Statement of Principles concerning Kaposi sarcoma (Reasonable Hypothesis) (No. 1 of 2020)

The central concept is the “reasonable hypothesis” standard of proof. Under section 120A of the VEA, for claims relating to operational service, the decision-maker must find that a disease is related to service if a reasonable hypothesis connecting the two is raised, and the contrary is not proved beyond reasonable doubt. This instrument is the Authority’s determination of what constitutes a reasonable hypothesis for Kaposi sarcoma. It does not purport to be a complete medical treatise; rather, it selects specific factors that, based on “sound medical‑scientific evidence”, are considered capable of raising that hypothesis. The Kaposi sarcoma definition in subsection 7(2) is precise: “a multicentric vascular neoplasm arising from endothelial cells and characterised by the proliferation of spindle cells, formation of new blood vessels and inflammation”. It explicitly excludes soft tissue sarcoma. The clinical note about coloured patches, plaques or nodules is illustrative, not exhaustive. The ICD‑10‑AM code C46 is referenced but the meaning is governed by subsection 7(2), not the code. Death from Kaposi sarcoma includes death contributed to by a terminal event such as pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function, as defined in the dictionary. The instrument lists 11 factors in section 9. The first two are infections with human herpesvirus type 8 (HHV‑8) or human immunodeficiency virus (HIV) before clinical onset. These reflect the well‑established aetiology. Factor 3 covers non‑Hodgkin lymphoma or chronic lymphocytic leukaemia/small lymphocytic lymphoma before clinical onset. Factors 4 through 6 require chronic renal failure, an autoimmune disease from the specified list, or diabetes mellitus, each for at least six months before onset. Factor 7 requires lymphoedema at the affected site for at least five years. Factor 8 covers solid organ, stem cell, or bone marrow transplantation without any minimum period. Factor 9 requires treatment with an immunosuppressive drug for a continuous period of at least three months before onset, and if treatment has ceased, onset must occur within ten years of cessation. The term “immunosuppressive drug” is defined as a drug or agent resulting in substantial suppression of immune responses, with non‑exhaustive examples including chemotherapeutic agents, corticosteroids (other than inhaled or topical), anti‑rejection drugs, and tumour necrosis factor‑α inhibitors. Factor 10 mirrors factor 9 but for angiotensin converting enzyme inhibitors. Factor 11, “inability to obtain appropriate clinical management”, is restricted by section 10(2) to cases where Kaposi sarcoma was already contracted before or during service but did not arise out of service; it applies only to material contribution or aggravation. The specified list of autoimmune diseases is closed and includes 14 conditions such as Addison disease, rheumatoid arthritis, systemic lupus erythematosus, and ulcerative colitis. The instrument does not allow extrapolation to other autoimmune diseases even if medically similar. Another key concept is “relationship to service” under section 10. Every factor must be related to the person’s relevant service. This is a higher threshold than mere existence of the factor - the factor itself must have been caused or contributed to by the type of service defined (operational, peacekeeping, hazardous, British nuclear test defence service under VEA, or warlike/non‑warlike under MRCA). The instrument also cross‑references other Statements of Principles under section 11: if a factor refers to an injury or disease for which a separate SoP exists, the factors in that other SoP apply as in force from time to time. This creates an integrated network of standards that must be read together.

The instrument directly affects veterans, members of the Peacekeeping Forces, and members of the Forces under the VEA, as well as members under the MRCA, who have rendered relevant service. Relevant service is exhaustively defined in the dictionary as operational service, peacekeeping service, hazardous service, or British nuclear test defence service under the VEA, and warlike or non‑warlike service under the MRCA. This includes Australian Defence Force personnel deployed on operations, peacekeeping missions, or hazardous duties, and those involved in British nuclear tests. It does not cover peacetime service that is not hazardous or operational under the VEA, nor does it cover civilians (except those who might qualify under other provisions not mentioned). The instrument also affects their dependents who claim death benefits under the VEA or MRCA, because death from Kaposi sarcoma is within scope. Beyond claimants, the instrument binds the Repatriation Commission and the Military Rehabilitation and Compensation Commission as decision‑makers. It is used by delegates in the Department of Veterans’ Affairs and by the Veterans’ Review Board and the Administrative Appeals Tribunal. Medical practitioners providing evidence for claims must be aware of the defined terms - for example, a diagnosis of “chronic renal failure” for factor 4 must meet the strict eGFR and duration criteria, not merely a clinical label. Legal representatives and advocates must be familiar with the closed list of autoimmune diseases and the exclusion of soft tissue sarcoma. The instrument also indirectly affects researchers and epidemiologists who analyse veteran health data, because it influences which claims succeed and thus which conditions appear in compensation statistics. The instrument does not affect serving members who have not yet claimed, but they will be affected if they develop Kaposi sarcoma and later seek compensation. There is no direct effect on employers, insurers, or the general public. The scope of persons affected is relatively narrow - only those with the defined veteran or member status and the specific disease. However, because Kaposi sarcoma is rare in the general population but more common in immunosuppressed individuals, the instrument’s careful delineation of factors means that not every veteran with Kaposi sarcoma will qualify. For instance, a veteran who develops classic (indolent) Kaposi sarcoma without HHV‑8, HIV, or immunosuppression would have no factor under section 9 and therefore cannot succeed under the reasonable hypothesis test. That is a deliberate limitation. The instrument also affects future claims by providing a transparent basis for decision, reducing the need for expert medical opinion on causation in each case, but it also creates a closed evidentiary framework that may exclude novel scientific developments.

The instrument does not impose duties on private persons. It imposes a duty on the decision‑maker to apply the factors strictly when determining whether a reasonable hypothesis has been raised. That duty arises under section 120A of the VEA and section 338 of the MRCA. The decision‑maker must consider each factor in section 9 and determine whether the claimant has demonstrated the existence of at least one factor related to relevant service. The decision‑maker has no discretion to accept a hypothesis based on medical evidence that does not correspond to one of the listed factors, even if that evidence is otherwise cogent. This is a significant constraint on the administrative discretion that would otherwise exist. Conversely, the instrument does not specify any positive duty on claimants to provide evidence; the onus is on the decision‑maker to determine whether the material raises a reasonable hypothesis, but in practice the claimant must adduce enough evidence to point to a factor. The rights of claimants are procedural: they have the right to have their claim assessed against the instrument as the authoritative standard. If a decision‑maker misapplies the instrument - for example, by requiring a five‑year period for lymphoedema when only two years is shown - the claimant has the right to seek review through the Veterans’ Review Board, the Administrative Appeals Tribunal, and ultimately the Federal Court. The instrument also confers a right (though not explicitly) to rely on factor 11, inability to obtain appropriate clinical management. That factor exists only for aggravation of a pre‑existing Kaposi sarcoma, not for initial onset. It is a potential avenue for claimants whose Kaposi sarcoma existed before service but worsened due to service‑related barriers to treatment. The instrument does not create a right to compensation itself; that is governed by the VEA and MRCA. Nor does it create any contractual or property rights. For the Repatriation Medical Authority, the instrument represents an exercise of its statutory duty under section 196B(2) to determine Statements of Principles based on sound medical‑scientific evidence. The Authority has a duty to keep such instruments under review and to repeal or replace them as evidence evolves. The repeal of the 2011 SoP and replacement with this instrument is an exercise of that duty.

This instrument contains no penalty provisions. It is not a regulatory instrument that prohibits or compels conduct; it is a factual standard used in the claims adjudication process. Enforcement of the compensation scheme occurs under the VEA and MRCA themselves, which include provisions for penalties for fraud, false statements, and other misconduct. For example, a person who knowingly makes a false or misleading statement in connection with a claim may be prosecuted under section 213 of the VEA (false statements) or under the Criminal Code. The instrument itself cannot be “breached” by a claimant because claimants are not required to comply with it; it is the decision‑maker who must apply it correctly. If a decision‑maker applies the instrument erroneously, the remedy is not a penalty but an internal review or tribunal appeal. The instrument can be enforced indirectly through judicial review. A claimant whose claim is rejected based on a misinterpretation of the definitions or the factors can seek review, and if the decision is set aside, the effect is that the decision‑maker must re‑determine the claim applying the correct interpretation. There is also the possibility of the Commonwealth Ombudsman investigating systemic misapplication, but that is not unique to this instrument. The instrument’s definitions are drafted with precision precisely to minimise the scope for arguable error. For example, “chronic renal failure” requires a specific eGFR threshold and duration, leaving little room for factual dispute. This reduces the risk of enforcement action against decision‑makers for arbitrary decisions, but it also increases the risk that a claimant with genuine disease fails because the facts do not perfectly fit the definition. The instrument is legally binding as a legislative instrument registered on the Federal Register of Legislation. If a decision‑maker fails to consider the instrument at all, that would be a jurisdictional error. However, no penalty attaches to the decision‑maker personally beyond potential adverse costs orders in tribunal or court proceedings. The instrument’s “enforcement” is thus through the accountability mechanisms of administrative law, not through fines or criminal sanctions.

The instrument is made under subsection 196B(2) of the VEA, which gives the Repatriation Medical Authority power to determine Statements of Principles for the purposes of section 120A of the VEA and section 338 of the MRCA. The instrument explicitly applies to claims under those provisions. It does not affect claims made under other legislation, such as the Safety, Rehabilitation and Compensation Act 1988 (SRCA) (the Comcare scheme) or the Defence Force Retirement and Death Benefits Act 1973. For those schemes, different standards of proof and different medical criteria apply. Within the veterans’ compensation framework, the instrument interacts with the VEA and MRCA as the primary legislation. Section 120A of the VEA requires the decision‑maker to determine whether a reasonable hypothesis is raised in accordance with any relevant Statement of Principles determined by the Authority. That means this instrument has direct statutory force; it is not merely a guideline but a binding instrument. The instrument also interacts with other Statements of Principles via section 11. If a factor refers to an injury or disease for which a separate SoP exists (for example, non‑Hodgkin lymphoma or diabetes mellitus), the factors in that other SoP must be applied as in force from time to time. This creates a cumulative framework: to satisfy factor 3 (non‑Hodgkin lymphoma), the claimant must first satisfy the SoP for non‑Hodgkin lymphoma in relation to service. This can significantly increase the evidentiary burden, because the claimant must prove not only the non‑Hodgkin lymphoma but also that it is service‑related, using a separate set of factors. The instrument also references the ICD‑10‑AM classification (Tenth Edition, effective 1 July 2017) for coding purposes, but the definition of Kaposi sarcoma in subsection 7(2) prevails over the code. This means that even if a medical practitioner assigns a C46 code, the decision‑maker must check that the condition meets the instrument’s definition, including the exclusion of soft tissue sarcoma. The instrument does not interact with state workers’ compensation schemes, private health insurance, or tort law. It does not override professional medical standards or the Therapeutic Goods Administration. Its interaction with other laws is confined to the veterans’ compensation legislation and the network of other SoPs.

The instrument recites that it repeals the Statement of Principles concerning Kaposi’s sarcoma No. 9 of 2011 (Federal Register of Legislation No. F2010L03266). That is the only amendment history disclosed in the source. The 2011 instrument was made under the same subsection 196B(2) and was in force until 26 January 2020. The new instrument commenced on 27 January 2020. The source does not provide a detailed comparison with the 2011 version, but the repeal indicates that the Authority considered the medical‑scientific evidence had changed sufficiently to warrant a new determination. The change in nomenclature from “Kaposi’s sarcoma” (with an apostrophe) to “Kaposi sarcoma” (without) is a minor textual update. The instrument itself has not been amended since its commencement; the source presents the original version. There is no mention of any subsequent amending instruments. Because the instrument is registered on the Federal Register of Legislation, any future amendments would be published as separate amending instruments. The current instrument remains in force unless repealed or replaced. The Authority regularly reviews SoPs based on new research and may issue a new instrument for Kaposi sarcoma in the future. The amendment history is minimal because the instrument is a single static determination. There is no legislative history of parliamentary debate or explanatory memorandum because it is a delegated legislative instrument, not a Bill. The statement of principles is accompanied by a declaration that the Authority is of the view that sound medical‑scientific evidence indicates the relationship, as required by the VEA.

The source itself contains no references to litigation. No cases are cited. However, Statements of Principles are routinely litigated in the Administrative Appeals Tribunal and the Federal Court of Australia. Claimants frequently challenge decisions that reject their claims based on the interpretation of SoPs. For this particular instrument, because it is relatively recent (commenced 2020) and Kaposi sarcoma is uncommon, there may be few reported decisions. The general approach to interpreting SoPs is established in cases such as Repatriation Commission v Gorton (2001) 110 FCR 321, which held that the SoP must be read according to its terms and that the decision‑maker must consider all factors. That case is not cited in the instrument but forms part of the legal background. The litigation risk for this instrument centres on the definitions. For example, a claimant might argue that their particular autoimmune disease, not listed in the specified list, should be accepted because it is medically analogous. The instrument is likely defended on the basis that the list is exhaustive. Another potential litigated issue is the interpretation of “continuous period of at least three months” for immunosuppressive drug treatment (factor 9). Does a gap of a few days break the continuity? The instrument does not define “continuous”, so tribunals may have to decide. The relationship to service under section 10 is also a frequent ground of review: the factor must be related to service, not just exist. Litigation may test whether a condition such as diabetes mellitus (factor 6) can be shown to be service‑related when it is ordinarily a lifestyle disease. Without specific case law on this SoP, the litigation history is effectively the general body of law on SoPs. The instrument’s limited scope means that litigation is likely to be case‑specific and fact‑intensive rather than raising novel legal principles.

Several aspects of the instrument can trip up claimants and even experienced advocates. First, the definition of “Kaposi sarcoma” in subsection 7(2) excludes soft tissue sarcoma entirely. This means that if a biopsy report uses “sarcoma” without further specification, the decision‑maker may classify it as soft tissue sarcoma and reject the claim unless the pathology confirms the spindle cell and endothelial characteristics. Claimants should ensure the diagnostic report explicitly states “Kaposi sarcoma” and references the endothelial origin. Second, the factor for lymphoedema (factor 7) requires involvement at the affected site for at least five years before clinical onset of Kaposi sarcoma. The “affected site” must be the same location where the Kaposi sarcoma lesions appear. A veteran with lymphoedema in one leg who develops lesions on the other leg will not satisfy this factor. Third, the immunosuppressive drug factor (factor 9) has a double condition: treatment for a continuous period of at least three months before onset, and if the treatment has ceased, onset within ten years of cessation. A claimant who took a two‑month course of corticosteroids five years ago and developed Kaposi sarcoma four years later would not meet the continuous period requirement. Also, note the definition of “immunosuppressive drug” excludes inhaled or topical corticosteroids, so steroid inhalers for asthma do not count. Fourth, the specified list of autoimmune diseases is closed and relatively short. It does not include common autoimmune conditions such as Hashimoto’s thyroiditis, Graves’ disease, coeliac disease, or multiple sclerosis. A veteran with multiple sclerosis who develops Kaposi sarcoma cannot use factor 5. Fifth, factor 10 (ACE inhibitor) applies only to angiotensin converting enzyme inhibitors, not to angiotensin receptor blockers (ARBs). A veteran taking an ARB does not qualify. Sixth, factor 11 (inability to obtain appropriate clinical management) is severely limited. It applies only to material contribution or aggravation of Kaposi sarcoma that was already present before or during service but did not arise out of service. It does not allow a claim for initial onset. The claimant must show that inability to obtain management worsened the disease. Seventh, the relationship requirement in section 10(1) means that simply proving the existence of, say, HIV infection (factor 2) is not enough; the claimant must also prove that the HIV infection itself is related to service. For most veterans, HIV infection will not be service‑related unless contracted during service (e.g., from a blood transfusion or occupational exposure). Eighth, the chronic renal failure definition is strict: an eGFR below 15 for three months, or need for renal replacement therapy, or chronic dialysis. A veteran with stage 4 chronic kidney disease (eGFR 15-29) who does not yet need dialysis does not satisfy the factor. Ninth, the instrument applies only to the reasonable hypothesis standard. If a claim is assessed under the reasonable satisfaction standard (e.g., for certain peacetime service), this SoP has no application. Tenth, the cross‑reference to other SoPs under section 11 can create an unexpected cascade. For example, factor 3 requires non‑Hodgkin lymphoma before Kaposi sarcoma. That lymphoma must itself satisfy its own SoP in relation to service, so the veteran may need to prove two separate connections. Finally, the instrument does not provide for a combination of factors to meet a single threshold if no single factor is present. The words “at least one of the following factors” means that a claimant cannot satisfy, say, two half‑factors to reach a hypothesis.

Compliance with this instrument is not a matter of following regulatory requirements but of properly using it in the claims process. For a claimant, the first step is to obtain a confirmed diagnosis of Kaposi sarcoma that meets the definition in subsection 7(2). A pathology report detailing the endothelial origin and spindle cell proliferation is ideal. The diagnosis should be coded C46 in the medical record, but the clinician should also note the exclusion of soft tissue sarcoma. Next, the claimant (or their advocate) must identify which of the 11 factors in section 9 may apply. This requires a thorough medical history, including past infections (HHV‑8, HIV), past diagnoses (non‑Hodgkin lymphoma, chronic lymphocytic leukaemia, autoimmune disease from the list, diabetes mellitus), prior transplants, medication history (immunosuppressive drugs, ACE inhibitors), and a history of lymphoedema. For each potential factor, the specific timing requirements must be satisfied. For factors 4, 5, 6 (chronic renal failure, autoimmune disease, diabetes mellitus), the condition must have existed at least six months before the clinical onset of Kaposi sarcoma. For factor 7, five years of lymphoedema at the affected site is needed. For factors 9 and 10, the drug treatment must have been continuous for at least three months before onset, and if stopped, onset within ten years. For factor 8 (transplantation), no minimum duration is stated, but the transplant must have occurred before onset. For factors 1 and 2 (HHV‑8 and HIV), the infection must be before onset, but no specific period is defined; however, the infection must have been active or documented. The claimant must also gather evidence that the identified factor is related to their relevant service. That evidence might include service records showing deployment to an area with high HIV prevalence, or records of a blood transfusion during military surgery, or evidence that immunosuppressive drugs were prescribed for a service‑related condition. If the factor is an injury or disease covered by another SoP (e.g., non‑Hodgkin lymphoma), the claimant must separately meet the factors of that SoP. The evidence should be submitted with the claim, along with a written submission explaining how the factor satisfies the instrument. For the decision‑maker, compliance means reading the instrument carefully, noting the definitions, and checking that each element of the factor is proven on the material. For example, when a claimant alleges an autoimmune disease, the decision‑maker must check that it appears on the specified list. If a claimant relies on HIV infection, the decision‑maker must confirm that the infection pre‑dates Kaposi sarcoma onset, and also whether the HIV infection is service‑related. The decision‑maker must also apply section 10 correctly, ensuring the factor is not merely present but arises from service. For aggravation claims, section 10(2) limits factor 11 to cases where Kaposi sarcoma preceded service. The instrument also requires the decision‑maker to incorporate other SoPs if a factor refers to an injury or disease covered by one (section 11). The decision‑maker should check the current version of each referenced SoP. Finally, the decision‑maker must record findings on each factor addressed and, if no factor is raised, explain why. Advocates and lawyers should advise clients that the instrument is a precise tool; a tangential medical connection will not suffice. The instrument’s rigidity is both a benefit (predictability) and a danger (exclusion of valid claims that do not fit the template). Regular updates to the instrument may occur, so always check the Federal Register of Legislation for the current version.