Statement of Principles concerning chronic gastritis and chronic gastropathy (Reasonable Hypothesis) (No. 101 of 2021) (Cth)

Statement of Principles concerning CHRONIC GASTRITIS AND CHRONIC GASTROPATHY (Reasonable Hypothesis) (No. 101 of 2021) The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(2) of the Veterans' Entitlements Act 1986.

Dated 1 October 2021

The Common Seal of the Repatriation Medical Authority was affixed to this instrument at the direction of:

Professor Terence Campbell AM Chairperson

Contents 1 Name 2 Commencement 3 Authority 4 Repeal 5 Application 6 Definitions 7 Kind of injury, disease or death to which this Statement of Principles relates 8 Basis for determining the factors 9 Factors that must exist 10 Relationship to service 11 Factors referring to an injury or disease covered by another Statement of Principles Schedule 1 - Dictionary 1 Definitions

1 Name This is the Statement of Principles concerning chronic gastritis and chronic gastropathy (Reasonable Hypothesis) (No. 101 of 2021). 2 Commencement This instrument commences on 1 November 2021. 3 Authority This instrument is made under subsection 196B(2) of the Veterans' Entitlements Act 1986. 4 Repeal The Statement of Principles concerning chronic gastritis and chronic gastropathy No. 25 of 2013 (Federal Register of Legislation No. F2013L00720) made under subsections 196B(2) and (8) of the VEA is repealed. 5 Application This instrument applies to a claim to which section 120A of the VEA or section 338 of the Military Rehabilitation and Compensation Act 2004 applies. 6 Definitions The terms defined in the Schedule 1 - Dictionary have the meaning given when used in this instrument. 7 Kind of injury, disease or death to which this Statement of Principles relates (1) This Statement of Principles is about chronic gastritis and chronic gastropathy and death from chronic gastritis and chronic gastropathy. Meaning of chronic gastritis and chronic gastropathy (2) For the purposes of this Statement of Principles: (a) chronic gastritis means inflammation of the gastric mucosa with histologically demonstrated chronic inflammatory cell infiltrate; and (b) chronic gastropathy means: (i) histologically demonstrated gastric epithelial cell damage and regeneration with minimal or no associated inflammation; and (ii) the presence of clinical manifestations that have persisted for at least 3 consecutive months. Note: Clinical manifestations of chronic gastritis and chronic gastropathy typically include epigastric pain, nausea, bloating and burning. (c) chronic gastritis and chronic gastropathy exclude: (i) acute gastritis; (ii) acute gastropathy; (iii) autoimmune gastritis; (iv) chronic non-infectious granulomatous gastritis; (v) eosinophilic gastritis; (vi) gastric antral vascular ectasia; (vii) ischaemic gastritis; (viii) lymphocytic gastritis; (ix) portal hypertensive gastropathy; (x) stress gastritis/ulcer; and (xi) uraemic gastritis. Death from chronic gastritis and chronic gastropathy (3) For the purposes of this Statement of Principles, chronic gastritis or chronic gastropathy, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's chronic gastritis or chronic gastropathy. Note: terminal event is defined in the Schedule 1 - Dictionary. 8 Basis for determining the factors The Repatriation Medical Authority is of the view that there is sound medical‑scientific evidence that indicates that chronic gastritis or chronic gastropathy and death from chronic gastritis or chronic gastropathy 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 MRCA. Note: MRCA, relevant service and VEA are defined in the Schedule 1 - Dictionary. 9 Factors that must exist At least one of the following factors must as a minimum exist before it can be said that a reasonable hypothesis has been raised connecting chronic gastritis or chronic gastropathy or death from chronic gastritis or chronic gastropathy with the circumstances of a person's relevant service: (1) for chronic gastritis only: (a) having a Helicobacter pylori infection of the gastric mucosa before the clinical onset of chronic gastritis; (b) having Helicobacter heilmannii sensu lato infection of the gastric mucosa before the clinical onset of chronic gastritis; Note: Helicobacter heilmannii sensu lato is defined in the Schedule 1 - Dictionary. (c) having an infection of the gastric mucosa from the specified list of infections at the time of the clinical onset of chronic gastritis; Note: specified list of infections is defined in the Schedule 1 - Dictionary. (d) being in an immunocompromised state as specified at the time of the clinical onset of chronic gastritis; or Note: immunocompromised state as specified is defined in the Schedule 1 - Dictionary. (e) taking an immune checkpoint inhibitor for at least the 4 weeks before the clinical onset of chronic gastritis; Note: Examples of immune checkpoint inhibitors include ipilimumab, tremelimumab, nivolumab and pembrolizumab. (2) for chronic gastropathy only: (a) having reflux of bile acids into the stomach at the time of the clinical onset of chronic gastropathy; Note: Examples of circumstances in which reflux of bile acids into the stomach can occur include post-gastrectomy, post-biliary surgery and decreased gastric or duodenal motility. (b) taking a non-topical, non-steroidal, anti-inflammatory drug, including aspirin, on more days than not for a continuous period of at least 2 weeks, within the 30 days before the clinical onset of chronic gastropathy; (c) taking a drug from the Specified List 1 of drugs for at least the 4 weeks before the clinical onset of chronic gastropathy; Note: Specified List 1 of drugs is defined in the Schedule 1 - Dictionary. (d) consuming an average of at least 350 grams of alcohol per week for at least the 2 years before the clinical onset of chronic gastropathy; Note: Alcohol consumption is calculated utilising the Australian Standard of 10 grams of alcohol per standard alcoholic drink. (e) undergoing a course of therapeutic radiation for cancer, where the stomach was in the field of radiation, within the 1 year before the clinical onset of chronic gastropathy; or (f) having received yttrium-90 microspheres as therapy for primary and metastatic liver tumours, within the 1 year before the clinical onset of chronic gastropathy; (3) having reflux of bile acids into the stomach at the time of the clinical worsening of chronic gastritis or chronic gastropathy; Note: Examples of circumstances in which reflux of bile acids into the stomach can occur include post-gastrectomy, post-biliary surgery and decreased gastric or duodenal motility. (4) taking a non-topical, non-steroidal, anti-inflammatory drug, including aspirin, on more days than not for a continuous period of at least 8 days, within the 30 days before the clinical worsening of chronic gastritis or chronic gastropathy; (5) taking a drug from the Specified List 2 of drugs at the time of the clinical worsening of chronic gastritis or chronic gastropathy; Note: Specified List 2 of drugs is defined in the Schedule 1 - Dictionary. (6) consuming an average of at least 350 grams of alcohol per week for at least the 6 months before the clinical worsening of chronic gastritis or chronic gastropathy; Note: Alcohol consumption is calculated utilising the Australian Standard of 10 grams of alcohol per standard alcoholic drink. (7) undergoing a course of therapeutic radiation for cancer, where the stomach was in the field of radiation, within the 1 year before the clinical worsening of chronic gastritis or chronic gastropathy; (8) having received yttrium-90 microspheres as therapy for primary and metastatic liver tumours, within the 1 year before the clinical worsening of chronic gastritis or chronic gastropathy; (9) for chronic gastritis only: (a) having a Helicobacter pylori infection of the gastric mucosa before the clinical worsening of chronic gastritis; (b) having Helicobacter heilmannii sensu lato infection of the gastric mucosa before the clinical worsening of chronic gastritis; Note: Helicobacter heilmannii sensu lato is defined in the Schedule 1 - Dictionary. (c) having an infection of the gastric mucosa from the specified list of infections at the time of the clinical worsening of chronic gastritis; Note: specified list of infections is defined in the Schedule 1 - Dictionary. (d) being in an immunocompromised state as specified at the time of the clinical worsening of chronic gastritis; or Note: immunocompromised state as specified is defined in the Schedule 1 - Dictionary. (e) taking an immune checkpoint inhibitor for at least the 4 weeks before the clinical worsening of chronic gastritis; Note: Examples of immune checkpoint inhibitors include ipilimumab, tremelimumab, nivolumab and pembrolizumab. (10) inability to obtain appropriate clinical management for chronic gastritis or chronic gastropathy. 10 Relationship to service (1) The existence in a person of any factor referred to in section 9, must be related to the relevant service rendered by the person. (2) The factors set out in subsections 9(3) to 9(10) apply only to material contribution to, or aggravation of, chronic gastritis or chronic gastropathy where the person's chronic gastritis or chronic gastropathy was suffered or contracted before or during (but did not arise out of) the person's relevant service. 11 Factors referring to an injury or disease covered by another Statement of Principles In this Statement of Principles: (1) if a factor referred to in section 9 applies in relation to a person; and (2) that factor refers to an injury or disease in respect of which a Statement of Principles has been determined under subsection 196B(2) of the VEA; then the factors in that Statement of Principles apply in accordance with the terms of that Statement of Principles as in force from time to time.