Health Insurance (Diagnostic Imaging Accreditation – Approved Accreditors) Instrument 2020

Administered by Department of Health, Disability and Ageing

Legislation au F2020L00370 In force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

Issued by the Authority of the Minister for Health

 

Health Insurance Act 1973

 

Health Insurance (Diagnostic Imaging Accreditation – Approved Accreditors)

Instrument 2020

 

Authority

The instrument to which this explanatory statement relates is made under subsection 23DZZIAA(1) of the Health Insurance Act 1973 (the Act). 

Subsection 33(3) of the Acts Interpretation Act 1901 provides that where an Act confers a power to make, grant or issue any instrument of a legislative or administrative character (including rules, regulations or by-laws), the power shall be construed as including a power exercisable in the like manner and subject to the like conditions (if any) to repeal, rescind, revoke, amend, or vary any such instrument.

The instrument is a legislative instrument for the purposes of section 8 of the Legislation Act 2003 (LIA).

Purpose

This instrument names the organisations approved to receive and make decisions on applications from proprietors seeking accreditation of diagnostic imaging premises and bases for mobile diagnostic imaging equipment (diagnostic imaging practices) in accordance with the Health Insurance (Diagnostic Imaging Accreditation) Instrument 2020.

This instrument repeals and replaces, with minimal change, the Health Insurance (Diagnostic Imaging - Approved Accreditors) Instrument 2010 (2010 Instrument) which was otherwise due to sunset on 1 April 2020 in accordance with the sunsetting provisions in the Legislation Act 2003.

This instrument also updates outdated references and corrects the name of two of the organisations, namely HDAA Australia Pty Ltd (formerly Health and Disability Auditing Australia Pty Ltd) and Quality Innovation Performance International Pty Ltd (formerly Quality in Practice Pty Ltd), approved to provide accreditation services under the 2010 Instrument.

Background

Subsection 23DZZIAA of the Act provides a legislative framework for accreditation of diagnostic imaging services under Medicare. Subsection 23DZZIAA(1)(a) allows the Minister to establish (by one or more legislative instruments) one or more schemes for the accreditation of diagnostic imaging practices. Subsection 23DZZIAA(1)(b) allows the Minister to approve, if required, one or more persons (approved accreditors) to accredit premises and bases under a scheme or schemes.

Pursuant to subsection 16EA(1) of the Act, and unless the Minister otherwise directs, a Medicare benefit is not payable for a diagnostic imaging service unless the service is rendered from a premises or a mobile base accredited under a diagnostic imaging accreditation scheme.

The diagnostic imaging accreditation scheme was implemented in stages. The first stage was established under the Health Insurance (Diagnostic Imaging Accreditation) Determination 2008 (no longer in force). It applied to all diagnostic imaging services in the Diagnostic Imaging Services Table (DIST) regulations made under section 4AA of the Act, except cardiac ultrasound, cardiac angiography, obstetric and gynaecological ultrasound, and nuclear medicine imaging services (known as non-radiology services). The first stage commenced on 1 July 2008 and concluded on 30 June 2010.

The second stage of the scheme was established by the Health Insurance (Diagnostic Imaging Accreditation) Instrument 2010. It commenced on 1 July 2010 and covers all diagnostic imaging services in the DIST Regulations, including those non-radiology services which had previously been exempted.

An Invitation to Apply process was conducted prior to the commencement of the stage two scheme inviting applications from organisations seeking approval to provide accreditation services. Applications received by the Department of Health (the Department) were assessed to identify preferred accreditors, which were submitted to the Minister for consideration. Those approved were named in the 2010 Instrument.

Consultation

The Department consulted the Diagnostic Imaging Accreditation Scheme Advisory Committee (the Committee) about the remaking of this instrument. The Committee comprises individuals with expertise in diagnostic imaging policy, practice, standards development and accreditation, health administration and health consumer advocacy. The Committee is responsible for providing advice on the administration of the scheme, including accreditation standards.

The Department also consulted those organisations which are named in the instrument at section 6, namely HDAA Australia Pty Ltd, Quality Innovation Performance International Pty Ltd and the National Association of Testing Authorities, which are approved to provide accreditation services under the stage two scheme.  T

This instrument commences on 1 April 2020.

Details of this instrument are set out in the Attachment.


ATTACHMENT

 

Details of the Health Insurance (Diagnostic Imaging Accreditation – Approved Accreditors) Instrument 2020

 

Section 1  Name

 

This section provides that the name of this instrument is the Health Insurance (Diagnostic Imaging Accreditation – Approved Accreditors) Instrument 2020.

 

Section 2 Commencement

 

This section provides that this instrument commences on 1 April 2020.

 

Section 3 Authority

 

This sections provides that the instrument is made under section 23DZZIAA(1) of the Health Insurance Act 1973.

 

Section 4 Definitions

 

This section defines terms used in the instrument as follows:

 Act means the Health Insurance Act 1973.

diagnostic imaging practice is a convenient term used in the instrument which means either a diagnostic imaging premises’ or a ‘base for mobile diagnostic imaging equipment’. These latter terms are defined in subsection 3(1) of the Act for the purposes of the requirements set out in Division 4, Diagnostic Imaging Register.

 

Section 5 Schedules

 

This section provides that each instrument that is specified in a Schedule to the instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to the instrument has effect according to its terms.

 

Section 6 Approval of persons to accredit diagnostic imaging practices

 

This section is made for the purposes of paragraph 23DZZIAA(1)(b) of the Act and specifies the organisations approved to accredit diagnostic imaging practices in accordance with the Health Insurance (Diagnostic Imaging Accreditation) Instrument 2020.

 

Schedule 1

 

This Schedule provides that the Health Insurance (Diagnostics Imaging Accreditation – Approved Accreditors) Instrument 2010 is repealed.


Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

Health Insurance (Diagnostic Imaging Accreditation – Approved Accreditors) Instrument 2020

 

This instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

 

Overview of the instrument

This instrument, the Health Insurance (Diagnostic ImagingApproved Accreditors) Instrument 2020, repeals and replaces with minimal change, the Health Insurance (Diagnostic Imaging Accreditation – Approved Accreditors) Instrument 2010 which is due to sunset on 1 April 2020.

 

This instrument specifies for subsection 23ZZIAA(1) of the Act the organisations who are approved to receive and make decisions on applications from proprietors seeking accreditation of diagnostic imaging premises and bases for mobile diagnostic imaging equipment (diagnostic imaging practices) in accordance with the Health Insurance (Diagnostic Imaging Accreditation) Instrument 2020.

 

Human rights implications

This instrument engages Articles 9 and 12 of the International Covenant on Economic Social and Cultural Rights (ICESCR), specifically the rights to health and social security.

 

The Right to Health

The right to the enjoyment of the highest attainable standard of physical and mental health is contained in Article 12(1) of the ICESCR. The UN Committee on Economic Social and Cultural Rights (the UN Committee) has stated that the right to health is not a right for each individual to be healthy, but is a right to a system of health protection which provides equality of opportunity for people to enjoy the highest attainable level of health.

 

The UN Committee reports that the ‘highest attainable standard of health’ takes into account the country’s available resources. This right may be understood as a right of access to a variety of public health and health care facilities, goods, services, programs, and conditions necessary for the realisation of the highest attainable standard of health.

 

The Right to Social Security

The right to social security is contained in Article 9 of the ICESCR. It requires that a country must, within its maximum available resources, ensure access to a social security scheme that provides a minimum essential level of benefits to all individuals and families that will enable them to acquire at least essential health care. Countries are obliged to demonstrate that every effort has been made to use all resources that are at their disposal in an effort to satisfy, as a matter of priority, this minimum obligation.

 

The UN Committee reports that there is a strong presumption that retrogressive measures taken in relation to the right to social security are prohibited under ICESCR. In this context, a retrogressive measure would be one taken without adequate justification that had the effect of reducing existing levels of social security benefits, or of denying benefits to persons or groups previously entitled to them. However, it is legitimate for a Government to re-direct its limited resources in ways that it considers to be more effective at meeting the general health needs of all society, particularly the needs of the more disadvantaged members of society.

 

Analysis

This instrument maintains and promotes rights to health and social security by ensuring that patients can continue to access Medicare funded diagnostic imaging services which are provided by practices that have been assessed as meeting safety and quality accreditation standards by competent and credible organisations approved for that purpose.

 

Conclusion

This instrument is compatible with human rights as it has a positive effect on the right to health and the right to social security.

 

Greg Hunt

Minister for Health

 

Overview

The Health Insurance (Diagnostic Imaging Accreditation – Approved Accreditors) Instrument 2020 was enacted to ensure the ongoing accreditation of diagnostic imaging practices in accordance with the Health Insurance Act 1973. This instrument, made under subsection 23DZZIAA(1) of the Act, identifies the organisations approved to assess and accredit diagnostic imaging premises and mobile equipment, thus ensuring that these services meet the required safety and quality standards for Medicare benefits. By repealing and replacing the 2010 Instrument, this legislative update maintains the accreditation framework and reflects current organisational names, ensuring continuity and clarity in the administration of diagnostic imaging services under Medicare. The policy objective of this instrument is to safeguard the right to health and social security by maintaining access to accredited diagnostic imaging services, which are essential for the provision of high-quality healthcare within the Australian community.

Scope and Application

The Health Insurance (Diagnostic Imaging Accreditation – Approved Accreditors) Instrument 2020 applies to the organisations that are approved to accredit diagnostic imaging practices in accordance with the Health Insurance (Diagnostic Imaging Accreditation) Instrument 2020. The instrument names specific organisations, such as HDAA Australia Pty Ltd, Quality Innovation Performance International Pty Ltd, and the National Association of Testing Authorities, which are authorised to assess and accredit diagnostic imaging services under the Medicare scheme. This instrument serves to update and replace the previous Health Insurance (Diagnostic Imaging – Approved Accreditors) Instrument 2010, ensuring the continuation of accreditation standards for diagnostic imaging services. It also maintains the legislative framework established under subsection 23DZZIAA of the Health Insurance Act 1973, which mandates that a Medicare benefit is not payable for a diagnostic imaging service unless rendered from a premises or mobile base accredited under a diagnostic imaging accreditation scheme. The geographic reach of this instrument is effectively national, as it applies to accredited practices providing services throughout Australia, ensuring uniformity and compliance with the Medicare standards across the country. This instrument does not introduce any new exclusions or exemptions; rather, it updates the list of approved accreditors and corrects previous organisational names to maintain clarity and accuracy within the regulatory framework.

Key Provisions

The Health Insurance (Diagnostic Imaging Accreditation – Approved Accreditors) Instrument 2020, made under section 23DZZIAA(1) of the Health Insurance Act 1973, specifies the organisations approved to accredit diagnostic imaging practices. These practices include both diagnostic imaging premises and bases for mobile diagnostic imaging equipment. This instrument, effective from 1 April 2020, replaces the 2010 Instrument, which was set to expire on the same date. It updates references and corrects the names of two of the approved organisations, HDAA Australia Pty Ltd and Quality Innovation Performance International Pty Ltd, ensuring compliance with current naming conventions. The approved accreditors, as detailed in section 6 of the instrument, are now HDAA Australia Pty Ltd, Quality Innovation Performance International Pty Ltd, and the National Association of Testing Authorities. These entities are responsible for assessing and accrediting diagnostic imaging practices to ensure they meet the necessary standards. Their approval is critical as Medicare benefits are not payable for diagnostic imaging services unless they are provided by an accredited premises or mobile base, as per subsection 16EA(1) of the Act. Organisations and individuals governed by this Act must ensure their diagnostic imaging practices are accredited by one of the approved entities. This involves submitting applications for accreditation and adhering to the standards set by the accreditors. The approved entities are required to conduct thorough assessments to verify that the diagnostic imaging practices comply with the established criteria, ensuring the delivery of safe and high-quality services. Failure to comply with the accreditation requirements can lead to serious consequences. Under subsection 16EA(1) of the Health Insurance Act 1973, if a diagnostic imaging service is provided from a non-accredited premises or mobile base, Medicare benefits will not be payable for that service. Additionally, any organisation or individual found to be providing services from non-accredited facilities may face legal actions, including fines and other penalties as prescribed under the Act. The instrument ensures that the integrity of the diagnostic imaging services provided under Medicare is maintained, protecting both the patients and the system.

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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.