Statement of Principles concerning osteonecrosis (Balance of Probabilities) (No. 14 of 2020) (Cth)

Statement of Principles concerning OSTEONECROSIS (Balance of Probabilities) (No. 14 of 2020) The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(3) of the Veterans' Entitlements Act 1986.

Dated 28 February 2020

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

Professor Nicholas Saunders AO Chairperson

Contents 1 Name 2 Commencement 3 Authority 4 Application 5 Definitions 6 Kind of injury, disease or death to which this Statement of Principles relates 7 Basis for determining the factors 8 Factors that must exist 9 Relationship to service 10 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 osteonecrosis (Balance of Probabilities) (No. 14 of 2020). 2 Commencement This instrument commences on 23 March 2020. 3 Authority This instrument is made under subsection 196B(3) of the Veterans' Entitlements Act 1986. 4 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. 5 Definitions The terms defined in the Schedule 1 - Dictionary have the meaning given when used in this instrument. 6 Kind of injury, disease or death to which this Statement of Principles relates (1) This Statement of Principles is about osteonecrosis and death from osteonecrosis. Meaning of osteonecrosis (2) For the purposes of this Statement of Principles, osteonecrosis: (a) means a disease of bone where death of bone tissue occurs as a result of the temporary or permanent loss of blood supply to bone; and (b) includes dysbaric osteonecrosis. Note: Osteonecrosis is also known as avascular necrosis, aseptic necrosis or ischaemic necrosis. (3) While osteonecrosis attracts ICD‑10‑AM code K10.2, M87, M90.3, M90.4 or M90.5, in applying this Statement of Principles the meaning of osteonecrosis 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 osteonecrosis (5) For the purposes of this Statement of Principles, osteonecrosis, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's osteonecrosis. Note: terminal event is defined in the Schedule 1 – Dictionary. 7 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 osteonecrosis and death from osteonecrosis 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. 8 Factors that must exist At least one of the following factors must exist before it can be said that, on the balance of probabilities, osteonecrosis or death from osteonecrosis is connected with the circumstances of a person's relevant service: (1) experiencing blunt or penetrating trauma, including surgery, to the affected bone within the two years before the clinical onset of osteonecrosis; (2) having a fracture, dislocation of a joint or subluxation of a joint of the affected bone within the two years before the clinical onset of osteonecrosis; (3) smoking at least 20 pack-years of cigarettes, or the equivalent thereof in other tobacco products, before the clinical onset of osteonecrosis, and where smoking has ceased, the clinical onset of osteonecrosis has occurred within five years of cessation; Note: pack-years of cigarettes, or the equivalent thereof in other tobacco products is defined in the Schedule 1 - Dictionary. (4) consuming an average of at least 320 grams of alcohol per week, for at least six months within the one year before the clinical onset of osteonecrosis; Note: Alcohol consumption is calculated utilising the Australian Standard of ten grams of alcohol per standard alcoholic drink. (5) having a solid organ malignancy at the time of the clinical onset of osteonecrosis; (6) having an autoimmune disorder from the specified list of autoimmune disorders at the time of the clinical onset of osteonecrosis; Note: specified list of autoimmune disorders is defined in the Schedule 1- Dictionary. (7) having a haematological disease from the specified list of haematological diseases at the time of the clinical onset of osteonecrosis; Note: specified list of haematological diseases is defined in the Schedule 1- Dictionary. (8) having a hypercoagulable state as specified at the time of the clinical onset of osteonecrosis; Note: hypercoagulable state as specified is defined in the Schedule 1- Dictionary. (9) having chronic renal failure at least one year before the clinical onset of osteonecrosis; Note: chronic renal failure is defined in the Schedule 1 – Dictionary. (10) having dyslipidaemia at the time of the clinical onset of osteonecrosis; Note: dyslipidaemia is defined in the Schedule 1 – Dictionary. (11) having Cushing syndrome at the time of the clinical onset of osteonecrosis; (12) having infection with human immunodeficiency virus at the time of the clinical onset of osteonecrosis; (13) having a localised bacterial, viral or fungal infection at the affected site at the time of the clinical onset of osteonecrosis; (14) having osteomyelitis at the affected site at the time of the clinical onset of osteonecrosis; (15) having glucocorticoid therapy as specified, before the clinical onset of osteonecrosis, and where the glucocorticoid therapy as specified has ceased or decreased, the last dose of the therapy was received within the five years before the clinical onset of osteonecrosis; Note: glucocorticoid therapy as specified is defined in the Schedule 1 - Dictionary. (16) taking bevacizumab, denosumab or testosterone within the 30 days before the clinical onset of osteonecrosis; (17) having a solid organ transplant, stem cell transplant or bone marrow transplant before the clinical onset of osteonecrosis; (18) undergoing a course of therapeutic radiation for cancer, where the affected site was in the field of radiation, before the clinical onset of osteonecrosis; (19) having internal deposition of radium-224, radium-226, or radium-228 before the clinical onset of osteonecrosis; (20) having decompression sickness within the two years before the clinical onset of osteonecrosis; (21) experiencing hyperbaric exposure as specified, within the two years before the clinical onset of osteonecrosis; Note: hyperbaric exposure as specified is defined in the Schedule 1- Dictionary. (22) being pregnant at the time of the clinical onset of osteonecrosis; (23) undergoing childbirth within the one year before the clinical onset of osteonecrosis; (24) for osteonecrosis of the jaw only: (a) having diabetes mellitus at the time of the clinical onset of osteonecrosis; (b) having periodontitis, periodontal abscess or dental pulp and apical disease within the three months before the clinical onset of osteonecrosis; (c) having syphilitic palatine gumma at the time of the clinical onset of osteonecrosis; or (d) having acute herpes zoster involving the trigeminal nerve within the six months before the clinical onset of osteonecrosis; (e) having substance use disorder, involving cocaine, at the time of the clinical onset of osteonecrosis; (f) being treated with an osteoclast inhibitor for at least six months before the clinical onset of osteonecrosis, where the last dose of the drug was taken within the two years before the clinical onset of osteonecrosis; or Note: osteoclast inhibitor is defined in the Schedule 1 - Dictionary. (g) being treated with an antiangiogenic agent for at least six months before the clinical onset of osteonecrosis, where the last dose of the drug was taken within the two years before the clinical onset of osteonecrosis; Note: antiangiogenic agent is defined in the Schedule 1 - Dictionary. (25) inability to obtain appropriate clinical management for osteonecrosis. 9 Relationship to service (1) The existence in a person of any factor referred to in section 8, must be related to the relevant service rendered by the person. (2) The factor set out in subsection 8(25) applies only to material contribution to, or aggravation of, osteonecrosis where the person's osteonecrosis was suffered or contracted before or during (but did not arise out of) the person's relevant service. 10 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 8 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.