Statement of Principles concerning gastric ulcer and duodenal ulcer No. 61 of 2015

Link to law: https://www.comlaw.gov.au/Details/F2015L00657

 
Statement of Principles
concerning
 
GASTRIC ULCER AND DUODENAL ULCER
No. 61 of 2015
 
for the purposes of the
 
Veterans’ Entitlements Act 1986
and
Military Rehabilitation and Compensation Act 2004
Title
1.         This Instrument may be cited as Statement of Principles concerning gastric ulcer and duodenal ulcer No. 61 of 2015.
Determination
2.         The Repatriation Medical Authority under subsection 196B(2) and (8) of the Veterans’ Entitlements Act 1986 (the VEA):
(a)        revokes Instrument No. 57 of 2006 concerning gastric ulcer and duodenal ulcer; and
(b)        determines in its place this Statement of Principles.
Kind of injury, disease or death
3.         (a)        This Statement of Principles is about gastric ulcer and duodenal ulcer and death from gastric ulcer and duodenal ulcer.
(b)               For the purposes of this Statement of Principles:
"gastric ulcer" means a non-malignant circumscribed break in the mucosal surface of the stomach, with a diameter of three millimetres or greater, and which extends through the muscularis mucosa into the submucosa; and
"duodenal ulcer" means a non-malignant circumscribed break in the mucosal surface of the duodenum, with a diameter of three millimetres or greater, and which extends through the muscularis mucosa into the submucosa.
This definition excludes acute haemorrhagic gastritis, subepithelial haemorrhages, and acute superficial mucosal erosions of the stomach and duodenum.  This definition also excludes ulcer associated with diseases of the gastric or duodenal mucosa such as Crohn's disease, sarcoidosis, amyloidosis, systemic mastocytosis, eosinophilic gastroenteritis or associated with uraemic gastritis.
(c)                Gastric ulcer and duodenal ulcer attracts ICD-10-AM code K25, K26, K27 or K28.
(d)               In the application of this Statement of Principles, the definition of "gastric ulcer and duodenal ulcer" is that given at paragraph 3(b) above.
Basis for determining the factors
4.         The Repatriation Medical Authority is of the view that there is sound medical-scientific evidence that indicates that gastric ulcer or duodenal ulcer and death from gastric ulcer or duodenal ulcer can be related to relevant service rendered by veterans, members of Peacekeeping Forces, or members of the Forces under the VEA, or members under the Military Rehabilitation and Compensation Act 2004 (the MRCA).
Factors that must be related to service
5.         Subject to clause 7, at least one of the factors set out in clause 6 must be related to the relevant service rendered by the person.
Factors
6.         The factor that must as a minimum exist before it can be said that a reasonable hypothesis has been raised connecting gastric ulcer or duodenal ulcer or death from gastric ulcer or duodenal ulcer with the circumstances of a person’s relevant service is:
(a)                being a prisoner of war before the clinical onset of gastric ulcer or duodenal ulcer; or
(b)               having Helicobacter pylori infection of the stomach or duodenum at the time of the clinical onset of gastric ulcer or duodenal ulcer; or
(c)                smoking at least one half of a pack-year of cigarettes, or the equivalent thereof in other tobacco products, before the clinical onset of gastric ulcer or duodenal ulcer, and:
(i)                 smoking commenced at least six months before the clinical onset of gastric ulcer or duodenal ulcer; and
(ii)               where smoking has ceased, the clinical onset of gastric ulcer or duodenal ulcer has occurred within one year of cessation; or
(d)               having a gastrin-secreting tumour at the time of the clinical onset of gastric ulcer or duodenal ulcer; or
(e)                having a critical illness or injury within the 30 days before the clinical onset of gastric ulcer or duodenal ulcer; or
(f)                being treated with a non-topical non-steroidal anti-inflammatory drug, including aspirin, at least every other day during a continuous period of at least eight days, within the three months before the clinical onset of gastric ulcer or duodenal ulcer; or
(g)               being treated with an immunosuppressive drug within the three months before the clinical onset of gastric ulcer or duodenal ulcer; or 
(h)               being treated with a drug or a drug from a class of drugs from Specified List 1 within the seven days before the clinical onset of gastric ulcer or duodenal ulcer; or
(i)                 being treated with a drug or a drug from a class of drugs from Specified List 2 for at least two weeks, within the three months before the clinical onset of gastric ulcer or duodenal ulcer; or
(j)                 having a specified infection of the gastric or duodenal mucosa at the time of the clinical onset of gastric ulcer or duodenal ulcer; or
(k)               undergoing a course of therapeutic radiation for cancer, where the stomach or duodenum was in the field of radiation, within the one year before the clinical onset of gastric ulcer or duodenal ulcer; or
(l)                 having received a cumulative equivalent dose of at least ten sieverts of ionising radiation to the stomach or duodenum within the one year before the clinical onset of gastric ulcer or duodenal ulcer; or
(m)             having received 90Yttrium microspheres as therapy for primary and metastatic liver tumours, within the one year before the clinical onset of gastric ulcer or duodenal ulcer; or
(n)               for gastric ulcer only:
(i)                 having partial gastrectomy within the five years before the clinical onset of gastric ulcer, where the ulcer occurs at the site of the surgical anastomosis; or
(ii)               having endoscopic mucosal resection or endoscopic sub-mucosal dissection of the gastric mucosa at the time of the clinical onset of gastric ulcer; or
(o)               having contact with a nasogastric tube or other foreign body at the site of the ulcer at the time of the clinical onset of gastric ulcer or duodenal ulcer; or
(p)               experiencing a category 1A stressor within the three months before the clinical onset of gastric ulcer or duodenal ulcer; or 
(q)               experiencing a category 1B stressor within the three months before the clinical onset of gastric ulcer or duodenal ulcer; or
(r)                 having posttraumatic stress disorder within the three months before the clinical onset of gastric ulcer or duodenal ulcer; or
(s)                having a clinically significant disorder of mental health as specified at the time of the clinical onset of gastric ulcer or duodenal ulcer; or
(t)                 having cirrhosis of the liver at the time of the clinical onset of gastric ulcer or duodenal ulcer; or
(u)               being a prisoner of war before the clinical worsening of gastric ulcer or duodenal ulcer; or
(v)               having Helicobacter pylori infection of the stomach or duodenum at the time of the clinical worsening of gastric ulcer or duodenal ulcer; or
(w)             smoking at least one half of a pack-year of cigarettes, or the equivalent thereof in other tobacco products, before the clinical worsening of gastric ulcer or duodenal ulcer; and:
(i)                 smoking commenced at least six months before the clinical worsening of gastric ulcer or duodenal ulcer; and
(ii)               where smoking has ceased, the clinical worsening of gastric ulcer or duodenal ulcer has occurred within one year of cessation; or
(x)               having a gastrin-secreting tumour at the time of the clinical worsening of gastric ulcer or duodenal ulcer; or
(y)               having a critical illness or injury within the 30 days before the clinical worsening of gastric ulcer or duodenal ulcer; or
(z)                being treated with a non-topical non-steroidal anti-inflammatory drug, including aspirin, at least every other day during a continuous period of at least eight days, within the three months before the clinical worsening of gastric ulcer or duodenal ulcer; or
(aa)            being treated with an immunosuppressive drug within the three months before the clinical worsening of gastric ulcer or duodenal ulcer; or 
(bb)           being treated with a drug or a drug from a class of drugs from Specified List 1 within the seven days before the clinical worsening of gastric ulcer or duodenal ulcer; or
(cc)            being treated with a drug or a drug from a class of drugs from Specified List 3 for at least two weeks, within the three months before the clinical worsening of gastric ulcer or duodenal ulcer; or
(dd)          having a specified infection of the gastric or duodenal mucosa at the time of the clinical worsening of gastric ulcer or duodenal ulcer; or
(ee)            undergoing a course of therapeutic radiation for cancer, where the stomach or duodenum was in the field of radiation, within the one year before the clinical worsening of gastric ulcer or duodenal ulcer; or
(ff)             having received a cumulative equivalent dose of at least ten sieverts of ionising radiation to the stomach or duodenum within the one year before the clinical worsening of gastric ulcer or duodenal ulcer; or
(gg)           having received 90Yttrium microspheres as therapy for primary and metastatic liver tumours, within the one year before the clinical worsening of gastric ulcer or duodenal ulcer; or
(hh)           for gastric ulcer only:
(i)                 having partial gastrectomy within the five years before the clinical worsening of gastric ulcer, where the ulcer occurs at the site of the surgical anastomosis; or
(ii)               having endoscopic mucosal resection or endoscopic sub-mucosal dissection of the gastric mucosa at the time of the clinical worsening of gastric ulcer; or
(ii)               having contact with a nasogastric tube or other foreign body at the site of the ulcer at the time of the clinical worsening of gastric ulcer or duodenal ulcer; or
(jj)               experiencing a category 1A stressor within the three months before the clinical worsening of gastric ulcer or duodenal ulcer; or 
(kk)           experiencing a category 1B stressor within the three months before the clinical worsening of gastric ulcer or duodenal ulcer; or
(ll)               having posttraumatic stress disorder within the three months before the clinical worsening of gastric ulcer or duodenal ulcer; or
(mm)       having a clinically significant disorder of mental health as specified at the time of the clinical worsening of gastric ulcer or duodenal ulcer; or
(nn)           having cirrhosis of the liver at the time of the clinical worsening of gastric ulcer or duodenal ulcer; or
(oo)           inability to obtain appropriate clinical management for gastric ulcer or duodenal ulcer.
Factors that apply only to material contribution or aggravation
7.         Paragraphs 6(u) to 6(oo) applies only to material contribution to, or aggravation of, gastric ulcer or duodenal ulcer where the person’s gastric ulcer or duodenal ulcer was suffered or contracted before or during (but not arising out of) the person’s relevant service.
Inclusion of Statements of Principles
8.         In this Statement of Principles if a relevant factor applies and that factor includes an injury or disease in respect of which there is a Statement of Principles then the factors in that last mentioned Statement of Principles apply in accordance with the terms of that Statement of Principles as in force from time to time.
Other definitions
9.         For the purposes of this Statement of Principles:
"a category 1A stressor" means one of the following severe traumatic events:
(a)                experiencing a life-threatening event;
(b)               being subject to a serious physical attack or assault including rape and sexual molestation; or
(c)                being threatened with a weapon, being held captive, being kidnapped, or being tortured;
"a category 1B stressor" means one of the following severe traumatic events:
(a)                being an eyewitness to a person being killed or critically injured;
(b)               viewing corpses or critically injured casualties as an eyewitness;
(c)                being an eyewitness to atrocities inflicted on another person or persons;
(d)               killing or maiming a person; or
(e)                being an eyewitness to or participating in, the clearance of critically injured casualties;
"a clinically significant disorder of mental health as specified" means one of the following conditions, which is of sufficient severity to warrant ongoing management, which may involve regular visits (for example, at least monthly) to a psychiatrist, counsellor or general practitioner:
(a)                an obsessive compulsive disorder;
(b)               anxiety disorder; or
(c)                panic disorder;
"a critical illness or injury" means any physical injury or illness requiring mechanical ventilation support or admission to an intensive care unit, or which causes septicaemia, adult respiratory distress syndrome, acute renal tubular necrosis, disseminated intravascular coagulation or multiple organ failure;
"a drug or a drug from a class of drugs from Specified List 1" means one of the following:
(a)               bisphosphonate, including alendronate;
(b)             chemotherapeutic agents delivered by hepatic arterial infusion; or
(c)             potassium chloride tablet (enteric coated or wax formulation);
"a drug or a drug from a class of drugs from Specified List 2" means one of the following:
(a)                clopidogrel;
(b)               corticosteroids, excluding topical or inhaled;
(c)                paracetamol of more than 2 grams daily; or
(d)               selective serotonin re-uptake inhibitors;
"a drug or a drug from a class of drugs from Specified List 3" means one of the following:
(a)                anticoagulants;
(b)               clopidogrel;
(c)                corticosteroids, excluding topical or inhaled;
(d)               paracetamol of more than 2 grams daily;
(e)                selective serotonin re-uptake inhibitors; or
(f)                spironolactone;
"a specified infection" means: 
(a)                Anisakis simplex infection (anisakiasis);
(b)               cytomegalovirus infection;
(c)                herpes simplex virus infection;
(d)               fungal infection;
(e)                Helicobacter heilmannii infection;
(f)                Mycobacterial infection (Mycobacterium tuberculosis, Mycobacterium avium intracellulare);
(g)               Strongyloides stercoralis infection (strongyloidiasis); or
(h)               Treponema pallidum infection (syphilis);
"an eyewitness" means a person who observes an incident first hand and can give direct evidence of it.  This excludes a person exposed only to media coverage of the incident;
"being treated with an immunosuppressive drug" means being treated with a drug or an agent which results in significant suppression of immune responses.  This definition includes corticosteroids other than inhaled or topical corticosteroids, drugs used to prevent transplant rejection, tumour necrosis factor-α inhibitors and chemotherapeutic agents used for the treatment of cancer;
"cumulative equivalent dose" means the total dose of ionising radiation received by the particular organ or tissue.  The formula used to calculate the cumulative equivalent dose allows doses from multiple types of ionising radiation to be combined, by accounting for their differing biological effect.  The unit of equivalent dose is the sievert.  For the purposes of this Statement of Principles, the calculation of cumulative equivalent dose excludes doses received from normal background radiation, but includes therapeutic radiation, diagnostic radiation, cosmic radiation at high altitude, radiation from occupation-related sources and radiation from nuclear explosions or accidents;
"death from gastric ulcer or duodenal ulcer" in relation to a person includes death from a terminal event or condition that was contributed to by the person’s gastric ulcer or duodenal ulcer;
"ICD-10-AM code" means a number assigned to a particular kind of injury or disease in The International Statistical Classification of Diseases and Related Health Problems, 10th Revision, Australian Modification (ICD-10-AM), Eighth Edition, effective date of 1 July 2013, copyrighted by the Independent Hospital Pricing Authority, and having ISBN 978-1-74128-213-9;
"pack-year of cigarettes, or the equivalent thereof in other tobacco products" means a calculation of consumption where one pack-year of cigarettes equals twenty tailor-made cigarettes per day for a period of one calendar year, or 7 300 cigarettes.  One tailor-made cigarette approximates one gram of tobacco or one gram of cigar or pipe tobacco by weight.  One pack-year of tailor-made cigarettes equates to 7.3 kilograms of smoking tobacco by weight.  Tobacco products mean cigarettes, pipe tobacco or cigars, smoked alone or in any combination;
"relevant service" means:
(a)                operational service under the VEA;
(b)               peacekeeping service under the VEA;
(c)                hazardous service under the VEA;
(d)               British nuclear test defence service under the VEA;
(e)                warlike service under the MRCA; or
(f)                non-warlike service under the MRCA;
"terminal event" means the proximate or ultimate cause of death and includes:
(a)               pneumonia;
(b)               respiratory failure;
(c)               cardiac arrest;
(d)              circulatory failure; or
(e)               cessation of brain function.
Application
10.       This Instrument applies to all matters to which section 120A of the VEA or section 338 of the MRCA applies.
Date of effect
11.       This Instrument takes effect from 1 June 2015.
Dated this   first   day of   May   2015
The Common Seal of the                    )
Repatriation Medical Authority          )
was affixed at the direction of:          )
PROFESSOR NICHOLAS SAUNDERS AO
CHAIRPERSON
 
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