Statement of Principles concerning polymyalgia rheumatica (Reasonable Hypothesis) (No. 5 of 2025)

The instrument’s core legal-medical concepts are: the statutory basis and application; the clinical definition of polymyalgia rheumatica for the Statement; the constitution of death from polymyalgia rheumatica; the discrete list of triggering factors that can raise a reasonable hypothesis linking the condition to relevant service; temporal limits and causal connection rules; and interplay with other Statements of Principles.

Clinical definition (s7(2)): polymyalgia rheumatica is defined for the instrument as an inflammatory rheumatic disorder with all of the following characteristics: bilateral aching and stiffness affecting specified proximal limb or axial regions; elevated acute phase reactants (erythrocyte sedimentation rate and/or C reactive protein) or systemic symptoms such as malaise, fatigue and a low-grade fever; and occurrence in the absence of other diseases capable of causing the musculoskeletal symptoms (s7(2)(a)-(c)). The instrument expressly excludes polymyalgia rheumatica coexistent with giant cell arteritis (s7(2)(2)).

Death (s7(4)): death from polymyalgia rheumatica is captured where death from a terminal event or condition was contributed to by the person’s polymyalgia rheumatica. The Schedule defines “terminal event” by example (pneumonia, respiratory failure, cardiac arrest, circulatory failure, cessation of brain function) (Schedule 1).

Factors raising a reasonable hypothesis (s9): at least one of three factors must exist, as a minimum, before a reasonable hypothesis is raised. Those factors are: (a) treatment with immune checkpoint inhibitors within one year before clinical onset or clinical worsening; (b) a COVID‑19 vaccine within four weeks before clinical onset or clinical worsening; and (c) inability to obtain appropriate clinical management for polymyalgia rheumatica before clinical worsening (s9(1)-(3)). The instrument includes a Note listing example immune checkpoint inhibitors (atezolizumab, avelumab, cemiplimab, durvalumab, ipilimumab, nivolumab, pembrolizumab) (s9 Note).

Relationship to service (s10): the existence of any factor in s9 must be related to the person’s relevant service (s10(1)). The instrument also treats “clinical worsening” aspects of the s9 factors as applying only to material contribution to, or aggravation of, polymyalgia rheumatica where the person’s polymyalgia rheumatica was suffered or contracted before or during, but did not arise out of, the person’s relevant service (s10(2)). This establishes a specific temporal-causal rule governing when “worsening” can be the basis for a reasonable hypothesis connected to service.

Interaction with other Statements (s11): if a factor in s9 refers to an injury or disease covered by another Statement of Principles made under subsection 196B(2) of the VEA, then the factors in that other Statement apply according to its terms.

Application scope (s5): the instrument applies to claims governed by s120A of the VEA or s338 of the MRCA. The Schedule provides key definitions used throughout, including “relevant service” (listing operational, peacekeeping, hazardous and British nuclear test defence service under the VEA, and warlike or non-warlike service under the MRCA) (Schedule 1).

Authority and repeal (s3-s4): the Repatriation Medical Authority makes the Statement under its statutory power and repeals the earlier Statement (No. 19 of 2016).

Direct statutory subjects: the Statement applies to claims under section 120A of the VEA or section 338 of the MRCA (s5). That means persons submitting those claims, and decision-makers administering those statutory schemes, are the primary users of the instrument. The Schedule defines “relevant service” (Schedule 1), so affected persons are those who rendered operational service, peacekeeping service, hazardous service, British nuclear test defence service under the VEA, or warlike or non-warlike service under the MRCA.

Medical practitioners and treating institutions: the instrument sets clinical criteria and time windows for factors such as prior use of immune checkpoint inhibitors and COVID‑19 vaccination (s7(2); s9). Practitioners will be a key source of the clinical evidence (diagnosis, ESR/CRP results, treatment dates, documentation of inability to obtain appropriate clinical management) that claimants will submit. The instrument’s Note about corticosteroid response (s7(3) Note) and the Note listing immune checkpoint inhibitors (s9 Note) indicate types of clinical detail that may be relevant to establishing the defined medical condition and factors.

Veterans’ affairs decision-makers and administrators: decision-makers applying the VEA and MRCA claim provisions and assessing whether a reasonable hypothesis is raised must use the criteria in the Statement (s5, s9, s10). The Statement’s repeal of the 2016 Statement (s4) means decision-makers will transition to the 2025 criteria from commencement.

Parties to claims where factors implicate other Statements: s11 contemplates that a factor in s9 may refer to an injury or disease covered by another Statement. Where that occurs, the persons affected will also include those whose conditions fall under the other Statement, and they must follow the terms of that other Statement as it applies.

Dependants and estates for death claims: the instrument brings death from polymyalgia rheumatica within scope where polymyalgia rheumatica contributed to death by way of a terminal event (s7(4); Schedule 1). That expands the class of claimants to include dependants or estates who pursue death benefits when evidence supports contribution by the condition.

Entities indirectly affected: insurers, private healthcare providers and employers are not mentioned in the instrument. However, in practice, proving factors such as vaccination timing, oncologic treatment with immune checkpoint inhibitors, or inability to obtain clinical management will typically require medical records, vaccination records, or service records. Providers holding those records will therefore have an evidentiary role in affected claims, although the Statement itself does not impose express duties on them.

Geographic and temporal scope: the Statement only applies to claims to which the specified sections of the VEA and MRCA apply (s5) and takes effect from its commencement date, 28 January 2025 (s2). It also repeals the earlier Statement, replacing its framework for cases after commencement (s4).

The instrument does not create criminal offences or direct private rights of action. It operates as a medical-evidentiary template used by administrators and decision-makers under the VEA and MRCA to determine whether a reasonable hypothesis exists connecting polymyalgia rheumatica, or death from it, to relevant service.

Minimum evidentiary threshold (s9): before a decision-maker can say that a reasonable hypothesis is raised linking the condition to service, at least one of the enumerated factors in s9 must, as a minimum, exist. That is a duty on claimants to demonstrate at least one of those factors as part of their claim. The text frames these as necessary preconditions for raising a reasonable hypothesis; the instrument’s operative effect is to channel evidential focus to those factors.

Requirement that factors be related to relevant service (s10(1)): any factor relied on under s9 “must be related to the relevant service rendered by the person.” This imposes an evidential and causal link requirement. Parties asserting a factor must connect its existence to the person’s relevant service. The instrument does not prescribe how that relation is to be proved, but the statutory text plainly conditions the raising of a reasonable hypothesis on that relationship.

Clinical worsening limitation (s10(2)): where reliance is placed on “clinical worsening” aspects of the s9 factors, those aspects apply only to material contribution to, or aggravation of, polymyalgia rheumatica where the person’s polymyalgia rheumatica was suffered or contracted before or during, but did not arise out of, their relevant service. This limits the duty to show aggravation to particular temporal and causal classes of pre-existing or contemporaneous but non-service-origin conditions.

Interplay with other Statements (s11): if a s9 factor refers to an injury or disease that has its own Statement, then the factors in that other Statement apply in accordance with that Statement’s terms. A claimant or decision-maker must therefore observe the duties set by any other relevant Statement when the s9 factor invokes another disease.

Diagnostic standard (s7(2)): the instrument defines polymyalgia rheumatica using specific clinical criteria. Evidence supporting diagnosis should address each of those elements: bilateral aching and stiffness in specified regions, elevated acute phase reactants and/or systemic symptoms, and exclusion of other diseases capable of causing the musculoskeletal symptoms. This represents an evidentiary duty for diagnosis in claims under the Statement.

Death claims (s7(4) and Schedule 1): where death is alleged to be from polymyalgia rheumatica, proof must show that a terminal event or condition that caused death was contributed to by the person’s polymyalgia rheumatica. The Schedule lists examples of terminal events. The duty is to link the contributory role of polymyalgia rheumatica to the proximate or ultimate cause of death.

Scope of application (s5): the Statement applies only to claims falling within the specified sections of the VEA and MRCA. Rights to have a claim assessed in accordance with this Statement therefore attach only to those statutory claim types. The Statement does not itself confer entitlements; it provides the medical basis for deciding whether a condition is related to service for the purposes of those Acts.

Administrative reliance and decision-maker discretion: the Repatriation Medical Authority expresses its view that there is sound medical-scientific evidence that PMR can be related to relevant service (s8). That view supplies the Authority’s medical basis, but the instrument leaves the statutory decision-making framework of the VEA and MRCA to apply those medical findings in each claim. The instrument does not itself set administrative procedures, review rights, or appeal mechanisms; those remain governed by the VEA/MRCA.

The instrument contains no express criminal or civil penalties, fines, or enforcement mechanisms within its text. Its legal force is as a Statement of Principles made under subsection 196B(2) of the VEA (s3), intended for application in claims under specified provisions of the VEA and MRCA (s5). Enforcement in relation to the instrument therefore occurs through administrative decision-making under the VEA and the MRCA rather than through penalties embedded in the Statement itself.

What the instrument does enforce, operationally, is an evidentiary threshold and specific connections required to raise a reasonable hypothesis linking polymyalgia rheumatica or death from it to relevant service (s9, s10). The practical effect is that administrative decision-makers will assess claims with reference to the Statement’s factors and definitions. While the instrument does not itself say how decision-makers must record or act upon that assessment, the statutory framework within which the Statement sits will determine administrative outcomes and any associated legal consequences (for example, acceptance or denial of service-connection for benefits). The Statement does not specify those downstream legal consequences.

There are no express obligations or penalties imposed on third parties (for example, treating clinicians or record-holders) in the Statement. The Schedule and Notes provide clinical descriptors and examples that are evidentiary in nature (s7(2), s7(3) Note, s9 Note), but do not create enforcement duties.

Relevance of repeal (s4): the repeal of the earlier 2016 Statement changes which medical-evidentiary framework applies to claims after the commencement date (s2, s4). Administrative decisions made under or guided by the earlier Statement prior to repeal remain outside the text of this instrument; the Statement does not itself address retrospective operation beyond its commencement and repeal provisions.

In practice, enforcement will be via the statutory claims process under the VEA and MRCA. The instrument supplies medical criteria and factor lists that decision-makers will use. Any procedural penalties, sanctions, review rights or appeals available to claimants are determined by the VEA and MRCA, not by this Statement.

Primary statutory interaction (s3, s5): this instrument is made under subsection 196B(2) of the VEA (s3). It explicitly applies to claims to which section 120A of the VEA or section 338 of the MRCA applies (s5). The Statement therefore functions as an instrument feeding medical findings into the statutory claims processes set by those Acts. The Statement does not amend the VEA or the MRCA; rather, it specifies medical principles that are to be used in applying those provisions.

Interaction with other Statements of Principles (s11): where a factor in s9 refers to an injury or disease that itself has a Statement of Principles determined under subsection 196B(2) of the VEA, then the factors in that other Statement apply in accordance with their terms. This creates a hierarchical or cross-referential interaction: the present Statement does not displace the detailed factors of other Statements when they are invoked by s9 factors; instead, it requires use of those other Statements’ terms. Practically, decision-makers and claimants must consult any referenced Statements to see how those factors operate.

ICD-10-AM reference (s7(5)-(6)): the Statement notes that polymyalgia rheumatica attracts ICD‑10‑AM code M35.3 but states that for the purposes of this Statement the meaning is the clinical definition given in s7(2) (s7(5)). It also clarifies that references to ICD‑10‑AM codes are to the specified Tenth Edition Australian Modification (effective date 1 July 2017) (s7(6)). The instrument therefore interacts with diagnostic coding systems by reference, but it displaces an ICD code as the sole definitional test by giving its own clinical criteria.

Relation to VEA/MRCA definitions of relevant service (Schedule 1): the Schedule reproduces or refers to the terms “relevant service”, listing the various types of service under the VEA and MRCA (Schedule 1). The instrument therefore embeds the statutory categories used in the surrounding legislation and ties the Statement to those service definitions.

Medical evidence and external regulation: the Statement prescribes clinical criteria and factor windows (for example, one year for immune checkpoint inhibitors, four weeks for COVID‑19 vaccine) (s7(2); s9). While it does not alter medical regulation or prescribing law, it will interact operationally with the records and standards maintained by treating practitioners, hospitals and private providers where those records are used in claims.

Absence of interaction with other statutory duties or penalties: the instrument itself does not create enforcement powers, administrative penalties, or private enforcement mechanisms. All such powers remain those provided in the VEA and MRCA and other relevant statutes; the Statement provides medical criteria to be used under those Acts.

Temporal transition from prior Statement (s4): the repeal of the No. 19 of 2016 Statement and replacement by the 2025 Statement means that future claims falling under the specified sections will be assessed under this instrument’s terms. The instrument does not specify transitional arrangements beyond repeal and commencement; the Acts’ administrative frameworks will determine handling of matters in progress.

This instrument is dated 17 December 2024 and is designated Statement of Principles concerning polymyalgia rheumatica (Reasonable Hypothesis) (No. 5 of 2025) (title and front matter). It commences on 28 January 2025 (s2). The Statement expressly repeals the earlier Statement of Principles concerning polymyalgia rheumatica (Reasonable Hypothesis) (No. 19 of 2016), Federal Register of Legislation No. F2016L00249, which was formerly made under subsection 196B(2) of the VEA (s4).

Other than that repeal, the instrument contains no internal amendment history, schedules of prior amendments, or modification clauses. The Schedule of definitions is included as part of the instrument and supplies the definitions used. The instrument replaces the 2016 Statement in its entirety as of the commencement date; the text does not itself describe staged or partial transition arrangements, nor does it list predecessors prior to 2016.

The source text provides the date of making and the commencement date; it does not list earlier amendments to the 2016 Statement, or any other earlier Statements, beyond the single repeal of the 2016 Statement. Any further legislative or administrative amendments to this 2025 Statement would have to be made by subsequent instruments under the same statutory power, but none are recorded in the text provided.

Practitioners and administrators should note the explicit repeal (s4) and the commencement date (s2) when determining which Statement is applicable to a given claim. The Statement does not specify whether claims lodged before commencement but finalised after it will be assessed under the 2016 or 2025 instruments; that question is determined by the VEA/MRCA application rules rather than by a provision in this Statement.

The Statement itself contains no references to litigation, court decisions, administrative tribunal determinations, or judicial interpretations. The text does not name any cases or report any litigation outcomes relevant to the Statement’s content. The Repatriation Medical Authority records its view on the existence of sound medical-scientific evidence linking polymyalgia rheumatica and death from polymyalgia rheumatica to relevant service (s8), but the Statement does not cite, summarise, or append legal authorities or judicial treatment.

For claimants, respondents, and advisers, that means the instrument must be used on its terms because it supplies the medical criteria decision-makers will apply. If parties intend to challenge how a decision-maker applies this Statement in an individual claim, they would need to rely on the review and appeal procedures provided in the VEA and the MRCA. The Statement does not set or modify those procedures, and it does not itself narrate any litigation or tribunal history.

Because the text is silent on litigation, practitioners seeking precedent on the interpretation or application of these provisions will need to consult decisions under the VEA and MRCA outside this instrument. The instrument does not identify such decisions. The absence of litigation references in the instrument also means that the Statement contains no judicial gloss on the meaning of its terms within the text itself.

Several points in the instrument are likely to generate factual or legal complexity in claims. These are concrete features that can produce evidentiary or interpretive issues and should be considered closely in assembling or assessing claims.

1. Clinical definition overrides ICD code alone (s7(2), s7(5)). Although the instrument notes that polymyalgia rheumatica attracts ICD‑10‑AM code M35.3 (s7(5)), it clarifies that the meaning of polymyalgia rheumatica for the Statement is the clinical definition in s7(2). Practitioners cannot rely solely on an ICD code entry; the clinical elements in s7(2) must be addressed (bilateral aching/stiffness in specified regions; elevated ESR/CRP or systemic symptoms; exclusion of other diseases).

2. Exclusion of giant cell arteritis (s7(2)(2)). The instrument explicitly excludes polymyalgia rheumatica coexistent with giant cell arteritis. Where a claimant’s record shows coexistent giant cell arteritis, the condition is outside this Statement. That exclusion is categorical and can be decisive.

3. Time windows for listed factors (s9). The three factors have differing temporal requirements: immune checkpoint inhibitors within one year before clinical onset or clinical worsening (s9(1)); COVID‑19 vaccine within four weeks before clinical onset or clinical worsening (s9(2)); and inability to obtain appropriate clinical management before clinical worsening (s9(3)), which is not limited to a precise window in the text. Failure to show these timing windows will likely be fatal to reliance on those factors.

4. Note examples versus exhaustive lists (s9 Note, s7(3) Note). The text’s Notes supply examples , for instance, a list of immune checkpoint inhibitors , but they are presented as examples. The Statement does not state that the list is exhaustive, but neither does it prescribe how other medications are to be treated. Practitioners should not assume that only the listed agents qualify without considering whether other agents could be analogous under the Statement’s terms, but the Statement itself provides no further guidance.

5. “Inability to obtain appropriate clinical management” is inherently factual and potentially hard to prove (s9(3)). The instrument requires that this factor existed before clinical worsening. The Statement does not define “appropriate clinical management” or provide examples; claimants must therefore assemble contemporaneous records, service medical documentation, correspondence, or other evidence to demonstrate lack of access or provision. The standard for what suffices as “inability” is not specified.

6. Clinical worsening limitation for pre-existing conditions (s10(2)). The Statement’s language confines the application of “clinical worsening” aspects of s9 to situations where the person’s polymyalgia rheumatica was suffered or contracted before or during, but did not arise out of, relevant service. That is a narrow application: where PMR arose out of service, the “clinical worsening” angle appears not to apply. Practitioners should note this precise qualification and ensure the temporal origin of PMR is clear in the evidence.

7. Death requires contribution to terminal event (s7(4); Schedule 1). For death claims, it is not enough to show a history of PMR; the claimant must show that PMR contributed to a terminal event or condition that caused death. The Schedule lists example terminal events. Demonstrating contributory causation to a terminal event may require clinical opinion evidence linking PMR to the fatal pathway.

8. Cross-referential complexity when other Statements apply (s11). If a s9 factor refers to another injury or disease that has its own Statement, claimants and decision-makers must also address that other Statement’s factors “as in force from time to time.” This can require multi-instrument analysis and careful attention to which versions of other Statements apply.

9. The instrument is silent about procedural standards and evidentiary burdens (s5, s8). While it specifies the medical thresholds, it does not set procedural rules about how evidence must be presented, the standard of proof in administrative practice, or how decision-makers should weigh competing medical opinions. Those procedural matters remain within the VEA and MRCA frameworks.

10. Repeal of the 2016 Statement may affect ongoing matters (s4). The repeal is absolute in text; however, the Statement provides no transitional clauses. Practitioners should check how the administrative machinery treats claims that straddle the repeal/commencement date.

For claimants, treating clinicians, and advisers preparing or evaluating claims that rely on this Statement, compliance means assembling evidence and legal narratives that directly map to the Statement’s definitional and factor requirements. Practical steps, tied to the instrument’s provisions, are as follows.

1. Establish the clinical diagnosis using the Statement’s definition (s7(2)). Evidence should address each of the three definitional elements:

   • Document bilateral aching and stiffness in the shoulder/proximal arm regions, hip/proximal thigh regions, or neck/lower back (s7(2)(a)).
   • Provide laboratory results showing elevated erythrocyte sedimentation rate and/or C reactive protein, or clinical notes documenting systemic symptoms such as malaise, fatigue or low-grade fever (s7(2)(b)).
   • Provide evidence that other diseases capable of causing the musculoskeletal symptoms were considered and excluded, through differential diagnosis notes, specialist reports, imaging, or lab work (s7(2)(c)).
   • Note the Statement’s clinical comment that patients who can take corticosteroids typically have a rapid response; while the Statement does not make corticosteroid response a formal requirement, responsive treatment notes may support the diagnosis (s7(3) Note).

2. For death claims, demonstrate contribution to a terminal event (s7(4); Schedule 1). Assemble clinical records, hospital summaries, death certificate material and treating clinician opinions that connect the person’s polymyalgia rheumatica to the terminal event (pneumonia, respiratory failure, cardiac arrest, circulatory failure or cessation of brain function are examples given) listed in the Schedule.

3. Select and prove at least one of the factors in s9, respecting the timing windows:

   • Immune checkpoint inhibitors: obtain oncology/medication records showing treatment with an immune checkpoint inhibitor within one year before clinical onset or clinical worsening (s9(1)). The Note lists example agents; provide drug names and administration dates (s9 Note).
   • COVID‑19 vaccination: obtain vaccination records proving the vaccine was administered within four weeks before clinical onset or clinical worsening (s9(2)).
   • Inability to obtain appropriate clinical management: document attempts to obtain care, contemporaneous service medical records, correspondence noting unavailable services, or administrative records showing denial or absence of appropriate management prior to clinical worsening (s9(3)). Because the Statement does not define “appropriate clinical management”, contemporaneous, specific documentary evidence is crucial.

4. Show the factor is related to relevant service (s10(1)). Evidence must connect the chosen factor to the person’s relevant service as defined in the Schedule (operational, peacekeeping, hazardous, British nuclear test defence service under the VEA; warlike or non-warlike service under the MRCA). This may require service records, deployment timelines, and medical entries dated during or shortly after relevant service.

5. When relying on clinical worsening, check the origin of the polymyalgia rheumatica (s10(2)). Clinical worsening aspects of s9 apply only where the person’s PMR was suffered or contracted before or during, but did not arise out of, relevant service. If the claimant’s PMR arose out of service, the “worsening” pathway under s10(2) is not available under the Statement. Evidence should therefore clarify onset timing and causal origin.

6. If a s9 factor implicates another Statement of Principles, consult and comply with that other Statement (s11). For example, if a s9 factor references an injury that itself has an SOP, identify that SOP and ensure evidence addresses its factors “as in force from time to time.”

7. Use contemporaneous medical records and specialist opinions. Because the Statement provides clinical criteria and temporal windows, contemporaneous records that show symptom onset dates, lab values, treatment start dates, vaccine dates, and notes on access to care will best support reliance on the appropriate s9 factor(s) and the linkage to relevant service.

8. Prepare medico-legal opinion to tie facts to the Statement’s criteria. A treating specialist or independent medical expert should explicitly address the required elements of s7 and s9, the timing windows, whether other diseases capable of causing the symptoms have been excluded, whether a listed treatment or vaccine preceded onset within the required period, and whether the factor is related to the person’s relevant service (s7(2); s9; s10(1)). For death claims, the opinion should address contributory causation to a terminal event (s7(4); Schedule 1).

9. Anticipate challenges on “inability to obtain appropriate clinical management” (s9(3)). Because the Statement does not define “appropriate” management, document efforts made to obtain care, the specific services unavailable, corroborating records from service medical units or other providers, and how the lack of management preceded clinical worsening.

10. Check versioning and timing. The 2025 Statement repeals the 2016 instrument (s4). Ensure the claim is presented under the correct Statement depending on the claim timing and the administrative rules governing instrument application (s2, s4).

11. Record and submit evidence of service categories. Because “relevant service” is defined in the Schedule, include service records that specify whether the person undertook operational, peacekeeping, hazardous, British nuclear test defence service, warlike service or non-warlike service, as applicable.

12. Be precise about terminology. Use the Statement’s language when framing medical and factual submissions: “clinical onset”, “clinical worsening”, “material contribution”, “aggravation”, and “relevant service” have specific roles in the instrument’s analysis (s9, s10, Schedule 1).

Following these steps will align claim preparation with the instrument’s explicit requirements. The Statement does not prescribe procedural formats for submission or evidentiary weight; those remain governed by the VEA and MRCA. Claimants and advisers should therefore coordinate medical documentation with the administrative practices of the decision-making bodies that process VEA and MRCA claims.