Statement of Principles concerning systemic sclerosis (Reasonable Hypothesis) (No. 25 of 2018)
1Statement of Principles concerning systemic sclerosis (Reasonable Hypothesis) (No. 25 of 2018)
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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 systemic sclerosis (Reasonable Hypothesis) (No. 25 of 2018).
2 Commencement
This instrument commences on 2 April 2018.
3 Authority
This instrument is made under subsection 196B(2) of the Veterans' Entitlements Act 1986.
4 Revocation
The Statement of Principles concerning systemic sclerosis No. 64 of 2009 made under subsection 196B(2) of the VEA is revoked.
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 systemic sclerosis and death from systemic sclerosis.
Meaning of systemic sclerosis
(2) For the purposes of this Statement of Principles, systemic sclerosis (also known as scleroderma):
(a) means an autoimmune, fibrosing connective tissue disorder characterised by deposition of collagen in skin and internal organs, and microvascular lesions, especially in the skin, lungs and kidneys; and
(b) excludes localised sclerosis, graft versus host disease with dermal fibrosis, and scleroderma-like conditions (for example, scleromyxoedema and eosinophilic fasciitis).
Note 1: The three main subsets of systemic sclerosis are limited cutaneous systemic sclerosis (previously referred to as CREST syndrome, comprising calcinosis cutis, Raynaud phenomenon, oesophageal dysmotility, sclerodactyly, telangiectasias), diffuse cutaneous systemic sclerosis and systemic sclerosis sine scleroderma.
Note 2: The diagnosis of systemic sclerosis is based on clinical findings, although histopathologic confirmation is sometimes needed to rule out other diseases. Serological markers for systemic sclerosis include elevated levels of anticentromere antibodies and anti-Scl-70 antibodies.
(3) While systemic sclerosis attracts ICD‑10‑AM code M34, in applying this Statement of Principles the meaning of systemic sclerosis 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 systemic sclerosis
(5) For the purposes of this Statement of Principles, systemic sclerosis, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's systemic sclerosis.
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 systemic sclerosis and death from systemic sclerosis 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 systemic sclerosis or death from systemic sclerosis with the circumstances of a person's relevant service:
(1) inhaling respirable crystalline silica dust, at the time material containing crystalline silica was being:
(a) produced;
(b) excavated;
(c) drilled, cut or ground; or
(d) used in construction, manufacturing, cleaning or blasting,
for a cumulative period of at least 2 500 hours before the clinical onset of systemic sclerosis;
(2) being treated with bleomycin at the time of the clinical onset of systemic sclerosis;
(3) inhaling, ingesting or having cutaneous contact with an organic solvent from the specified list of organic solvents for a cumulative period of at least 2 000 hours within a period of ten consecutive years, before the clinical onset of systemic sclerosis;
Note: specified list of organic solvents is defined in the Schedule 1 - Dictionary.
(4) being treated with an ergot alkaloid for migraine, for at least the ten years before the clinical onset of systemic sclerosis;
Note: ergot alkaloid is defined in the Schedule 1 - Dictionary.
(5) inhaling respirable crystalline silica dust, at the time material containing crystalline silica was being:
(a) produced;
(b) excavated;
(c) drilled, cut or ground; or
(d) used in construction, manufacturing, cleaning or blasting,
for a cumulative period of at least 2 500 hours before the clinical worsening of systemic sclerosis;
(6) being treated with bleomycin at the time of the clinical worsening of systemic sclerosis;
(7) inhaling, ingesting or having cutaneous contact with an organic solvent from the specified list of organic solvents for a cumulative period of at least 2 000 hours within a period of ten consecutive years, before the clinical worsening of systemic sclerosis;
Note: specified list of organic solvents is defined in the Schedule 1 - Dictionary.
(8) being treated with an ergot alkaloid for migraine, for at least the ten years before the clinical worsening of systemic sclerosis;
Note: ergot alkaloid is defined in the Schedule 1 - Dictionary.
(9) for clinical worsening of systemic sclerosis manifesting as scleroderma renal crisis only, being treated with 15 milligrams or more per day of prednisone, or equivalent oral glucocorticoid therapy, for a period of at least four weeks within the six months before the clinical worsening of systemic sclerosis;
Note: equivalent oral glucocorticoid therapy and scleroderma renal crisis are defined in the Schedule 1 - Dictionary.
(10) smoking at least 20 pack-years of cigarettes, or the equivalent thereof in other tobacco products, before the clinical worsening of systemic sclerosis, and where smoking has ceased, the clinical worsening of systemic sclerosis has occurred within ten years of cessation;
Note: pack-years of cigarettes, or the equivalent thereof in other tobacco products is defined in the Schedule 1 - Dictionary.
(11) inability to obtain appropriate clinical management for systemic sclerosis.
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(5) to 9(11) apply only to material contribution to, or aggravation of, systemic sclerosis where the person's systemic sclerosis 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:
equivalent oral glucocorticoid therapy means a glucocorticoid in the following table, at the doses specified in the table, or a therapeutically equivalent dose of another glucocorticoid:
Glucocorticoid
Minimum average<br>rate (milligrams/day)
cortisone
75
hydrocortisone
60
prednisone
15
prednisolone
15
ergot alkaloid means methysergide, ergotamine or dihydroergotamine.
MRCA means the Military Rehabilitation and Compensation Act 2004.
pack-years of cigarettes, or the equivalent thereof in other tobacco products means a calculation of consumption where one pack-year of cigarettes equals 20 tailor-made cigarettes per day for a period of one calendar year, or 7 300 cigarettes. One tailor-made cigarette approximates one gram of tobacco or one gram of cigar or pipe tobacco by weight. One pack-year of tailor-made cigarettes equates to 7.3 kilograms of smoking tobacco by weight. Tobacco products mean cigarettes, pipe tobacco or cigars, smoked alone or in any combination.
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.
scleroderma renal crisis means a disorder characterised by the abrupt onset of marked hypertension, rapidly progressive renal failure due to thrombotic microangiopathy vasospasm, and tissue ischaemia. Up to 10 percent of patients with scleroderma renal crisis are normotensive, although their blood pressure may be increased from baseline values.
specified list of organic solvents means:
(a) aliphatic hydrocarbon solvents;
(b) aromatic hydrocarbon solvents;
(c) chlorinated organic solvents;
(d) oxygenated organic solvents; or
(e) white spirits.
systemic sclerosis—see subsection 7(2).
terminal event means the proximate or ultimate cause of death and includes the following: