Statement of Principles
concerning
LOCALISED SCLEROSIS
(Balance of Probabilities)
(No. 62 of 2018)
The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(3) of the Veterans' Entitlements Act 1986.
Dated 22 June 2018
The Common Seal of the
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Professor Nicholas Saunders AO Chairperson
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Contents
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 localised sclerosis (Balance of Probabilities) (No. 62 of 2018).
This instrument commences on 23 July 2018.
This instrument is made under subsection 196B(3) of the Veterans' Entitlements Act 1986.
4 Repeal
The Statement of Principles concerning localised sclerosis No. 67 of 2009 (Federal Register of Legislation No. F2009L03230) made under subsection 196B(3) of the VEA is repealed.
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.
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 localised sclerosis and death from localised sclerosis.
Meaning of localised sclerosis
(2) For the purposes of this Statement of Principles, localised sclerosis (also known as localised scleroderma or morphea):
(a) means an autoimmune, fibrosing connective tissue disorder characterised by localised skin thickening with increased quantities of collagen; and
(b) excludes systemic sclerosis, graft versus host disease with dermal fibrosis, and scleroderma-like conditions (for example, lipodermatosclerosis, scleromyxoedema, eosinophilic fasciitis and chronic radiation dermatitis).
Note 1: Localised sclerosis is limited to the skin, subcutaneous tissue and underlying bone.
Note 2: Localised sclerosis typically presents with an absence of sclerodactyly, Raynaud phenomenon and nailfold capillary changes, and is not associated with major vascular symptoms or with visceral disease.
Note 3: The diagnosis of localised sclerosis is based on clinical findings, although histopathologic confirmation is sometimes needed to rule out other diseases. Serological markers for localised sclerosis include elevated levels of antinuclear antibody, anti-ssDNA antibody, anti-topoisomerase II alpha antibody and rheumatoid factor.
(3) While localised sclerosis attracts ICD‑10‑AM code L94.0 or L94.1, in applying this Statement of Principles the meaning of localised 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 localised sclerosis
(5) For the purposes of this Statement of Principles, localised sclerosis, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's localised sclerosis.
Note: terminal event is defined in the Schedule 1 – Dictionary.
8 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 localised sclerosis and death from localised sclerosis 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.
(1) being treated with a drug or a drug from a class of drugs from the specified list of drugs at the time of the clinical onset of systemic sclerosis;
Note: specified list of drugs is defined in the Schedule 1 - Dictionary.
(2) undergoing a course of therapeutic radiation for cancer, where the affected site was in the field of radiation, before the clinical onset of localised sclerosis;
(3) being treated with a drug or a drug from a class of drugs from the specified list of drugs at the time of the clinical worsening of systemic sclerosis;
Note: specified list of drugs is defined in the Schedule 1 - Dictionary.
(4) undergoing a course of therapeutic radiation for cancer, where the affected site was in the field of radiation, before the clinical worsening of localised sclerosis;
(5) inability to obtain appropriate clinical management for localised sclerosis.
(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(3) to 9(5) apply only to material contribution to, or aggravation of, localised sclerosis where the person's localised 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(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.
Note: See Section 6
In this instrument:
localised sclerosis—see subsection 7(2).
MRCA means the Military Rehabilitation and Compensation Act 2004.
relevant service means:
(a) eligible war service (other than operational service) under the VEA;
(b) defence service (other than hazardous service and British nuclear test defence service) under the VEA; or
(c) peacetime service under the MRCA.
Note: MRCA and VEA are also defined in the Schedule 1 - Dictionary.
specified list of drugs means:
(a) balicatib;
(b) bleomycin;
(c) enfuvirtide;
(d) pemetrexed;
(e) taxanes; or
(f) tumour necrosis factor-α inhibitors.
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.