Statement of Principles concerning erectile dysfunction (Balance of Probabilities) (No. 73 of 2022) (Cth)

Statement of Principles

concerning

ERECTILE DYSFUNCTION
 (Balance of Probabilities)

(No. 73 of 2022)

The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(3) of the Veterans' Entitlements Act 1986.

Dated    24 June 2022

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

Professor Terence Campbell AM
Chairperson

Contents

1Name........................................................................................................................................... 3

2Commencement........................................................................................................................ 3

3Authority..................................................................................................................................... 3

4Repeal......................................................................................................................................... 3

5Application................................................................................................................................. 3

6Definitions.................................................................................................................................. 3

7Kind of injury, disease or death to which this Statement of Principles relates............... 3

8Basis for determining the factors........................................................................................... 4

9Factors that must exist............................................................................................................. 4

10Relationship to service............................................................................................................. 8

11Factors referring to an injury or disease covered by another Statement of Principles. 8

Schedule 1 - Dictionary........................................................................................... 10

1Definitions.................................................................................................................................. 10

1. Name

This is the Statement of Principles concerning erectile dysfunction (Balance of Probabilities) (No. 73 of 2022).

1. Commencement

This instrument commences on 25 July 2022.

1. Authority

This instrument is made under subsection 196B(3) of the Veterans' Entitlements Act 1986.

1. Repeal

The Statement of Principles concerning erectile dysfunction No. 44 of 2013 (Federal Register of Legislation No. F2013L01137) made under subsections 196B(3) and (8) of the VEA is repealed.

1. 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.

1. Definitions

The terms defined in the Schedule 1 - Dictionary have the meaning given when used in this instrument.

1. Kind of injury, disease or death to which this Statement of Principles relates

(1)This Statement of Principles is about erectile dysfunction and death from erectile dysfunction.

Meaning of erectile dysfunction

(2)For the purposes of this Statement of Principles, erectile dysfunction:

(a)means persistent or recurrent inability to develop or maintain an erection adequate for sexual intercourse; and

(b)includes psychogenic and organic impotence; and

(c)excludes transient failure of erection due to fatigue, situational anxiety, alcohol or drugs.

(3)While erectile dysfunction attracts ICD‑10‑AM code F52.2 or N48.4, in applying this Statement of Principles the meaning of erectile dysfunction 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 erectile dysfunction

(5)For the purposes of this Statement of Principles, erectile dysfunction, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's erectile dysfunction.

Note: terminal event is defined in the Schedule 1 - Dictionary.

1. 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 erectile dysfunction and death from erectile dysfunction 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. Factors that must exist

At least one of the following factors must exist before it can be said that, on the balance of probabilities, erectile dysfunction or death from erectile dysfunction is connected with the circumstances of a person's relevant service:

(1)having a clinically significant disorder of mental health as specified at the time of the clinical onset of erectile dysfunction;

Note: clinically significant disorder of mental health as specified is defined in the Schedule 1 - Dictionary.

(2)having a cardiovascular disease from the specified list of cardiovascular diseases at the time of the clinical onset of erectile dysfunction;

Note: specified list of cardiovascular diseases is defined in the Schedule 1 - Dictionary.

(3)having a medical condition from the specified list of medical conditions at the time of the clinical onset of erectile dysfunction;

Note: specified list of medical conditions is defined in the Schedule 1 - Dictionary.

(4)having systemic sclerosis (scleroderma) at the time of the clinical onset of erectile dysfunction;

(5)having an endocrine disorder from the specified list of endocrine disorders at the time of the clinical onset of erectile dysfunction;

Note: specified list of endocrine disorders is defined in the Schedule 1 - Dictionary.

(6)having a neurological disorder from the specified list of neurological disorders at the time of the clinical onset of erectile dysfunction;

Note: specified list of neurological disorders is defined in the Schedule 1 – Dictionary.

(7)having a urological condition from the specified list of urological conditions, where that condition causes lower urinary tract symptoms, for at least the 6 months before the clinical onset of erectile dysfunction; 

Note: specified list of urological conditions is defined in the Schedule 1 – Dictionary.

(8)having an infection from the specified list of infections at the time of the clinical onset of erectile dysfunction;

Note: specified list of infections is defined in the Schedule 1 – Dictionary.

(9)having herpes zoster affecting a sacral dermatome at the time of the clinical onset of erectile dysfunction;

(10)having hypertension at the time of the clinical onset of erectile dysfunction;

(11)having chronic renal failure at the time of the clinical onset of erectile dysfunction;

Note: chronic renal failure is defined in the Schedule 1 – Dictionary.

(12)having Peyronie disease before the clinical onset of erectile dysfunction;

Note: Peyronie disease is defined in the Schedule 1 – Dictionary.

(13)having ischaemic priapism for a continuous period of at least the 4 hours before the clinical onset of erectile dysfunction;

Note: ischaemic priapism is defined in the Schedule 1 – Dictionary.

(14)having a surgical operation from the specified list of surgical operations within the 3 months before the clinical onset of erectile dysfunction;

Note: specified list of surgical operations is defined in the Schedule 1 – Dictionary.

(15)having a trauma or surgery involving the brain, spinal cord, thoracolumbosacral nerve roots, cauda equina or the nerve supply to the penis, where the trauma or surgery results in permanent neurological impairment, within the 3 months before the clinical onset of erectile dysfunction;

(16)having blunt trauma, penetrating trauma including surgical trauma, explosive blast injury or gunshot injury to the external genitals, perineum or pelvis, within the 3 months before the clinical onset of erectile dysfunction;

Note: blunt trauma is defined in the Schedule 1 – Dictionary.

(17)having internal burns, substantial external burns, or electrical injury to the external genitals, perineum or pelvic region within the 3 months before the clinical onset of erectile dysfunction;

Note: substantial external burns is defined in the Schedule 1 – Dictionary.

(18)having smoked tobacco products:

(a)in an amount of at least 15 pack-years before the clinical onset of erectile dysfunction; and

(b)if smoking has ceased before the clinical onset of erectile dysfunction, then that onset occurred within 20 years of cessation;

Note: one pack-year is defined in the Schedule 1 - Dictionary.

(19)undergoing a course of therapeutic radiation for cancer, where the penis, pelvis or perineal region was in the field of radiation, within the 10 years before the clinical onset of erectile dysfunction;

(20)being obese at the time of the clinical onset of erectile dysfunction;

Note: being obese is defined in the Schedule 1 - Dictionary.

(21)taking a drug from the specified list of drugs at the time of the clinical onset of erectile dysfunction;

Note: specified list of drugs is defined in the Schedule 1 - Dictionary.

(22)inability to undertake any physical activity greater than 3 METs for at least the 5 years before the clinical onset of erectile dysfunction;

Note: MET is defined in the Schedule 1 - Dictionary.

(23)having a clinically significant disorder of mental health as specified at the time of the clinical worsening of erectile dysfunction;

Note: clinically significant disorder of mental health as specified is defined in the Schedule 1 - Dictionary.

(24)having a cardiovascular disease from the specified list of cardiovascular diseases at the time of the clinical worsening of erectile dysfunction;

Note: specified list of cardiovascular diseases is defined in the Schedule 1 - Dictionary.

(25)having a medical condition from the specified list of medical conditions at the time of the clinical worsening of erectile dysfunction;

Note: specified list of medical conditions is defined in the Schedule 1 - Dictionary.

(26)having systemic sclerosis (scleroderma) at the time of the clinical worsening of erectile dysfunction;

(27)having an endocrine disorder from the specified list of endocrine disorders at the time of the clinical worsening of erectile dysfunction;

Note: specified list of endocrine disorders is defined in the Schedule 1 - Dictionary.

(28)having a neurological disorder from the specified list of neurological disorders at the time of the clinical worsening of erectile dysfunction;

Note: specified list of neurological disorders is defined in the Schedule 1 – Dictionary.

(29)having a urological condition from the specified list of urological conditions, where that condition causes lower urinary tract symptoms, for at least the 6 months before the clinical worsening of erectile dysfunction; 

Note: specified list of urological conditions is defined in the Schedule 1 – Dictionary.

(30)having an infection from the specified list of infections at the time of the clinical worsening of erectile dysfunction;

Note: specified list of infections is defined in the Schedule 1 – Dictionary.

(31)having herpes zoster affecting a sacral dermatome at the time of the clinical worsening of erectile dysfunction;

(32)having hypertension at the time of the clinical worsening of erectile dysfunction;

(33)having chronic renal failure at the time of the clinical worsening of erectile dysfunction;

Note: chronic renal failure is defined in the Schedule 1 – Dictionary.

(34)having Peyronie disease before the clinical worsening of erectile dysfunction;

Note: Peyronie disease is defined in the Schedule 1 – Dictionary.

(35)having ischaemic priapism for a continuous period of at least the 4 hours before the clinical worsening of erectile dysfunction;

Note: ischaemic priapism is defined in the Schedule 1 – Dictionary.

(36)having a surgical operation from the specified list of surgical operations within the 3 months before the clinical worsening of erectile dysfunction;

Note: specified list of surgical operations is defined in the Schedule 1 – Dictionary.

(37)having a trauma or surgery involving the brain, spinal cord, thoracolumbosacral nerve roots, cauda equina or the nerve supply to the penis, where the trauma or surgery results in permanent neurological impairment, within the 3 months before the clinical worsening of erectile dysfunction;

(38)having blunt trauma, penetrating trauma including surgical trauma, explosive blast injury or gunshot injury to the external genitals, perineum or pelvis, within the 3 months before the clinical worsening of erectile dysfunction;

Note: blunt trauma is defined in the Schedule 1 – Dictionary.

(39)having internal burns, substantial external burns, or electrical injury to the external genitals, perineum or pelvic region within the 3 months before the clinical worsening of erectile dysfunction;

Note: substantial external burns is defined in the Schedule 1 - Dictionary.

(40)having smoked tobacco products:

(a)in an amount of at least 15 pack-years before the clinical worsening of erectile dysfunction; and

(b)if smoking has ceased before the clinical worsening of erectile dysfunction, then that worsening occurred within 20 years of cessation;

Note: one pack-year is defined in the Schedule 1 - Dictionary.

(41)undergoing a course of therapeutic radiation for cancer, where the penis, pelvis or perineal region was in the field of radiation, within the 10 years before the clinical worsening of erectile dysfunction;

(42)being obese at the time of the clinical worsening of erectile dysfunction;

Note: being obese is defined in the Schedule 1 - Dictionary.

(43)taking a drug from the specified list of drugs at the time of the clinical worsening of erectile dysfunction;

Note: specified list of drugs is defined in the Schedule 1 - Dictionary.

(44)inability to undertake any physical activity greater than 3 METs for at least the 5 years before the clinical worsening of erectile dysfunction;

Note: MET is defined in the Schedule 1 - Dictionary.

(45)inability to obtain appropriate clinical management for erectile dysfunction.

1. 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(23) to 9(45) apply only to material contribution to, or aggravation of, erectile dysfunction where the person's erectile dysfunction was suffered or contracted before or during (but did not arise out of) the person's relevant service.

1. 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.

Schedule 1 - Dictionary

Note: See Section 6

1. Definitions

In this instrument:

acromegaly means a chronic disease of adults resulting from excessive production of growth hormone after closure of the epiphyses.

being obese means:

(a)having a Body Mass Index (BMI) of 30 or greater; or

(b)for males, having a waist circumference exceeding 102 centimetres; or

(c)for females, having a waist circumference exceeding 88 centimetres.

Note: BMI is also defined in the Schedule 1 - Dictionary.

blunt trauma means an injury that results in pain and swelling or tenderness for at least 48 hours and which is of sufficient severity to warrant medical attention.

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 renal failure means:

(a)having a glomerular filtration rate of less than 15 mL/min/1.73 m² for a period of at least 3 months; or

(b)a need for renal replacement therapy (dialysis or transplantation) for treatment of complications of decreased glomerular filtration rate which would otherwise increase the risk of morbidity and mortality; or

(c)undergoing chronic dialysis.

clinically significant disorder of mental health as specified means one of the following conditions, which is of sufficient severity to warrant ongoing management:

(a)bipolar disorder;

(b)cannabis use disorder;

(c)depressive disorder; or

(d)schizophrenia and other persistent psychoses.

Note 1: Management of the condition may involve regular visits (for example, at least monthly) to a psychiatrist, counsellor or general practitioner.

Note 2: To warrant ongoing management does not require that any actual management was received or given for the condition.

erectile dysfunction—see subsection 7(2).

iron overload means an accumulation of excess iron in tissues and organs which has been confirmed by elevated ferritin or transferrin saturation levels. Causes include haemochromatosis and blood transfusions.

ischaemic priapism means a persistent erection marked by rigidity of the corpora cavernosa, and little or no cavernous arterial inflow.

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.

MRCAmeans the Military Rehabilitation and Compensation Act 2004.

obstructive sleep apnoea means a type of sleep apnoea characterised on sleep study by repetitive cessation or decrease of airflow during sleep, despite respiratory effort.

Note: Obstructive sleep apnoea includes upper airway resistance syndrome, which involves prolonged, partial obstruction of the upper airway during sleep.

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.

Peyronie disease means fibrosis of the corpora cavernosa of the penis, characterised by a circumscribed, firm, painless plaque or band, usually situated on the dorsum of the penis.

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 cardiovascular diseases means:

(a)aortic aneurysm and aortic wall disorders;

(b)non-aneurysmal aortic atherosclerotic disease; or

(c)peripheral artery disease.

specified list of drugs means:

(a)5-alpha-reductase inhibitors for the treatment of benign prostatic hyperplasia, including finasteride and dutasteride;

(b)anabolic steroids;

(c)androgen deprivation therapy for prostate cancer;

(d)antiandrogens;

(e)amiloride;

(f)antidepressants;

(g)antipsychotics;

(h)beta-blockers;

(i)chlortalidone or chlorthalidone;

(j)cimetidine;

(k)clonidine;

(l)degarelix;

(m)gabapentin;

(n)gemfibrozil;

(o)hydrochlorothiazide;

(p)indapamide;

(q)methyldopa;

(r)methadone;

(s)oral itraconazole or ketoconazole;

(t)oral retinoids including isotretinoin and acitretin;

(u)phentermine;

(v)sotalol;

(w)spironolactone;

(x)tamoxifen; or

(y)testosterone.

specified list of endocrine disorders means:

(a)acromegaly;

(b)hyperprolactinaemia;

(c)hyperthyroidism, including goitre and Graves diseases that has resulted in hyperthyroidism;

(d)hypogonadism;

(e)hypopituitarism; or

(f)thyrotoxicosis. 

Note: acromegaly is also defined in the Schedule 1 - Dictionary.

specified list of infections means:

(a)chronic hepatitis B virus infection;

(b)human immunodeficiency virus infection;

(c)human T-cell lymphotropic virus type 1 infection; or

(d)tuberculosis of the penis.

specified list of medical conditions means:

(a)cirrhosis of the liver;

(b)diabetes mellitus;

(c)iron overload;

(d)malignant neoplasm of the penis, seminal vesicles, prostate, or testis and paratesticular tissues; or

(e)obstructive sleep apnoea.

Note: iron overload and obstructive sleep apnoea are also defined in the Schedule 1 - Dictionary.

specified list of neurological disorders means:

(a)cerebrovascular accident;

(b)epilepsy;

(c)Guillain-Barre syndrome;

(d)multiple sclerosis;

(e)multiple system atrophy;

(f)neuromyelitis optica spectrum disorder;

(g)Parkinson's disease or secondary parkinsonism;

(h)peripheral autonomic neuropathy;

(i)transverse myelitis; or

(j)compression, neoplasm, infection, degeneration or inflammation of the brain, spinal cord, thoracolumbosacral nerve roots, cauda equina or the somatic or autonomic nerve supply to the penis.

Note: An example of degeneration of the spinal cord and autonomic nerve supply to the penis is vitamin B12 deficiency.

specified list of surgical operations means:

(a)cystectomy;

(b)prostate surgery excluding biopsy;

(c)resection of malignant neoplasm of the prostate; or

(d)resection of malignant neoplasm of the rectum.

specified list of urological conditions means:

(a)benign prostatic hyperplasia;

(b)bladder outlet obstruction;

(c)prostatitis; or

(d)a condition which presents with urinary storage, voiding or post-micturition symptoms.

substantial external burns means an injury to a least 20 percent of the surface area of the skin, where that injury results in pain and swelling or tenderness for at least 48 hours and which is of sufficient severity to warrant medical attention.

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.