Statement of Principles concerning malignant neoplasm of the gallbladder (Reasonable Hypothesis) (No. 36 of 2024) (Cth)

Statement of Principles concerning MALIGNANT NEOPLASM OF THE GALLBLADDER (Reasonable Hypothesis) (No. 36 of 2024) The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(2) of the Veterans' Entitlements Act 1986.

Dated 26 April 2024.

Professor Terence Campbell AM Chairperson by and on behalf of The Repatriation Medical Authority

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 gallbladder (Reasonable Hypothesis) (No. 36 of 2024). 2 Commencement This instrument commences on 28 May 2024. 3 Authority This instrument is made under subsection 196B(2) of the Veterans' Entitlements Act 1986. 4 Repeal The Statement of Principles concerning malignant neoplasm of the gallbladder (No. 89 of 2015) (Federal Register of Legislation No. F2015L00921) made under subsections 196B(2) and (8) of the VEA is repealed. 5 Application This instrument applies to a claim to which section 120A of the VEA or section 338 of the Military Rehabilitation and Compensation Act 2004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 malignant neoplasm of the gallbladder and death from malignant neoplasm of the gallbladder. Meaning of malignant neoplasm of the gallbladder (2) For the purposes of this Statement of Principles, malignant neoplasm of the gallbladder: (a) means a primary malignant neoplasm arising from the epithelial cells of the gallbladder; and (b) includes: (i) adenocarcinoma of the gallbladder; (ii) adenosquamous carcinoma of the gallbladder; (iii) carcinoma of the gallbladder; (iv) clear cell carcinoma of the gallbladder; (v) poorly cohesive carcinoma of the gallbladder; (vi) squamous cell carcinoma of the gallbladder; and (vii) carcinoma in situ of the gallbladder; and (c) excludes: (i) soft tissue sarcoma; (ii) malignant neoplasm of the bile duct; (iii) neuroendocrine carcinoma of the gallbladder; (iv) non-Hodgkin lymphoma; and (v) Hodgkin lymphoma. (3) While malignant neoplasm of the gallbladder attracts ICD‑10‑AM code C23, in applying this Statement of Principles the meaning of malignant neoplasm of the gallbladder 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 gallbladder (5) For the purposes of this Statement of Principles, malignant neoplasm of the gallbladder, 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 gallbladder. 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 malignant neoplasm of the gallbladder and death from malignant neoplasm of the gallbladder 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 malignant neoplasm of the gallbladder or death from malignant neoplasm of the gallbladder with the circumstances of a person's relevant service: (1) having cholelithiasis before clinical onset; (2) having a chronic biliary infection of Salmonella typhi or Salmonella paratyphi detected on at least 2 separate occasions, at least a month apart, and within 2 years before clinical onset; Note: A biliary infection by Salmonella can be ascertained by detection of specific antibodies in serum or detection of Salmonella sp. in stool samples. (3) having primary sclerosing cholangitis before clinical onset; Note: primary sclerosing cholangitis is defined in the Schedule 1 - Dictionary. (4) having had an intravascular injection of Thorotrast (thorium dioxide) before clinical onset; (5) having porcelain gallbladder before clinical onset; Note: porcelain gallbladder is defined in the Schedule 1 – Dictionary. (6) being obese for at least 5 years within the 20 years before clinical onset; Note: being obese is defined in the Schedule 1 – Dictionary. (7) being overweight for at least 5 years within the 20 years before clinical onset; Note: being overweight is defined in the Schedule 1 – Dictionary. (8) having diabetes mellitus for at least 5 years before clinical onset; (9) smoking at least 20 pack-years of cigarettes, or the equivalent thereof in other tobacco products, before clinical onset, and: (a) smoking commenced at least 5 years before clinical onset; and (b) where smoking has ceased, clinical onset has occurred within 20 years of cessation; Note: one pack-year is defined in the Schedule 1 - Dictionary. (10) having non-alcoholic fatty liver disease for at least 5 years within the 20 years before clinical onset; (11) having chronic infection with hepatitis B or C virus before clinical onset; Note: chronic infection with hepatitis B or C virus is defined in the Schedule 1 - Dictionary. (12) being exposed to high levels of dietary aflatoxins, on more days than not, for a period of at least 5 years within the 30 years before clinical onset; Note: being exposed to high levels of dietary aflatoxins is defined in the Schedule 1 – Dictionary. (13) inability to obtain appropriate clinical management of malignant neoplasm of the gallbladder before clinical worsening. 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 subsections 9(13) applies only to material contribution to, or aggravation of, malignant neoplasm of the gallbladder where the person's malignant neoplasm of the gallbladder 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.