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Guide to using SOPs
Guide to Using SOPs
- SOPs and Diagnosis
- SOP definitions
- Choosing the correct SOP
- SOP names and diagnostic labels
- SOP information in CLIK
- SOP factors
- Reasonable Hypothesis (RH) versus Balance of Probabilities (BOP) SOPs
- Non-SOP conditions
This guide has been written by DVA Policy Support Branch without any involvement by the Repatriation Medical Authority.
The following information relates to claims made under the Veterans’ Entitlements Act 1986 (VEA) or the Military Rehabilitation and Compensation Act 2004 (MRCA), but not claims made under the Safety, Rehabilitation and Compensation Act 1988 (SRCA).
Statements of Principles (SOPs) are legislative instruments made by the Repatriation Medical Authority (RMA), an independent statutory authority. They are used when deciding whether medical conditions or deaths can be accepted as related to service under the VEA and the MRCA.
SOPs made by the RMA are about types of diseases and injuries (and deaths due to those diseases or injuries). Some SOPs cover single diseases or injuries, some cover groups of related diseases or injuries. The RMA does not make SOPs about exposures (e.g. radiation, herbicides), classes of veterans, symptoms (e.g. back pain) or other entities that are not diseases or injuries.
In each SOP the RMA sets out the factors by which the disease or injury in question may be potentially related to service. The factors are based on sound medical-scientific evidence about how the disease or injury may be caused or worsened, or how the risk of developing that disease or having that injury may be increased.
Most claims for disease, injury or death, under both the VEA and the MRCA, are determined using SOPs. The exceptions are when:
- The RMA has not determined a SOP for the particular type of disease or injury, or the kind of death, and has not declared that it does not propose to make such a SOP (see Non-SOP conditions, below, and Declarations by the RMA);
- Death is directly due to an accepted disability (see Departmental Instruction C04 of 2005);
- The injury or disease was caused or aggravated as an unintended consequence of treatment provided by the Commonwealth (MRCA claims only – Section 29);
- There has been aggravation of signs or symptoms of an injury or disease by service (MRCA claims only – Section 30).
For all other claims, the SOPs are legally binding on decision makers and must be used. A decision maker has no discretion to disregard a SOP, or to consider any factors that are not covered by a relevant SOP.
When a claim is lodged to have a medical condition accepted as service related, one of the steps is to determine the medical diagnosis or diagnoses that apply for each claimed condition.
For death claims it is necessary to determine the diagnoses for the medical condition/s that caused the death.
Decisions about diagnosis are made using the reasonable satisfaction standard of proof. They are based on advice from suitably qualified medical practitioners.
Once the diagnosis has been determined it is then necessary to see whether there is a SOP that applies for that particular condition. Each SOP has a definition of the kind of disease, injury or death that the SOP is about. That definition is used to decide whether a particular SOP applies. The name of the SOP is not sufficient to decide whether the SOP applies to a particular claim. This is discussed further, in the next section.
SOP definitions do not have any formal role in determining diagnoses for claimed conditions. However, SOP definitions generally correspond with how a disease or injury would be defined for clinical purposes and so can be used as a guide for diagnosis.
For more information, see Advisory note no. 8 of 2004 in the Compensation and Support Reference Library in CLIK. This concerns the Full Federal Court decision in the case of Benjamin v The Repatriation Commission.
SOP definitions vary in nature with the type of injury or disease that the SOP is about. Some are simple and straightforward. Some contain multiple criteria, or thresholds that must be reached, or a list of excluded conditions. Many require clinical manifestations (symptoms or signs) to be present, but some do not.
All necessary requirements stated in a SOP definition must be met before that SOP can be applied.
There are situations where the RMA will set particular requirements or exclude certain sub-types of a disease, e.g. because of the nature of the available medical-scientific evidence, or for other practical reasons. In such cases the definition may differ from one that might be used clinically. For example, a malignant carcinoid tumour arising in the lung is a rare type of lung cancer that has a different aetiology (causation) to the more common types of lung cancer (adenocarcinoma, squamous carcinoma) and is unrelated to smoking. It is excluded from the SOP for malignant neoplasm of the lung.
Although the SOP definitions do not have a formal legal role in diagnosis, for practical reasons and as a matter of policy, the Department uses benchmarks set by the RMA in SOP definitions to decide when a disease or injury is present. For example, for psychiatric disorders, the RMA SOP definitions are based on the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition) or its predecessor, DSM-IV-TR. The Department also requires DSM-5 or DSM-IV-TR criteria to be met before a diagnosis for a psychiatric disorder can be confirmed.
A SOP definition may or may not include the ICD codes (ICD-10-AM – the International Classification of Diseases, 10th revision, Australian Modification) that the SOP attracts. When they are included their purpose is to assist decision makers when using Departmental computer-based decision systems, which are ICD code driven.
SOPs are classified and organised in a different way to the ICD code system. ICD codes don’t always neatly fit and correspond with the disease or injury that a SOP is about. ICD codes will not be included as part of the SOP definition if there is conflict or inconsistency between the codes and the words of the definition.
The words of a SOP definition determine whether a SOP applies, not the ICD codes.
SOPs are regularly reviewed and updated by the RMA. The update may take the form of a revocation of the previous SOP and the determination of a new (replacement) SOP, or there may be an amendment made to an existing SOP.
Amendments are made by issuing separate instruments. A SOP may have been amended more than once, so there can be multiple separate SOP instruments that together comprise the SOP that is currently in force. For amended SOPs a compilation version is available that combines the original instrument and the amendments into one document.
Updates to a SOP can sometimes involve a change to the name of the SOP or to the conditions covered under the SOP.
The SOPs section of the RMA intranet site has the current SOPs, the previous SOPs and compilation SOPs for those that have been amended. The What’s new section of the RMA site details recently issued SOPs.
There is a pair of SOPs for each condition. The "reasonable hypothesis" (RH) SOP applies to operational (including warlike and non-warlike), peacekeeping, hazardous, or British nuclear test defence service under the VEA, or warlike or non-warlike service under the MRCA. The "balance of probabilities" (BOP) SOP applies to other eligible and defence service under the VEA and peacetime service under the MRCA.
The SOP instruments are numbered, with the lower number of a pair being the RH instrument. Amending instruments are usually issued as pairs, but at times an amendment will be made to only the RH SOP or only the BOP SOP. As a consequence, the type of instrument (RH or BOP) is not denoted by whether it is an odd or even number.
The SOP (as amended, if applicable) that is current at the time a claim is decided, and that relates to the relevant standard of proof/type of service, must be applied. There can be accrued rights for an older SOP to be considered in certain review/appeal situations.
For each disease or injury for which there is a SOP, there will be only one SOP (or one pair of SOPs, if there are different types of service) that applies. There are a small number of exceptions to this "rule".
If more than one SOP is being considered for a particular condition, this will generally mean that the diagnosis has not been properly resolved. In this case the diagnosis needs to be decided, on balance, first.
The specific diagnostic label that is given to a claimed disease or injury is important. It needs to be sufficiently descriptive and accurate, so that the extent of liability can be established, the appropriate compensation provided and treatment eligibility determined, now and in the future.
It will often be appropriate or suitable to use the name of a relevant SOP as the diagnostic label given to a claimed condition. Sometimes more information should be included, such as the side or site of the body that is involved (particularly for joint conditions).
Sometimes the SOP name should not be used, e.g.:
- The gastric ulcer and duodenal ulcer SOP covers two discrete conditions. A person will generally have one or the other, but not both.
- Physical injury due to munitions discharge – using this SOP name as a diagnostic label gives no information to the claimant, a treatment provider, or someone assessing impairment, as to what specific injury or injuries have been accepted or rejected.
For each disease or injury for which there are SOPs CLIK provides a range of information, including:
- Links to the current RMA SOPs;
- A link to a SOP bulletin containing details of changes made in the most recent SOPs;
- A brief description of the condition;
- Information on what evidence is needed to confirm the diagnosis and that the SOP applies;
- Lists of diagnostic labels that are and are not covered by the SOP;
- Information on identifying when the clinical onset of the condition occurred; and
- Information on SOP factors, taken from the CCPS Rulebase. Note: this information is unlikely to be up-to-date for the current SOPs.
The diagnostic and clinical onset information provided has been prepared by Departmental medical advisers for the assistance of decision makers and SOP users. It is Departmental policy, but it does not have the binding legal status of the SOPs themselves.
Each SOP has a factor or factors that set out how the disease or injury may be related to service. There are two general types of factors in SOPs: clinical onset factors; and clinical worsening factors.
In a given SOP, there may be no clinical onset factors, or no clinical worsening factors (apart from inability to obtain appropriate clinical management - see below). This depends on the nature of the condition and on the available medical-scientific evidence.
There are some factors that apply only to certain subtypes of a disease or injury. For example, the cerebrovascular accident (stroke) SOP covers ischaemic stroke, haemorrhagic stroke and transient ischaemic attacks. Within that SOP there are some factors that apply for all types of stroke covered by the SOP, but also other factors that apply only for ischaemic stroke, or only for haemorrhagic stroke.
Clinical onset factors concern causal factors, or risk factors, for developing a disease or sustaining an injury. Accurately determining the clinical onset is important, because for many SOP factors the timing of exposure required by the factor is based around when the clinical onset occurred.
Clinical onset generally means when sufficient, relevant symptoms or signs or other evidence of a condition were first present, such that they would allow an appropriate medical practitioner to say that the condition first manifested at that time. This will often be a retrospective evaluation. For example: a diagnosis may have been confirmed by a test result at one point in time; symptoms consistent with that diagnosis may have been present for say, three months prior to the test: the clinical onset would then be three months before the test.
Backdating of the clinical onset to before the time of confirmation of the diagnosis may not always be possible, e.g. in the case of vague or general symptoms that are not specific to the disease or injury.
For SOPs that have diagnostic thresholds or criteria, the clinical onset will be when those thresholds were first reached, or the criteria first satisfied. This may be sometime after the first ever symptoms or other indications. For example the clinical onset of diabetes mellitus will be when the required plasma glucose levels were first demonstrated. Earlier testing showing elevated levels, but not to the degree required for a diabetes diagnosis, might indicate a person at risk of developing diabetes, but would not permit a medical practitioner to say that diabetes was present at that time.
Clinical worsening factors concern factors that can aggravate an existing disease or injury.
For clinical worsening factors to be considered, certain conditions need to be met. Clinical worsening factors can apply when:
- The disease or injury was contracted or suffered before the end of eligible service, but did not arise out of that service; and
- Service rendered after the disease was contracted or the injury was suffered aggravated or materially contributed to that disease or injury.
In practice this means that:
- If the injury or disease had its clinical onset after service then clinical worsening factors cannot be considered.
- There needs to have been a permanent worsening of the condition due to service, over and above what would have been the normal course of the disease or injury.
Many diseases tend to become worse over time, but the course of a disease can vary substantially from individual to individual. Establishing whether permanent worsening has occurred can be difficult and will require medical opinion.
A factor for inability to obtain appropriate clinical management for the disease or injury that the SOP is about is routinely included in SOPs. This is a type of clinical worsening factor, so the conditions for clinical worsening (see above) need to be met. It can apply if appropriate clinical management (for the standards and knowledge of the time) for an existing disease or injury could not be obtained and this led to a permanent worsening of the disease or injury.
A factor for inability to obtain appropriate clinical management has been included in nearly every SOP made to date, with a few exceptions (e.g. sudden unexplained death). The inclusion of this factor does not necessarily mean that there is or was contemporary treatment available that could alter the natural course of the disease or injury. The circumstances in each case need to be considered on their merits.
For more information on this subject see Advisory note 7 of 1999 in the Compensation and Support Reference Library in CLIK.
Many SOP factors contain terms or phrases that are defined (elsewhere) in the SOP. For example, the SOP for osteoarthritis contains a factor for "having trauma to the affected joint before the clinical onset of osteoarthritis in that joint". The phrase "trauma to the affected joint" is defined in that SOP and has the meaning (and only the meaning) given by that definition.
The procedure to interpret a SOP factor that has an associated definition, is to substitute the words of the definition into the factor: For example, the SOP for plantar fasciitis has a factor for:
‘having an acquired biomechanical abnormality involving the affected foot before the clinical onset of plantar fasciitis’
and a definition for:
‘"biomechanical abnormality" means injury or disease that has resulted in overpronation or underpronation, or decreased ankle or forefoot flexibility’
having an acquired injury or disease that has resulted in overpronation or underpronation, or decreased ankle or forefoot flexibility involving the affected foot before the clinical onset of plantar fasciitis.
If a SOP factor includes an "a" or an "an" immediately before a defined term (e.g., the factor is "being in an immunocompromised state as specified at the time of the clinical onset of" (disease X) and the associated definition is for "immunocompromised state as specified", then when substituting the definition into the factor, the "a" or "an" can be omitted, if needed, to retain grammatical sense.
Some definitions themselves contain terms that are also, separately defined.
Terms or phrases in SOPs that are not defined should be given their plain English meaning.
If a SOP factor concerns a disease or injury for which there is another SOP, then that other SOP has to be applied in deciding whether a claim can be accepted via that SOP factor. This is true even if that other disease or injury has been previously accepted as service-related. This procedure is referred to as propagation.
For example, if a claim is made to have ischaemic heart disease (IHD) accepted as service related and a contention is made that:
- the IHD was caused by diabetes mellitus (a factor in the IHD SOP); and
- the diabetes, in turn, was related to service,
then the diabetes mellitus SOP has to be applied when considering that contention. This does not mean that a separate claim needs to be made to have the diabetes accepted.
In some cases is may be necessary to propagate down a chain of SOPs (e.g. IHD to diabetes mellitus to cirrhosis to hepatitis B).
For each SOP factor being considered there is a two part test that needs to be applied:
- Are the requirements of the factor met in the particular case?
- If so, can the factor be related to (relevant eligible) service?
Are the requirements of the factor met?
SOP factors set out the requirements that must, as a minimum, be met before a connection to service can be considered. Some factors have quantitative elements (e.g. dose, duration, or timing of exposure) and some do not. All the requirements of a SOP factor have to be fulfilled before the factor can be regarded as met. The relationship to service does not need to be considered at this point. For factors with quantitative elements, exposure occurring outside of service can be included when deciding whether the factor requirements have been met. However, exposure occurring after the clinical onset of a disease or injury is only potentially relevant for clinical worsening and cannot be considered for clinical onset.
The way in which a factor can cause or contribute to a disease or injury varies with the type of factor and the nature of the disease or injury. The timing of the exposure and the amount of the exposure are specified in SOPs in a range of ways. Careful attention should be paid to how the timing requirements are expressed in the SOP (e.g.: at the time of versus at least X time before; a continuous period versus a cumulative period of exposure).
Can the factor be related to service?
This is a separate consideration to whether the requirements of the factor have been met. Nothing should be assumed about a relationship to service just because a factor is in a SOP. The connection to service needs to be evaluated on a case-by-case basis.
Most SOP factors are based on medical-scientific evidence that relates to non-military populations. SOP factors run the gamut from those that can be readily related to service to those where an association with service is very difficult to imagine. The inclusion of a factor in a SOP, of itself, should not be taken as indicating any more than that the RMA is of the view that it is theoretically possible that the factor could be related to service.
For factors that have quantitative requirements, it is not necessary for all of the minimum required exposure to be wholly due to service for a connection to that service to be made. Service need make only a material contribution to the exposure requirements. For more information on this see Advisory Note 4 of 2003 concerning the Federal Court Decision in Kattenberg v Repatriation Commission.
Although service-related exposure doesn’t have to make up the total dose, where there are timing of exposure requirements in the SOP factor, service-related exposure must have occurred during the specified period for a connection to service to be made.
For more information on this see Advisory Note 2 of 2008 concerning the Federal Court Decision in Repatriation Commission v Newson.
If the requirements of a SOP factor have been met and the factor can be related to service, a decision maker can, in limited, specific circumstances, still be satisfied that the claim should not succeed (e.g., if on the facts of the case, the condition was clearly and wholly caused by some other non-service-related factor). For more information on this see the Commission Guidelines following the Full Federal Court Case of Deledio.
The differences in the two standards of proof that apply for the different types of service are reflected in SOPs in several ways
- The RH SOP may contain additional factors that are not included in the BOP SOP.
- The same factors may be in both SOPs but the dose, duration, or timing requirements may be more generous in the RH SOP.
- The same factors may be in both SOPs but the associated definitions may be different. For example, a factor may be about having treatment with a drug from a defined specified list. The specified list of drugs may include more drugs in the RH SOP than in the BOP SOP.
In other instances there may be no difference between a factor in the RH and BOP SOPs. This is more likely when there are no quantitative elements to a factor.
For more information on the two standards of proof and how they relate to SOPs, see the RMA practices and procedures document, available on the What we do section of the RMA internet site.
The SOPs cover more than 90% of claims. However, there are many uncommon conditions for which no SOP has been determined.
If a claimed medical condition:
- Is diagnosed to be a disease or injury;
- Is not covered by an existing SOP;
- Is not covered by a declaration by the RMA that it does not propose to make a SOP for that condition; and
- Is not subject to a current investigation by the RMA;
Then the claim is determined as a non-SOP condition.
For more information on determining non-SOP conditions see the Commission Guidelines following the Full Federal Court Case of Deledio.
There are a number of medical conditions that are not particular diseases or injuries and that should not be diagnosed (as non-SOP conditions) in answer to a claim. These include:
- End stage processes such as cardiac failure or renal failure – the underlying disease causing the problem should be diagnosed;
- Symptoms (e.g. pain);
- Certain sub-clinical infections (e.g. asymptomatic Epstein-Barr virus infection);
- Certain degenerative or age-related conditions that have not resulted in clinical manifestations (e.g. asymptomatic joint degeneration seen on X-ray or minor atherosclerosis without clinical symptoms or signs);
- Certain abnormalities on e.g. blood tests that are not themselves a disease, e.g. elevated blood lipid levels; and
- Temporary conditions (e.g. seasickness).
The RMA has declared a number of conditions not to be diseases or injuries for SOP purposes. These conditions cannot be accepted as service related. See Declarations by the RMA for more information.