Statement of Principles concerning varicocoele (Balance of Probabilities) (No. 80 of 2019)

Varicocoele: The instrument defines varicocoele in subsection 7(2) as an abnormal tortuosity and dilatation of the veins of the pampiniform plexus within the spermatic cord in the scrotum. This is the medical condition of varicocele, using the alternative spelling "varicocoele" (the instrument uses this spelling throughout). It notes that varicocoele usually presents as a scrotal swelling and may be associated with male infertility. The ICD-10-AM code I86.1 is assigned to varicocoele, but the instrument expressly provides that the meaning in subsection 7(2) governs, not the code's scope. This is a typical feature of Statements of Principles that define conditions more precisely than the classification system. The instrument also extends the definition to include death from a terminal event contributed to by varicocoele (subsection 7(5)). Terminal event is defined in the Dictionary to mean pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function. So a person whose varicocoele contributed to any of those terminal events is considered to have died from varicocoele for the purposes of the SoP.

Balance of probabilities: The instrument is expressly made under subsection 196B(3) of the VEA, which relates to Statements of Principles determined on the balance of probabilities standard. This standard requires that the factors set out in section 9 must be established as being more likely than not. This is a lower threshold than the "reasonable satisfaction" standard applied to operational service claims under subsection 120(1) VEA. The instrument therefore applies only to claims where the legislative standard is the civil balance of probabilities. This is reinforced by section 5, which confines the instrument's application to claims under sections 120B VEA and 339 MRCA, both of which operate on the balance of probabilities.

Clinical onset and clinical worsening: The factors in section 9 are divided between those that apply to clinical onset (subsections 9(1) to (4)) and those that apply to clinical worsening (subsections 9(5) to (9)). Clinical onset refers to the first appearance of varicocoele in a person who previously did not have the condition. Clinical worsening refers to a material increase in severity or symptoms of a pre-existing varicocoele. Section 10(2) provides that the worsening factors apply only where the varicocoele was suffered or contracted before or during, but did not arise out of, the person's relevant service. This means that if a person developed varicocoele while on peacetime service but not due to that service, and later it worsened, the worsening can be linked to service via the factors. But if the varicocoele arose out of service in the first place, the initial connection would already be established, and the worsening factors would not be needed.

Occlusion or stenosis: Defined in the Dictionary as complete or partial obstruction to the blood flow of a blood vessel, due to causes including thrombosis, tumour invasion, or external compression of a vein. The definition provides a non-exhaustive list of causes of external compression: cyst, left renal vein entrapment syndrome (nutcracker syndrome), neoplasm, pseudocyst, renal arteriovenous malformation, retroperitoneal fibrosis, and retroperitoneal mass. This factor is the most technical and may require advanced imaging to prove. The instrument also clarifies the blood vessels of the testicular venous drainage system in notes to subsections 9(1) and (5), including inferior vena cava, internal iliac vein, left or right renal vein, lumbar vein, pampiniform plexus, and testicular vein, and notes that rare anatomical variants may exist.

Arteries supplying the testis: Defined in the Dictionary and includes the cremasteric artery, deferential artery, external pudendal artery, and testicular artery. This definition is relevant for the arterio-venous fistula factor (subsections 9(3) and (7)). A fistula between any of those arteries and a vein of the pampiniform plexus must exist at the time of clinical onset or worsening.

Inability to obtain appropriate clinical management: Factor 9(9) applies where the person is unable to obtain appropriate clinical management for varicocoele. This is the broadest factor, but it applies only to clinical worsening, not onset, as per section 10(2). It does not define what constitutes "appropriate clinical management" or "inability". It would require evidence that the person's service prevented them from receiving standard treatment (for example, due to posting to a remote location or lack of medical facilities).

Relevant service: The Dictionary defines relevant service specifically for this SoP: it means eligible war service (other than operational service) under the VEA, defence service (other than hazardous service and British nuclear test defence service) under the VEA, or peacetime service under the MRCA. This is a tailored definition that excludes operational service and hazardous service, which are subject to different SoPs or different standards. The effect is that this SoP covers the lower-risk categories of service where the balance of probabilities standard applies.

The immediate subjects of this instrument are veterans and members of the Australian Defence Force who render eligible war service (other than operational service), defence service (other than hazardous service and British nuclear test defence service) under the VEA, or peacetime service under the MRCA, and who suffer from varicocoele or die from varicocoele. It also affects the dependants of such persons who claim compensation following death from varicocoele. These claimants must establish that at least one of the factors in section 9 exists and is related to their relevant service. The instrument does not create any new rights for persons with operational service or hazardous service; those persons must rely on different SoPs determined under subsection 196B(2) VEA (the reasonable satisfaction SoPs) or the direct operation of the VEA without a SoP.

The instrument also directly affects decision-makers within the Department of Veterans' Affairs and the Military Rehabilitation and Compensation Commission. They are bound to apply the factors when determining claims for varicocoele that fall within the scope of sections 120B VEA or 339 MRCA. For any claim on the balance of probabilities standard, the decision-maker must check whether any of the nine factors is present and, if so, whether that factor is related to the person's relevant service. If no factor is present, the claim must be rejected, subject to any residual discretion under the VEA or MRCA to find connection on other evidence if the SoP is not exhaustive (though the VEA generally requires that a SoP be applied).

Medical practitioners who provide reports for claimants or the Department are also affected. They need to be familiar with the definitions of varicocoele, occlusion or stenosis, and the specific arterial and venous anatomy referenced. The instrument places a premium on diagnostic precision, especially for the occlusion/stenosis and arterio-venous fistula factors, which require imaging evidence. The one-year time limit for nephrectomy (subsections 9(2) and (6)) means that the medical history must establish when the nephrectomy occurred relative to clinical onset or worsening. For the ankylosing spondylitis factor (subsections 9(4) and (8)), a diagnosis of that specific rheumatological condition is required.

Legal practitioners and advocates who advise claimants must ensure that evidence is marshalled to meet one of the factors. They must also be aware that the instrument applies only to the balance of probabilities standard, so a client with operational service or hazardous service cannot rely on this SoP and must instead seek the relevant SoP made under subsection 196B(2) or argue that no SoP is required. The Veterans' Review Board, the Administrative Appeals Tribunal, and the Federal Court on review or appeal are also affected, as they must apply the instrument's factors when reviewing decisions made under the VEA and MRCA. The instrument does not contain any sunset clause or automatic review date, so it will remain in effect until repealed or replaced by a later SoP.

This instrument does not impose duties in the sense of obligations to act; it is a Statement of Principles that sets out the factual prerequisites for a legal finding. However, the instrument creates a duty on the part of the Repatriation Medical Authority to have determined the SoP based on sound medical-scientific evidence, as stated in section 8. That section is the basis for the instrument's validity; if the evidence were not sound, the instrument might be subject to challenge, but the source provides no mechanism for enforcement of that duty beyond possible judicial review.

The primary duty that arises from the instrument is on the decision-maker (the Department of Veterans' Affairs or the Commission) to apply the factors faithfully when determining a claim under section 120B VEA or section 339 MRCA. Section 9 states that at least one of the listed factors must exist "before it can be said that ... varicocoele ... is connected with the circumstances of a person's relevant service". This is a mandatory requirement: if no factor exists, the decision-maker cannot find a connection on the balance of probabilities. Conversely, if a factor exists and is related to service, the decision-maker must find that the condition is service-related, unless some other provision of the VEA or MRCA displaces that conclusion (for example, statutory exclusions). This confers a right on the claimant to have the claim decided in their favour if the factor is established.

The right of a claimant is to have the instrument applied correctly. The claimant bears the evidentiary burden of proving that at least one factor exists and is related to service. The instrument does not shift the burden of proof; it defines what must be proved. The definitions in the Schedule 1 Dictionary are binding, so a claimant cannot rely on a broader medical definition of varicocoele than that in subsection 7(2). For example, a mild varicocoele that does not involve abnormal tortuosity and dilatation might not satisfy the definition, even though a clinician might use the term. Similarly, "occlusion or stenosis" is defined with a specific list of causes; if the occlusion is due to something not listed, it may still fall within the inclusive definition if it is thrombosis, tumour invasion, or external compression of a vein from any cause. The list is illustrative, not exhaustive.

The instrument also creates a right for persons whose varicocoele was caused by a factor that is itself covered by another SoP. Section 11 provides that if a factor in section 9 refers to an injury or disease in respect of which a separate SoP has been determined under subsection 196B(3), then the factors in that other SoP apply. For example, if "occlusion or stenosis" is due to a neoplasm, and that neoplasm has its own SoP (say, renal cell carcinoma), then the claimant must also satisfy the factors in that cancer SoP to establish that the neoplasm is service-related. This cross-referencing chains the evidentiary requirements.

The instrument does not confer any private right of action or right to damages. It operates solely within the administrative compensation framework for veterans and defence members. It also does not create any duty on medical practitioners to diagnose or treat varicocoele; it only defines the evidentiary standards for those who choose to make a claim.

The Statement of Principles itself contains no penal provisions. It is a legislative instrument that defines eligibility criteria for compensation benefits; it does not create offences, impose fines, or authorise prosecution. The "penalties" that arise from the instrument are indirect and consist of the denial of compensation where the factors are not met. If a claimant fails to establish one of the nine factors, the decision-maker must refuse the claim, which can be a significant financial and medical consequence for the individual. Conversely, if the decision-maker incorrectly applies the instrument (for example, by finding a factor exists when the evidence does not support it), that decision may be overturned on review, and the Department may be ordered to pay compensation plus arrears.

Enforcement of the instrument occurs through the usual administrative review mechanisms. A claimant who is dissatisfied with a decision that relies on this SoP may seek review by the Veterans' Review Board, then appeal to the Administrative Appeals Tribunal, and ultimately the Federal Court on a question of law. The instrument is judicially reviewable under the Administrative Decisions (Judicial Review) Act 1977. The failure to apply the correct factor, or the misapplication of a definition, could ground an application for review. The instrument does not specify any internal review procedures; those are governed by the VEA and MRCA.

There is no penalty for a claimant who makes a false statement to establish a factor, but that conduct would be punishable under other provisions of the criminal law, such as fraud or making false statements to obtain a financial benefit. The instrument itself does not address that. For decision-makers, there is no personal liability for errors, as the Department is vicariously liable. However, systematic failure to apply this SoP could lead to adverse findings by the Commonwealth Ombudsman or the Inspector-General of the ADF.

The only enforcement mechanism specifically created by the instrument is the power of the Repatriation Medical Authority to repeal or replace it. Under section 196B of the VEA, the Authority may determine new SoPs as medical evidence evolves. The repealed SoP No. 4 of 2011 was replaced by this 2019 instrument. If future medical research undermines the factors in this instrument, claimants may still be bound until a new SoP is issued. There is no sunset date or mandatory review in the instrument itself.

This instrument is made under the Veterans' Entitlements Act 1986, specifically subsection 196B(3). It is a legislative instrument and for the purposes of the Legislation Act 2003 is registered on the Federal Register of Legislation. Its primary interaction is with the VEA and the MRCA. Section 5 of the instrument states that it applies to a claim under section 120B of the VEA or section 339 of the MRCA. Those sections establish the balance of probabilities standard for claims relating to eligible war service (other than operational service), defence service (other than hazardous service), and peacetime service respectively. The instrument does not apply to claims under section 120 of the VEA (operational service, reasonable satisfaction) or section 338 of the MRCA (hazardous service, reasonable satisfaction). If a claimant has operational service and suffers varicocoele, the relevant SoP would be one made under subsection 196B(2) of the VEA, which uses a different standard. This instrument expressly limits its application to the balance of probabilities standard, so it operates as a complementary instrument to any reasonable satisfaction SoP for the same condition. The Authority typically publishes two SoPs for most conditions: one for each standard.

The instrument also interacts with other Statements of Principles through section 11. If a factor in section 9 refers to an injury or disease that has its own SoP under subsection 196B(3), the factors in that other SoP must be applied. For example, the factor in subsection 9(1) refers to occlusion or stenosis. If the occlusion is caused by a retroperitoneal mass, and there is a SoP for that mass, the claimant must satisfy that mass SoP as in force from time to time. This creates a vertical integration of evidentiary requirements. The cross-reference is dynamic, meaning it refers to the SoP as amended from time to time, not the version in force at the date of this instrument.

The instrument's definition of varicocoele interacts with the ICD-10-AM classification. Subsection 7(3) provides that varicocoele attracts ICD-10-AM code I86.1, but the meaning for the SoP is that given in subsection 7(2). This ensures that the instrument's own clinical definition prevails, which may be narrower or broader than the ICD code. The fourth edition of the ICD-10-AM (2017) is referenced in subsection 7(4), so the instrument is tied to that edition. If ICD codes change, the instrument does not automatically update unless amended.

The instrument repeats section 10(2), which confines certain factors to material contribution or aggravation where the varicocoele was suffered before or during service. This is consistent with section 9 of the VEA and Part 2 of the MRCA dealing with liability for aggravation. It also includes the section 11 cross-reference as a standard provision in many SoPs. There is no interaction with state workers' compensation laws, as the VEA and MRCA are exclusive Commonwealth regimes for eligible service. However, if a person also has a claim under the Safety, Rehabilitation and Compensation Act 1988 (SRCA) for the same condition, that act's definition of disease and causation standards may differ, and this SoP would not apply directly to an SRCA claim.

The instrument repeals the previous Statement of Principles concerning varicocele No. 4 of 2011 (registered as F2010L03251). That earlier instrument was made under the same power, subsection 196B(3) VEA. The new instrument does not state the reasons for repeal, but recites in section 8 that the Authority is of the view, on the sound medical-scientific evidence available, that varicocoele can be related to relevant service. This implies that the Authority considered new evidence or decided to update the factors. A comparison with the repealed 2011 SoP is not possible from this source alone, but the 2019 instrument contains some factors that were likely in the predecessor: occlusion/stenosis, nephrectomy, arterio-venous fistula, and inability to obtain appropriate clinical management. The inclusion of ankylosing spondylitis as a factor (subsections 9(4) and (8)) may be new, or it may have been carried over; the source does not say.

The instrument was made on 23 August 2019 and commences on 23 September 2019, a 30-day delay typical for legislative instruments to allow for notification and transition. No transitional provisions are included in the instrument itself; it simply declares in section 5 that it applies to a claim under the relevant sections of the VEA and MRCA. This means that claims lodged before 23 September 2019 but not yet determined as at that date would be decided under the new 2019 SoP, unless the decision-maker considers that the old SoP is preserved by some transitional rule in the VEA or common law. The VEA does not generally preserve old SoPs; the relevant provision is section 120B(7), which provides that a SoP as in force at the time of the decision applies. So the new 2019 SoP will govern decisions made on or after 23 September 2019 regardless of when the claim was lodged.

No subsequent amendments to this instrument are visible in the source text. It is possible that minor corrections or amendments were made after 2019, but the source is the original version as registered. The instrument number (No. 80 of 2019) indicates it was the 80th SoP made in 2019 under subsection 196B(3). The Authority frequently updates SoPs, and this one may be amended or replaced in future if medical evidence changes.

The source text does not mention any litigation concerning this specific instrument. Since it commenced on 23 September 2019, it is possible that some decisions under it have been reviewed by the Veterans' Review Board or the Administrative Appeals Tribunal, but no court cases are referenced. The instrument is legislative in nature and could be challenged on grounds such as procedural error by the Authority (failure to base it on sound medical evidence) or incorrect interpretation of its terms. However, judicial review of Statements of Principles is constrained; courts typically defer to the Authority on matters of medical science unless the instrument is manifestly irrational or ultra vires.

The predecessor SoP No. 4 of 2011 may have been considered in litigation, but the source does not provide that history. The inclusion of explicit definitions (such as occlusion or stenosis with a list of causes) may reflect responses to past interpretive disputes. For example, the expansive note on external compression of a vein and the list of eight possible causes (including nutcracker syndrome and retroperitoneal fibrosis) suggests that previous cases may have raised arguments about what constitutes compression. Similarly, the definition of arteries supplying the testis with four specific vessels includes the cremasteric artery, deferential artery, external pudendal artery, and testicular artery, which may have been litigated as to scope.

The instrument has a standard section 11 cross-reference to other SoPs. That provision could generate litigation if a factor depends on another SoP and that SoP is later amended or repealed. The dynamic reference "as in force from time to time" means that changes in other SoPs automatically flow into this instrument, which could cause uncertainty if a claimant relied on a factor that was subsequently removed from the other SoP. No cases are known from the source, but this is a potential source of future litigation.

The instrument is also relevant to the standard of proof. A claimant might argue that the Authority should have determined the SoP under subsection 196B(2) (reasonable satisfaction) instead of (3), or that the instrument does not cover their type of service (e.g., if the service is wrongly classified). These issues would be litigated in the context of a specific claim. The source provides no indication of any such challenges having been decided.

Timing of the factors. The instrument carefully distinguishes between clinical onset and clinical worsening. Factor 9(9) (inability to obtain appropriate clinical management) applies only to clinical worsening by virtue of section 10(2). Many claimants and their advisers might assume that this factor can also establish initial onset, but the instrument expressly restricts it. If a person had untreated varicocoele before service and worsened during service due to lack of care, factor (9) is available. But if the varicocoele first appeared during service and was not properly treated, factor (9) does not help; instead, the claimant must rely on one of the onset factors (1) to (4). That distinction can be critical.

Definition of relevant service. The instrument defines relevant service narrowly: eligible war service (other than operational service), defence service (other than hazardous service and British nuclear test defence service) under the VEA, and peacetime service under the MRCA. A claimant who performed operational service in a war zone or hazardous service in a specified area cannot rely on this SoP; they must use a different SoP under subsection 196B(2) or argue without a SoP. Similarly, a member who performed hazardous service under the MRCA cannot use this instrument. The exclusion of British nuclear test defence service is specific to those who served in the British nuclear tests in Australia; they are also excluded.

The nephrectomy one-year time limit. Subsections 9(2) and (6) require that the nephrectomy occur within the one year before the clinical onset or worsening of the ipsilateral (same side) varicocoele. A nephrectomy on the left side can only explain a left-sided varicocoele. If the nephrectomy occurred more than one year before onset, even if still causally related, the factor does not apply. The instrument gives no exception for long-latency presentations.

Ankylosing spondylitis as a factor. Factor 9(4) and (8) require the presence of ankylosing spondylitis at the time of clinical onset or worsening. Ankylosing spondylitis is a specific seronegative spondyloarthropathy. A general diagnosis of inflammatory back pain or undifferentiated spondyloarthritis does not satisfy the factor. The claimant must have a confirmed diagnosis of ankylosing spondylitis. Moreover, the factor does not require a causal mechanism; it is merely a co-existing condition that the Authority considers probative. If a claimant has ankylosing spondylitis that is not service-related but is present at the time varicocoele worsens, the factor can still be satisfied as long as the ankylosing spondylitis is related to service (per section 10, the factor must be related to service). That is a significant gotcha: the ankylosing spondylitis itself must be service-related for the factor to apply. If a veteran developed ankylosing spondylitis after service, it is not related to service, and the factor cannot be used.

Occlusion or stenosis requires proof of the underlying cause. The definition includes thrombosis, tumour invasion, or external compression of a vein. The note lists eight examples, but they are illustrative. However, the decision-maker will require evidence of the specific cause, and that cause itself may need to be service-related. For example, if external compression is due to a renal cyst, and the cyst is not service-related, then the occlusion factor fails because the factor (the occlusion) is not related to service. The chain of causation can be long.

Inability to obtain appropriate clinical management: what is "appropriate"? Factor 9(9) is the broadest, but the instrument does not define appropriate clinical management. It could mean standard surgical or conservative management. If a person was stationed in a location where no urologist was available, or treatment was delayed due to operational commitments, that could count. But the factor requires the inability, not mere difficulty. It also requires that the inability be related to service (per section 10(1)). If the person simply chose not to seek treatment, factor (9) would not apply.

Application to claims under both VEA and MRCA. The instrument applies to both schemes, but the definitions of service differ. A person with MRCA peacetime service can use this SoP, but a person with MRCA hazardous service cannot. The same person might have multiple periods of service; the decision-maker must determine which period is relevant and apply the correct SoP.

Not: the instrument uses "varicocoele" throughout, not the more common "varicocele". This is not a definitional difference, but practitioners should be aware when searching for the instrument.

For a claimant seeking to establish that varicocoele is related to their relevant service on the balance of probabilities, compliance with this instrument requires a step-by-step approach. First, confirm that the claim falls within the scope of section 120B VEA or section 339 MRCA. If the service is operational or hazardous, the claimant cannot rely on this SoP and must seek a different one. For peacetime service or eligible war service/defence service (non-operational, non-hazardous), the claimant must assemble medical evidence to show that the condition meets the definition of varicocoele in subsection 7(2): abnormal tortuosity and dilatation of the veins of the pampiniform plexus. A simple ultrasound report stating "varicocele" may suffice, but the report should use language consistent with the definition. If the claim is for death from varicocoele, the claimant must also show that a terminal event was contributed to by the varicocoele.

Second, identify which of the nine factors in section 9 may apply. The claimant should obtain a full medical history and any imaging studies. For the occlusion or stenosis factor (subsections 9(1) and (5)), a CT venogram or Doppler ultrasound may be needed to demonstrate an obstruction in the testicular venous drainage system. The specific cause of the occlusion (e.g., retroperitoneal fibrosis, nutcracker syndrome) should be diagnosed. For the nephrectomy factor (subsections 9(2) and (6)), the date of the nephrectomy must be no more than one year before the onset or worsening. Medical records confirming the nephrectomy date and side are required. For the arterio-venous fistula factor (subsections 9(3) and (7)), angiography or Doppler studies must show an abnormal communication between an artery supplying the testis (specifically one of the four listed in the Dictionary) and a vein of the pampiniform plexus. For the ankylosing spondylitis factor (subsections 9(4) and (8)), a rheumatologist's diagnosis of that specific condition is needed, along with evidence that it existed at the time of onset or worsening. For the inability to obtain appropriate clinical management factor (9(9)), the claimant must show that the varicocoele worsened because they were unable to receive standard treatment (e.g., due to deployment, lack of specialist access, or combat conditions), and that inability was related to service. This may require operational records or witness statements.

Third, for each factor relied upon, the claimant must show that the factor itself is related to the relevant service. For example, if the factor is occlusion of the testicular vein due to a renal vein thrombosis, the claimant must establish that the thrombosis was caused by service (or that the underlying disease is service-related). This requires application of section 10(1). For factors that involve other medical conditions (ankylosing spondylitis, nephrectomy, etc.), the claimant must prove that those conditions are service-related, unless the factor itself is a direct consequence of service (e.g., a nephrectomy resulting from a service injury). Section 11 may require compliance with other SoPs if the underlying condition has its own SoP.

Fourth, document the relationship between service and the factor in detail. The medical report should explicitly state that the factor existed before clinical onset or worsening, and how it is related to the person's service. For example, "Veteran X had an occlusion of the left testicular vein due to retroperitoneal fibrosis that developed as a result of exposure to asbestos during service." The decision-maker will assess whether the evidence meets the balance of probabilities standard.

Fifth, be cautious with the distinction between onset and worsening. If the varicocoele existed before service and only worsened during or after service, only factors (5) to (9) apply (subsections 9(5)-(9) per section 10(2)). Do not mix onset factors for a worsening claim. Conversely, if the varicocoele first appeared during service, only factors (1)-(4) and possibly (9) apply for worsening? Actually, factor (9) applies only to worsening, so if the onset occurred during service, the claim is for initial development, and factor (9) does not help unless there is also a worsening after onset. The interplay is complex; claimants should seek advice.

Finally, ensure that the claim is lodged with all supporting evidence. The Department will apply the SoP as binding. If the claim is refused, the claimant has review rights. Keep records of imaging, specialist reports, and service documents to demonstrate each element. The instrument does not prescribe a specific form of evidence, but the more precise the evidence, the better the chance of satisfying the definitions.