Statement of Principles concerning Cushing syndrome (Reasonable Hypothesis) (No. 43 of 2018)

This instrument is a Statement of Principles (SoP) made under subsection 196B(2) of the Veterans’ Entitlements Act 1986 (VEA). It replaces the previous SoP concerning Cushing’s syndrome No. 33 of 2009, which it revokes in full (section 4). The SoP sets out the factors that must exist before a reasonable hypothesis can be raised connecting Cushing syndrome, or death from Cushing syndrome, with the circumstances of a person’s relevant service under the VEA or the Military Rehabilitation and Compensation Act 2004 (MRCA). Mechanically, the SoP operates as a binding evidentiary standard for decision-makers determining claims for compensation or treatment. It does not create new substantive rights or duties outside the VEA and MRCA frameworks. Instead, it narrows the range of factual scenarios that can satisfy the “reasonable hypothesis” test for this specific condition. The instrument defines Cushing syndrome as an endocrine disorder resulting from an excess of endogenous or exogenous glucocorticoids, with a clinical description and a list of ICD-10-AM codes (E24.0, E24.2, E24.3, E24.8, E24.9) for reference, but the legal meaning is governed by subsection 7(2), not the codes. The SoP applies to claims under either section 120A of the VEA or section 338 of the MRCA (section 5). It commences on 28 May 2018 (section 2). The authority for the instrument is the Repatriation Medical Authority’s determination that sound medical-scientific evidence indicates that the condition can be related to relevant service (section 8). The central operative provision, section 9, lists four factors: having a specified condition (adrenal neoplasm, ACTH-secreting pituitary neoplasm, macronodular or micronodular adrenal hyperplasia, or neuroendocrine neoplasm) at the time of clinical onset; having glucocorticoid therapy as specified before clinical onset, with cessation within 30 days if therapy stopped; being treated with medroxyprogesterone acetate or megestrol acetate for malignant disease or HIV for at least four weeks before onset (again with a 30-day cessation window); or inability to obtain appropriate clinical management. Section 10 requires that any factor must be related to the person’s relevant service, and the “inability to obtain appropriate clinical management” factor applies only to material contribution or aggravation of Cushing syndrome that was suffered or contracted before or during (but did not arise out of) service. The SoP also cross-references other Statements of Principles via section 11, incorporating their factors as they apply from time to time for any factor that refers to an injury or disease covered by another SoP. The Schedule 1 Dictionary contains detailed definitions, including dose thresholds for glucocorticoid therapy, a table of “equivalent glucocorticoid therapy” with minimum cumulative doses and average rates, a list of “equivalent inhaled glucocorticoids”, a definition of high or very high potency topical glucocorticoids, a “specified list of drugs” (21 drugs that strongly inhibit CYP3A4), and definitions of “adrenal neoplasm”, “neuroendocrine neoplasm”, “terminal event”, and “relevant service”. The effect of the SoP is to create a strict, quantifiable set of criteria that must be met for a claim to succeed at the reasonable hypothesis stage. Claimants cannot rely on vague assertions of glucocorticoid use; they must show specific doses, routes, durations, and timing relative to clinical onset. The revocation of the 2009 SoP means that the new, tighter definitions (especially the table of equivalent glucocorticoid therapy and the specified list of drugs) replace any earlier interpretations.

The central concept is the “reasonable hypothesis” standard, derived from section 196B(2) of the VEA. This is a lower evidentiary threshold than proof on the balance of probabilities. The SoP defines the medical and factual content of that hypothesis for Cushing syndrome. A reasonable hypothesis is not a speculative claim; it must be grounded in factors that the Repatriation Medical Authority has determined, on sound medical-scientific evidence, can be related to relevant service. The SoP codifies those factors. The key medical concept is “Cushing syndrome”, defined as an endocrine disorder from excess of endogenous or exogenous glucocorticoids. The instrument does not rely solely on ICD-10-AM codes; it gives a substantive definition in subsection 7(2) and lists typical features (proximal muscle weakness, facial plethora, centripetal fat, moon facies, purplish striae, bruising, supraclavicular and dorsocervical fat pads) as a note. This means the condition is not confined to a particular code; if a person has the described endocrine disorder but falls under a different code, the SoP may still apply if the definition is met. However, the listed codes (E24.0, E24.2, E24.3, E24.8, E24.9) are the expected ones. A major concept is “glucocorticoid therapy as specified”, which is a multi-part definition covering seven distinct scenarios. Each scenario has quantitative thresholds: for high or very high potency topical glucocorticoids, at least 30% of total skin surface area daily for at least six months; for inhaled glucocorticoids, at least 4,000 micrograms of budesonide or equivalent daily for at least six months; for oral or injectable hydrocortisone, a cumulative dose of at least 1,500 mg at a minimum rate of 50 mg/day, or equivalent glucocorticoid therapy as per the table (e.g., prednisolone 375 mg cumulative at 12.5 mg/day); concurrent use of a glucocorticoid with a drug that inhibits CYP3A4 by at least 30% for at least four weeks (not six months); concurrent use with any of the 21 specified drugs for at least four weeks; use of a clobetasol-containing oral preparation daily for at least four weeks; or use of glucocorticoid-containing enemas daily for at least six months. The “equivalent glucocorticoid therapy” table provides minimum cumulative doses and average daily rates for eight named glucocorticoids (betamethasone, cortisone, dexamethasone, methylprednisolone, paramethasone, prednisolone, prednisone, triamcinolone) and allows therapeutically equivalent doses of other glucocorticoids. This is a concept of potency and duration combined: both a cumulative dose floor and a minimum average rate over the treatment period must be met. The “specified list of drugs” includes protease inhibitors, macrolide antibiotics, azole antifungals, and other CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole, ritonavir). The concept is that these drugs impair glucocorticoid metabolism, increasing systemic exposure and the risk of iatrogenic Cushing syndrome. Another key concept is “specified condition”, which covers five endogenous causes: adrenal neoplasm (benign or malignant), ACTH-secreting pituitary neoplasm, macronodular or micronodular adrenal hyperplasia, and neuroendocrine neoplasm (defined as non-pituitary neoplasms secreting ACTH or CRH, with examples like oat cell lung carcinoma, carcinoid, islet cell tumour, thymus tumours, medullary thyroid carcinoma, phaeochromocytoma). These are the pre-existing conditions that can cause Cushing syndrome independently of exogenous glucocorticoids. The factor is that the person had such a condition at the time of clinical onset. The “inability to obtain appropriate clinical management” factor is a residual concept, but it is limited to material contribution or aggravation of Cushing syndrome that was already present before or during service (but not arising out of service). This prevents it being used for initial onset claims. The concept of “terminal event” defines death from Cushing syndrome broadly: includes death from pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function contributed to by the Cushing syndrome. This means the condition does not have to be the sole cause; it suffices if it contributed to a listed terminal event.

This SoP directly affects veterans, members of the Peacekeeping Forces, and members of the Forces under the VEA, as well as members under the MRCA, and their dependants who make claims for compensation or treatment related to Cushing syndrome. It also affects the decision-makers processing those claims: delegates of the Department of Veterans’ Affairs, the Military Rehabilitation and Compensation Commission, the Veterans’ Review Board, and the Administrative Appeals Tribunal when reviewing decisions. For claimants, the SoP defines the evidence they must produce to raise a reasonable hypothesis. A veteran who has endogenous Cushing syndrome from a pituitary tumour must show that tumour existed at clinical onset (factor 9(1)). A veteran who took prednisolone for asthma must prove the dose met the threshold in the table: cumulative 375 mg at an average of 12.5 mg/day, and if therapy ceased, that clinical onset occurred within 30 days. For those who used topical steroids for eczema, the SoP requires daily application of a high or very high potency glucocorticoid to at least 30% of body surface for at least six months , a very demanding standard for conditions that often affect smaller areas. Claimants using inhaled steroids must show at least 4,000 micrograms of budesonide (or equivalent) daily for six months, which is a high dose even for severe asthma. Those with HIV or malignancy treated with medroxyprogesterone acetate or megestrol acetate must show at least four weeks of treatment before onset, with a 30-day cessation window. The “inability to obtain appropriate clinical management” factor affects those whose Cushing syndrome existed before or during service but who later suffered worsening due to lack of proper treatment. This could cover veterans whose condition was not diagnosed or was mismanaged. Nevertheless, the factor must be related to relevant service; the inability must arise from service circumstances (e.g., service in a remote area with poor medical access). The SoP also affects the Repatriation Medical Authority itself, which must maintain this instrument and review it when sound medical-scientific evidence changes. Healthcare professionals treating veterans may need to document glucocorticoid use precisely to assist future claims. The definitions of “equivalent glucocorticoid therapy” and “equivalent inhaled glucocorticoid” create a compliance burden for prescribers and claimants: doses of less common glucocorticoids must be converted to the equivalents listed, and the conversion may require expert opinion. The SoP also affects other decision-makers under different Acts: section 5 applies it to claims under MRCA section 338, which covers warlike and non-warlike service. The cross-reference in section 11 means that if a factor in this SoP refers to another injury or disease (e.g., a specified condition like adrenal neoplasm), the SoP for that other condition may also become relevant, incorporating its factors into the Cushing syndrome claim. This can cascade into multiple SoPs being applied. The definitions of “relevant service” under the VEA and MRCA are broad: operational, peacekeeping, hazardous, British nuclear test defence service, warlike and non-warlike service. This means the SoP applies to a wide range of service types, not just combat. The practical effect is that any veteran or member who served under those definitions and has Cushing syndrome could potentially claim, but only if they can meet one of the very specific factors. The tight quantitative thresholds will exclude many claims where glucocorticoid use was significant but below the defined floors, or where the timing of cessation does not fit the 30-day window.

The SoP does not create new duties or rights directly; it operates within the existing VEA and MRCA frameworks. The key right for claimants is the right to have a claim for Cushing syndrome assessed under the reasonable hypothesis standard using the factors in section 9. If a claimant can show that they have at least one factor and that factor is related to relevant service, then a reasonable hypothesis is raised, and the claim must be accepted unless the decision-maker disproves the hypothesis beyond reasonable doubt (the standard under VEA section 120(1) for operational service). For warlike and non-warlike service under MRCA, the standard may differ but the SoP still defines the hypothesis. Claimants have the right to rely on the SoP as the definitive list of what constitutes a reasonable connection. Conversely, decision-makers have the duty to apply the SoP strictly. If a factor requires that glucocorticoid therapy ceased within 30 days before clinical onset, but the claimant stopped therapy 31 days before onset, the factor is not met. The decision-maker cannot use a different medical opinion to accept the claim unless the condition falls outside the SoP altogether (e.g., if the medical evidence shows a novel cause not listed). The Repatriation Medical Authority has the duty under section 196B(2) to make the SoP based on sound medical-scientific evidence. That duty is satisfied in the recital at section 8. The Authority must also keep the SoP current; revocation of the 2009 SoP indicates it did so. The SoP imposes no duties on clinicians or pharmaceutical companies, but in practice, the specificity of the definitions creates an evidentiary burden on claimants to produce detailed treatment records. The “inability to obtain appropriate clinical management” factor imposes a duty on decision-makers to assess whether the failure to provide appropriate clinical management was related to service. This requires an analysis of what “appropriate” means in the context of the person’s service circumstances. The factor only applies to material contribution or aggravation, not initial onset, so the decision-maker must distinguish between the pre-service condition and the service-related worsening. The definitions of “terminal event” give a right to claim for death where Cushing syndrome contributed to any of the listed causes, even if the actual mechanism of death is not explicitly Cushing syndrome. The cross-reference in section 11 means that if a factor refers to a condition covered by another SoP, the claimant must also satisfy that other SoP’s factors. This imports additional duties to prove those conditions. For example, if a claimant relies on having an adrenal neoplasm (a specified condition), they may need to show that adrenal neoplasm itself is related to service under its own SoP, unless the adrenal neoplasm is unrelated to service and simply existed at the time of onset. The wording of factor 9(1) is “having a specified condition at the time of the clinical onset of Cushing syndrome”. It does not require that the specified condition be service-related; the Service-relatedness is established separately through section 10(1) by linking the factor to service. But factor 9(1) itself just requires the condition to exist. So the duty to prove service connection attaches to the factor, not the specified condition. This is a subtle point: the “having” is the factor; that having must be related to service. If the specified condition is not service-related, it cannot satisfy factor 9(1). Therefore, the claimant must show that the presence of the adrenal neoplasm or pituitary tumour is itself related to service. That is a heavy duty.

This SoP does not create any direct penalties or enforcement mechanisms. It is not a regulatory instrument that imposes fines or criminal liability. Its enforcement is through the claims adjudication process. If a claimant provides false or misleading information to satisfy a factor, that could attract penalties under the VEA or the Criminal Code, but those are separate from the SoP itself. The SoP’s role is to define what evidence is required. The “penalty” for failing to meet the SoP is a rejection of the claim or denial of entitlement to compensation or treatment. That is a civil consequence, not a penalty in the punitive sense. The Repatriation Medical Authority has no enforcement role; its function ends with the making of the SoP. For decision-makers, the risk is that applying the SoP incorrectly could lead to a successful appeal. If a delegate wrongly rejects a claim that meets a factor, the veteran can appeal to the Veterans’ Review Board and then the Administrative Appeals Tribunal. That is a review process, not a penalty. The SoP does not itself provide for any sanction against decision-makers. However, the instrument is legally binding on decision-makers under the VEA and MRCA. Failure to follow it could result in the decision being set aside on review. That is a form of enforcement through the legal system. The instrument also contains no sunset clause or review date; it remains in force until revoked or amended. The practical enforcement of the dose thresholds and timing requirements relies on medical records. Claimants who cannot produce records of cumulative dose or average rate may struggle to satisfy the SoP, effectively being penalised by lack of documentary evidence. The definitions of “equivalent glucocorticoid therapy” and “equivalent inhaled glucocorticoid” create the risk of misinterpretation: if a decision-maker incorrectly calculates the equivalent dose, the claim may be wrongly denied or granted. There is no penalty for that beyond reversal on appeal. The “specified list of drugs” is exhaustive; using a CYP3A4 inhibitor not on the list (e.g., grapefruit juice, though not a drug) would not satisfy factor 9(3)(e) even if it had the same pharmacological effect. This could be seen as arbitrary, but the SoP is binding. The list includes 21 drugs; drugs that strongly inhibit CYP3A4 but are omitted (e.g., nefazodone, conivaptan) are not covered. Claimants using those drugs would need to rely on factor 9(3)(d) (inhibition by at least 30%), but that requires proof of the degree of inhibition, which may be difficult. The consequence is that claims may fail on a technicality, which is a form of de facto penalty on claimants who used drugs not on the list.

The SoP is made under the VEA and applies to claims under section 120A of the VEA and section 338 of the MRCA. It interacts with the primary legislation by providing the evidentiary framework for the reasonable hypothesis test. It does not override the substantive provisions of those Acts; rather, it fills in the medical-scientific content. Section 11 of the SoP explicitly cross-references other Statements of Principles. If a factor in this SoP refers to an injury or disease for which a separate SoP exists under subsection 196B(2) of the VEA, then the factors in that other SoP apply in accordance with its terms as in force from time to time. This creates a dynamic interaction: the other SoP may be amended or revoked, and those changes automatically affect the application of this SoP. For example, if factor 9(1) refers to “adrenal neoplasm”, and there is an SoP for adrenal neoplasm, that SoP’s factors become relevant. The claimant may need to satisfy both SoPs to link the specified condition to service, or at least to rely on that SoP to establish that the adrenal neoplasm itself is related to service. The note to “specified condition” defines it with references to other defined terms in Schedule 1, which in turn may reflect medical classifications that could change over time (e.g., ICD-10-AM updates). The SoP is frozen at the Tenth Edition, effective 1 July 2017 (subsection 7(4)). If ICD-10-AM is updated, this SoP still uses the 2017 edition unless amended. This could lead to discrepancies between the medical coding used in clinical records and the SoP’s reference. The MRCA and VEA are separate statutory regimes with different definitions of “relevant service” and different standards of proof in some circumstances. The SoP applies uniformly to both, but the underlying Acts may produce different outcomes for the same factors because of differing causation standards. For operational service under VEA, once a reasonable hypothesis is raised, the claim succeeds unless disproved beyond reasonable doubt. For warlike service under MRCA, the standard is similar but not identical. The SoP does not address those differences; it only provides the hypothesis content. The SoP also interacts with the general law of medical causation and evidence. It does not prevent a claimant from raising a hypothesis based on a factor not listed, but that hypothesis would not be considered “reasonable” under the SoP; the SoP is exclusive for the purpose of the VEA and MRCA. Inability to obtain appropriate clinical management (factor 9(4)) interacts with the concept of “aggravation” under VEA section 9 and MRCA section 4. The SoP limits this factor to material contribution or aggravation where the Cushing syndrome was suffered or contracted before or during (but did not arise out of) service. That mirrors the common law distinction between initial causation and worsening. The factor does not apply if the Cushing syndrome arose out of service; in that case, the other factors would be used. The definition of “terminal event” interacts with the death compensation provisions of the VEA and MRCA. It allows a claim where Cushing syndrome contributed to any of the listed terminal events, even if the death certificate does not mention Cushing syndrome as the immediate cause. The list is exhaustive: pneumonia, respiratory failure, cardiac arrest, circulatory failure, cessation of brain function. This may exclude other terminal events like sepsis or renal failure unless they fit into one of those categories (e.g., septic shock could be circulatory failure).

This instrument revokes the Statement of Principles concerning Cushing’s syndrome No. 33 of 2009 (section 4). The 2009 SoP is replaced in full. The new SoP commences on 28 May 2018 (section 2). No other amendment history is recorded within the instrument itself. The instrument does not list interim amendments between 2009 and 2018; the Repatriation Medical Authority evidently determined that a complete replacement was necessary rather than piecemeal amendments. The 2018 SoP includes several substantive changes compared to the 2009 version, as discernible from the text: a more detailed definition of “glucocorticoid therapy as specified” with explicit dose tables for both systemic and inhaled glucocorticoids; a new “equivalent inhaled glucocorticoid” definition with specific microgram amounts for beclometasone, ciclesonide, fluticasone propionate, fluticasone furoate, and triamcinolone; the addition of the “specified list of drugs” (21 drugs that inhibit CYP3A4) as a stand-alone factor (9(3)(e)) rather than relying solely on general CYP3A4 inhibition; the inclusion of clobetasol-containing oral preparations and glucocorticoid-containing enemas as separate scenarios; the factor for medroxyprogesterone acetate and megestrol acetate treatment (9(3)) which may not have been in the 2009 version; and the factor for inability to obtain appropriate clinical management (9(4)). The definitions of “high or very high potency topical glucocorticoid” list nine specific products and strengths, which appears more refined than earlier versions. The dictionary now defines “adrenal neoplasm” and “neuroendocrine neoplasm” explicitly. The 2009 SoP was likely less detailed on dose thresholds. The revocation is automatic upon commencement of this instrument. Any pending claims that had not been finally determined before 28 May 2018 would be assessed under the new SoP, unless transitional provisions in the VEA preserve the old version. The instrument does not contain transitional rules; the VEA itself would determine whether the new SoP applies to pending claims. Typically, a new SoP applies to all claims not yet determined. This means claimants who had gathered evidence under the 2009 factors may find their claims fail under the stricter 2018 thresholds. The instrument is a legislative instrument but is not disallowable under the Legislation Act 2003 because it is made by the Repatriation Medical Authority, not a Minister. However, it is subject to judicial review. The Authority may amend or revoke this SoP in the future if further sound medical-scientific evidence emerges. The instrument does not set a review date. The absence of an automatic sunset provision means it remains in force until the Authority chooses to act. There is no indication of any consultation process or explanatory statement in the instrument itself.

The instrument itself does not record any litigation history. No specific cases are referenced in the text. However, Statements of Principles under the VEA have been the subject of numerous decisions in the Administrative Appeals Tribunal and the Federal Court, typically concerning the interpretation of factor definitions or challenges to the Authority’s determination that sound medical-scientific evidence exists. Because the source does not name any cases, we cannot discuss any particular litigation. We can note that the SoP is legally binding and therefore may be judicially reviewed. Claimants who are denied compensation because they do not meet a factor might challenge the validity of the SoP itself if they argue it is not based on sound medical-scientific evidence. That challenge would go to the Federal Court, but no such cases are mentioned in this instrument. The Repatriation Medical Authority has been subject to litigation over other SoPs, but not necessarily this one. The 2009 SoP for Cushing’s syndrome may have been litigated, but this instrument provides no details. The revocation of the 2009 SoP could have been prompted by a court decision or by new evidence, but the text does not say. In terms of application, the SoP has been cited in many VEA and MRCA claim decisions, but those are administrative determinations, not reported cases. The definition of “glucocorticoid therapy as specified” with its specific dose thresholds is likely to generate disputes over whether a particular treatment regimen meets the criteria. For example, whether “daily” use for a topical steroid means every day without missing any day, or substantially daily, may be litigated. The meaning of “equivalent inhaled glucocorticoid” with a conversion table may also lead to expert disagreement. The “inability to obtain appropriate clinical management” factor is vague and could generate litigation over what constitutes “appropriate clinical management” and whether the inability was related to service. However, without any case citations in the instrument, we cannot comment further. The prudent approach is to state that the instrument does not contain any litigation history and that any such history would be found in external case law which is not referenced here.

Several provisions in the SoP are traps for the unwary. The first is the requirement in factor 9(2) that if glucocorticoid therapy has ceased or decreased, the last dose was received within the 30 days before clinical onset. This 30-day window is absolute. Even one day outside it, and the factor fails. Claimants whose Cushing syndrome appears after a longer gap must rely on other factors, which may not apply. The second is that “glucocorticoid therapy as specified” includes multiple sub-scenarios, each with distinct dose and duration requirements. For oral or injectable glucocorticoids, the claimant must show both a minimum cumulative dose and a minimum average rate per day. For example, prednisolone requires at least 375 mg cumulative and at least 12.5 mg/day average. A claimant who took prednisolone 25 mg daily for 14 days would have a cumulative dose of 350 mg (under the threshold) and would fail, even though the daily dose was high. Alternatively, a claimant who took 10 mg daily for 40 days would have 400 mg cumulative but 10 mg/day average (under the 12.5 rate). Both thresholds must be met. The third gotcha is the “equivalent inhaled glucocorticoid” definition. It lists specific daily doses for five drugs: 2,000 mcg beclometasone, 1,600 mcg ciclesonide, 2,500 mcg fluticasone propionate, 1,000 mcg fluticasone furoate, 10,000 mcg triamcinolone. But factor 9(3)(b) requires inhaling at least 4,000 micrograms of budesonide or equivalent daily. So if a person used fluticasone propionate 500 mcg daily, that is only one-fifth of the equivalent threshold (2,500 mcg) and would not count. The conversion to other inhaled glucocorticoids is not clearly a simple ratio; the definition says “a therapeutically equivalent dose of another inhaled glucocorticoid”. The word “therapeutically equivalent” may be interpreted differently by different experts, creating uncertainty. The fourth gotcha: the “specified list of drugs” is closed. A claimant taking ritonavir (on the list) would satisfy factor 9(3)(e) if they concurrently used a glucocorticoid for at least four weeks. But a claimant taking nefazodone (a strong CYP3A4 inhibitor not on the list) would have to rely on factor 9(3)(d) which requires proof that the drug inhibits CYP3A4 by at least 30%. That may require expert evidence about the specific drug’s inhibition potency, which is harder to prove. The fifth gotcha: factor 9(4) (inability to obtain appropriate clinical management) applies only to material contribution or aggravation where the Cushing syndrome was suffered or contracted before or during (but did not arise out of) service. It cannot be used for initial onset of Cushing syndrome that first appeared after service. This is explicit in section 10(2). Many claimants might mistakenly try to use it as a catch-all for causation. The sixth gotcha: the definition of “terminal event” is exhaustive (pneumonia, respiratory failure, cardiac arrest, circulatory failure, cessation of brain function). Death from other causes like pulmonary embolism or multi-organ failure would not be covered unless those causes fit into one of the five categories. The decision-maker must determine whether the actual cause of death can be classified within that list. The seventh gotcha: the “high or very high potency topical glucocorticoid” list names specific products. Clobetasol proprionate 0.05% is listed, but clobetasol butyrate is not. A claimant using a different ester may need to show it is of equivalent potency, which requires expert determination. The eighth gotcha: factor 9(1) requires having a specified condition “at the time of the clinical onset of Cushing syndrome”. If the specified condition appears after the clinical onset, it does not satisfy. For example, if a pituitary adenoma is discovered after Cushing syndrome is diagnosed, but the adenoma existed at onset in retrospect, the timing must be established. The ninth gotcha: the SoP requires that the factor be related to relevant service. This means even if a claimant meets all the dose criteria for glucocorticoid therapy, they still must prove that the therapy itself was related to service (e.g., prescribed for a service-related condition). If the glucocorticoid was used for a non-service condition, the factor is not related to service. The instrument does not presume service connection simply because treatment occurred during service. The tenth gotcha: section 11 incorporates other SoPs as in force from time to time. If another SoP is amended after this Cushing syndrome SoP was made, the new version applies. Claimants must monitor changes to other SoPs that affect their claim.

For claimants and their representatives, compliance means assembling evidence that meets at least one factor in section 9 and proving the factor is related to relevant service. Start by obtaining a diagnosis of Cushing syndrome that matches the definition in subsection 7(2). A specialist endocrinologist’s report confirming the disorder from excess glucocorticoids is ideal. The report should note the ICD-10-AM code if possible, but the substantive definition governs. Next, identify which factor potentially applies. If the cause is endogenous, obtain imaging and pathology to confirm a specified condition (adrenal neoplasm, pituitary ACTH neoplasm, adrenal hyperplasia, or neuroendocrine neoplasm). The time of clinical onset of Cushing syndrome must be established from medical records or symptoms. The specified condition must have been present at that time; if the tumour is discovered later, a retrospective medical opinion that it existed at onset is needed. For exogenous glucocorticoid use, compile a complete treatment history including drug names, doses, routes, frequency, and duration. For oral or injectable glucocorticoids, calculate the cumulative dose and average daily rate across the entire treatment period, not just the period before onset. Use the table in the definition of “equivalent glucocorticoid therapy” to convert different glucocorticoids to the listed ones. For example, if the patient took methylprednisolone, ensure the cumulative dose is at least 300 mg and the average rate at least 10 mg/day. If the therapy was intermittent or tapered, the calculation may be complex. Document the date of the last dose; if therapy ceased, the clinical onset must be within 30 days. For topical glucocorticoids, identify the product and potency: check if it is on the list of high or very high potency topical glucocorticoids. If not, an expert opinion on equivalent potency is needed. Document that the product was applied to at least 30% of total skin surface area daily for at least six months. This requires a specialist dermatologist’s assessment. For inhaled glucocorticoids, convert the daily dose to budesonide equivalents using the “equivalent inhaled glucocorticoid” definition. For example, fluticasone propionate 1,000 mcg daily is equivalent to (1,000/2,500)*4,000 = 1,600 mcg budesonide, which is below the 4,000 mcg threshold. Only if the dose reaches at least 4,000 mcg budesonide equivalent for at least six months does the factor apply. For concurrent use with a drug that inhibits CYP3A4, either show that the drug is on the specified list or provide pharmacological evidence that it inhibits CYP3A4 by at least 30%. The concurrent use must be daily for at least four weeks. For medroxyprogesterone acetate or megestrol acetate treatment for malignant disease or HIV, show treatment duration at least four weeks and ensure clinical onset occurs within 30 days of cessation if treatment stopped. For inability to obtain appropriate clinical management, document the circumstances: what management was appropriate, why it was not obtained, how that is related to service (e.g., lack of medical facilities during deployment), and how it materially contributed to or aggravated pre- or during-service Cushing syndrome. This factor only applies to aggravation, not initial onset. Decision-makers must verify each element: the diagnosis, the factor’s existence, timing, and service connection. They should not assume a connection because the treatment occurred during service; the treatment itself must be for a service-related condition or the circumstances of service must have led to the inability to obtain management. For all factors, maintain a clear chronological timeline: clinical onset date, treatment dates, cessation dates, and diagnosis dates. The 30-day window is critical. If the evidence is ambiguous, a specialist medical opinion may be necessary to estimate onset. The SoP does not prescribe a standard of proof for the evidence; the reasonable hypothesis standard applies, but the factors must still be established on the balance of probabilities as a matter of fact. Claimants should also check if any other SoP applies via section 11. If the factor refers to a specified condition, the decision-maker may need to apply that condition’s SoP if it exists. Compliance is burdensome, particularly in obtaining dose calculations and expert opinions on equivalence. Given the strict thresholds, many claims will fail unless the treatment records are exceptionally detailed.