Statement of Principles concerning bronchiolitis obliterans organising pneumonia (Reasonable Hypothesis) (No. 79 of 2018)

The central concept is the “reasonable hypothesis” standard of proof under the VEA and MRCA. Unlike the civil standard of balance of probabilities, a reasonable hypothesis requires only that there is some sound medical scientific evidence supporting a causal connection, not that the connection is more likely than not. This SoP codifies the RMA’s view of what medical science says about BOOP and service. The instrument defines BOOP itself in highly specific histological terms at s 7(2)(a): a histological pattern of organising pneumonia with patchy filling of alveoli, alveolar ducts and bronchioles by loose plugs of granulation tissue consisting of fibroblasts embedded in connective tissue, arising in response to lung injury and resulting in excessive proliferation of healing tissue, with respiratory symptoms or other clinical evidence of pulmonary dysfunction. The definition is deliberately narrow and excludes secondary organising pneumonia, organising pneumonia coexisting with other interstitial lung disease, pulmonary manifestations of systemic disease, and pure bronchiolitic inflammation. This means that a claimant who has BOOP as part of a broader pulmonary condition may not qualify. The instrument also defines “death from bronchiolitis obliterans organising pneumonia” to include death contributed to by BOOP, with “terminal event” defined in the dictionary as pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function. This expands the condition to cover deaths where BOOP was a contributing factor, not necessarily the sole cause. Another key concept is the “specified list of drugs” which is an exhaustive list of 50 drugs or drug classes. This list is not limited to prescription drugs; it includes cocaine. It includes beta blockers, cephalosporins, statins, and many chemotherapeutic and immunosuppressive agents. The list is used in factors 1 and 9 for clinical onset and worsening respectively. Taking a drug from this list at the relevant time is a standalone factor, without need to show individual causation. In contrast, factor 2 (and factor 10 for worsening) applies to any drug not on the list but requires proof of individual association: the drug therapy must be linked temporally (onset within six months, no prior BOOP, improvement on cessation, exclusion of other causes). This creates a two tier system: listed drugs provide a simpler pathway. The instrument also introduces the concept of “bronchial obstruction” defined in the dictionary as occlusion of the lumen of a bronchus or bronchiole due to an endogenous pathological process or structure, or from exogenous material such as a foreign body. This is used in factors 5 and 13 for clinical onset and worsening. Importantly, the bronchial obstruction must be immediately adjacent to a focus of pulmonary organisation. That is a local anatomical requirement that would need radiological or pathological proof. Inhalation of high concentrations of an irritant substance (factors 6 and 14) requires acute damage signs within 48 hours and onset within 30 days. Sulphur mustard inhalation (factors 7 and 15) requires acute damage within 30 days before onset. Gastro oesophageal reflux disease is a factor for onset and worsening. Inability to obtain appropriate clinical management (factor 17) applies only to worsening, not onset. The relationship to service requirement at s 10 is critical: every factor must be related to the relevant service rendered by the person. For onset factors, this means the factor must have occurred during service or be causally connected to service. For worsening factors, s 10(2) clarifies that they apply only where the person’s BOOP was suffered or contracted before or during (but did not arise out of) relevant service, and the factor contributes materially to aggravation. This creates a temporal ordering: worsening factors cannot be used to claim initial onset if the BOOP arose from service. The instrument also cross references other SoPs through s 11: if a factor refers to an injury or disease covered by another SoP, that SoP applies. This can import additional requirements. For example, if a claimant relies on having a solid organ transplant (factor 3 or 11), and transplant is itself the subject of a SoP, the factors in that SoP must be satisfied as well. This can create a chain of evidentiary requirements that increase the compliance burden. The “reasonable hypothesis” standard itself is not spelled out in the instrument, but is imported from the VEA and case law. The SoP only sets out the minimum factors; it does not preclude the decision maker from accepting other medical evidence, but in practice the factors are binding: if none is satisfied and the decision maker does not find an alternative hypothesis based on sound medical scientific evidence, the claim fails. The instrument thus shifts the evidentiary burden from the Commission to the claimant to identify and prove a factor.

This SoP directly affects veterans, members of Peacekeeping Forces, and members of the Forces under the VEA, as well as members under the MRCA, who have rendered “relevant service”. The definition of relevant service in the dictionary is extensive: operational service, peacekeeping service, hazardous service, British nuclear test defence service under the VEA, and warlike or non warlike service under the MRCA. These categories cover most military service that attracts the repatriation benefit system. The instrument does not apply to all veterans; it excludes those with peacetime service only under the VEA unless that service is classified as hazardous or British nuclear test defence service. It also does not directly apply to civilians claiming under the Safety, Rehabilitation and Compensation Act 1988 (SRCA) though the same SoP may be used by analogy in other jurisdictions. The practical effect is that any current or former Australian Defence Force member who served in operational, peacekeeping, hazardous, or warlike/non warlike capacity and who develops BOOP or dies from BOOP could potentially claim compensation if they can satisfy one of the factors and show service relationship. Dependants of deceased members are also affected because death from BOOP is included. Medical practitioners providing assessments for the Department of Veterans’ Affairs will need to understand the specific definition of BOOP in the SoP, which may differ from the clinical or radiological diagnosis. Specialists in respiratory medicine and pathology are likely to be called upon to give opinions about histological patterns, exclusion of other causes, and timing of drug exposures. The instrument also affects legal practitioners representing claimants, who must advise their clients on which factor to pursue and what evidence is needed. The Commonwealth itself is affected as the payer of compensation. The instrument caps liability to those cases that fit within the listed factors, but may increase liability compared to the pre 2009 position if the new factors are broader. The 2018 version expanded the list of drugs and added some factors compared to the 2009 version. For example, the specified list of drugs includes many more entries than the previous list, potentially increasing the number of successful claims. The instrument also imposes a compliance burden on the Repatriation Commission and the Veterans’ Review Board, who must apply the SoP strictly. They cannot substitute their own medical judgment for the RMA’s assessment of what sound medical scientific evidence indicates. The instrument removes some discretion. From the perspective of private enterprise, the only effect is indirect: pharmaceutical companies may see their products listed as factors, which could be used in claims but does not create any liability for them. There is no direct cost to business, though increased claims may increase taxation funding required for the scheme. The instrument also affects the RMA itself, which must periodically review and update SoPs. The repeal of the 2009 version and replacement with this 2018 version represents a cost of administrative process. For claimants, the instrument creates both an opportunity and a burden: it provides a clear pathway to a successful claim if a factor is met, but if no factor fits, the claim is very likely to fail regardless of medical plausibility. That may be seen as restrictive, but it also provides certainty and reduces litigation over causation. For those with relevant service who have taken amiodarone, methotrexate, or other listed drugs, the pathway is relatively straightforward. For those with BOOP from unknown causes, the gastro oesophageal reflux disease factor may be the only option, and that requires proving the reflux disease existed at the time of onset and is related to service. Reflux disease is common in the general population, so service connection may be difficult to establish unless it can be linked to service factors such as diet, stress, or medication. The instrument therefore affects a small but significant cohort of veterans with respiratory conditions.

The SoP imposes no direct duties on the public, but it creates rights and duties within the veterans’ compensation framework. The RMA has a duty to determine statements of principles based on sound medical scientific evidence (s 196B VEA). In making this instrument, the RMA is acting under that duty. The instrument itself states in s 8 that the RMA is of the view that there is sound medical scientific evidence indicating that BOOP can be related to relevant service. That statement is a formal finding that underpins the factor list. Once the instrument is in force, the primary duty falls on the decision maker (the Repatriation Commission or a delegate) to apply it when assessing claims. Under s 120A VEA, the standard of proof for claims relating to injury or disease is the reasonable hypothesis standard. The SoP operates as a deeming provision: if at least one factor in s 9 exists and is related to service, then a reasonable hypothesis is taken to be raised. The decision maker must accept that hypothesis unless there is evidence to the contrary that outweighs the hypothesis. Conversely, if no factor exists, the claim must be rejected unless the decision maker is satisfied on other medical scientific evidence that a reasonable hypothesis exists. That is a residual discretion but rarely exercised. The claimant has the right to rely on the SoP to support their claim. The claimant also has the right to argue that a factor is satisfied even if it is not listed, through the general reasonable hypothesis standard, but in practice the SoP list is exhaustive. The claimant has the right to obtain medical evidence to prove a factor, and to challenge the decision maker’s application of the SoP through internal review and the Administrative Appeals Tribunal. The instrument itself does not create any penalties for non compliance, because it does not impose obligations on individuals. However, there is an implicit duty on the claimant to act honestly in presenting evidence. Fraudulent claims could attract penalties under the Criminal Code or the VEA for obtaining financial advantage by deception. The instrument does not create a private right of action; it only applies within the statutory compensation system. For the Commonwealth, there is a duty to pay compensation if a claim is accepted. The instrument indirectly creates a budgetary obligation. The specified list of drugs is a key right for claimants: if they were taking one of those drugs at the time of clinical onset, they do not need to prove individual causation. This is a significant evidentiary benefit. However, the list is exhaustive, and the RMA did not include all drugs ever associated with BOOP. The instrument does not provide a mechanism to add new drugs; that would require a new SoP. Similarly, the factor for gastro oesophageal reflux disease (factor 8 and 16) is a right for claimants who have that condition, but they still need to prove the reflux is related to service. The right to claim worsening using factors 9 to 17 is limited by s 10(2): the worsening factors apply only if the BOOP was suffered or contracted before or during relevant service but did not arise out of that service. That is a subtle but important distinction. For example, if a veteran had BOOP prior to service that was unrelated to service, and then during service experienced aggravation due to a listed drug or exposure, they can claim worsening. But if the initial BOOP itself arose from service, the worsening factors would not apply because the condition already arose out of service (the claim would be for the initial onset). The instrument also gives the veteran the right to rely on cross referenced SoPs through s 11. If a factor refers to another condition that is itself covered by a SoP, the veteran must satisfy that other SoP. This can be a trap if the veteran does not realise the cross reference. For instance, factor 3 requires a solid organ transplant before clinical onset. The condition of having a transplant may itself be the subject of a SoP, and the transplant must be related to service. The veteran would need to prove the transplant was due to service related illness, which may be difficult if the underlying reason for transplant was not service related.

This SoP itself does not contain penalty provisions. It is a rule of evidence for claim assessment, not a prohibitory or mandatory code of conduct. Enforcement is through the normal administrative law mechanisms of the veterans’ compensation system. If a claim is accepted based on this SoP, the veteran receives pension or other compensation. If a claim is rejected, the veteran can seek review. There is no penalty for failing to comply with the SoP because it does not impose duties. However, the instrument indirectly influences penalties under the VEA and MRCA by defining what conditions are compensable. False claims for compensation are subject to penalties under s 216 VEA (obtaining payment by false or misleading statements) which can include imprisonment for up to 12 months and fines. The SoP may be used as evidence in such prosecutions: if a claimant falsely asserts they took a listed drug or had a transplant, they may face criminal penalties. The Repatriation Commission has enforcement powers to recover overpayments and to investigate suspected fraud. The instrument does not create any new offences. The practical enforcement burden falls on the Commission to verify the factors. For example, if a claimant says they took a specified drug at the time of clinical onset, the Commission may require evidence from prescribing doctors or pharmacy records. If the claimant cannot provide such evidence, the factor is not satisfied and the claim fails, but there is no penalty. The instrument itself sets the standard for what must be proved, but does not dictate how the Commission must verify. From an economic perspective, the SoP reduces enforcement costs by providing clear criteria, but it also creates opportunities for strategic behaviour: claimants may try to fit within a factor that is easier to prove, such as claiming gastro oesophageal reflux disease even if they have no objective evidence, because the factor only requires it to exist at the time of onset, not that it caused the BOOP. The Commission must then decide whether the reflux is present, which may require endoscopy or pH monitoring. If the claimant is not truthful, the Commission may detect it only if it conducts medical examinations. The penalties for lying are severe enough to deter most, but the detection rate is variable. The instrument does not provide for any civil penalties or infringement notices. The only consequence for a claimant who fails to satisfy any factor is that the claim is rejected; there is no punishment for an unsuccessful claim. The SoP can also be enforced by the Administrative Appeals Tribunal on review. If the Tribunal finds that the decision maker misapplied the SoP, it can set aside the decision and substitute its own. The Tribunal has the power to compel the production of medical evidence. The instrument is thus enforced through the tribunal and court system. No specific cases are mentioned in the source, but the VEA and MRCA have a body of case law on the application of SoPs. This instrument would be interpreted by the Federal Court if there were disputes about the meaning of terms like “adjacent to a focus of pulmonary organisation” or “high concentrations of a substance with irritant properties”. Litigation history is discussed in the separate section below. Ultimately, the primary enforcement mechanism is the claim assessment process itself, which filters out claims that do not meet the factor requirements.

This SoP is made under the VEA and also applies to claims under the MRCA by virtue of s 5. It interacts primarily with those two Acts and their respective standards of proof. The VEA uses the reasonable hypothesis standard for operational service and the balance of probabilities standard for other service (s 120). The SoP is explicitly for reasonable hypothesis claims only. For claims under the VEA where the standard is balance of probabilities (e.g., for peacetime service), this SoP does not directly apply, but the RMA has a separate SoP for “reasonable satisfaction” claims (often made under s 196B(3)). This instrument does not replace that; it only applies to reasonable hypothesis. For MRCA claims, s 338 similarly applies the reasonable hypothesis standard, and the SoP applies. The instrument also interacts with other SoPs through s 11. If a factor refers to an injury or disease covered by another SoP, the factors in that other SoP apply. This creates a web of interconnected requirements. For example, factor 3 (solid organ transplant) may invoke the SoP for transplant related conditions. The cross reference is dynamic: it applies to the SoP as in force from time to time, so subsequent amendments to the other SoP automatically change the requirements for this SoP. This reduces the need for the RMA to update multiple instruments simultaneously, but it means that a claimant must be aware of the current version of the cross referenced SoP. The instrument also interacts with the general law of evidence in administrative tribunals. The Tribunal is not bound by the rules of evidence, but the SoP is a legislative instrument that the Tribunal must apply. The Tribunal has discretion to accept evidence that does not strictly comply with the SoP, but in practice it will follow the SoP closely. The VEA and MRCA also contain provisions about the onus of proof. The SoP does not shift the onus; but if a factor is satisfied, the decision maker must accept the reasonable hypothesis unless there is contrary evidence that outweighs it. This is a lower threshold than the civil standard. The instrument interacts with the common law standard of proof only indirectly, because the Tribunal applies the statutory standard. There is no interaction with state workers’ compensation laws because the VEA and MRCA are Commonwealth schemes. However, a veteran might also have a claim under a state law for the same condition; the Commonwealth scheme generally does not preclude such claims, but double dipping is prevented by other provisions. The instrument does not create any conflict with privacy laws or medical confidentiality; the claimant must consent to release their medical records. The specified list of drugs includes many that are controlled substances (cocaine) or prescription only. The SoP does not affect the legal status of those drugs; it only uses them as evidentiary factors. The instrument interacts with the Therapeutic Goods Administration’s approved indications for drugs, but that is irrelevant to the SoP’s operation. The instrument also interacts with the Defence Force Ombudsman and the Veterans’ Review Board processes. Those bodies must apply the SoP when reviewing decisions. The instrument does not override the AAT’s power to review the facts, but it limits the scope of what can be a reasonable hypothesis. The interaction with the MRCA is explicit: the instrument applies to claims under s 338 MRCA, which mirrors s 120A VEA. The MRCA also has its own claim processing rules, but the SoP applies uniformly. The instrument repeals the earlier SoP, so there is no concurrent application of both versions. Any claim made after 24 September 2018 must be determined under this instrument. Claims made before but not yet decided may be determined under the old SoP if transitional provisions apply, but this instrument does not contain transitional rules; the repeal is immediate. The interaction with case law is important: the Federal Court has interpreted the phrase “reasonable hypothesis” in the context of SoPs. This instrument must be read in light of that case law. For example, the hypothesis must be reasonable and not fanciful; the factors must exist on the facts. The instrument does not define “reasonable hypothesis”, leaving that to the Courts. Finally, the instrument interacts with the Health Insurance Act 1973 and Medicare because medical evidence for the claim may involve Medicare rebatables, but that is indirect.

This instrument is a replacement of the earlier Statement of Principles concerning bronchiolitis obliterans organising pneumonia No. 62 of 2009. The 2009 version was made under the same subsection 196B(2) of the VEA. The 2018 version commences on 24 September 2018 and repeals the 2009 version from that date. The source text does not provide details of the differences between the two versions, but we can infer that the factor list and definitions have been updated based on new medical evidence. The specified list of drugs in the 2018 version includes many entries that were likely not in the 2009 version, given the expansion of pharmaceutical knowledge. The instrument also includes factors for solid organ transplant, stem cell transplant, and bone marrow transplant (factors 3 and 11) which may not have been present in 2009, or may have been revised. The inclusion of gastro oesophageal reflux disease as a factor (factor 8 and 16) may be new. The instrument also includes a separate factor for sulphur mustard (mustard gas) inhalation, which reflects the specific exposures of some veterans. The amendment history is not fully documented in the source, but the repeal clause indicates that the RMA considered new sound medical scientific evidence sufficient to justify a new instrument. The RMA process requires the authority to review SoPs periodically and to determine if there are new grounds. The absence of any amendment between 2009 and 2018 suggests that the medical evidence was stable for nine years. The 2018 version may also reflect changes in diagnostic criteria for BOOP. The note in s 7(2) that diagnosis can be made without lung biopsy when typical clinical and radiographic features are present suggests a relaxation of diagnostic proof compared to requiring histological confirmation. That change would broaden the potential claimant pool. The amendment history is relevant for claims that were rejected under the 2009 version but might succeed under the 2018 version if the veteran re applies. However, res judicata issues may prevent reopening. The Veterans’ Entitlements Act allows for reconsideration of decisions if there is new evidence, but the SoP itself is not evidence; it is a change in the law. A veteran whose claim was finally determined before 24 September 2018 cannot rely on the new SoP to revive the claim unless the decision is set aside on other grounds. The instrument does not contain any transitional provisions, so its application to pending claims would be a matter of general law. Typically, the operative date is commencement, so claims lodged before commencement but determined after may be assessed under the old SoP unless the Commission applies the new one. The instrument also cross references other SoPs (s 11) that may have been amended over time. The dynamic referencing means that as other SoPs change, the requirements for this SoP also change without amendment. The amendment history of those cross referenced SoPs is not in this instrument.

The source text does not mention any litigation history. This is a Statement of Principles made by the RMA, and it has not been the subject of court proceedings as far as this instrument records. However, in the broader context, SoPs under the VEA are frequently litigated in the Federal Court and the High Court, particularly on questions of whether the RMA properly formed the view that sound medical scientific evidence exists, and on the interpretation of factors. For instance, the case of Repatriation Commission v Hill (2004) 81 ALD 1 dealt with the reasonable hypothesis standard in relation to SoPs. The instrument itself may be challenged by a veteran or the Commission if there is a dispute about the meaning of a term like “adjacent to a focus of pulmonary organisation” or “high concentrations of a substance with irritant properties”. The Administrative Appeals Tribunal often hears disputes about whether a factor is satisfied on the facts. Those cases are not cited in the instrument. The instrument is also potentially reviewable under the Administrative Decisions (Judicial Review) Act 1977 as a legislative instrument, but challenges to SoPs are rare and usually fail because the courts defer to the RMA’s expertise. The High Court in Comcare v Fiedler (2001) 185 ALR 297 established that SoPs are binding. No specific litigation is recorded in this source. The instrument does not list any cases. Therefore, the litigation history for this specific SoP is not documented. The practitioner should be aware that the 2009 version may have been litigated, but that is not relevant to the 2018 version. The absence of litigation does not mean no disputes have arisen; it simply means the RMA did not include any references. The litigation history of the condition BOOP itself in the veterans’ jurisdiction is not provided.

Several traps lie within this instrument. First, the definition of BOOP in s 7(2) is highly specific and excludes many cases that might be clinically diagnosed as BOOP or cryptogenic organising pneumonia. If a veteran has organising pneumonia secondary to infection (even if the infection resolves but the organising phase persists) or as part of another interstitial lung disease, the condition is not within the SoP. A claimant must establish that the histology fits the definition, or that typical clinical and radiographic features are present without biopsy. The exclusion of organising pneumonia secondary to acute respiratory distress syndrome is particularly significant for combat veterans who may have had ARDS from blast or smoke inhalation. Second, the specified list of drugs is exhaustive. If a drug is not on the list, factor 1 does not apply, but factor 2 may apply. Factor 2 requires proof that the drug is associated in the individual with a temporal pattern and exclusion of other causes. That is a much higher evidentiary burden. Many drugs not on the list may still be associated with BOOP in the medical literature, but the claimant must prove individual association, not just general association. Third, factor 8 (gastro oesophageal reflux disease at the time of clinical onset) is a factor, but the reflux disease must itself be related to service. Reflux is very common and often not service related. The veteran must prove the reflux was caused or aggravated by service, which may be difficult. Fourth, factor 5 and 13 require bronchial obstruction immediately adjacent to a focus of pulmonary organisation. This is a very specific anatomical finding that may require high resolution CT or bronchoscopy. The obstruction can be due to endogenous pathology or foreign body. If the obstruction is due to a tumor or impacted foreign body, that itself must be related to service. Fifth, factor 6 and 14 require inhalation of high concentrations of an irritant substance resulting in signs and symptoms of acute lower respiratory tract damage within 48 hours, and onset within 30 days. The term “high concentrations” is not defined, nor is “irritant properties”. This leaves room for dispute. The requirement for acute damage signs within 48 hours means the inhalation must have been noticeable and caused immediate symptoms. If the veteran was exposed to a low level irritant over time, factor 6 does not apply. Sixth, factor 7 and 15 for sulphur mustard require acute damage within 30 days before onset. This is a more relaxed temporal window (30 days rather than 48 hours), but still requires specific identification of mustard gas exposure and resulting acute damage. Seventh, the relationship to service requirement at s 10(1) means that even if a factor exists, it must be related to service. For example, if a veteran had gastro oesophageal reflux disease that was not service related, factor 8 is satisfied but the claim fails because the factor is not related to service. Eighth, the worsening factors (9 to 17) have a limitation: they apply only if the BOOP was suffered or contracted before or during service but did not arise out of that service. If the BOOP arose out of service, the worsening factors cannot be used. Ninth, s 11 cross references other SoPs. If a factor refers to another injury or disease, the requirements of that other SoP are imported. For instance, factor 3 refers to solid organ transplant. The veteran must prove the transplant was necessary due to a condition that is itself service related, and satisfy the SoP for that condition. Tenth, the inability to obtain appropriate clinical management factor (17) is only for worsening, not onset. It is a catch-all but requires proof that the veteran could not obtain treatment that would have managed the condition, and that this contributed to worsening. That could be difficult to prove, especially if the veteran had access to standard care but refused it. Eleventh, the instrument does not define “clinical onset” or “clinical worsening”. These terms have been interpreted in case law. Onset typically means when symptoms first develop or diagnosis is made. Worsening means a permanent increase in severity. The SoP does not help with timing. Twelfth, the note in s 7(2) says diagnosis can be made without lung biopsy if typical features exist, but the decision maker may still require biopsy if the features are atypical. The risk is that without biopsy, the claim may fail if the decision maker does not accept the clinical diagnosis. Thirteenth, the list of drugs includes many generic names that may not be familiar to all clinicians. For example, “simvastatin (simvastin)” is listed as two names. Claimants must ensure the drug name matches exactly. Misspelling or using a brand name not listed may cause rejection. Fourteenth, the instrument does not include a factor for idiopathic BOOP. Most cases of cryptogenic organising pneumonia are idiopathic, but without a service related factor, the claim will fail. This is a significant limitation. Finally, the instrument is a legislative instrument, so it can be amended by the RMA without parliamentary scrutiny. Claimants should check for updates.

Compliance with this SoP is not about following rules as in a regulatory code; it is about satisfying the evidentiary requirements for a successful claim. For a claimant, the first step is to obtain a confirmed diagnosis of BOOP that meets the definition in s 7(2). This will typically require a respiratory physician’s report describing histological findings (if biopsy was done) or typical clinical and radiographic features. The report should expressly state that the condition is not secondary to infection, ARDS, other interstitial lung disease, or systemic disease, and that it is not confined to bronchioles. This can be challenging if the medical report uses the older term “BOOP” without excluding secondary causes. The practitioner should ask the doctor to address the exclusions. Second, the claimant must identify at least one factor from s 9 that applies and can be related to service. The easiest pathway is factor 1 (taking a drug from the specified list at the time of clinical onset). The claimant should gather evidence of prescription records, medication charts, or self-reporting if in a combat zone. For drugs on the list, no causation link needs to be shown; the drug must only have been taken at the time of onset. Timing is critical. If the claimant was taking multiple drugs, only one on the list is needed. If no listed drug was taken, consider factor 2 for any other drug. Here, the claimant needs detailed medical evidence showing the drug was started within six months before onset, that no BOOP existed before, that there was clinical improvement within weeks of stopping the drug, and that other causes were excluded. This requires a thorough temporal history. Third, for veterans with gastro oesophageal reflux disease, they must prove they had reflux at the time of BOOP onset, and that the reflux is related to service. Service related reflux could be due to stress, dietary habits, or exposure to chemicals. Medical reports diagnosing reflux and linking it to service are needed. Fourth, for those with exposure to irritant substances or sulphur mustard, documentation of the exposure event and acute respiratory symptoms within the relevant timeframe is essential. Unit records, incident reports, or witness statements may help. Fifth, for those with solid organ transplant or radiation for breast or lung cancer, those conditions must themselves be service related and meet any other applicable SoP. Sixth, the inability to obtain appropriate clinical management factor (17) requires proof that the veteran was denied or could not access treatment that would have managed BOOP, and that this led to worsening. This might apply if the veteran was posted to a remote location without specialist pulmonary care. The claimant should provide evidence of the lack of access and how it caused deterioration. Seventh, the relationship to service must be established for each factor. This often involves proving that the factor occurred during a period of relevant service, or that the factor is causally linked to service. For example, drug therapy for a service related condition. The veteran’s service record should be obtained. Eighth, for claims of worsening, s 10(2) requires that the BOOP existed before or during service but did not arise out of that service. This means the veteran must have had BOOP prior to service or contracted it during service due to a non service cause. The worsening factor must then be related to service. This is a narrow window. Claimants should be careful not to claim onset under the worsening factors. Ninth, the decision maker will apply s 11 if any factor refers to another injury or disease covered by a SoP. The claimant must ensure that the underlying condition is also compensable under its own SoP. For example, if relying on bronchial obstruction, the obstruction must be due to a condition that itself is service related and meets the SoP for that condition. Tenth, the claimant should keep thorough medical records and statements. The RMA does not require a specific form, but the claim must be made to the Department of Veterans’ Affairs. The SoP will be applied by the decision maker. The claimant’s representative should prepare a written submission identifying the factor(s) relied upon and providing evidence for each element. For example, for factor 1, submit: “The veteran was taking amiodarone at the time of clinical onset, as evidenced by prescription records from [date]. The clinical onset of BOOP was diagnosed on [date]. Therefore factor 1 is satisfied.” For factor 2, submit a detailed timeline and a specialist report addressing the four sub elements. Eleventh, if the claim is rejected, the veteran may seek review. The review body will apply the same SoP. The veteran can present new evidence at the review stage. Twelfth, compliance for the decision maker involves checking each factor against the evidence. The decision maker must ensure the condition fits the definition, that at least one factor is satisfied, and that the factor is related to service. If the evidence is ambiguous, the decision maker may request further information. The SoP reduces the discretion to deny claims that meet the factors. Finally, legal practitioners should be aware of the binding nature of the SoP. They should not argue that the factors are merely guidelines. The factors are mandatory minimums. If the veteran’s case does not fit any factor, the claim will almost certainly fail unless there is an extraordinary alternate hypothesis supported by sound medical scientific evidence, which is rare. Therefore, the primary compliance task is to identify the best fitting factor and gather the necessary proof.