Health Insurance (Diagnostic Imaging Services Table) Amendment Regulations 2009 (No. 6)

Administered by Department of Health, Disability and Ageing

Legislation au F2009L04016 Regulations Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

 

Select Legislative Instrument 2009 No. 370

 

Health Insurance Act 1973

 

Health Insurance (Diagnostic Imaging Services Table) Amendment Regulations 2009 (No. 6)

 

Subsection 133(1) of the Health Insurance Act 1973 (the Act) provides, that the 
Governor-General may make regulations, not inconsistent with the Act, prescribing all matters required or permitted by the Act to be prescribed, or necessary or convenient to be prescribed for carrying out or giving effect to the Act.

 

The Act provides, in part, for payments of Medicare benefits in respect of professional services rendered to eligible persons.  Section 9 of the Act provides that Medicare benefits shall be calculated by reference to the fees for medical services, including diagnostic imaging services, set out in prescribed tables.

 

Subsection 4AA(1) of the Act provides that the regulations may prescribe a table of diagnostic imaging services, the amount of fees applicable in respect of each item and the rules for interpretation of the table.  Schedule 1 of the Health Insurance (Diagnostic Imaging Services Table) Regulations 2009 (the Principal Regulations) currently prescribe such a table.

 

From 1 July 2010, the Regulations insert two new nuclear medicine items, item 61369 and item 61650, into Schedule 1 to the Principal Regulations.   Originally, these nuclear medicine imaging items were set out in separate 3C Determinations made under subsection 3C(1) of the Act for the purpose of monitoring and evaluating the volume of use and cost to the Medicare outlays.  Since the introduction of public funding for these nuclear medicine items, usage has been low.  There is no longer a need for these items to be managed in this way.

 

Inserting item 61369 and item 61650, (currently contained in the Health Insurance

(Indium-labelled Octreotide Study) Determination HS/09/2006; and the Health Insurance (LeukoScan) Determination HS/08/2006 respectively), into Schedule 1 to the Principal Regulations means that these items are captured under the Diagnostic Imaging Accreditation Scheme (the Scheme) and are required from 1 July 2010 to be rendered from an accredited practice to be eligible for a Medicare benefit.   

 

The Act contains the framework for the Scheme, including the approval of persons to accredit.  In the Act, section 16EA coupled with the provisions in Division 5 of Part IIB, cover the conditions for the Scheme.   The Scheme is being introduced in stages. 

 

The Stage 2 Scheme commences on 1 July 2010 and covers all diagnostic imaging items of service prescribed in the Principal Regulations.  The Stage 1 Scheme commenced on 1 July 2008 and covers practices providing radiology services.  The Stage 2 Scheme will continue the arrangements for practices providing radiology services and commence the arrangements for practices providing only non-radiology services or a combination of radiology and non-radiology services, not accredited under the Scheme. 

 

Details of the Regulations are set out in the Attachment.

 

Consultation

 

In February 2009, the Minister for Health and Ageing, the Hon Nicola Roxon MP agreed that from 1 July 2010 the scope of the Diagnostic Imaging Accreditation Scheme be broadened to include all diagnostic imaging services, both radiology and non-radiology services, listed in the Diagnostic Imaging Services Table of the Medicare Benefits Schedule (MBS).  The Department of Health and Ageing (the Department) commenced consultation about the decision to broaden the scope of the Scheme in early March 2009.  The Department wrote to peak representative organisations for providers of non-radiology services including the Australian and New Zealand Association of Physicians in Nuclear Medicine, the Cardiac Society of Australia and New Zealand and the Royal Australian and New Zealand College of Obstetricians and Gynaecologists.  Also during that month, the Department met with members of the Executive of each of these organisations to discuss the implementation arrangements.

 

In April 2009, the Department released its consultation paper “Broadening the Scope of the Accreditation Scheme” outlining the decision to broaden the scope of the Scheme and proposals for transitioning providers of non-radiology services into the Scheme by 1 July 2010.  The Information Paper was provided to all State and Territory Health Departments and around 30 professional and industry organisations representing all providers of services.  Consultation with non-radiology providers focused on enabling their incremental participation and keeping the compliance burden to a minimum. 

 

The Act specifies no conditions that need to be satisfied before the power to make the Regulations may be exercised.

 

The Regulations are a legislative instrument for the purposes of the Legislative Instruments Act 2003.

 

The Regulations commence on 1 July 2010.

 

 


ATTACHMENT

 

DETAILS OF THE HEALTH INSURANCE (DIAGNOSTIC IMAGING SERVICES TABLE) AMENDMENT REGULATIONS 2009 (No. 6)

 

Regulation 1 – Name of Regulations

 

Regulation 1 provides that the title of the Regulations is the Health Insurance (Diagnostic Imaging Services Table) Amendment Regulations 2009 (No. 6).

 

Regulation 2 – Commencement

 

Regulation 2 provides for the Regulations to commence on 1 July 2010.

 

Regulation 3 – Amendment of Health Insurance (Diagnostic Imaging Services Table) Regulations 2009

 

Regulation 3 provides that the Principal Regulations are amended as set out in
Schedule 1.

 

Schedule 1 – Amendments to Services and Fees

 

Item [1] Schedule 1, Part 3, after item 61368

Item 1 inserts into Schedule 1, Part 3, after item 61368, the nuclear medicine imaging item 61369 – Indium-labelled Octreotide Study. This item sets out the service and assign to the service the applicable item number, item descriptor and fee.

Item [2] Schedule 1, Part 3, item 61505, note

Item 2 removes the note at the end of item 61505 in Schedule 1, Part 3 that refers to item 61650 as being taken as an item in the table for the purpose of the Health Insurance (LeukoScan) Determination HS/08/2006, given that this Determination will be repealed on 1 July 2010.

 

Item [3] Schedule 1, Part 3, after item 61505, in Group I4

Item 3 insert into Schedule 1, Part 3, after item 61505, in Group I4, the nuclear medicine imaging item 61650 – LeukoScan Study. This item sets out the service and assign to the service the applicable item number, item descriptor and fee.

 

Overview

The Health Insurance Act 1973, enacted by the Parliament of Australia, serves as the legislative framework for the Medicare system, which provides eligible Australians with access to healthcare services, including diagnostic imaging. The Act was designed to address the need for a structured system to manage and reimburse healthcare services. One of the key gaps identified was the need for a comprehensive and regulated approach to the provision and reimbursement of diagnostic imaging services, which led to the establishment of the Diagnostic Imaging Accreditation Scheme (the Scheme). The Health Insurance (Diagnostic Imaging Services Table) Amendment Regulations 2009 (No. 6) were introduced to further refine this Scheme by incorporating additional nuclear medicine imaging items into the Medicare Benefits Schedule. These amendments, effective from 1 July 2010, were made to align with the policy objective of broadening the scope of the Scheme to include all diagnostic imaging services, thereby ensuring that such services are rendered from accredited practices to be eligible for Medicare benefits.

Scope and Application

The Health Insurance (Diagnostic Imaging Services Table) Amendment Regulations 2009 (No. 6) apply to the services and fees listed within Schedule 1, which is amended to include two new nuclear medicine items, item 61369 and item 61650, effective from 1 July 2010. These amendments are made under the authority provided by Subsection 133(1) of the Health Insurance Act 1973, which allows the Governor-General to make regulations that are necessary or convenient to carry out the Act. The Act itself governs the payments of Medicare benefits for professional services rendered to eligible persons and specifies that fees for medical services, including diagnostic imaging services, are to be calculated by reference to prescribed tables. These Regulations are applicable across the Commonwealth of Australia and pertain to entities and individuals providing diagnostic imaging services, particularly those offering nuclear medicine services as defined in the new items. The geographic reach of these Regulations is therefore national, impacting all states and territories uniformly. The Regulations do not contain specific exclusions or thresholds but are designed to integrate the new nuclear medicine items into the broader Diagnostic Imaging Accreditation Scheme, ensuring that these services must be rendered by accredited practices to be eligible for Medicare benefits. The Regulations extend the application of the Scheme, which was initially limited to radiology services, to include all diagnostic imaging services from 1 July 2010, thereby enhancing the oversight and quality control measures for the provision of these services.

Key Provisions

The Health Insurance (Diagnostic Imaging Services Table) Amendment Regulations 2009 (No. 6) introduce two new nuclear medicine items, item 61369 and item 61650, into Schedule 1 of the Health Insurance (Diagnostic Imaging Services Table) Regulations 2009. These new items will be effective from 1 July 2010 and will be applicable for services rendered under the Medicare Benefits Schedule (MBS). Specifically, item 61369 relates to an Indium-labelled Octreotide Study and item 61650 to a LeukoScan Study. By inserting these items into the Schedule, the Regulations ensure that these services are now governed by the Diagnostic Imaging Accreditation Scheme (the Scheme) and must be rendered by accredited practices to be eligible for a Medicare benefit. Under the Health Insurance Act 1973 (the Act), practices providing diagnostic imaging services must comply with the requirements of the Scheme. The Act, through sections such as 16EA and provisions in Division 5 of Part IIB, provides the framework for the Scheme, including the approval process for accrediting practices. The Scheme is being introduced in stages, with Stage 2 commencing on 1 July 2010, covering all diagnostic imaging items of service prescribed in the Principal Regulations. This means that from this date, practices providing non-radiology services, or a combination of radiology and non-radiology services, must be accredited under the Scheme to provide eligible services for Medicare benefits. The Regulations impose specific obligations on the parties involved. Practices providing the new nuclear medicine services must ensure that they are accredited under the Scheme to be eligible for Medicare benefits for these services. This involves meeting the accreditation criteria set out in the Act and complying with the rules and standards of the Scheme. Accredited practices must also ensure that they render these services in accordance with the fees and descriptors specified in the Regulations. Failure to comply with these requirements can result in the services not being eligible for Medicare benefits. The Act and the Regulations do not explicitly state the offences, penalties, or civil/criminal consequences for non-compliance with the accreditation requirements. However, non-compliance with the Medicare Benefit Scheme, including the failure to be accredited where required, could potentially lead to significant financial penalties. The Act provides for the imposition of civil penalties for contravening the Medicare provisions, including fines and reimbursement of benefits improperly claimed. Additionally, there may be criminal consequences for wilfully making false or misleading statements in relation to Medicare benefits, as provided for under other sections of the Act. The specific penalties would depend on the nature and extent of the non-compliance.

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