Health Insurance (LeukoScan) Determination HS/08/2006

Administered by Department of Health, Disability and Ageing

Legislation au F2006L03530 Not in force Legislative Instrument

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Explanatory Statement

Health Insurance Act 1973

Health Insurance (LeukoScan) Determination HS/08/2006

Issued by the authority of the Minister for Health and Ageing

Background

Subsection 3C(1) of the Health Insurance Act 1973 (the Act) provides that the Minister may, by writing, determine that a health service not listed in the diagnostic imaging services table (the Table) shall, in specified circumstances and for specified statutory provisions, be treated as if it were so listed. The Table is set out in the Health Insurance (Diagnostic Imaging Services Table) Regulations 2006 which are remade each year.

A determination made under subsection 3C(1) is a legislative instrument (see subsection 3C(4) of the Act and paragraph 6(d) of the Legislative Instruments Act 2003).

Health Insurance (LeukoScan) Determination HS/02/2004

On 27 April 2004, the then Minister for Health and Aged Care made Health Insurance (LeukoScan) Determination HS/02/2004 (the Current Determination) under subsection 3C(1) of the Act. The Current Determination permits the payment of Medicare benefit in relation to the LeukoScan diagnostic imaging service specified in the Schedule to the Current Determination.

LeukoScan is a nuclear medicine diagnostic service used in the detection of osteomyelitis (an infection of the bone). A LeukoScan procedure involves the labelling of white blood cells within the patient’s body. Alternative imaging procedures for osteomyelitis involve the removal of blood from the patient, with attendant risks to the patient and health care workers through needlestick injury or contamination.

LeukoScan was introduced under a 3C Determination because it was unclear what its utilisation level and impact on overall nuclear medicine outlays would be. It was therefore considered desirable to maximise scope to control the item’s use.

The Current Determination provides that the LeukoScan diagnostic imaging service specified in the Schedule to the Current Determination shall be treated as if it were listed in the Table, for the purposes of the statutory provisions specified in clause 4 of the Current Determination. The statutory provisions specified in clause 4 of the Current Determination are those contained in the Act, the National Health Act 1953 and the regulations made under each Act which relate to professional services and medical services generally, and rule 27 of the Health Insurance (Diagnostic Imaging Services Table) Regulations 2003 (as in force from time to time) which relates specifically to nuclear scanning diagnostic imaging services.

Health Insurance (LeukoScan) Determination HS/08/2006

Health Insurance (LeukoScan) Determination HS/08/2006 (the Determination) remakes the Current Determination.

The Determination revises the wording of various provisions of the Current Determination to reflect updated drafting practice and to clarify the operation of certain provisions.

In addition, the Determination provides for an increase of 1 percent in the fee in respect of the service covered by the Determination compared to the fee in respect of the same service in the Current Determination. This fee increase is in line with the 1 percent fee increase that is being applied to nuclear medicine services in the Table from 1 November 2006.

Details of the Determination are set out in the Attachment.

Consultation

No consultation was undertaken in the making of the Determination as the instrument is machinery in nature and does not substantially alter existing arrangements.

ATTACHMENT

Notes on sections

Section 1

Section 1 provides for the name of the Determination.

Section 2

This section provides that the Determination is to commence on 1 November 2006.

Section 3

Section 3 provides that the Determination revokes Health Insurance Determination HS/02/2004.

Section 4

Subsection 4(1) defines terms used in the Determination.

A key term is 'relevant service' which means a service defined in paragraph 3C(8) of the Act which is specified in the Schedule of the Determination. There is one such relevant service in the Schedule.

Subsection 4(2) provides that a reference to a provision of an Act or regulations, including the Act, the National Health Act 1953 and the regulations made under these Acts, is a reference to the provision as in force from time to time (as authorised by subsection 3C(3) of the Act).

Section 5

Paragraph 5(a) provides that the relevant service specified in the Schedule to the Determination shall be treated as if it were both a professional service and a medical service for the purposes of the provisions of the Act and the National Health Act 1953 and regulations made under each Act that make provision for medical services or professional services.

Paragraph 5(b) provides that the relevant service shall be treated as if there were an item in the diagnostic imaging services table that related to the relevant service and specified a fee in respect of that service, being the fee specified in the Schedule to the Determination in relation to the service.

Paragraph 5(c) provides that rule 27 of Schedule 1, Part 2 of the Health Insurance (Diagnostic Imaging Services Table) Regulations 2006 applies to the relevant service as if the reference in that rule to “items 61302 to 61499” included a reference to item 61650.

Schedule

The Schedule sets out the relevant service and assigns to the service the applicable item number, item descriptor and fee.

Overview

The Health Insurance (LeukoScan) Determination HS/08/2006 was introduced to amend the Health Insurance (LeukoScan) Determination HS/02/2004, which was made under the Health Insurance Act 1973. The Health Insurance Act 1973, enacted in 1973, establishes the framework for Australia's Medicare system, which provides for the payment of benefits for certain medical services. The Health Insurance Act 1973 was introduced to address the need for a national health insurance scheme that ensures Australians have access to necessary medical services. The Health Insurance (LeukoScan) Determination HS/08/2006 was made by the Minister for Health and Ageing under subsection 3C(1) of the Act, which allows the Minister to determine that a health service not listed in the diagnostic imaging services table shall be treated as if it were so listed, in specified circumstances. The policy objective of the Determination is to ensure that the LeukoScan diagnostic imaging service, used in the detection of osteomyelitis, is covered by Medicare and that the fee for the service is updated in line with other nuclear medicine services. The Determination also revises the wording of various provisions of the Current Determination to reflect updated drafting practice and to clarify the operation of certain provisions.

Scope and Application

The Health Insurance (LeukoScan) Determination HS/08/2006 applies to the LeukoScan diagnostic imaging service, which is used in the detection of osteomyelitis. This determination allows the service to be treated as if it were listed in the diagnostic imaging services table of the Health Insurance Act 1973. The Determination applies to the Commonwealth of Australia and is relevant to patients, health care providers, and Medicare. It specifies the fee for the LeukoScan service and treats it as both a professional and a medical service under the Health Insurance Act 1973 and the National Health Act 1953, including relevant regulations. The Determination also incorporates a 1 percent fee increase in line with other nuclear medicine services. This legislative instrument remakes the previous Health Insurance (LeukoScan) Determination HS/02/2004, clarifying certain provisions and updating the fee. There are no exclusions or exemptions specified in this Determination, which is effective from 1 November 2006.

Key Provisions

The main operative sections of the Health Insurance (LeukoScan) Determination HS/08/2006 are outlined in sections 1 through 5. Section 1 provides the name of the determination, while Section 2 sets the commencement date as 1 November 2006. Section 3 revokes the previous Health Insurance Determination HS/02/2004, and Section 4 defines key terms used within the determination. Section 5 provides the specific provisions regarding how the LeukoScan diagnostic imaging service will be treated under the Health Insurance Act 1973 and the National Health Act 1953, as well as the associated fee structure. The obligations imposed by the Act on the parties it governs are primarily outlined in Section 5. This section specifies that the LeukoScan service is to be treated as both a professional and medical service for the purposes of the statutory provisions mentioned. Additionally, it mandates that the service be considered as if it were listed in the diagnostic imaging services table, with the fee specified in the Schedule to the Determination. This ensures that the service is subject to the same regulations and fee structures as other listed services. The Determination imposes no direct obligations on entities or individuals beyond those already established under the Health Insurance Act 1973 and the National Health Act 1953. However, it does clarify and update the terms and conditions under which the LeukoScan service is covered, thereby indirectly affecting how service providers and patients interact with these Acts. There are no explicit offences, penalties, or civil/criminal consequences outlined specifically within this Determination. However, any breach of the conditions set out in the Health Insurance Act 1973 or the National Health Act 1953, which this Determination seeks to clarify, could result in penalties under those Acts. For instance, unauthorised use of Medicare benefits could lead to civil or criminal penalties, including fines and imprisonment. The specific penalties would be dictated by the relevant provisions of the primary Acts.

Area of Law: Health Law
Instrument: Determination
Concepts: Definitions & Interpretation; Regulatory Standards; Fee Schedules

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.

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