and causal plausibility in medical reports: clinicians should explain how a listed factor could have materially contributed to DVT in the claimant’s circumstances and whether the factor was related to the claimant’s relevant service as required by s 10. For factor 32 (inability to obtain appropriate clinical management), ensure the factual narrative establishes that the DVT pre‑dated or occurred during service but did not arise out of it, and then show how lack of access materially contributed to or aggravated the DVT (s 10(2)).

Experts should use the Schedule’s terminology when forming opinions. For upper limb DVT claims premised on exercise, reports should address whether the activity involved strenuous repetitive abduction of the shoulder or arm as defined (Schedule 1). For hypercoagulable states or specified drugs, clinicians should identify whether the claimant’s condition or medication is listed in the Schedule, and if it is not listed, explain why it should be considered under another factor. For deaths where DVT contributed to a terminal event, provide the chain of causation showing how the DVT contributed to the terminal event listed in the Schedule or to another proximate cause (s 7(3), Schedule 1 terminal event).

Finally, always check the current version of the Statement and its endnotes on the legislation register to confirm definitions have not been amended since the compilation used for preparation; the compilation notes an amendment to the one pack‑year definition (Endnote 4). When in doubt about how a fact aligns to a Schedule definition or look‑back window, obtain a specialist medical opinion that addresses the specific enumerated factor and the linkage to relevant service required by s 10.