Statement of Principles concerning peripheral artery disease (Reasonable Hypothesis) (No. 70 of 2020) made under subsection 196B(2) of the Veterans' Entitlements Act 1986 Compilation No. 1 Compilation date: 19 September 2022 Includes amendments up to: Veterans' Entitlements (Statements of Principles—definition of "one pack-year") Amendment Determination 2022 (No. 94 of 2022) (F2022L01128) The day of commencement of this Amendment Determination is 19 September 2022. About this compilation This compilation This is a compilation of the Statement of Principles concerning peripheral artery disease (Reasonable Hypothesis) (No. 70 of 2020) that shows the text of the law as amended and in force on 19 September 2022. The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law. Uncommenced amendments The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law. Application, saving and transitional provisions for provisions and amendments If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes. Modifications If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law. Self‑repealing provisions If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes. Contents 1 Name 3 Authority 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 Endnotes Endnote 1—About the endnotes Endnote 2—Abbreviation key Endnote 3—Legislation history Endnote 4—Amendment history 1 Name This is the Statement of Principles concerning peripheral artery disease (Reasonable Hypothesis) (No. 70 of 2020). 3 Authority This instrument is made under subsection 196B(2) of the Veterans' Entitlements Act 1986. 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 peripheral artery disease and death from peripheral artery disease. Meaning of peripheral artery disease (2) For the purposes of this Statement of Principles, peripheral artery disease means atherosclerosis of one or more arteries of the upper or lower limbs which causes partial or complete occlusion of those vessels and either: (a) warrants medical treatment; or (b) results in at least one of the following clinical manifestations: (i) chronic limb ischaemia; (ii) critical limb ischaemia; or (iii) intermittent claudication or other exertional leg pain symptoms that restrict walking ability. Note 1: Signs of chronic limb ischaemia typically include subcutaneous atrophy, hair loss, thickened nails, smooth and shiny skin, coolness, pallor, cyanosis and dependent rubor. Note 2: Signs of critical limb ischaemia typically include rest pain, ulceration, gangrene and necrosis. Note 3: This definition includes atherosclerosis of the iliac arteries. (3) While peripheral artery disease attracts ICD‑10‑AM code I70.2, in applying this Statement of Principles the meaning of peripheral artery disease 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 peripheral artery disease (5) For the purposes of this Statement of Principles, peripheral artery disease, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's peripheral artery disease. 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 peripheral artery disease and death from peripheral artery disease 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 peripheral artery disease or death from peripheral artery disease with the circumstances of a person's relevant service: (1) having hypertension before the clinical onset of peripheral artery disease; (2) having diabetes mellitus before the clinical onset of peripheral artery disease; (3) being obese for at least five years within the 20 years before the clinical onset of peripheral artery disease; Note: being obese is defined in the Schedule 1 - Dictionary. (4) having dyslipidaemia before the clinical onset of peripheral artery disease; Note: dyslipidaemia is defined in the Schedule 1 - Dictionary. (5) where smoking has not permanently ceased, having smoked at least one pack-year of tobacco products before the clinical onset of peripheral artery disease; Note: one pack-year is defined in the Schedule 1 - Dictionary. (6) where smoking has permanently ceased before the clinical onset of peripheral artery disease: (a) having smoked at least five pack-years of tobacco products; or (b) having smoked at least one pack-year but less than five pack-years of tobacco products, and the clinical onset of peripheral artery disease has occurred within 20 years of smoking cessation; Note: one pack-year is defined in the Schedule 1 - Dictionary. (7) where exposure to second-hand smoke has not permanently ceased, being exposed to second-hand smoke for at least 1,000 hours before the clinical onset of peripheral artery disease; Note: being exposed to second-hand smoke is defined in the Schedule 1 - Dictionary. (8) where exposure to second-hand smoke has permanently ceased before the clinical onset of peripheral artery disease: (a) being exposed to second-hand smoke for at least 5,000 hours; or (b) being exposed to second-hand smoke for at least 1,000 hours, but less than 5,000 hours, and the clinical onset of peripheral artery disease has occurred within five years of the last exposure to second-hand smoke; Note: being exposed to second-hand smoke is defined in the Schedule 1 - Dictionary. (9) having hyperhomocysteinaemia before the clinical onset of peripheral artery disease; (10) an inability to undertake any physical activity greater than three METs for at least five years within the 20 years before the clinical onset of peripheral artery disease; Note: MET is defined in the Schedule 1 - Dictionary. (11) having chronic kidney disease before the clinical onset of peripheral artery disease; Note: chronic kidney disease is defined in the Schedule 1 - Dictionary. (12) undergoing a course of therapeutic radiation for cancer, where the affected artery was in the field of radiation, before the clinical onset of peripheral artery disease; (13) having received a cumulative equivalent dose of at least 0.5 sievert of ionising radiation to the affected artery before the clinical onset of peripheral artery disease; Note: cumulative equivalent dose is defined in the Schedule 1 - Dictionary. (14) an inability to consume an average of at least 100 grams per day of any combination of fruit and vegetables, for at least five consecutive years within the 20 years before the clinical onset of peripheral artery disease; (15) having periodontitis for at least the two years before the clinical onset of peripheral artery disease; (16) having an autoimmune disease before the clinical onset of peripheral artery disease; Note: Examples of autoimmune diseases include systemic lupus erythematosus, psoriasis and rheumatoid arthritis. (17) having a clinically significant depressive disorder for at least five years before the clinical onset of peripheral artery disease; Note: clinically significant is defined in the Schedule 1 - Dictionary. (18) taking the tyrosine kinase inhibitors nilotinib or ponatinib before the clinical onset of peripheral artery disease; (19) having hypertension before the clinical worsening of peripheral artery disease; (20) having diabetes mellitus before the clinical worsening of peripheral artery disease; (21) being obese for at least five years within the 20 years before the clinical worsening of peripheral artery disease; Note: being obese is defined in the Schedule 1 - Dictionary. (22) having dyslipidaemia before the clinical worsening of peripheral artery disease; Note: dyslipidaemia is defined in the Schedule 1 - Dictionary. (23) where smoking has not permanently ceased, having smoked at least one pack-year of tobacco products before the clinical worsening of peripheral artery disease; Note: one pack-year is defined in the Schedule 1 - Dictionary. (24) where smoking has permanently ceased before the clinical worsening of peripheral artery disease: (a) having smoked at least five pack-years of tobacco products; or (b) having smoked at least one pack-year but less than five pack-years of tobacco products, and the clinical worsening of peripheral artery disease has occurred within 20 years of smoking cessation; Note: one pack-year is defined in the Schedule 1 - Dictionary. (25) where exposure to second-hand smoke has not permanently ceased, being exposed to second-hand smoke for at least 1,000 hours before the clinical worsening of peripheral artery disease; Note: being exposed to second-hand smoke is defined in the Schedule 1 - Dictionary. (26) where exposure to second-hand smoke has permanently ceased before the clinical worsening of peripheral artery disease: (a) being exposed to second-hand smoke for at least 5,000 hours; or (b) being exposed to second-hand smoke for at least 1,000 hours, but less than 5,000 hours, and the clinical worsening of peripheral artery disease has occurred within five years of the last exposure to second-hand smoke; Note: being exposed to second-hand smoke is defined in the Schedule 1 - Dictionary. (27) having hyperhomocysteinaemia before the clinical worsening of peripheral artery disease; (28) an inability to undertake any physical activity greater than three METs for at least five years within the 20 years before the clinical worsening of peripheral artery disease; Note: MET is defined in the Schedule 1 - Dictionary. (29) having chronic kidney disease before the clinical worsening of peripheral artery disease; Note: chronic kidney disease is defined in the Schedule 1 - Dictionary. (30) undergoing a course of therapeutic radiation for cancer, where the affected artery was in the field of radiation, before the clinical worsening of peripheral artery disease; (31) having received a cumulative equivalent dose of at least 0.5 sievert of ionising radiation to the affected artery before the clinical worsening of peripheral artery disease; Note: cumulative equivalent dose is defined in the Schedule 1 - Dictionary. (32) an inability to consume an average of at least 100 grams per day of any combination of fruit and vegetables, for at least five consecutive years within the 20 years before the clinical worsening of peripheral artery disease; (33) having periodontitis for at least the two years before the clinical worsening of peripheral artery disease; (34) having an autoimmune disease before the clinical worsening of peripheral artery disease; Note: Examples of autoimmune diseases include systemic lupus erythematosus, psoriasis and rheumatoid arthritis. (35) having a clinically significant depressive disorder for at least five years before the clinical worsening of peripheral artery disease; Note: clinically significant is defined in the Schedule 1 - Dictionary. (36) taking the tyrosine kinase inhibitors nilotinib or ponatinib before the clinical worsening of peripheral artery disease; (37) inability to obtain appropriate clinical management for peripheral artery disease. 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(19) to 9(37) apply only to material contribution to, or aggravation of, peripheral artery disease where the person's peripheral artery disease 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: abnormality of kidney structure or function means: (a) having a glomerular filtration rate of less than 60 mL/min/1.73 m2; or (b) having kidney damage, as evidenced by renal biopsy, imaging studies, albuminuria, urinary sediment abnormalities or other markers of abnormal renal function; or (c) having had a kidney transplant. being exposed to second-hand smoke means being in an enclosed space and inhaling smoke from burning tobacco products or smoke that has been exhaled by another person who is smoking. being obese means having a Body Mass Index (BMI) of 30 or greater. Note: BMI is also defined in the Schedule 1 - Dictionary. BMI means W/H2 where: (a) W is the person's weight in kilograms; and (b) H is the person's height in metres. chronic kidney disease means an abnormality of kidney structure or function that has been present for at least three months. Note: abnormality of kidney structure or function is also defined in the Schedule 1 - Dictionary. clinically significant means sufficient to warrant ongoing management, which may involve regular visits (for example, at least monthly), to a psychiatrist, counsellor or general practitioner. Note: To warrant ongoing management does not require that any actual management was received or given for the condition. cumulative equivalent dose means the total dose of ionising radiation received by the particular organ or tissue from external exposure, internal exposure or both, apart from normal background radiation exposure in Australia, calculated in accordance with the methodology set out in Guide to calculation of 'cumulative equivalent dose' for the purpose of applying ionising radiation factors contained in Statements of Principles determined under Part XIA of the Veterans' Entitlements Act 1986 (Cth), Australian Radiation Protection and Nuclear Safety Agency, as in force on 2 August 2017. Note 1: Examples of circumstances that might lead to exposure to ionising radiation include being present during or subsequent to the testing or use of nuclear weapons, undergoing diagnostic or therapeutic medical procedures involving ionising radiation, and being a member of an aircrew, leading to increased levels of exposure to cosmic radiation. Note 2: For the purpose of dose reconstruction, dose is calculated as an average over the mass of a specific tissue or organ. If a tissue is exposed to multiple sources of ionising radiation, the various dose estimates for each type of radiation must be combined. dyslipidaemia means persistently abnormal blood lipid levels, diagnosed by a medical practitioner and evidenced by: (a) a serum high density lipoprotein cholesterol level less than 1.0 mmol/L; or (b) a serum low density lipoprotein level greater than 4.0 mmol/L; or (c) a serum triglyceride level greater than or equal to 2.0 mmol/L; or (d) a total serum cholesterol level greater than 5.5 mmol/L; or (e) the regular administration of drug therapy to normalise blood lipid levels. MET means a unit of measurement of the level of physical exertion. 1 MET = 3.5 ml of oxygen/kg of body weight per minute or, 1.0 kcal/kg of body weight per hour, or resting metabolic rate. 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. peripheral artery disease—see subsection 7(2). 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 also 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. Endnotes Endnote 1—About the endnotes The endnotes provide information about this compilation and the compiled law. The following endnotes are included in every compilation: Endnote 1—About the endnotes Endnote 2—Abbreviation key Endnote 3—Legislation history Endnote 4—Amendment history Abbreviation key—Endnote 2 The abbreviation key sets out abbreviations that may be used in the endnotes. Legislation history and amendment history—Endnotes 3 and 4 Amending laws are annotated in the legislation history and amendment history. The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation. The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law. Misdescribed amendments A misdescribed amendment is an amendment that does not accurately describe the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation "(md)" added to the details of the amendment included in the amendment history. If a misdescribed amendment cannot be given effect as intended, the abbreviation "(md not incorp)" is added to the details of the amendment included in the amendment history. Endnote 2—Abbreviation key o = order(s) ad = added or inserted Ord = Ordinance am = amended orig = original amdt = amendment par = paragraph(s)/subparagraph(s) c = clause(s) /sub‑subparagraph(s) C[x] = Compilation No. x pres = present Ch = Chapter(s) prev = previous def = definition(s) (prev…) = previously Dict = Dictionary Pt = Part(s) disallowed = disallowed by Parliament r = regulation(s)/rule(s) Div = Division(s) exp = expires/expired or ceases/ceased to have reloc = relocated effect renum = renumbered F = Federal Register of Legislation rep = repealed gaz = gazette rs = repealed and substituted LA = Legislation Act 2003 s = section(s)/subsection(s) LIA = Legislative Instruments Act 2003 Sch = Schedule(s) (md) = misdescribed amendment can be given Sdiv = Subdivision(s) effect SLI = Select Legislative Instrument (md not incorp) = misdescribed amendment SR = Statutory Rules cannot be given effect Sub‑Ch = Sub‑Chapter(s) mod = modified/modification SubPt = Subpart(s) No. = Number(s) underlining = whole or part not commenced or to be commenced Endnote 3—Legislation history Name Registration Commencement Application, saving and transitional provisions Statement of Principles concerning peripheral artery disease (Reasonable Hypothesis) (No. 70 of 2020) 30 October 2020 30 November 2020 F2020L01374 Veterans' Entitlements (Statements of Principles—definition of "one pack-year") Amendment Determination 2022 (No. 94 of 2022) 26 August 2022 19 September 2022 F2022L01128 Endnote 4—Amendment history Provision affected How affected Section 2………………. rep LA s 48D Section 4………………. rep LA s 48C Subsection 9(5) note..... rs No. 94 of 2022 Subsection 9(6) note..... rs No. 94 of 2022 Subsection 9(23) note... rs No. 94 of 2022 Subsection 9(24) note... rs No. 94 of 2022 Schedule 1 – Dictionary – one pack-year...…….. rs No. 94 of 2022