Statement of Principles concerning Paget disease of bone (Balance of Probabilities) (No. 63 of 2023)

The instrument relies on a small set of legal and clinical concepts that control its application. Each concept is defined or described in the instrument itself and governs how decision‑makers and claimants are to treat Paget disease of bone claims.

Paget disease of bone, as used in the SoP, is a clinical concept. Subsection 7(2) describes it as a focal disease of bone at single or multiple sites, with repeated episodes of accelerated bone resorption followed by disorganised new bone formation resulting in bone of impaired integrity and structure. The instrument adds a clinical note about typical manifestations such as bone pain, enlargement, deformity or bowing, and common anatomical sites including skull, spine, pelvis and long bones of the lower extremity (s 7(2) and note). The instrument acknowledges that Paget disease of bone attracts the ICD‑10‑AM code M88 but stresses that, for the SoP, the meaning given in subsection 7(2) controls (s 7(3)-(4)).

Death from Paget disease of bone is included where death is from a terminal event or condition contributed to by the person’s Paget disease of bone (s 7(5)). The Schedule defines terminal event by reference to proximate or ultimate causes and gives examples: pneumonia, respiratory failure, cardiac arrest, circulatory failure, and cessation of brain function (Schedule 1 terminal event). This sets a causal link requirement for death benefits: death must be from a terminal event or condition to which Paget disease contributed.

Relevance of service is a central legal concept. The Schedule defines relevant service narrowly as three categories: (a) eligible war service (other than operational service) under the VEA; (b) defence service (other than hazardous service and British nuclear test defence service) under the VEA; or (c) peacetime service under the MRCA (Schedule 1 relevant service). That definition determines which kinds of service contexts the SoP addresses.

Evidentiary standard and the RMA’s posture are explicit. Section 8 states the RMA’s view, on the sound medical‑scientific evidence available, that it is more probable than not that Paget disease of bone and death from it can be related to relevant service. The title of the instrument makes the standard explicit: it is prepared on the balance of probabilities.

The single factor that must exist is defined in section 9(1): inability to obtain appropriate clinical management for Paget disease of bone before the clinical worsening of Paget disease of bone. Section 10 further constrains how that factor operates: it must be related to the person’s relevant service (s 10(1)), and it applies only to material contribution to, or aggravation of, disease where the disease was suffered or contracted before or during, but did not arise out of, the relevant service (s 10(2)).

Interaction with other Statements of Principles is handled by section 11. If a factor in this SoP refers to an injury or disease covered by another SoP made under s 196B(3) VEA, then the factors in that other SoP apply according to its terms. This creates a mechanism for cross‑reference and compound causation where multiple conditions or injuries are implicated.

In sum, the main operational concepts are (i) the clinical definition of Paget disease of bone and its ICD‑10‑AM reference (s 7), (ii) the terminal event definition for death causation (Schedule 1), (iii) the limited evidentiary pathway for connection to service via inability to obtain appropriate clinical management (s 9), (iv) the requirement that any factor be related to relevant service as defined in the Schedule (s 10; Schedule 1), and (v) the cross‑SoP application rule (s 11). Each of these concepts drives which claims can succeed and how decision‑makers should characterise medical evidence.

Directly, this SoP affects claimants seeking to establish that Paget disease of bone or death from Paget disease of bone is connected with their relevant service in proceedings where section 120B of the Veterans' Entitlements Act 1986 or section 339 of the Military Rehabilitation and Compensation Act 2004 apply (s 5). Those persons include veterans and members of the Forces whose claims fall within the VEA or MRCA claim provisions cited. The Schedule defines the relevant categories of service that qualify for the SoP: eligible war service other than operational service, defence service other than hazardous service and British nuclear test defence service, and peacetime service under the MRCA (Schedule 1 relevant service). That means only claims arising from the types of service listed in the Schedule fall within this SoP’s direct ambit.

Administratively, the instrument binds or guides decision‑makers who adjudicate claims under the cited statutory provisions. The Repatriation Medical Authority is the maker of the SoP under s 196B(3) (s 3), and the document sets the RMA’s medical‑scientific findings that decision‑makers are to take into account when establishing service connection on a balance of probabilities (s 8). The instrument therefore shapes the evidentiary and causal framework used by those adjudicators.

Medical practitioners and record custodians are also affected in practice. The sole qualifying factor for nexus is an inability to obtain appropriate clinical management prior to clinical worsening (s 9(1)). Establishing that factor will normally require contemporaneous clinical records, evidence of attempts to obtain care, or expert medical opinion documenting the clinical history and timing of worsening. While the instrument does not prescribe the documents or procedures, the operation of the factor means that medical records, appointment logs, referrals, and administrative records will be material.

The SoP also affects persons whose death is claimed to be contributed to by Paget disease of bone. The definition of death from Paget disease covers death from a terminal event or condition contributed to by the person’s Paget disease (s 7(5)), and the Schedule lists examples of terminal events. This affects survivors and estate matters where causation of death is relevant to entitlements.

Finally, the repeal of the earlier 2015 SoP (s 4) affects persons and decision processes that were using the previous instrument. Claims and assessments made after commencement will be governed by the new SoP; decision‑makers must apply it to relevant claims from 25 July 2023 onward (s 2; s 4). The instrument does not expressly state transitional arrangements; however the repeal clause and commencement date make clear the temporal point at which the new SoP takes effect.

The instrument itself does not create statutory duties or criminal sanctions. It establishes the medical‑scientific framework that must be used when determining whether Paget disease of bone or death from it is connected with relevant service for claims under s 120B VEA or s 339 MRCA (s 5; s 8). From that framework certain practical duties and rights for claimants and decision‑makers follow.

Duties of decision‑makers and evidence handlers

• Apply the SoP’s definition of Paget disease of bone as the relevant clinical meaning in subsection 7(2) rather than relying solely on an ICD‑10‑AM code (s 7(2)-(4)). The SoP instructs that while the disease attracts ICD‑10‑AM code M88, the legal meaning is the clinical definition provided.
• Require, and act on, proof that at least one of the factors in section 9 exists before concluding, on the balance of probabilities, that Paget disease of bone or death from it is connected to service (s 9). The instrument constrains causation to the enumerated factors.
• Where a factor in this SoP refers to another injury or disease covered by a separate SoP made under s 196B(3), apply the factors in that other SoP according to its terms (s 11). This imposes an obligation to reference other SoPs where applicable.

Duties of claimants

• Establish, on the balance of probabilities, that the specified factor exists and that it is related to their relevant service (s 9; s 10(1)). The SoP is framed around the evidentiary standard and requires claimants to show the nexus facts to the requisite civil standard.
• For cases relying on section 9(1), show inability to obtain appropriate clinical management occurred before clinical worsening of Paget disease of bone and that the inability is related to relevant service as defined (s 9(1); s 10(1)-(2)).

Rights or entitlements affected

• The SoP governs the medical‑scientific basis upon which rights under the VEA and MRCA are adjudicated for the specified claims (s 5; s 8). If a claimant establishes the required factor and relevant service relationship on the balance of probabilities, that will be the medical basis for concluding a connection for the purposes of the statutory provisions referenced (the SoP itself is the instrument used in establishing medical causation).
• The inclusion of death contributed to by Paget disease as within the SoP’s scope (s 7(5)) means survivors or estates can rely on this SoP as part of a death‑benefit claim framework where the required causal relationship is established.

Burden and standard of proof

• The instrument frames causation in terms of the balance of probabilities; it repeatedly uses the phrase “on the balance of probabilities” and the title notes “(Balance of Probabilities)”. Section 8 records the RMA’s view that, on the sound medical‑scientific evidence available, it is more probable than not that Paget disease of bone and death from it can be related to relevant service. The practical effect is that claimants bear the task of persuading decision‑makers that, more likely than not, the listed factor existed and was related to service.

Limitations and constraints

• Section 10(2) narrows the application of the factor in subsection 9(1) to situations where the disease pre‑dated or was present during service but did not arise out of it, and the factor can material contribute to or aggravate the condition. This constrains how duties to consider aggravation or material contribution arise and limits the universe of claimants who can rely on that factor.

The instrument therefore functions as a rulebook for allocating evidentiary burdens in determinations of service connection for Paget disease of bone in the VEA/MRCA claim streams, rather than imposing operational duties such as treatment provision or monetary penalties.

The Statement of Principles does not create criminal offences or civil penalties in its text, and it does not itself prescribe mechanisms of coercive enforcement. The instrument’s form and content indicate that its enforcement is administrative and evidentiary: it prescribes the medical‑scientific criteria decision‑makers must use when deciding claims that fall under section 120B of the VEA or section 339 of the MRCA (s 5; s 8). Enforcement therefore occurs within the claim adjudication processes established by the VEA and MRCA, rather than by the SoP itself.

Enforcement mechanics, as deriveable from the instrument, are these:

• Adjudicators must apply the SoP’s definitions and factors when assessing causation on the balance of probabilities for relevant claims (s 7; s 9; s 8). The SoP supplies the medical basis for causal conclusions that feed into statutory determinations under the VEA and the MRCA.
• The SoP imposes no fine, sanction, or disciplinary penalty for non‑compliance on claimants or medical practitioners. Non‑compliance or failure to meet the SoP’s requirements simply means the claimant will not have succeeded in proving the required factor to establish connection with relevant service. The instrument does not provide for remedial payments or penalties; such consequences, if any, follow from the underlying Acts and their administrative procedures rather than from the SoP text.
• The repeal of the prior SoP (s 4) is enforced by the commencement clause (s 2). From the commencement date, the earlier instrument is of no legal effect. The SoP does not articulate transitional enforcement rules; it simply replaces the earlier instrument.

Because the instrument deals exclusively with evidentiary guidance and does not set out enforcement systems, any coercive measures or remedies are those provided in the VEA and MRCA. The SoP’s role in enforcement is therefore indirect: it informs whether a claimant’s evidence satisfies the medical‑scientific nexus required for entitlement decisions, and adjudicators will apply that assessment within the statutory decision‑making framework prescribed by the Acts cited at s 5.

Practical enforcement implications follow. Decision‑makers will need to form a view whether a claimant has established the inability to obtain appropriate clinical management before clinical worsening (s 9(1)); where a factor references another SoP, decision‑makers must apply that other SoP’s factors in accordance with their terms (s 11). The instrument therefore channels medical causation enquiries and narrows the range of medical fact patterns that will be treated as connecting Paget disease to relevant service.

The instrument situates itself within the statutory architecture of veterans’ entitlements and military compensation. It is made under subsection 196B(3) of the Veterans' Entitlements Act 1986 (s 3). It explicitly applies to claims to which section 120B of the VEA or section 339 of the Military Rehabilitation and Compensation Act 2004 apply (s 5). The SoP therefore functions as a statutory instrument that provides the medical‑scientific basis for causal determinations within those claim streams.

Key interactions with other legal instruments and references in the SoP are:

• The Veterans' Entitlements Act 1986: the SoP is an instrument made under s 196B(3) of the VEA (s 3). The VEA thus provides the enabling power. The SoP is intended to be used in claims processes created by the VEA, specifically section 120B claims as identified (s 5).
• The Military Rehabilitation and Compensation Act 2004: the SoP applies to claims under s 339 of the MRCA (s 5). It therefore interacts directly with MRCA claim adjudication procedures to the extent they invoke the SoP for medical causation findings.
• Other Statements of Principles: section 11 establishes a direct mechanism of interaction. If a factor in this SoP refers to an injury or disease that is covered by another SoP determined under the same subsection 196B(3) of the VEA, then the factors in that other SoP apply according to its terms (s 11). This produces layered legal interaction where complex causation involving multiple conditions requires adjudicators to consult and apply the relevant SoPs together.
• ICD‑10‑AM coding and diagnostic classification: the instrument references the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Australian Modification (ICD‑10‑AM), Tenth Edition, as the source of the code M88 that is associated with Paget disease of bone (s 7(3)-(4)). The instrument clarifies that the statutory meaning for the SoP is the clinical definition in subsection 7(2), with the ICD reference provided for indexing and classification. Thus, the SoP interacts with diagnostic coding regimes only as a cross‑reference while reserving the legal definition to the text.
• Repeal and replacement of prior instruments: the SoP repeals the earlier No. 50 of 2015 instrument (s 4). Where prior determinations were made using the old SoP, decision‑makers will need to apply the new SoP from its commencement unless other statutory transitional provisions apply in the VEA or MRCA (the instrument itself contains no transitional clauses).
• Definitions and statutory categories: the Schedule defines MRCA and VEA, relevant service and terminal event. These definitions determine the overlap and exclusions in coverage and thus interact with the way relevant service categories in the underlying Acts are interpreted for SoP purposes (Schedule 1).

Absent from the instrument are references to other statutory remedies, judicial review procedures, or administrative appeal rights. The SoP does not itself set out how it is to be considered in appeals or outlines review pathways under administrative law. Those procedural interactions will be governed by the procedural provisions of the VEA and MRCA and general administrative law, but the SoP supplies the substantive medical criteria these processes will use.

In effect, the SoP is a medical‑scientific layer slotted into the decision‑making architecture of the VEA and MRCA, cross‑referencing other SoPs and diagnostic classification systems where relevant, and replacing a prior comparable instrument.

The instrument contains concise information relevant to its own origin and immediate amendment history. The SoP is identified as No. 63 of 2023 and is dated 23 June 2023 (cover page). It commences on 25 July 2023 (s 2). The instrument expressly repeals the earlier Statement of Principles concerning Paget's disease of bone No. 50 of 2015, Federal Register number F2015L00256, which was also made under subsection 196B(3) of the VEA (s 4). The repeal clause therefore records a single direct amendment event in the SoP series for this disease: replacement of the 2015 instrument with the 2023 instrument.

There is no additional amendment history contained in the instrument text beyond the repeal of No. 50 of 2015 and the dates given. The document’s header shows the Repatriation Medical Authority affixed its common seal at the direction of Professor Terence Campbell AM, Chairperson, which is the formal attestation of the instrument (cover page). No subsequent amending instrument, amendment clause, or transitional provision is included in the text.

For practitioners tracking the evolution of medical criteria in veterans’ claims, the immediate concrete points in the instrument’s amendment history are:

• Old SoP removal: Statement No. 50 of 2015 is repealed as of the commencement date (s 4; s 2). This means that after 25 July 2023 adjudicators and claimants are to use the No. 63 of 2023 SoP.
• New SoP enactment date and authority: the SoP is issued under the VEA power at subsection 196B(3), signed 23 June 2023, effective 25 July 2023 (cover page; s 2; s 3).

No other amendments, revision logs, or prior amendments to No. 50 of 2015 are contained in the text. If record of earlier amendments, consultation, or reasons for change is required, the instrument does not include them; external materials such as explanatory memoranda or RMA consultation records are not part of the operative text provided here.

The instrument contains no litigation history, case references, or references to judicial determinations. There are no judicial decisions, appeals, review proceedings, or administrative law challenges recorded in the SoP text. The SoP does not refer to any cases, decisions, or legal proceedings in its text or Schedule.

Because the SoP is a determinative medical‑scientific instrument designed for use in statutory adjudication under the VEA and MRCA, any litigation that might arise would appear in the external record of administrative appeals or judicial proceedings rather than within the instrument itself. The instrument does not supply a record of such litigation, nor does it identify precedent or prior case law guiding its medical‑scientific conclusions.

For users seeking litigation context, the immediate facts in the instrument are:

• No cases are named, cited, or referenced in the SoP.
• The instrument does not purport to summarise prior judicial interpretation of similar SoPs or to rely on court decisions to justify its factors.
• The SoP’s legal foundation is the statutory power under subsection 196B(3) of the VEA; the text does not reference any legal challenge to the use of that power.

Practically, the absence of litigation history in the instrument means that authoritative guidance on how courts have treated this SoP’s tests, or how tribunals have applied similar SoPs in contentious appeals, must be sought outside the instrument. The SoP itself simply records the RMA’s medical‑scientific determinations and the factors to be applied administratively.

Applying this SoP in claims processes raises several concrete practical traps and interpretation risks that appear from the instrument’s text. These are mechanics and evidentiary points that can materially affect claim outcomes.

Narrowness of the enumerated factor

• The SoP identifies only one primary factor that must exist to establish connection on the balance of probabilities: inability to obtain appropriate clinical management for Paget disease of bone before clinical worsening (s 9(1)). There is no broader list of risk exposures, environmental triggers, or occupational factors; the statutory pathway to connection is narrow. Claimants looking to establish nexus on other grounds will not find those grounds in this SoP.

Temporal and causal limitation

• Section 10(2) narrows application further. The factor in s 9(1) applies only to material contribution to, or aggravation of, Paget disease where the disease was suffered or contracted before or during, but did not arise out of, the person’s relevant service. In plain terms, the inability to obtain clinical management may support a claim of aggravation or material contribution only where Paget disease pre‑exists or is present during service and is not itself caused by service. If the disease is alleged to have arisen out of service, s 9(1) and its described factor are not, on the face of the text, the operative pathway. Claimants whose disease began after service in a way claimed to arise out of service may face a different evidentiary posture than claimants alleging exacerbation of a pre‑existing condition.

Undefined phrase: “appropriate clinical management”

• The SoP does not define what constitutes “appropriate clinical management.” This is a practical gap. Decision‑makers will need to interpret what level, timeliness, and standard of care the phrase implies in the claimant’s clinical context. The absence of a statutory definition creates an interpretive discretion for adjudicators and potential disputes about whether the care available was “appropriate” in the circumstances and whether attempts to obtain it were adequate.

Proof of “inability to obtain”

• The qualifying factor requires inability to obtain appropriate clinical management prior to clinical worsening. That requires positive evidence not only of clinical worsening but also of attempts to access care and barriers to obtaining it. The SoP does not prescribe what documentary or testimonial proof suffices. Consequently, claimants will typically need contemporaneous administrative, appointment, referral, correspondence, or other records showing efforts to obtain treatment and the nature of the obstacles encountered. Where such records are absent, the narrow factor may be difficult to prove.

Interaction with other SoPs

• Section 11 requires applying factors in another SoP where a factor in this SoP refers to an injury or disease covered by that other SoP. In practice, that creates potential complexity for claims implicating multiple conditions,for example, where the inability to obtain care arises from or leads to another injury or disease. Practitioners must check the terms of any cross‑referenced SoP and reconcile the requirements of both instruments. The SoP’s cross‑reference rule may cause evidentiary layering that increases claimant burden.

Relevance of service categories

• The Schedule’s definition of relevant service excludes certain service categories by qualification: eligible war service other than operational service, defence service other than hazardous service and British nuclear test defence service, and peacetime service under the MRCA (Schedule 1 relevant service). The precise qualification language may be a trap for claims that involve operational, hazardous, or British nuclear test service. Those service categories, if present, fall outside the SoP’s expressed definition of relevant service and therefore outside the SoP’s direct application.

ICD code is not determinative

• Subsections 7(3)-(4) state that although Paget disease attracts ICD‑10‑AM code M88, the statutory meaning for the SoP is the clinical description in 7(2). Relying solely on an ICD code in medical records without demonstrating the clinical features set out in 7(2) could be inadequate for establishing that the condition claimed is the disease as defined in the SoP.

Death causation and terminal event scope

• Death is included only where a terminal event or condition was contributed to by Paget disease of bone (s 7(5)). The Schedule lists examples of terminal events, but those examples are illustrative. Establishing that Paget disease contributed to the terminal event will require medical evidence linking the disease to the proximate or ultimate cause of death. Practitioners should note that the listed terminal events are specific categories that adjudicators will look for when considering death claims.

No transitional provisions included

• The instrument repeals the 2015 SoP (s 4) without setting out transitional provisions. Claims spanning the repeal and commencement dates will require careful treatment to determine which instrument controls; the text itself provides only the repeal and commencement dates.

Balance of probabilities standard

• The instrument’s repeated emphasis on the balance of probabilities means that claimants must tip the scales in a civil standard. The SoP does not alter the substantive standard but defines the factual elements a claimant must establish to meet that standard with respect to Paget disease.

These are interpretive and practical “gotchas” inherent in the instrument’s text. They create evidentiary pressure points and areas of adjudicative discretion that practitioners should anticipate and address when preparing claims or reviewing administrative decisions under the VEA and MRCA.

Compliance in the context of this SoP means assembling and presenting evidence so that a decision‑maker applying the SoP can conclude, on the balance of probabilities, that at least one of the factors in section 9 exists and that it is related to the claimant’s relevant service as defined.

For claimants and their advisers

• Establish clinical diagnosis as defined by the SoP: ensure medical records demonstrate the clinical features of Paget disease of bone as set out in subsection 7(2), not merely an ICD code entry. The SoP explicitly adopts the description in 7(2) as the operative meaning (s 7(2)-(4)). Records should document bone resorption and disorganised new bone formation, and where possible note classical manifestations such as bone pain, enlargement, deformity and typical anatomical sites.
• Prove the factor in s 9(1): assemble contemporaneous documentary evidence that demonstrates inability to obtain appropriate clinical management before a documented clinical worsening of Paget disease. Evidence may include correspondence with health providers, appointment records, referral refusals, treatment availability statements, waitlists, or other administrative records showing unavailability or denial of clinically appropriate services. Medical experts should link the absence of appropriate management to the subsequent clinical worsening.
• Demonstrate timing relative to service: show that the inability to obtain appropriate clinical management is related to relevant service as defined in the Schedule (Schedule 1 relevant service; s 10(1)). For claims relying on s 9(1), also show that the disease was suffered or contracted before or during, but did not arise out of, relevant service if asserting material contribution or aggravation (s 10(2)).
• Address death claims with terminal event evidence: where the claim is for death from Paget disease, provide medical evidence that Paget disease contributed to the terminal event or condition listed in the Schedule or to a proximate or ultimate cause of death (s 7(5); Schedule terminal event). Death certificates, hospital records, post‑mortem reports and expert opinions will be required to make that link.
• Consider cross‑referenced SoPs: if the inability to obtain appropriate clinical management references care for another injury or disease that has its own SoP, obtain and apply the factors required by that other SoP under section 11. Practitioners should identify any such cross‑references early and gather evidence accordingly (s 11).
• Prepare expert medical opinion: given the clinical and causal questions, authoritative medical opinions that align clinical facts with the SoP definitions and factors will be critical. Experts should address the SoP’s definition of Paget disease, timing of worsening relative to attempts to obtain care, and the causal link between the inability to obtain care and disease progression or death.

For decision‑makers and administrators

• Use the SoP definitions as authoritative: adopt the clinical meaning in s 7(2) and apply the ICD reference only as an index (s 7(3)-(4)). The adjudicative task is to determine whether the medical evidence meets the SoP’s definition on the balance of probabilities.
• Apply the factor test strictly: before finding a connection on the balance of probabilities, ensure that at least one of the section 9 factors exists and is related to relevant service (s 9; s 10(1)). For s 9(1), confirm that the inability to obtain appropriate clinical management preceded clinical worsening and that the required temporal and causal links to service are established.
• Check service type against the Schedule: confirm the claimant’s service falls within the SoP’s definition of relevant service before applying these factors (Schedule 1 relevant service). Where service falls outside those categories, the SoP is not the operative SoP for that claim.
• Follow cross‑SoP rules: where a factor refers to another SoP, apply the factors of that other SoP in accordance with its terms (s 11). This may require consulting multiple SoPs for complex causation patterns.
• Record findings against SoP elements: make findings of fact in terms that map directly to the SoP language,e.g. diagnosis as per 7(2), factor existence as per 9(1), relationship to relevant service as per 10(1), and whether the disease arose out of relevant service for the purposes of s 10(2). Clear mapping aids review and appeal.

Documentation and proof standards

• Where inability to obtain care is asserted, decision‑makers should seek and consider contemporaneous documentary evidence, and experts should be asked to address how the absence of appropriate management would, on the balance of probabilities, lead to clinical worsening.
• For death claims, require evidence linking the claimant’s Paget disease to the proximate cause, consistent with the Schedule’s terminal event concept.

Transitional considerations

• As the 2015 SoP is repealed (s 4) and the 2023 SoP commences on 25 July 2023 (s 2), practitioners should check the timing of events and claims to determine which instrument applies. The SoP text contains no transitional rules, so careful temporal analysis is required where events straddle the repeal and commencement dates.

In short, compliance requires aligning evidentiary practice to the SoP’s narrow factor structure, documenting the clinical diagnosis against the SoP description, proving inability to obtain appropriate clinical management and its timing relative to clinical worsening, and demonstrating the relationship between that factor and the type of relevant service defined in the Schedule.