Statement of Principles concerning pulmonary thromboembolism (Reasonable Hypothesis) (No. 37 of 2021)

The central legal-technical concept the SoP creates is a mechanistic, evidence-oriented threshold for establishing a “reasonable hypothesis” that pulmonary thromboembolism or death from pulmonary thromboembolism is related to relevant service. That threshold is expressed as the existence of at least one enumerated factor occurring within a specified temporal window before the clinical onset of PTE, or present at the time of clinical onset (s 9). The expression “reasonable hypothesis” is the operative causation standard the SoP supports; s 9 frames the listed factors as the minimum required to raise that hypothesis.

Key definitional concepts are set out in the Schedule (Schedule 1). The SoP replaces reliance on an ICD code by supplying its own clinical definition: pulmonary thromboembolism means obstruction of the pulmonary artery or one of its branches by a mass of clotted blood (s 7(2)). The Schedule contains operational measures and thresholds used throughout the factors: Body Mass Index (BMI) computed as weight divided by height squared (Schedule 1: BMI), overweight/obese as BMI ≥ 25 (Schedule 1: being overweight or obese), one pack-year defined as smoking 20 cigarettes per day for one year (Schedule 1: one pack-year) with an explicit conversion to grams of tobacco (7,300 grams per pack-year) for non-cigarette products.

Temporal specificity is a repeated structural feature. Many factors require presence “at the time of the clinical onset” (e.g. malignant neoplasm, aneurysm of a deep vein, infection with HIV or hepatitis C) while others look to discrete look‑back windows (for example, deep vein thrombosis within six months; superficial vein thrombosis within 12 months; SARS‑CoV‑2 infection within three months; cytomegalovirus within 30 days) (s 9(1)-(14), (11)). Certain exposures require continuous duration thresholds (implantation of an intravenous device for at least 24 hours within six months (s 9(19)); surgery under general, spinal or epidural anaesthetic within six months (s 9(20)); restricted mobility continuous for at least 4 hours within eight weeks (s 9(22)); altitude at least 3,000 metres for five days within the three months before onset (s 9(28)). Some factors require specified treatment exposures or medication lists (s 9(25)-(26) together with Schedule 1: specified list of drugs).

Two cross-reference concepts alter application mechanics. First, s 11 requires that if a factor refers to an injury or disease covered by another SoP, then the factors in that other SoP apply in accordance with its terms. Second, s 10(1) imposes that any factor in s 9 must be “related to the relevant service” rendered by the person; therefore, the SoP does not itself make service the causal link, it sets out the medical/temporal predicates that, when both present and linked to service, satisfy raising the reasonable hypothesis.

The RMA’s evidentiary posture is recorded in s 8: the Repatriation Medical Authority states it is of the view that “sound medical‑scientific evidence” indicates a relationship between PTE and relevant service. That statement explains the basis for the SoP but does not itself define operational rules beyond the factor list and windows.

The instrument affects claimants, decision-makers and medical advisers engaged in the assessment of disability or compensation claims under the VEA and MRCA framework. By s 5 it applies to claims to which s 120A of the VEA or s 338 of the MRCA applies. The Schedule defines “relevant service” (operational, peacekeeping, hazardous, British nuclear test defence under the VEA; warlike or non‑warlike under the MRCA), so the population principally affected is veterans and members of the Forces whose service falls within those categories (Schedule 1: relevant service).

For claimants and their advisers the SoP governs evidentiary thresholds for asserting that PTE or death from PTE is related to relevant service. To raise the statutory “reasonable hypothesis” linking PTE to service, at least one of the enumerated factors in s 9 must exist and that factor must be related to the claimant’s relevant service (s 9, s 10(1)). For practitioners preparing claims, the SoP prescribes which clinical conditions, infections, exposures, procedures and time windows are material for raising the relevant hypothesis.

Decision-makers in veterans’ affairs, including medical officers, claims officers and tribunals, will use the SoP as an authoritative medical-evidence instrument when applying s 120A VEA or s 338 MRCA to decide causal linkage. The SoP’s definition of PTE (s 7(2)) and the list of factors (s 9) are the RMA’s determinations for the purpose of those statutory decision processes. The instrument also affects clinicians and forensic practitioners who provide expert reports for claims: the list of required temporal windows and definitions (for example BMI calculation, pack‑year conversions, specified drug lists) defines the granularity and kind of evidence experts will be asked to verify.

Indirectly, the instrument affects administrative agencies that hold service, medical, hospital and pharmaceutical records. Evidence of device implantation (s 9(19)), surgery (s 9(20)), ICU admission or mechanical ventilation (Schedule: injury or illness as specified, item (c)), infection diagnoses and dates (s 9(11)-(14)), smoking history (s 9(27), Schedule: one pack-year) and medication administration (s 9(25) and Schedule: specified list of drugs) will be required to demonstrate the presence and timing of listed factors.

The SoP also affects cases where a factor is itself another SoP condition (s 11). Practitioners will need to locate and apply the relevant other SoP(s) to which those factors refer, because s 11 makes their terms applicable “as in force from time to time.”

The SoP does not impose duties in the criminal or regulatory‑penalty sense. Its operative function is evidentiary and definitional: it sets the minimum evidential facts that must exist before a decision-maker can say a reasonable hypothesis has been raised connecting PTE or death from PTE with relevant service (s 9). Consequently, the principal “duty” in practical terms is on claimants and their advisers to adduce evidence demonstrating the presence of at least one listed factor within the required temporal parameters and to establish that the factor is related to the claimant’s relevant service (s 9 and s 10(1)).

Decision-makers have the right and administrative task of applying the SoP when assessing claims that fall under s 120A VEA or s 338 MRCA (s 5). The SoP provides them with RMA-determined definitions and factor lists which are authoritative for that purpose (s 3, s 8). Section 11 gives decision-makers a right/obligation to apply other SoPs where a listed factor refers to another injury/disease covered by a separate SoP.

For claimants who cannot demonstrate any of the listed factors, the SoP establishes that, at least per the instrument, the “reasonable hypothesis” is not raised by reference to these factors; it does not, however, on its face preclude reliance on other kinds of evidence outside the SoP (the SoP is a statutory instrument determining the RMA’s view, but the broader decision-making framework under the VEA/MRCA controls whether non-SoP evidence can be relied upon , note that the SoP expressly sets out the RMA’s view and lists factors it considers sufficient for raising a reasonable hypothesis (s 8, s 9)). The Schedule’s definitions create rights to measured, standardised conversions for clinical metrics used in claims: BMI is to be calculated as W/H2 (Schedule 1: BMI); pack-years are to be converted as specified (Schedule 1: one pack-year).

A discrete procedural feature is that the factor s 9(29) , inability to obtain appropriate clinical management , is limited by s 10(2): it applies only to material contribution or aggravation scenarios where the PTE was suffered or contracted before or during (but did not arise out of) relevant service. Practically, that narrows when and how lack‑of‑treatment evidence can be relied upon.

Finally, the endnotes document the amendment history and dates of registration/commencement (Endnotes 3 and 4). Practitioners must therefore ensure they apply the SoP version current at the date of decision, because s 11 instructs that other SoPs apply “as in force from time to time.”

The instrument contains no penalty provisions and does not itself create criminal, civil fine or statutory enforcement mechanisms. It is a statutory medical-evidence instrument produced by the Repatriation Medical Authority under s 196B(2) of the VEA (s 3). Enforcement in the sense of application flows through the VEA and MRCA administrative decision-making frameworks: the SoP is applied by decision-makers determining whether a claim raises the “reasonable hypothesis” linking pulmonary thromboembolism (or death from it) to relevant service under the statutory claims processes to which s 120A VEA or s 338 MRCA apply (s 5).

The practical enforcement consequence is evidentiary. If a claimant’s dossier discloses at least one of the enumerated factors within its required temporal parameters and the factor can be related to relevant service (s 9 and s 10(1)), then per the instrument a reasonable hypothesis is raised , that is the SoP’s allocative effect on the administrative causal threshold. Conversely, absence of any listed factor eliminates the RMA‑defined minimum predicate for raising that reasonable hypothesis under this SoP; the decision-maker will record that the SoP’s minimum factors do not support raising the reasonable hypothesis. The instrument does not itself preclude decision-makers from considering other medical or factual material in accordance with the VEA and MRCA statutory frameworks, but the SoP is the RMA’s expression of the factors which, if present, suffice to raise the reasonable hypothesis.

No enforcement agency is created or conferred with new powers by the instrument; its role is confined to prescribing medical and temporal factors and definitions. The endnotes indicate amendments to the SoP (Endnote 4), which may change the evidentiary landscape over time; practitioners should apply the version of the SoP that is in force at the time of decision.

Because the SoP is an administrative instrument used in adjudicating entitlements, dispute resolution and review processes under the VEA/MRCA (for example internal review, AAT review, judicial review) will be the venues where disagreements about the correct application of the SoP are litigated. The compilation does not list any litigation history or cases concerning this SoP.

The instrument is made under the VEA (s 3) and expressly applies to claims under particular provisions of the VEA and the MRCA (s 5). The Schedule defines “relevant service” by reference to classes of service recognised under the VEA and MRCA (Schedule 1: relevant service). The SoP operates as a Repatriation Medical Authority determination under s 196B(2) of the VEA, and thus interacts with the statutory decision-making regimes created by the VEA and MRCA: it supplies medical definitions and causation predicates that are to be used in applying the claim provisions to which it applies (s 5, s 8).

Section 11 is a direct cross‑instrument interaction rule: where a factor in s 9 refers to an injury or disease covered by another SoP determined 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 an operational dependence between SoPs and requires practitioners and decision-makers to consult other SoPs when a listed factor is itself the subject of another SoP. The effect is to modularise medical causation across multiple SoPs: a factor listed here that is itself defined elsewhere imports that other instrument’s requirements.

The instrument references ICD‑10‑AM code I26 (s 7(3)-(4)) but clarifies that, while PTE attracts that code, for the purpose of the SoP the meaning is the textual definition in s 7(2). Thus there is an interaction between the RMA’s statutory definition and widely used clinical classification schemes; the SoP explicitly states which definition controls for claims assessment.

The SoP does not amend the substantive grants or obligations within the VEA or MRCA, nor does it itself change entitlement rules; rather it supports the operation of those Acts by prescribing the medical evidence that raises the reasonable hypothesis in relation to PTE. The endnotes document amendments to the SoP instrument itself (Endnotes 3-4); application of the SoP therefore depends on correctly identifying which version is operative at the relevant decision date.

Because the instrument is evidentiary, its practical interaction with other laws and processes will be through administrative practice: the SoP informs how decision-makers apply statutory causation standards in the VEA/MRCA frameworks, how tribunal reviewers treat the RMA’s expert view, and how medical experts prepare evidence. It does not create independent private rights outside the VEA/MRCA claims processes.

The compilation’s endnotes record the legislative/administrative history. The SoP was registered as Statement of Principles concerning pulmonary thromboembolism (Reasonable Hypothesis) (No. 37 of 2021) on 9 March 2021 and commenced on 5 April 2021 (Endnote 3). An amendment instrument, Veterans' Entitlements (Statements of Principles,definition of "one pack-year") Amendment Determination 2022 (No. 94 of 2022), was registered on 26 August 2022 and commenced on 19 September 2022 (Endnote 3). The compilation date of the consolidated instrument is 19 September 2022.

Endnote 4 provides a granular amendment history list identifying which provisions were affected by amending instruments. It records that subsection notes to s 9(27) and Schedule 1 , the “one pack-year” definition , were revised by No. 94 of 2022 (Endnote 4: entries “Subsection 9(27) note... rs No. 94 of 2022” and “Schedule 1 - Dictionary - one pack-year... rs No. 94 of 2022”). The endnote also lists amendments affecting sections 2 and 4 referencing the Legislation Act 2003 (rep LA s 48D and rep LA s 48C) but the compilation itself contains the current text only.

Mechanically, those amendment entries mean that the instrument as compiled on 19 September 2022 incorporates the 2022 change to the definition/calculation method for “one pack‑year” and related notes concerning the smoking factor in s 9(27). The precise textual content of the prior version is not shown in the compilation; the endnotes identify the registration and commencement details so readers can locate prior versions if required.

Practitioners should be attentive to the amendment history because the Schedule’s operational definitions (BMI, one pack‑year, specified drug lists, specified kidney diseases, hypercoagulable state list, and the injury/illness list) determine evidentiary thresholds. Any subsequent amendment to the SoP or to another SoP cross-referenced by s 11 may materially change which facts raise the reasonable hypothesis in future claims.

The compilation contains no case law, judicial determinations or tribunal decisions concerning this SoP. The only recorded legal history in the instrument is the registration and commencement information for the SoP and its amendment(s) set out in the endnotes (Endnote 3 and Endnote 4). No specific legal challenges, appeals or judicial reviews are recorded in the compilation.

Practitioners should therefore be aware that, at least based on the text supplied in this compilation, there is no reported litigation history appended to the instrument. That absence in the compilation does not preclude the existence of decisions elsewhere that interpret or apply this SoP in disputed claims under the VEA or MRCA. The SoP expressly operates within the VEA/MRCA statutory frameworks, so its interpretation and application may be contested in administrative and judicial review venues; however, the compilation itself contains no transcripts, annotations or summaries of such cases.

Because s 11 imports the terms of other SoPs when an enumerated factor refers to an injury or disease covered by another SoP, case law on those other SoPs could be materially relevant in disputes implicating factors in s 9. Given that the compilation records a relatively recent amendment (2022) to the “one pack‑year” definition and related notes, litigated issues may arise as to application of the revised conversion metrics for historical claims; the text here records the amendment dates but not any adjudicative interpretation.

If a practitioner requires a litigation history, the compilation’s endnotes give registration and commencement dates and amendment instrument identifiers, which are the references needed to search administrative tribunal or court databases for decisions that cite or address this particular SoP or its amended provisions.

The instrument contains multiple technical features that, if missed, can materially affect claim preparation and adjudication.

• Narrow temporal windows. Many factors require precise timing relative to the clinical onset of PTE: DVT within six months (s 9(1)); superficial vein thrombosis within 12 months (s 9(2)); cytomegalovirus within 30 days (s 9(11)); SARS‑CoV‑2 infection within three months (s 9(14)); pregnancy within three months (s 9(10)); restricted mobility continuous for at least four hours within eight weeks (s 9(22)). Failure to document the onset dates and the timing of the factor in relation to onset is likely to be dispositive.

• “At the time of the clinical onset” requirement. Several factors require presence at the time of clinical onset (for example heart failure, malignant neoplasm, aneurysm of a deep vein, autoimmune disease, hypercoagulable states) (s 9(4)-(7), (15), (17)). Practitioners must establish contemporaneous clinical evidence rather than historical diagnoses.

• Measurement definitions matter. BMI is defined and overweight/obese is BMI ≥ 25 (Schedule 1: BMI; being overweight or obese). The SoP prescribes the formula and numerical threshold; a claimant’s BMI must therefore be calculable or inferred from contemporaneous weight and height records. Absent contemporaneous measurements, retrospective estimation may be challenged.

• Smoking calculation. The Schedule defines one pack‑year and provides a grams-of-tobacco conversion and calculation method (Schedule 1: one pack-year). The SoP also contains a smoking cessation proviso: if smoking has ceased before clinical onset, the onset must be within six months of cessation for the smoking factor to apply (s 9(27)). The recent 2022 amendment expressly revised the note to s 9(27) and the one pack‑year definition (Endnote 4), so practitioners must apply the post‑19 September 2022 wording.

• Cross-referencing to other SoPs. If a factor in s 9 refers to an injury or disease that is the subject of another SoP, s 11 requires that the other SoP’s factors apply “as in force from time to time.” This can add layers of evidentiary complexity and requires locating, reading and applying the other SoP(s).

• Limited scope for factor 29. The inability-to-obtain-appropriate-clinical-management factor (s 9(29)) is constrained by s 10(2): it applies only where the PTE was suffered or contracted before or during (but did not arise out of) relevant service, and only to material contribution or aggravation. Where PTE arose out of service, s 9(29) does not apply. Practitioners must understand which bodily event is being characterised as “suffered or contracted” and whether the service connection is pre‑existing/during or arising out of service.

• Device and surgery duration specifics. Implantation of an intravenous device must have been for a continuous period of at least 24 hours within six months before onset (s 9(19)); surgery must have required a general, spinal or epidural anaesthetic within six months (s 9(20)). Shorter device insertions or procedures under local anaesthesia will not meet these predicates.

• Altitude and restricted mobility thresholds. The altitude factor requires continuous residence at ≥ 3,000 metres for at least five days within three months before onset (s 9(28)). Restricted mobility requires continuous four-hour duration within eight weeks before onset (s 9(22)). Evidence of travel itineraries, flight/transport logs or detainment records may be required.

• Specified lists. Several items are expressed as “specified list” categories in the Schedule (hypercoagulable state, specified list of drugs, specified list of kidney diseases, clinically significant disorder of mental health as specified, injury or illness as specified). The Schedule’s lists are exhaustive for the purpose of the SoP; where a claimant’s condition is not one of the items listed, reliance on the generic category will fail under the SoP.

• ICD‑10‑AM code note. Although PTE attracts ICD‑10‑AM code I26 (s 7(3)), the SoP explicitly states that for the purposes of the instrument the definition is that given in s 7(2). Practitioners should not rely on code alone; clinical description must match s 7(2).

• Death causation framing. The SoP includes death from PTE as death from a terminal event or condition that was contributed to by the person’s PTE (s 7(5)). This creates a proximate/ultimate cause framing for death claims: proof that PTE contributed to a terminal event listed in the Schedule is required to bring a death within the SoP’s coverage.

• Evidence assembly burden. The SoP’s specificity transfers evidential burden to claimants and their advisers: contemporaneous medical records, imaging, pathology, device insertion notes, surgical/anesthesia records, ICU and ventilation documentation, drug administration logs, infection test results and travel/residence records will commonly be required to prove the listed factors within their specified temporal windows.

For claimants, lawyers and medical advisers preparing a claim that relies on this SoP, compliance is primarily documentary and clinical: establish that at least one factor in s 9 existed within the required temporal window and that the factor is related to the claimant’s relevant service (s 9, s 10(1)). Below is a practical evidence checklist mapped to the enumerated factors and the Schedule definitions.

1. Diagnosis of pulmonary thromboembolism and clinical onset date

• Obtain hospital discharge summaries, imaging studies (CT pulmonary angiography, V/Q scans), clinician notes and pathology reports stating the date of clinical onset to anchor timing for all look‑back windows. The SoP defines PTE as obstruction of the pulmonary artery or a branch by clotted blood (s 7(2)); ensure records document that pathology.

2. Temporal documentation for each factor

• Deep vein thrombosis (s 9(1)): DVT diagnosis within six months prior to PTE onset. Provide duplex ultrasound, D-dimer results, specialist notes.
• Superficial vein thrombosis (s 9(2)): within 12 months. Provide vascular imaging and clinical records.
• Acute myocardial infarction (s 9(3)): diagnosis within six months. Provide troponin trends, ECG, cardiology notes.
• Heart failure or right-sided intracardiac thrombus (s 9(4)): contemporaneous echocardiography, cardiology notes.
• Malignant neoplasm (s 9(5)): evidence of active or recent malignancy at time of PTE: pathology, oncology notes, staging, treatment records.
• Aneurysm of deep venous system (s 9(6)): imaging evidence.
• Overweight/obese (s 9(7)): contemporaneous weight and height to compute BMI ≥ 25 (Schedule 1: BMI and being overweight or obese). If contemporaneous measures not available, supply earliest reliable proximate measures and clinical notes.
• COPD, sleep apnoea (s 9(8)-(9)): pulmonary function tests, sleep studies, specialist records.
• Pregnancy (s 9(10)): obstetric records within three months before onset.
• Infections: cytomegalovirus (s 9(11) within 30 days), HIV/hepatitis C (s 9(12)), active tuberculosis (s 9(13) within 30 days), SARS‑CoV‑2 (s 9(14) within three months): supply lab confirmation and dates.
• Autoimmune disease, diabetes (s 9(15)-(16)): specialist notes, serology, diabetes records.
• Hypercoagulable state (s 9(17)): schedule lists conditions (antiphospholipid antibody syndrome, etc.); provide haematology reports, test results, and evidence of anticoagulation access where relevant.
• Kidney disease (s 9(18)): Schedule specifies acute kidney injury, chronic kidney disease or nephrotic syndrome; provide creatinine trends, GFR reporting, renal imaging, biopsy and transplant records.
• Implanted intravenous device ≥ 24 hours within six months (s 9(19)): surgical/device insertion records, device logs.
• Surgery with general/spinal/epidural anaesthetic within six months (s 9(20)): operative notes, anaesthetic records.
• Injury/illness as specified within six months (s 9(21), Schedule list): fractures, severe TBI, ICU admission or mechanical ventilation: hospital, operative and ICU records.
• Restricted mobility continuous ≥ 4 hours within eight weeks (s 9(22)): travel or restraint documentation, transport logs, detention records.
• Neurological disease causing motor impairment within three months (s 9(23)): neurology notes, imaging, rehabilitation records.
• Clinically significant mental health disorder (s 9(24)): psychiatric notes showing ongoing management for depressive disorder, PTSD or schizophrenia; the Schedule notes that “ongoing management” may not require actual management to have been provided, but evidence must show the condition is of sufficient severity.
• Specified drugs within three months (s 9(25)): medication charts, pharmacy dispensing records, oncology treatment logs for lenalidomide, thalidomide, tamoxifen etc.
• Hormone therapy or combined contraception (s 9(26)): prescribing records showing continuous four-week use within three months prior to onset.
• Smoking (s 9(27)): detailed smoking history, pack-year calculation per Schedule: one pack‑year = 20 cigarettes/day for one year; conversion factors provided. If smoking ceased, demonstrate cessation date and that PTE onset occurred within six months of cessation to meet the requirement.
• Altitude exposure (s 9(28)): travel/residence documentation showing continuous ≥ 3,000 m for at least five days within three months.
• Inability to obtain appropriate clinical management (s 9(29)): to use this factor, document that the claimant’s PTE was suffered or contracted before or during (but did not arise out of) relevant service and evidence of lack of access to appropriate care; remember the s 10(2) constraint.

3. Service linkage evidence

• Demonstrate “relevant service” as defined in the Schedule (operational, peacekeeping, hazardous, British nuclear test defence, warlike or non‑warlike service). Provide service records, deployment orders, unit diaries, or other documentary proof to show the claimant’s service category and dates, and evidence linking the listed factor to that service (medical treatment records during service, exposures recorded in unit logs, travel itineraries from deployments).

4. Cross-referenced SoPs

• Where s 9 refers to a condition that is the subject of another SoP, obtain that other SoP and apply its factors per s 11. For example, if the factor refers to a condition covered by a separate SoP, collect the evidence that satisfies the other SoP’s predicates as well.

5. Expert reports

• Obtain contemporaneous medical practitioner notes and expert opinions that trace chronology and causation using the SoP’s definitions. Experts should compute BMI using the Schedule formula, compute pack‑years per the Schedule conversion, and explicitly address whether the listed factor existed within the precise time window and whether it can be related to service.

6. Addressing gaps

• If contemporaneous measures are absent, collate best available evidence with affidavits from treating clinicians, employment or travel records and any ancillary sources. Note that absence of contemporaneous evidence makes meeting the SoP’s minimum predicates harder given the instrument’s temporal precision.

7. Version control

• Confirm which version of the SoP applies at the time of the claim. The instrument has been amended (Endnote 3 and 4). Use the compiled version current at the decision date; changes such as the 2022 amendment to “one pack‑year” may affect smoking factor calculations.

8. Practical litigation/administrative strategies

• Frame evidence to show at least one factor present within required timing, and separately demonstrate how that factor relates to service under s 10(1). For s 9(29), ensure the factual narrative fits within the constraint of s 10(2): PTE suffered or contracted before/during service but not arising out of service.

In sum, compliance requires mapping clinical facts to the SoP’s enumerated factors and Schedule definitions, documenting precise dates and durations, and producing evidence that the factor both existed in the specified window and is related to the claimant’s relevant service. The Schedule’s calculation rules (BMI, pack‑year) and the lists of specified conditions and drugs should be checked and applied concretely in expert reports.