EXPLANATORY STATEMENT
HEALTH INSURANCE ACT 1973
Health Insurance (Eligible Pathology Laboratories) Determination 2026
Purpose and operation
The Health Insurance (Eligible Pathology Laboratories) Determination 2026 (the 2026 Determination) prescribes categories of accredited pathology laboratories as eligible pathology laboratories.
The 2026 Determination repeals and remakes the Health Insurance (Eligible Pathology Laboratories) Determination 2015 (the 2015 Determination). The 2015 Determination sunsets on 1 April 2026.
The 2026 Determination maintains the existing approach by prescribing laboratories allocated Category GX (General), Category GY (General) or Category S (Specialised) as eligible pathology laboratories.
Authority
Subsection 23DBA(1) of the Health Insurance Act 1973 (the Act) provides that the Minister may, by legislative instrument prescribe categories of accredited pathology laboratory for the purposes of the definition of an ‘eligible pathology laboratory’ in subsection 23DA(1) of the Act.
Subsection 23DBA(2) of the Act provides that the Minister may do so by applying, adopting or incorporating, with or without modification, the provisions of principles determined by the Minister under section 23DNA of the Act. These are currently, the Health Insurance (Accredited Pathology Laboratories-Approval) Principles 2017 (the Approval Principles).
Reliance on subsection 33(3) of the Acts Interpretation Act 1901
Under subsection 33(3) of the Acts Interpretation Act 1901, where an Act confers a power to make, grant or issue any instrument of a legislative or administrative character, the power includes a power to repeal, rescind, revoke, amend, or vary the instrument in the same manner and subject to the same conditions.
Background
Medicare benefits are payable for a pathology service only where the pathology specimen is collected from the patient at a location specified in subsection 16A(5AA) of the Act. One such location is an ‘approved collection centre,’ being a specimen collection centre approved by the Minister under section 23DNBA of the Act.
Section 23DNBA of the Act provides that the Minister:
- may grant an approval to an approved pathology authority to operate an eligible collection centre on premises they own, lease, sub-lease or otherwise occupies, and
- must determine, by legislative instrument, principles that apply to the granting of approvals of eligible collection centres. These are currently, the Health Insurance (Approvals for Eligible Collection Centres)Principles 2020.
Section 23DA of the Act defines an eligible collection centre as a collection centre on premises owned, leased or sub-leased by an approved pathology authority that is also the sole proprietor of at least one eligible pathology laboratory.
The 2026 Determination prescribes category GX(General), GY(General) or S(Specialised) accredited pathology laboratories for the definition of eligible pathology laboratory in subsection 23DA(1) of the Act.
The approval of premises as an accredited pathology laboratory under section 23DN of the Act specifies the category of accreditation allocated to the premises. These categories, and the criteria applying to them, are set out in section 17 of the Approval Principles, as in force from time to time.
Remake of the 2015 Determination and minor amendments
The 2026 Determination remakes the 2015 Determination with minor amendments to:
- update references to the Approval Principles, and
- exclude the grandfathered category in subsection 5(d) of the 2015 Determination.
The excluded provision related to a class of accredited pathology laboratory where:
- the approved pathology authority, as the sole proprietor of that laboratory, had an arrangement with another approved pathology authority to use a category GX(General) or GY(General) accredited pathology laboratory; and
- immediately before 1 December 2001, the approved pathology authority operated a collection centre that was in a rural or remote area that was not on the premises of a public hospital.
This provision does not align with current policy on the accreditation of pathology laboratories and approval of eligible collection centres.
Commencement
The 2026 Determination commences on 1 April 2026.
Consultation
The Department consulted the National Association of Testing Authorities (NATA) as part of its assessment to exclude the 25-year-old grandfathered provision from the 2026 Determination. NATA is the sole independent body responsible for assessing the conformity of laboratory premises with relevant accreditation standards. No broader consultation was completed. This is because the 2026 Determination remakes the sunsetting instrument in substantially the same form, with minor technical changes that are unlikely to affect approved pathology authorities currently operating approved collection centres, or patient access to specimen collection services.
General
The 2026 Determination is a legislative instrument for the purposes of the Legislation Act 2003.
Details of the 2026 Determination are set out in Attachment A.
The 2026 Determination is compatible with the human rights and freedoms recognised or declared under section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. A full statement of compatibility is set out in Attachment B.
ATTACHMENT A
Details of the Health Insurance (Eligible Pathology Laboratories) Determination 2026
Section 1 Name
Section 1 provides that the name of the instrument is the Health Insurance (Eligible Pathology Laboratories) Determination 2026.
Section 2 Commencement
Section 2 provides that the whole of the instrument commences on 1 April 2026.
Section 3 Authority
This section provides that the instrument is made under subsection 23DBA(1) of the Health Insurance Act 1973 (the Act).
Section 4 Schedules
Section 4 provides that the instrument specified in Schedule 1, the Health Insurance (Eligible Pathology Laboratories) Determination 2015 is repealed.
Section 5 Definitions
Section 5 defines key terms used in the instrument. Unless otherwise defined they have the same meaning as in the Act.
The instrument defines the relevant laboratory categories by reference to section 17 of the Health Insurance (Accredited Pathology Laboratories-Approval) Principles 2017, as in force from time to time. This incorporation is permitted by section 14 of the Legislation Act 2003, and that the provisions of the Act are incorporated as in force from time to time.
Section 6 Categories of eligible pathology laboratories
Section 6 prescribes the categories of accredited pathology laboratories for the purposes of the definition of eligible pathology in subsection 23DA(1) of the Act. These are laboratories allocated Category GX(General), Category GY(General) or Category S(Specialised) in the approval of premises as an accredited pathology laboratory given under section 23DN of the Act.
ATTACHMENT B
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Health Insurance (Eligible Pathology Laboratories) Determination 2026
This disallowable legislative 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 Disallowable Legislative Instrument
The Health Insurance (Eligible Pathology Laboratories) Determination 2026 (the 2026 Determination) remakes the Health Insurance (Eligible Pathology Laboratories) Determination 2015 (the 2015 Determination) which sunsets on 1 April 2026.
It prescribes categories of ‘accredited pathology laboratory’ for the purpose of the definition of an ‘eligible pathology laboratory’ in subsection 23DA(1) of the Health Insurance Act 1973 (the Act).
Subsection 16A(5AA) of the Act provides that Medicare benefits are payable for pathology services rendered where, pathology specimens are collected in an ‘approved collection centre,’ or in other specified circumstances.
Section 23DNBA of the Act provides that the Minister may grant an approval to an approved pathology authority to operate an ‘eligible collection centre’ on premises owned, leased or otherwise occupied by the approved pathology authority. Once approved, an eligible collection centre becomes an approved collection centre.
Subsection 23DA(1) of the Act provides that an eligible collection centre is a collection centre on premises owned, leased or sub-leased by an approved pathology authority that is also the sole proprietor of at least one eligible pathology laboratory. Section 23DBA of the Act empowers the Minister, by determination in writing, to prescribe categories of accredited pathology laboratory for the purposes of the definition of an eligible pathology laboratory.
The 2026 Determination prescribes the categories of accredited pathology laboratories for the purposes of the definition of eligible pathology in subsection 23DA(1) of the Act. These are laboratories allocated category GX(General), GY(General) or S(Specialised) in the approval of premises as an accredited pathology laboratory given under section 23DN of the Act.
To align with the current policy for the accreditation of pathology laboratories and the approval of eligible collection centres, the 2026 Determination removes the grandfathered provision in subsection 5(d) of the 2015 Determination. The removed provision related to a class of accredited pathology laboratory in respect of which the approved pathology authority operated a collection centre:
- in a rural or remote area that was not on the premises of a public hospital; and
- before 1 December 2001.
Human rights implications
The 2026 Determination does not engage any of the applicable human rights or freedoms. It prescribes categories of accredited pathology laboratories that are eligible pathology laboratories.
It aligns with current policy for the accreditation of pathology laboratories and approval of eligible collection centres. It will not affect patient access to Medicare eligible pathology services.
Conclusion
The 2026 Determination is compatible with human rights as it does not raise any human rights issues.
Mark Butler
Minister for Health and Ageing