Statement of Principles concerning MALIGNANT NEOPLASM OF THE ANUS AND ANAL CANAL (Balance of Probabilities) (No. 83 of 2022) The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(3) of the Veterans' Entitlements Act 1986. Dated 23 August 2022. 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 malignant neoplasm of the anus and anal canal (Balance of Probabilities) (No. 83 of 2022). 2 Commencement This instrument commences on 19 September 2022. 3 Authority This instrument is made under subsection 196B(3) of the Veterans' Entitlements Act 1986. 4 Repeal The Statement of Principles concerning malignant neoplasm of the anus and anal canal No. 52 of 2013 (Federal Register of Legislation No. F2013L01639) made under subsection 196B(3) of the VEA is repealed. 5 Application This instrument applies to a claim to which section 120B of the VEA or section 339 of the Military Rehabilitation and Compensation Act 2004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 malignant neoplasm of the anus and anal canal and death from malignant neoplasm of the anus and anal canal. Meaning of malignant neoplasm of the anus and anal canal (2) For the purposes of this Statement of Principles, malignant neoplasm of the anus and anal canal: (a) means a primary malignant neoplasm arising from the epithelial cells of the anus or anal canal; and (b) includes: (i) adenocarcinoma; (ii) adenocarcinoma in situ; (iii) carcinoma in situ; (iv) high-grade anal squamous intra-epithelial lesion (HSIL); and (v) squamous cell carcinoma; and (c) excludes: (i) atypical squamous cell histology of undetermined significance in the anal canal; (ii) haematolymphoid tumours including Hodgkin's lymphoma and non-Hodgkin lymphoma; (iii) low-grade anal squamous intra-epithelial lesion (LSIL); (iv) malignant melanoma; (v) mesenchymal tumours including soft tissue sarcoma; (vi) neoplasms of the perianal skin (anal margin); and (vii) neuroendocrine tumours. Note: Anatomically, the anus and anal canal extends from the anus (anal verge) to the junction of the anal canal with the rectum, including the anorectal transformation zone. (3) While malignant neoplasm of the anus and anal canal attracts ICD‑10‑AM codes C21.0, C21.1, C21.2 or D01.3, in applying this Statement of Principles the meaning of malignant neoplasm of the anus and anal canal is that given in subsection (2). (4) For subsection (3), a reference to an ICD-10-AM code is a reference to the code assigned to a particular kind of injury or disease in The International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Australian Modification (ICD-10-AM), Tenth Edition, effective date of 1 July 2017, copyrighted by the Independent Hospital Pricing Authority, ISBN 978-1-76007-296-4. Death from malignant neoplasm of the anus and anal canal (5) For the purposes of this Statement of Principles, malignant neoplasm of the anus and anal canal, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's malignant neoplasm of the anus and anal canal. Note: terminal event is defined in the Schedule 1 – Dictionary. 8 Basis for determining the factors On the sound medical‑scientific evidence available, the Repatriation Medical Authority is of the view that it is more probable than not that malignant neoplasm of the anus and anal canal and death from malignant neoplasm of the anus and anal canal can be related to relevant service rendered by veterans 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 exist before it can be said that, on the balance of probabilities, malignant neoplasm of the anus and anal canal or death from malignant neoplasm of the anus and anal canal is connected with the circumstances of a person's relevant service: (1) having smoked tobacco products: (a) in an amount of at least 10 pack-years before the clinical onset of malignant neoplasm of the anus or anal canal; and (b) commencing at least 5 years before the clinical onset of malignant neoplasm of the anus or anal canal; and if smoking has ceased before the clinical onset of malignant neoplasm of the anus or anal canal, then that onset occurred within 20 years of cessation; Note: one pack-year is defined in the Schedule 1 - Dictionary. (2) having infection of the epithelium of the anal canal with a specified human papillomavirus before the clinical onset of malignant neoplasm of the anus or anal canal; Note: specified human papillomavirus is defined in the Schedule 1 – Dictionary. (3) having receptive anal intercourse at least 2 years before the clinical onset of malignant neoplasm of the anus or anal canal; (4) having infection with human immunodeficiency virus before the clinical onset of malignant neoplasm of the anus or anal canal; (5) taking an immunosuppressive drug for organ or tissue transplantation for at least the 1 year before the clinical onset of malignant neoplasm of the anus or anal canal; Note: organ or tissue transplantation is defined in the Schedule 1 - Dictionary. (6) having perianal manifestations of Crohn disease for at least the 3 years before the clinical onset of malignant neoplasm of the anus or anal canal; Note: perianal manifestations of Crohn disease is defined in the Schedule 1 - Dictionary. (7) inability to obtain appropriate clinical management for malignant neoplasm of the anus and anal canal. 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 factor set out in subsection 9(7) applies only to material contribution to, or aggravation of, malignant neoplasm of the anus and anal canal where the person's malignant neoplasm of the anus and anal canal 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(3) 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. Schedule 1 - Dictionary Note: See Section 6 1 Definitions In this instrument: malignant neoplasm of the anus and anal canal—see subsection 7(2). MRCA means the Military Rehabilitation and Compensation Act 2004. one pack-year means the amount of tobacco consumed in smoking 20 cigarettes per day for a period of 1 year, or an equivalent amount of tobacco products. Note 1: An equivalent amount of tobacco products is 7,300 grams of smoking tobacco by weight, either in cigarettes, pipe tobacco or cigars, or a combination of same. For pipe tobacco, cigars or combinations of multiple tobacco types, 1 gram of tobacco is considered to be equal to one cigarette. Note 2: Pack-years are calculated by dividing the number of cigarettes smoked per day by 20 and multiplying this number by the number of years the person has smoked. For example, smoking 10 cigarettes per day for 10 years is equal to 5 pack-years, and smoking 40 cigarettes per day for 10 years is equal to 20 pack-years. organ or tissue transplantation means the transplantation of: (a) all or part of an organ or tissue; or (b) a substance obtained from an organ or tissue. perianal manifestations of Crohn disease means the presence of perianal fistula, perianal abscess, anal canal fissures or anal canal strictures associated with Crohn disease. relevant service means: (a) eligible war service (other than operational service) under the VEA; (b) defence service (other than hazardous service and British nuclear test defence service) under the VEA; or (c) peacetime service under the MRCA. Note: MRCA and VEA are also defined in the Schedule 1 - Dictionary. specified human papillomavirus means human papilloma virus type 16, 18, 31, 33, 35, 45, 51, 52, 58 or 68. terminal event means the proximate or ultimate cause of death and includes the following: (a) pneumonia; (b) respiratory failure; (c) cardiac arrest; (d) circulatory failure; or (e) cessation of brain function. VEA means the Veterans' Entitlements Act 1986.