Statement of Principles concerning OSTEOMYELITIS (Reasonable Hypothesis) (No. 23 of 2024) The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(2) of the Veterans' Entitlements Act 1986. Dated 22 February 2024. 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 osteomyelitis (Reasonable Hypothesis) (No. 23 of 2024). 2 Commencement This instrument commences on 26 March 2024. 3 Authority This instrument is made under subsection 196B(2) of the Veterans' Entitlements Act 1986. 4 Repeal The Statement of Principles concerning osteomyelitis No. 90 of 2014 (Federal Register of Legislation No. F2014L01380) made under subsections 196B(2) and (8) of the VEA is repealed. 5 Application This instrument applies to a claim to which section 120A of the VEA or section 338 of the Military Rehabilitation and Compensation Act 2004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 osteomyelitis and death from osteomyelitis. Meaning of osteomyelitis (2) For the purposes of this Statement of Principles, osteomyelitis: (a) means inflammation of bone caused by infection; and (b) excludes chondritis, septic arthritis and discitis. Note 1: Osteomyelitis can affect all bones including the jaw, bones of the inner ear, and vertebrae. Note 2: Osteomyelitis can be caused by bacteria, fungi, some parasites of the Echinococcus, Trichinella and Schistosoma genus. (3) While osteomyelitis attracts ICD‑10‑AM codes M90.2, M86, M46.2 and K10.2, in applying this Statement of Principles the meaning of osteomyelitis 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 osteomyelitis (5) For the purposes of this Statement of Principles, osteomyelitis, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's osteomyelitis. 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 osteomyelitis and death from osteomyelitis 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 osteomyelitis or death from osteomyelitis with the circumstances of a person's relevant service: (1) having a wound, laceration, other injury or disease disrupting the skin or mucosa at the site or adjacent to the site of osteomyelitis, within the 2 years before the clinical onset of osteomyelitis; Note: Examples of injuries that disrupt the skin include penetrative injuries, compound fractures, burns or pressure ulcers. Examples of diseases that disrupt the skin include chronic ischaemia or diabetes mellitus. (2) having a dental, medical or surgical procedure which breaches the skin or mucosa at the site or adjacent to the site of osteomyelitis within the 2 years before the clinical onset of osteomyelitis; Note: Examples of procedures that breach the skin or mucosa include lumbar puncture, epidural anaesthesia and tooth extraction. (3) having septicaemia, bacteraemia, systemic fungal infection or parasitic infection with Echinococcus granulosus, Trichinella spiralis, or Schistosoma species within the 2 years before the clinical onset of osteomyelitis; Note: Echinococcus granulosus, Trichinella spiralis, and Schistosoma species are types of parasitic worms. (4) having a foreign body at the site or adjacent to the site of osteomyelitis at the time of the clinical onset of osteomyelitis; Note: Examples of foreign bodies associated with osteomyelitis include internal fixation devices, joint replacements, vascular grafts, shrapnel and bullets. (5) having diabetes mellitus at the time of the clinical onset or clinical worsening of osteomyelitis; (6) having one of the following chronic medical conditions before the clinical onset or clinical worsening of osteomyelitis: (a) chronic renal failure; (b) cirrhosis of the liver; (c) Crohn disease; or (d) sickle cell disorder. Note: chronic renal failure is defined in the Schedule -1 Dictionary. (7) having chronic ischaemia of the affected lower limb from chronic venous insufficiency or atherosclerotic peripheral vascular disease at the time of the clinical onset or clinical worsening of osteomyelitis; (8) having a substantially compromised immune system due to: (a) chronic renal failure; (b) haematological malignancy; (c) infection with human immunodeficiency virus; (d) severe malnutrition; (e) solid organ, stem cell or bone marrow transplantation; or (f) taking an immunosuppressive drug; at the time of the clinical onset or clinical worsening of osteomyelitis; Note 1: chronic renal failure and immunosuppressive drug and severe malnutrition are defined in the Schedule -1 Dictionary. (9) undergoing a course of radiotherapy for cancer, where the affected site was in the field of radiation, before the clinical onset of osteomyelitis; (10) having osteonecrosis at the site of osteomyelitis before the clinical onset of osteomyelitis; (11) inability to obtain appropriate clinical management for osteomyelitis before the clinical worsening of osteomyelitis. 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 clinical worsening aspects of factors set out in section 9 apply only to material contribution to, or aggravation of, osteomyelitis where the person's osteomyelitis 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. Schedule 1 - Dictionary Note: See Section 6 1 Definitions In this instrument: Body Mass Index (BMI) means W/H2 and where: (a) W is the person's weight in kilograms; and (b) H is the person's height in metres. chronic renal failure means: (a) having a glomerular filtration rate of less than 15 mL/min/1.73 m2 for a period of at least 3 months; or (b) a need for renal replacement therapy (dialysis or transplantation) for treatment of complications of decreased glomerular filtration rate which would otherwise increase the risk of morbidity and mortality; or (c) undergoing chronic dialysis. immunosuppressive drug means: (a) corticosteroids other than inhaled or topical corticosteroids; (b) drugs used to prevent transplant rejection; (c) tumour necrosis factor-α inhibitors; or (d) chemotherapeutic agents used for the treatment of cancer. MRCA means the Military Rehabilitation and Compensation Act 2004. osteomyelitis—see subsection 7(2). protein-calorie malnutrition means undernourishment due to inadequate intake, absorption or utilisation of protein or energy foods. 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. Note: MRCA and VEA are defined in the Schedule 1 - Dictionary. severe malnutrition means having protein-calorie malnutrition associated with a body mass index (BMI) less than or equal to 18.5 kg/m2. Note : Body Mass Index (BMI) and protein-calorie malnutrition are defined in the Schedule 1 - Dictionary. 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.