Statement of Principles concerning osteoporosis No. 67 of 2002

Administered by Department of Veterans' Affairs

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Statement of Principles

concerning

OSTEOPOROSIS

Instrument No. 67 of 2002 as amended

made under section 196B(2) of the

Veterans’ Entitlements Act 1986

This compilation was prepared on 8 November 2005
taking into account Amendment of Statement of Principles concerning OSTEOPOROSIS (Instrument No. 25 of 2004)

Prepared by the Repatriation Medical Authority Secretariat, Brisbane

Revocation and Determination

of

Statement of Principles

concerning

 

OSTEOPOROSIS

 

ICD-10-AM CODES: M80.0 - M80.9, M81.0 - M81.9, M82.0, M82.1, M82.8

 

Veterans’ Entitlements Act 1986

 

 

1. The Repatriation Medical Authority under subsection 196B(2) of the Veterans’ Entitlements Act 1986 (the Act):

 

(a) revokes Instrument No.61 of 1997; and

 

(b) determines in its place the following Statement of Principles.

 

Kind of injury, disease or death

2. (a) This Statement of Principles is about osteoporosisosteoporosis and death from osteoporosisosteoporosis.

 

(b) For the purposes of this Statement of Principles, “osteoporosisosteoporosis means a disease of the skeleton characterised by generalised reduction in bone density and microarchitectural deterioration of bone tissue with the normal ratio of mineral to organic content of bone retained, which leads to a propensity to fracture.  Osteoporosis is considered to be present when:

(i) bone mineral density is more than 2.5 standard deviations below the mean bone mineral density of young adult sex-matched controls; or

 

(ii)              there is radiological evidence of a fracture together with radiological evidence of reduced bone density in the region of the fracture prior to or at the time of the fracture.

 

Osteoporosis attracts ICD-10-AM code M80.0 - M80.9, M81.0 - M81.9, M82.0, M82.1 or M82.8.

 

Basis for determining the factors

3. The Repatriation Medical Authority is of the view that there is sound medical-scientific evidence that indicates that osteoporosis and death from osteoporosis can be related to relevant service rendered by veterans, members of Peacekeeping Forces, or members of the Forces.

 

Factors that must be related to service

4. Subject to clause 6, at least one of the factors set out in clause 5 must be related to any relevant service rendered by the person.

 

Factors

5. The factors that must as a minimum exist before it can be said that a reasonable hypothesis has been raised connecting osteoporosis or death from osteoporosis with the circumstances of a person’s relevant service are:

 

(a) being a prisoner of war before the clinical onset of osteoporosis; or

 

(b) smoking at least 10 pack years of cigarettes or the equivalent thereof in other tobacco products before the clinical onset of osteoporosis and where smoking has ceased, the clinical onset has occurred within 20 years of cessation; or

 

(c) for men, consuming at least 150kg of alcohol within any 10 year period within the 20 years immediately before the clinical onset of osteoporosis; or

 

(d) for women, consuming at least 75kg of alcohol within any 10 year period within the 20 years immediately before the clinical onset of osteoporosis; or

 

(e) suffering from chronic renal failure or chronic cholestatic liver disease at the time of the clinical onset of osteoporosis; or

 

(f) being treated with a specified drug before the clinical onset of osteoporosis; or

 

(g) suffering from, decreased or absent secretion of hormones from the ovaries or testes; or hyperprolactinaemia, for a continuous period of at least one year within the 10 years immediately before the clinical onset of osteoporosis; or

 

(h) suffering from Cushing’s syndrome, thyrotoxicosis or hyperparathyroidism, for a continuous period of at least one year within the 10 years immediately before the clinical onset of osteoporosis; or

 

(i) suffering from rheumatoid arthritis at the time of the clinical onset of osteoporosis; or

 

(j) suffering from systemic mastocytosis or disseminated malignancy at the time of the clinical onset of osteoporosis; or

 

(k) undergoing renal, liver, cardiac or bone marrow transplantation before the clinical onset of osteoporosis; or

 

(l)                suffering from gastrointestinal malabsorption resulting from:

 

(i)                total or partial gastrectomy,

(ii)              short bowel syndrome,

(iii)           contaminated small bowel syndrome,

(iv)            pancreatic insufficiency,

(v)              cholestasis, or

(vi)            coeliac disease,

 

for a continuous period of at least one year within the 10 years immediately before the clinical onset of osteoporosis; or

 

(m) suffering from anorexia nervosa at the time of the clinical onset of osteoporosis; or

 

(n) being immobile for a continuous period of at least 60 days within the year immediately before the clinical onset of osteoporosis; or

 

(o) suffering from Crohn’s disease or ulcerative colitis before the clinical onset of osteoporosis; or

 

(p) having an altered dietary pattern resulting in a decrease in average daily calcium intake to 400mg/day or less, for a period of 2 years before age 20 years, or for a period of 7 years after that age, or the equivalent combination thereof, before the clinical onset of osteoporosis; or

 

(q) being a prisoner of war before the clinical worsening of osteoporosis; or

 

(r) smoking at least 10 pack years of cigarettes or the equivalent thereof in other tobacco products before the clinical worsening of osteoporosis and where smoking has ceased, the clinical worsening has occurred within 20 years of cessation; or

 

(s) for men, consuming at least 150kg of alcohol within any 10 year period within the 20 years immediately before the clinical worsening of osteoporosis; or

 

(t) for women, consuming at least 75kg of alcohol within any 10 year period within the 20 years immediately before the clinical worsening of osteoporosis; or

 

(u) suffering from chronic renal failure or chronic cholestatic liver disease at the time of the clinical worsening of osteoporosis; or

 

(v) being treated with a specified drug before the clinical worsening of osteoporosis; or

 

(w) suffering from, decreased or absent secretion of hormones from the ovaries or testes; or hyperprolactinaemia, for a continuous period of at least one year within the 10 years immediately before the clinical worsening of osteoporosis; or

 

(x) suffering from Cushing’s syndrome, thyrotoxicosis or hyperparathyroidism, for a continuous period of at least one year within the 10 years immediately before the clinical worsening of osteoporosis; or

 

(y) suffering from rheumatoid arthritis at the time of the clinical worsening of osteoporosis; or

 

(z) suffering from systemic mastocytosis or disseminated malignancy at the time of the clinical worsening of osteoporosis; or

 

(za) undergoing renal, liver, cardiac or bone marrow transplantation before the clinical worsening of osteoporosis; or

 

(zb)          suffering from gastrointestinal malabsorption resulting from:

 

(i)                total or partial gastrectomy,

(ii)              short bowel syndrome,

(iii)           contaminated small bowel syndrome,

(iv)            pancreatic insufficiency,

(v)              cholestasis, or

(vi)            coeliac disease,

 

for a continuous period of at least one year within the 10 years immediately before the clinical worsening of osteoporosis; or

 

(zc) suffering from anorexia nervosa at the time of the clinical worsening of osteoporosis; or

 

(zd) being immobile for a continuous period of at least 60 days within the year immediately before the clinical worsening of osteoporosis; or

 

(ze) suffering from Crohn’s disease or ulcerative colitis before the clinical worsening of osteoporosis; or

 

(zf) having an altered dietary pattern resulting in a decrease in average daily calcium intake to 400mg/day or less, for a period of 2 years before age 20 years, or for a period of 7 years after that age, or the equivalent combination thereof, before the clinical worsening of osteoporosis; or

 

(zg) inability to obtain appropriate clinical management for osteoporosisosteoporosis osteoporosis.

 

Factors that apply only to material contribution or aggravation

6. Paragraphs 5(q) to 5(zg) apply only to material contribution to, or aggravation of, osteoporosis where the person’s osteoporosis was suffered or contracted before or during (but not arising out of) the person’s relevant service; paragraph 8(1)(e), 9(1)(e), 70(5)(d) or 70(5A)(d) of the Act refers.

 

Inclusion of Statements of Principles

7. In this Statement of Principles if a relevant factor applies and that factor includes an injury or disease in respect of which there is a Statement of Principles then the factors in that last mentioned Statement of Principles apply in accordance with the terms of that Statement of Principles.

 

Other definitions

8.                  For the purposes of this Statement of Principles:

 

“alcohol” is measured by the alcohol consumption calculations utilising the Australian Standard of 10 grams of alcohol per standard alcoholic drink;

 

“anorexia nervosa” means a mental disorder characterised by refusal to maintain a normal minimal body weight; intense fear of becoming obese that is undiminished by weight loss; disturbance of body image resulting in a feeling of being fat even when extremely emaciated; and amenorrhoea (in females);

 

“being immobile” means continuous restriction to a lying or sitting position for a prolonged period, from strict bed rest, quadriplegia, or spinal traction;

 

“being treated with a specified drug” means being treated with any of the drugs (including where those drugs are contained in preparations) listed in the following Table of Drugs, under the circumstances as specified in the Table, with regard to the mode of administration, dose level, minimum duration of treatment, and temporality (time relationship between the administration of the drug and the onset of the disease):

Table of Drugs

Drug or Group of Drugs

Mode *

Dose

Minimum Duration of Treatment

Temporality

prednisolone or

pharmacologic equivalent glucocorticoid

IV, IM, O

0.5 gm over a period of 6 months

6 months

 

within the five years immediately before

3 gm

NS

within the 10 years immediately before

 

beclomethasone, budesonide,

fluticasone

 

Inhal.

750 g /day on average

 

12 months

within the five years immediately before

3 gm

NS

within the 10 years immediately before

 

corticotrophins

NS

at least weekly

12 months

within the 10 years immediately before

heparin

IV, SC

at least 20,000 units/day

3 months

within the five years immediately before

thyroxine, Liothyronine

O

suppressive dose

6 months

 

within the two years immediately before.

 

Table of Drugs Continued

Drug or Group of Drugs

Mode *

Dose

Minimum Duration of Treatment

Temporality

Chemotherapy for cancer

Not topical

NS

NS

NS

Medroxyprogesterone acetate, without any oestrogen supplementation †

O, IM

NS

12 months

within the 10 years immediately before

GnRH analogues

NS

NS

12 months

within the 10 years immediately before

Antiandrogen

therapy ‡

NS

NS

12 months

within the 10 years immediately before

Oral anticoagulant

oral

 

12 months

within the 10 years immediately before

Anti-HIV therapy

oral

NS

12 months

within the 10 years immediately before

Anticonvulsants

oral

NS

60 months

within the 10 years immediately before

* Abbreviations:  IV = intravenous; IM = intramuscular; SC = subcutaneous; O = oral; 

Inhal. = inhalation; NS = not specified.

in premenopausal women only.  In males only.

GnRH means Gonadotrophin Releasing Hormone.

 

“Suppressive dose” means the treatment with thyroxine (or equivalent)

 

(i)                   that results in a TSH level below the normal range in the assay, or

(ii)                 that results in a suppressed response to thyrotrophin test, or

(iii)               that the measured daily dose of T4 (or equivalent) is greater than 200 g.

 

“chronic renal failure” means renal injury of a sustained nature that is not reversible and leads to destruction of nephron mass and is associated with a demonstrable functional abnormality of the kidney which raises the level of creatinine;

 

“chronic cholestatic liver disease” means any chronic intrahepatic or extrahepatic disorder which inhibits bile secretion into the gastrointestinal tract, allowing accumulation of biliary substances particularly bile acids in the plasma and which is associated with conjugated hyperbilirubinemia and resultant jaundice;

 

“death from osteoporosis” in relation to a person includes death from a terminal event or condition that was contributed to by the person’s osteoporosis;

 

“disseminated malignancy” means:

(i)                the presence of secondary deposits of neoplastic cells at multiple sites distant from the primary malignancy in the case of solid malignancies (eg breast cancer); or

(ii)              involvement of multiple sites in the body in the case of haemopoietic malignancies (eg lymphomas);

 

“hyperparathyroidism” means increased levels of parathyroid hormone in the blood;

 

“hyperprolactinaemia” means increased levels of prolactin in the blood;

 

“ICD-10-AM code” means a number assigned to a particular kind of injury or disease in The International Statistical Classification of Diseases and Related Health Problems, 10th revision, Australian Modification (ICD-10-AM), Third Edition, effective date of 1 July 2002, copyrighted by the National Centre for Classification in Health, Sydney, NSW, and having ISBN 1 86487 413 9.  Where in this Statement of Principles an ICD code is referenced, such reference is not to constrain or limit the proper meaning of the definition or words preceding the alphanumeric code reference;

 

“or the equivalent combination” in paragraphs 5(p) and 5(zf) means a calculation where one year of exposure before age 20 years is equivalent to 3.5 years of exposure after age 20;

 

“pack years of cigarettes or the equivalent thereof in other tobacco products” means a calculation of consumption where one pack year of cigarettes equals twenty 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 7 300 cigarettes, or 7.3kg of smoking tobacco by weight.  Tobacco products means either cigarettes, pipe tobacco or cigars smoked, alone or in any combination;

 

“relevant service” means:

(a) operational service; or

(b) peacekeeping service; or

(c)               hazardous service;

 

“systemic mastocytosis” means a mast cell hyperplasia that is generally detected in the bone marrow, skin, gastrointestinal mucosa, liver or spleen;

 

“terminal event” means the proximate or ultimate cause of death and includes:

(a)         pneumonia;

(b)         respiratory failure;

(c)         cardiac arrest;

(d)         circulatory failure; or

(e)         cessation of brain function;

 

“thyrotoxicosis” means a condition caused by excessive quantities of thyroid hormones.

 

Application

9. This Instrument applies to all matters to which section 120A of the Act applied.

 


Notes to Statement of Principles concerning osteoporosis (Instrument No. 67 of 2002)

The Statement of Principles concerning osteoporosis (Instrument No. 67 of 2002) in force under section 196B(2) of the Veterans’ Entitlements Act 1986, as shown in this compilation is amended as indicated in the Tables below.

Table of Instruments

Title

Date of notification
in Gazette or FRLI registration

Date of
commencement

Application, saving or
transitional provisions

Statement of Principles concerning osteoporosis (Instrument No. 67 of 2002)

16 October 2002

(see Gazette 2002, No. GN41)

16 October 2002

 

Amendment of Statement of Principles concerning osteoporosis (Instrument No. 25 of 2004)

25 August 2004

(see Gazette 2004, No. GN34)

25 August 2004

 


Table of Amendments

ad. = added or inserted      am. = amended      rep. = repealed      rs. = repealed and substituted

Provision affected

How affected

Paragraph 2(b)(i)

rs. Instrument  No.25 of 2004

Paragraph 5 factor (p)

rs. Instrument  No.25 of 2004

Paragraph 5 factor (zf)

rs. Instrument  No.25 of 2004

Paragraph 8 – “or the equivalent combination”

ad. Instrument  No.25 of 2004

 

Overview

The Statement of Principles concerning Osteoporosis (Instrument No. 67 of 2002), made under section 196B(2) of the Veterans’ Entitlements Act 1986, was introduced to address the issue of osteoporosis and related deaths among veterans, members of Peacekeeping Forces, and members of the Forces. The Statement of Principles was developed by the Repatriation Medical Authority to provide a framework for the assessment of claims related to osteoporosis, ensuring that these claims are properly evaluated and considered in light of the veterans' service. The underlying policy objective is to provide comprehensive and fair recognition of the medical conditions that may arise from or be aggravated by the circumstances of the individuals' service, thereby ensuring appropriate compensation and support for those affected. This legislative instrument revokes the previous Statement of Principles concerning Osteoporosis (Instrument No. 61 of 1997) and replaces it with updated criteria that reflect the current understanding of osteoporosis and its connections to relevant service factors. The Statement of Principles outlines specific factors that must be related to the service to establish a link between osteoporosis or death from osteoporosis and the individual's circumstances during their service.

Scope and Application

This legislative instrument, being the Statement of Principles concerning Osteoporosis (Instrument No. 67 of 2002) made under section 196B(2) of the Veterans' Entitlements Act 1986, applies to matters covered by section 120A of the Act. This Statement of Principles pertains to the disease of osteoporosis and death from osteoporosis in veterans, members of Peacekeeping Forces, and members of the Australian Defence Force. Osteoporosis is defined as a skeletal disease marked by a reduction in bone density and deterioration of bone tissue, which predisposes individuals to fractures. The Instrument outlines specific factors that must be related to the person's relevant service, such as being a prisoner of war, smoking history, alcohol consumption, and other medical conditions or treatments that could be linked to the onset or worsening of osteoporosis. The Statement of Principles also includes a Table of Drugs that identifies specific medications and their dosages and durations that may contribute to the development or aggravation of osteoporosis. The application of these principles is subject to certain conditions, such as the temporal relationship between the service and the onset or worsening of osteoporosis, and may be amended by subordinate instruments as evidenced by the Amendment of Statement of Principles concerning Osteoporosis (Instrument No. 25 of 2004).

Key Provisions

This legislative instrument, under section 196B(2) of the Veterans’ Entitlements Act 1986, revokes Instrument No.61 of 1997 and establishes a new Statement of Principles concerning osteoporosis and death from osteoporosis. The Repatriation Medical Authority considers that there is sound medical-scientific evidence that indicates that osteoporosis and death from osteoporosis can be related to relevant service rendered by veterans, members of Peacekeeping Forces, or members of the Forces. At least one of the factors listed must be related to any relevant service rendered by the person, such as being a prisoner of war before the clinical onset of osteoporosis, smoking at least 10 pack years of cigarettes or the equivalent thereof in other tobacco products before the clinical onset of osteoporosis, or suffering from chronic renal failure or chronic cholestatic liver disease at the time of the clinical onset of osteoporosis. This Act imposes specific obligations and requirements on the parties or entities it governs. The Repatriation Medical Authority must determine if there is a reasonable hypothesis connecting osteoporosis or death from osteoporosis with the circumstances of a person’s relevant service, based on the factors outlined in the Statement of Principles. Medical evidence must be provided to support the claim, and the factors must be related to the relevant service rendered by the individual. Breach of the provisions of this legislative instrument may result in civil or criminal consequences, although the specific penalties are not outlined within the text. The Act may impose penalties for providing false or misleading information, or for failing to comply with the requirements set out in the Statement of Principles. The penalties for such offences may vary depending on the severity of the breach and the jurisdiction in which the offence occurred. It is important for individuals and entities governed by this Act to ensure compliance with the requirements to avoid any potential penalties or legal repercussions.

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