Statement of Principles concerning malignant neoplasm of the small intestine (Reasonable Hypothesis) (No. 80 of 2023)

The central concept is a two‑part test that translates medical findings into a legal threshold for claims assessment. First, the instrument defines the disease it covers. "Malignant neoplasm of the small intestine" is defined as a primary malignant neoplasm arising from the epithelial cells of the small intestine (s 7(2)(a)); it excludes soft tissue sarcoma, non‑Hodgkin and Hodgkin lymphoma, and carcinoid tumour (s 7(2)(b)). Although ICD‑10‑AM code C17 is associated with malignant neoplasm of the small intestine, the instrument specifies that the meaning used here is the statutory definition at s 7(2) rather than an automatic reliance on the code (s 7(3)-(4)). The instrument also treats death from the neoplasm as including death from a terminal event or condition that was contributed to by the neoplasm, with "terminal event" given a specific definition in the Schedule (s 7(5); Schedule 1).

Second, the instrument enumerates discrete factors that, singly, are sufficient to raise a reasonable hypothesis that the condition is related to relevant service. At least one of the listed factors in s 9 must exist. The factors are clinical states or procedural histories with specific duration thresholds where applicable: Crohn disease of the small intestine prior to clinical onset (s 9(1)); coeliac disease for at least five years prior to clinical onset (s 9(2)); adenoma of the small intestine prior to clinical onset (s 9(3)); for adenocarcinoma of an ileostomy or ileal pouch only, an ileostomy or ileal pouch for at least two years prior to clinical onset (s 9(4)); being obese for at least ten years prior to clinical onset (s 9(5)); cholecystectomy at least five years prior to clinical onset (s 9(6)); diabetes mellitus for at least five years prior to clinical onset (s 9(7)); and inability to obtain appropriate clinical management for the neoplasm before clinical worsening (s 9(8)).

Third, the instrument overlays the medical list with a service‑connection requirement. Any factor relied on must be related to the person's relevant service (s 10(1)). The instrument also limits the application of the inability to obtain appropriate clinical management factor: that factor applies only to material contribution to, or aggravation of, the disease where the disease was suffered or contracted before or during (but did not arise out of) the relevant service (s 10(2)). Finally, the instrument includes cross‑reference mechanics: if a factor refers to an injury or disease covered by another Statement of Principles, the terms of that other Statement apply as in force from time to time (s 11).

Complementary definitional material appears in Schedule 1. Of particular importance for claims are the BMI threshold for "being obese" (BMI of 30 or greater) and the BMI formula W/H2 where W is weight in kilograms and H is height in metres (Schedule 1 definitions). The Schedule also defines "relevant service" by reference to the categories under the VEA and MRCA, and lists examples of "terminal event" for death‑from‑disease cases.

Directly, the instrument affects persons making claims under the veterans' entitlements and military compensation frameworks. The Statement of Principles applies to claims to which s 120A of the VEA or s 338 of the MRCA applies (s 5). Those claim pathways are for persons asserting that a condition is connected to their relevant service as defined in the Schedule. "Relevant service" is defined to include operational, peacekeeping and hazardous service and British nuclear test defence service under the VEA, and warlike and non‑warlike service under the MRCA (Schedule 1 definitions). Therefore the population affected is veterans and members of Forces with any of those categories of service.

Practitioners preparing or assessing claims are affected because the instrument is an evidentiary and medical benchmark used by the Repatriation Medical Authority and decision‑makers to determine whether a "reasonable hypothesis" exists that links malignant neoplasm of the small intestine (or death from it) with service. The Authority expressly states it has formed the view that there is sound medical‑scientific evidence that indicates such a relationship may exist between the disease and relevant service (s 8). Claimants, their medical providers, advocates and decision‑makers therefore need to assess whether at least one of the s 9 factors is present and connected to relevant service (s 9 and s 10).

Indirectly, the instrument will affect record‑keeping and evidentiary practices. Because the factors include precise temporal thresholds (for example, coeliac disease or diabetes mellitus for at least five years, obesity for at least ten years, ileostomy or ileal pouch for at least two years), claimants will need longitudinal medical records demonstrating onset dates and duration. The BMI definition and calculation in Schedule 1 makes weight and height measurements relevant evidence for the obesity factor. Surgical history (cholecystectomy) and histopathology (adenoma) are also implicated.

Decision‑makers and medical advisors within the Department and the Repatriation Medical Authority will be affected in the sense that they must apply this instrument as the Authority's Statement of Principles for the named condition (s 3). Finally, other Statement of Principles that cover related conditions may be engaged; where a factor in s 9 refers to an injury or disease covered by another Statement, the terms of that other Statement apply (s 11), so administrators and advisers must identify any overlapping Statements when a factor invokes another disease category.

This instrument does not itself create new statutory duties of conduct or criminal offences. Instead it establishes a set of medical criteria that are used within the statutory framework of the VEA and MRCA to assess whether a reasonable hypothesis exists linking malignant neoplasm of the small intestine (including death) with relevant service (s 3, s 8-s 11). The core "duty", in practical terms, is on claimants and their representatives to present evidence that at least one of the factors in s 9 exists and that the factor is related to the person's relevant service (s 9; s 10(1)). The Authority's position is that those factors, singly, are sufficient to raise a reasonable hypothesis; they therefore operate as evidentiary triggers rather than as strict causation rules.

Rights in this context are procedural and remedial under the VEA and MRCA claims regimes. If a claimant demonstrates a factor in s 9 that is related to relevant service, the statutory process for determination of entitlement under the VEA or MRCA is engaged. The instrument also preserves the interplay with other Statements: where a s 9 factor refers to a disease covered by another Statement, the claimant or decision‑maker must apply the other Statement’s factors as in force from time to time (s 11).

Some elements impose specific evidentiary thresholds rather than open or discretionary standards. For example, the durations required for coeliac disease, diabetes mellitus, cholecystectomy and obesity are expressed as fixed time periods before clinical onset (s 9(2), s 9(6), s 9(7), s 9(5)), and ileostomy/ileal pouch requires at least two years before clinical onset for adenocarcinoma of those sites (s 9(4)). These are not expressed as probabilistic scales; they set minimum temporal conditions for the reasonable hypothesis to be raised.

The instrument also circumscribes the application of one factor. The inability to obtain appropriate clinical management factor (s 9(8)) applies only in the specific context of material contribution to, or aggravation of, the disease where the disease was suffered or contracted before or during but did not arise out of relevant service (s 10(2)). That limits the circumstances in which failures of care can be used to found a claim under this Statement.

Finally, the Authority clarifies disease scope and exclusions. Malignant neoplasm of the small intestine is defined as primary epithelial malignancy of the small intestine, excluding soft tissue sarcoma, lymphomas and carcinoid tumour (s 7(2)). That definitional specificity is a limiting right for claimants: cancers excluded by s 7(2)(b) are outside this Statement and will need to be considered under other Statements or technical routes.

The instrument itself does not create criminal sanctions, fines, or administrative penalties. It is a Statement of Principles made under subsection 196B(2) of the VEA (s 3) and operates as the Repatriation Medical Authority’s view of medical‑scientific evidence for claims assessment. Enforcement in the usual sense is carried out through the VEA and MRCA statutory decision processes to which this Statement applies (s 5). The instrument therefore functions as a component of the decision‑making architecture rather than as a standalone sanctions instrument.

Practical enforcement consequences arise because the presence or absence of the listed factors will materially affect entitlement determinations under the VEA and MRCA claims frameworks. If a claimant cannot establish that at least one of the s 9 factors exists and is related to their relevant service, the reasonable hypothesis threshold will not be met on the basis of this Statement. Conversely, if a factor is established and linked to relevant service, the claims process will proceed on that evidentiary footing. The instrument gives clear temporal thresholds and definitional exclusions that decision‑makers can apply; that increases predictability in adjudication but does not substitute for the statutory decision‑making powers and procedures in the VEA and MRCA themselves.

The instrument references ICD‑10‑AM coding (s 7(3)-(4)) but states that the statutory meaning is the meaning given in s 7(2); reliance on diagnostic codes alone is not determinative. Administrative enforcement therefore rests on medical evidence rather than code assignment alone.

No enforcement body, penalty regime, appeal mechanism or judicial process is created by this instrument; such processes will be those available under the VEA and MRCA and related administrative law. The instrument simply supplies the Authority's medical criteria that decision‑makers are to use in raising a reasonable hypothesis.

The instrument is expressly made under subsection 196B(2) of the VEA (s 3) and applies to claims under s 120A of the VEA or s 338 of the MRCA (s 5). It therefore operates within, and as part of, the VEA and MRCA statutory frameworks. The Schedule defines "relevant service" by reference to categories in the VEA and MRCA (Schedule 1 definitions), and the instrument’s application is limited to claims that fall within those statutory pathways (s 5).

The instrument engages with the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Australian Modification (ICD‑10‑AM) for coding but not to supplant the statutory definition: while malignant neoplasm of the small intestine may attract ICD‑10‑AM code C17, the instrument specifies that its meaning is the one given in s 7(2), and it expressly cites the ICD‑10‑AM edition and effective date it refers to (s 7(3)-(4)). This clarifies that diagnostic coding is a reference tool rather than the defining legal criterion.

Cross‑Statement interaction is governed by s 11. If a s 9 factor refers to an injury or disease covered by another Statement of Principles made under s 196B(2) of the VEA, then the factors in that other Statement apply in accordance with their terms as in force from time to time. That means decision‑makers must identify when a listed factor invokes another Statement and then apply that other Statement, which may have its own thresholds, definitions and temporal requirements. The instrument therefore sits in a network of Statements and requires administrators to consider other Statements where factors overlap.

The instrument does not explicitly reference other areas of law such as tort, workers compensation, public health statutes, or coronial law; but because the instrument governs the medical evidentiary threshold for claims under the VEA and MRCA, it will interact operationally with administrative law procedures, statutory entitlement rules and any judicial review avenues applicable to decisions under those Acts. Those procedural and substantive interactions are governed by the VEA and MRCA rather than by this instrument alone.

This Statement of Principles is identified as No. 80 of 2023 in its title and is dated 25 August 2023 (instrument heading). It commences on 26 September 2023 (s 2). The instrument expressly repeals the earlier Statement of Principles concerning malignant neoplasm of the small intestine No. 1 of 2015, which was registered on the Federal Register of Legislation as F2014L01807 and made under subsection 196B(2) of the VEA (s 4). That is the only repeal or replacement recorded within this instrument.

No further amendments, schedules of transitional arrangements or savings provisions are contained in the text provided. The instrument does provide that factors in other Statements of Principles apply "as in force from time to time" where s 9 factors refer to other injuries or diseases (s 11). That language contemplates future amendments to other Statements and preserves their current and future content for cross‑application; it also means that the effective body of rules that interact with this Statement can change as other Statements are amended.

The instrument does not itself set an amendment mechanism or specify review dates. As a statutory Statement of Principles made under s 196B(2) of the VEA, any amendment, repeal or replacement of this instrument would need to follow the making provisions and processes under that subsection and the VEA. The instrument does not list prior amendments to itself because it is a replacement instrument that repealed the No. 1 of 2015 Statement on commencement.

The text of the instrument contains no record of litigation history. It does not cite cases and does not include judicial determinations or examples of prior decisions applying the Statement of Principles. The instrument is a standalone Statement of Principles; any litigation concerning its application, interpretation or the conduct of decision‑makers under the VEA or MRCA would be recorded in external judicial or tribunal records, which are not contained in this instrument.

For claims practitioners, the absence of litigation references in the instrument means that one must look to administrative decisions, tribunal determinations and court judgments under the VEA and MRCA case law for precedential treatment of similar Statements, but those sources are outside the four corners of this instrument. Within the instrument itself, the Repatriation Medical Authority records only its view that there is sound medical‑scientific evidence indicating a link between malignant neoplasm of the small intestine and relevant service (s 8); it does not summarise or cite that evidence in the instrument text.

The instrument contains several technical features and definitional limits that can produce unexpected outcomes if overlooked.

• Exclusions in the disease definition. The Statement covers primary epithelial malignancies of the small intestine (s 7(2)(a)) and expressly excludes soft tissue sarcoma, non‑Hodgkin lymphoma and Hodgkin lymphoma, and carcinoid tumour (s 7(2)(b)). A claimant whose tumour is classified as one of these excluded histologies will not fall within this Statement and must look elsewhere for a Statement of Principles that covers that histology.

• ICD‑10‑AM code is not determinative. Although malignant neoplasm of the small intestine "attracts" ICD‑10‑AM code C17, the instrument makes clear that the statutory meaning is set by s 7(2) and not by code assignment alone (s 7(3)-(4)). Reliance exclusively on diagnostic coding without recourse to histopathology and the statutory definition may therefore be insufficient.

• Temporal thresholds are precise. Many factors require specific minimum durations before clinical onset: coeliac disease, diabetes mellitus and cholecystectomy require five years (s 9(2), s 9(6), s 9(7)); obesity requires ten years (s 9(5)); ileostomy or ileal pouch requires two years for ileostomy/ileal pouch adenocarcinoma (s 9(4)). The instrument uses the phrase "before the clinical onset of malignant neoplasm of the small intestine" for these durations. Accurately establishing the date of clinical onset is therefore critical, and differing interpretations of onset date may materially affect whether a factor meets the stated threshold.

• Definitions may create evidentiary traps. "Being obese" is defined as a BMI of 30 or greater and BMI is defined by the formula W/H2 (Schedule 1). The instrument therefore requires evidence of weight and height over time if obesity for a period is relied upon. Absence of recorded weights or heights for earlier periods may make it difficult to satisfy the ten‑year duration element.

• Ambiguity in "inability to obtain appropriate clinical management". Factor s 9(8) uses the phrase "inability to obtain appropriate clinical management for malignant neoplasm of the small intestine before the clinical worsening" without a definition of "appropriate" or how access is measured. Additionally, s 10(2) limits this factor to material contribution to, or aggravation of, the disease where the disease was suffered or contracted before or during but did not arise out of relevant service. That interlocking limitation creates potential interpretive difficulties for evidence establishing both the timing and the causal weight of lack of management.

• Relationship to service is required for every factor. Even where a claimant can demonstrate a s 9 factor, subsection 10(1) requires that the factor "must be related to the relevant service rendered by the person." The instrument does not specify how the relationship is to be demonstrated or assessed; that assessment therefore rests on the decision‑making framework and medical evidence used under the VEA/MRCA processes.

• Cross‑Statement dependencies. If a s 9 factor refers to an injury or disease covered by another Statement, practitioners must locate and apply that other Statement as it is "in force from time to time" (s 11). Failure to identify and apply linked Statements correctly will affect the claim assessment.

• Terminal event construct for death claims. For death‑from‑disease claims, s 7(5) includes death from a terminal event or condition that was contributed to by the neoplasm. "Terminal event" is defined in Schedule 1 and includes causes such as pneumonia, respiratory failure and cardiac arrest. Establishing that a terminal event was contributed to by the malignant neoplasm will require medical evidence tying the proximate or ultimate cause of death to the neoplasm rather than to an unrelated terminal event.

• Narrow histological scope. The statutory definition targets primary epithelial neoplasms. Secondary metastatic tumours involving the small intestine or tumours arising from non‑epithelial tissues may not be covered by the Statement.

These notches in the instrument mean that claimants and advisers must translate clinical records carefully into the statutory language and must be attentive to onset dates, durations and histopathological classification. Ambiguities such as "appropriate clinical management" and the need to show that a factor is "related to" relevant service generate implementation risk and may increase dispute over factual findings.

Compliance, in practice, means assembling and presenting the medical and service evidence necessary to establish that at least one of the s 9 factors existed and that the factor is related to the claimant’s relevant service (s 9; s 10(1)). The instrument provides specific guidance about the form and substance of evidence that will be relevant; below are concrete steps mapped to the instrument’s requirements, based solely on the instrument’s text.

1. Confirm the disease and histology. Ensure the tumour is a primary epithelial malignant neoplasm of the small intestine as defined in s 7(2)(a) and not an excluded histology listed in s 7(2)(b). Histopathology reports that record cell type and tumour origin are the primary documents to show whether the statutory definition is met. Remember the instrument treats the statutory definition as controlling even where ICD‑10‑AM coding is present (s 7(3)-(4)).

2. Establish the date of clinical onset. Most s 9 factors require duration thresholds "before the clinical onset of malignant neoplasm of the small intestine" (s 9). Obtain medical records that show the date when clinical signs, symptoms, imaging or histopathology first established the clinical onset. Where onset is contested, contemporaneous notes, imaging dates and pathology reporting are the core evidence.

3. Produce evidence for the asserted s 9 factor with the required duration. For each listed factor:

   • Crohn disease (s 9(1)): provide diagnostic records showing Crohn disease of the small intestine and that it predated the clinical onset of the neoplasm.

   • Coeliac disease (s 9(2)): provide diagnostic records that show a diagnosis of coeliac disease and evidence that it persisted for at least five years before clinical onset.

   • Adenoma (s 9(3)): provide histopathology and clinical notes documenting an adenoma of the small intestine prior to clinical onset.

   • Ileostomy/ileal pouch adenocarcinoma (s 9(4)): for adenocarcinoma arising in an ileostomy or ileal pouch, provide records showing an ileostomy or ileal pouch in place for at least two years before clinical onset.

   • Obesity (s 9(5) and Schedule 1): provide weight and height records sufficient to calculate BMI over time. "Being obese" is BMI of 30 or greater and BMI is defined as W/H2 where W is weight in kilograms and H is height in metres (Schedule 1 definitions). To meet the ten‑year requirement, evidence of sustained BMI at or above 30 for the relevant period is necessary.

   • Cholecystectomy (s 9(6)): provide surgical records documenting cholecystectomy and the date, and show that the operation occurred at least five years before clinical onset.

   • Diabetes mellitus (s 9(7)): provide diagnostic and management records demonstrating diabetes diagnosis and that it existed for at least five years before clinical onset.

   • Inability to obtain appropriate clinical management (s 9(8)): document attempts to obtain care, referrals, hospital or outpatient attendance data, waiting lists, refusal records, or other objective evidence demonstrating inability to obtain clinical management prior to clinical worsening. Note the instrument limits this factor under s 10(2) to cases where the disease was suffered or contracted before or during but did not arise out of relevant service.

4. Demonstrate the relationship to relevant service. For any factor relied upon, provide service records, deployment histories, medical records contemporaneous with service and expert evidence connecting the factor to the nature, timing or conditions of relevant service as defined in Schedule 1 (operational, peacekeeping, hazardous, British nuclear test defence service under the VEA or warlike/non‑warlike service under the MRCA). The instrument requires that the factor be related to relevant service (s 10(1)); how that relationship is established will rely on medical evidence aligned to the service record.

5. Address cross‑Statement issues. If a s 9 factor refers to a disease covered by another Statement of Principles, obtain and follow the relevant Statement in force (s 11). That may require assembling evidence specified in the other Statement.

6. For death claims, link terminal events to the neoplasm. If claiming death from malignant neoplasm of the small intestine, assemble the clinical course, cause of death certificate, contemporaneous hospital records and any autopsy or pathology reports that show the terminal event or condition (as defined in Schedule 1) was contributed to by the neoplasm (s 7(5); Schedule 1).

7. Be precise about histology and site. The instrument is limited to primary epithelial malignancies of the small intestine extending from the lower border of the pyloric sphincter up to the ileocaecal junction, including duodenum, jejunum and ileum (note to s 7(2)). Confirm tumour site in records and imaging.

8. Prepare for disputed onset dates and ambiguous terms. Because the instrument uses phrases such as "clinical onset," "clinical worsening" and "appropriate clinical management" without further definition, assemble objective documentary evidence and consider engaging medical experts who can opine within the statutory language.

9. Record‑keeping for BMI and longitudinal conditions. For obesity and other chronic conditions with duration thresholds, historical clinical records are essential. Where older records are sparse, consider obtaining corroborative evidence such as regular general practice notes, hospital records, fitness or workplace health assessments.

10. Keep an eye on dates of the instrument. This Statement commences on 26 September 2023 and replaced the 2015 Statement (s 2, s 4). For claims spanning the repeal and commencement dates, consider whether the new Statement or the prior Statement applies, and document the dates of diagnosis and claim lodgement to determine which instrument governs.

Following the instrument’s explicit criteria and thresholds is the operative way to ensure the Claim is presented in the terms the Repatriation Medical Authority has set out. Evidence that maps clearly onto the statutory language in s 7, s 9, s 10 and the Schedule will allow decision‑makers to apply the Authority’s Statement without recourse to extraneous interpretation.