EXPLANATORY STATEMENT
HEALTH INSURANCE ACT 1973
Health Insurance (Accredited Pathology Laboratories—Approval) Amendment (Relevant Standards) Principles (No. 4) 2026
Authority
Subsection 23DNA(1) of the Health Insurance Act 1973 provides for the Minister to determine the principles to be applied in exercising his or her powers under section 23DN of the Act to approve or refuse to approve premises as an accredited pathology laboratory. The current principles determined under section 23DNA are the Health Insurance (Accredited Pathology Laboratories—Approval) Principles 2017 (the Approval Principles).
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 (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.
Purpose and operation
The Health Insurance (Accredited Pathology Laboratories—Approval) Amendment (Relevant Standards) Principles (No. 4) 2026 (the Amending Instrument) amends the Approval Principles to correct the title of an accreditation standard that was incorporated into the Approval Principles on 13 July 2026.
This is achieved by amending Schedule 1 (table item 4) to:
- Repeal the “Requirements for information, communication and reporting (Sixth Edition 2026)”; and
- Substitute the “Requirements for information communication and reporting (Sixth Edition 2026”.
In accordance with section 14 of the Legislation Act 2003, Schedule 1 of the Approval Principles will be amended to incorporate the Requirements for information communication and reporting (Sixth Edition 2026) as it exists at the time of commencement of the Amending Instrument.
Accreditation materials referenced in the Approval Principles are readily accessible free of charge on the Commission’s Pathology Standards webpage (https://www.safetyandquality.gov.au/accreditation/natonal pathology accreditation scheme).
Background
With the exception of some basic tests conducted by some medical practitioners within their own medical practice, Medicare benefits for pathology services are only payable when they are rendered by or on behalf of an approved pathology practitioner (APP), in an accredited pathology laboratory (APL) operated by an approved pathology authority (APA).
The Approval Principles are made under subsection 23DNA(1) of the Act and they:
- operate to ensure that relevant quality standards are met and maintained in pathology laboratories providing Medicare eligible services; and
- underpin the National Pathology Accreditation Scheme (NPAS), a compulsory accreditation scheme which requires pathology laboratories to meet relevant quality standards to provide services that are eligible for Medicare benefits.
The Approval Principles set out the criteria for different categories of APLs and specify the standards that must be met as part of the accreditation assessment for each category of laboratory and kinds of services provided in that laboratory. The objectives of the Approval Principles include promoting the delivery of reliable test results and reducing the risk of misdiagnosis in the provision of pathology services.
Schedule 1 to the Approval Principles specifies accreditation materials that set out the relevant quality standards against which applicants for accreditation are assessed. These documents are developed and maintained by the National Pathology Accreditation Advisory Council (NPAAC) to ensure pathology best practice, support the therapeutics regulatory framework and assure the quality of Australian pathology services. Individual accreditation standards should be read in conjunction with the overarching accreditation standard, the Requirements for Medical Pathology Services (Third Edition 2018) which sets out the core elements of good laboratory practice.
The NPAAC is a committee established under subsection 9(1) of the National Health
Act 1953. Their responsibilities include making recommendations to the Australian Government and the states and territories on matters relating to the accreditation of pathology laboratories and the introduction and maintenance of uniform standards of practice in Australian pathology laboratories. Its membership includes pathology experts from various professional and scientific organisations, consumer representatives and representatives from the Australian Government and states and territories.
NPAAC and the NPAS are supported by the Commission under an arrangement with the Department of Health, Disability and Ageing (Department). The Department retains policy and regulatory responsibilities for pathology accreditation and the National Association of Testing Authorities, Australia (NATA) is the independent assessment body that assesses the conformity of pathology laboratories with relevant accreditation standards.
Requirements for information communication and reporting (Sixth Edition 2026)
This minor technical amendment removes a comma from the title of an accreditation standard that was incorporated into the Approval Principles on 13 July 2026 by the Health Insurance (Accredited Pathology Laboratories—Approval) Amendment (Relevant Standards) Principles (No. 3) 2026. This is achieved by amending Schedule 1 (table item 4) of the Approval Principles to:
- Repeal the “Requirements for information, communication and reporting (Sixth Edition 2026)”; and
- Substitute the “Requirements for information communication and reporting (Sixth Edition 2026”.
Commencement
This Amending Instrument commences immediately after the commencement of Part 1 of Schedule 1 of the Health Insurance (Accredited Pathology Laboratories—Approval) Amendment (Relevant Standards) Principles (No. 3) 2026, which commences on
13 July 2026.
Consultation
The Department has consulted with the Commission on this minor technical amendment.
General
The Amending Instrument is a legislative instrument for the purposes of the
Legislation Act 2003. Details of this instrument are set out in Attachment A.
The Amending Instrument 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 (Accredited Pathology Laboratories—Approval) Amendment (Relevant Standards) Principles (No. 4) 2026
1. Name
Section 1 provides that the title of this instrument is the Health Insurance (Accredited Pathology Laboratories—Approval) Amendment (Relevant Standards) Principles (No. 4) 2026 (the Amending Instrument).
2. Commencement
Section 2 provides that the Amending Instrument commences immediately after the commencement of Part 1 of Schedule 1 of the Health Insurance (Accredited Pathology Laboratories—Approval) Amendment (Relevant Standards) Principles (No. 3) 2026, which commences on 13 July 2026.
3. Authority
Section 3 provides that the authority to make the Amending Instrument is subsection 23DNA(1) of the Health Insurance Act 1973.
4. Schedules
Section 4 provides that each instrument that is specified in a Schedule to the Amending 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 Amending Instrument has effect according to its terms.
There is one Schedule in this Amending Instrument. This Schedule provides for the amendments to the Health Insurance (Accredited Pathology Laboratories—Approval) Principles 2017 (Approval Principles).
Schedule 1- Part 1
Health Insurance (Accredited Pathology Laboratories—Approval) Principles 2017
Item 1
Item 1 repeals the accreditation standard listed in item 4 of the table in clause 1 of Schedule 1 of the Approval Principles and substitutes “Requirements for information communication and reporting (Sixth Edition 2026)”.This amendment corrects the title of this standard by removing a comma from its title.
ATTACHMENT B
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Health Insurance (Accredited Pathology Laboratories—Approval) Amendment (Relevant Standards) Principles
(No. 4) 2026
The Health Insurance (Accredited Pathology Laboratories-Approval) Amendment (Relevant Standards) Principles (No. 4) 2026 is a disallowable legislative instrument. 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 Disallowable Legislative Instrument
This instrument amends the Health Insurance (Accredited Pathology Laboratories – Approval) Principles 2017 (the Approval Principles) to correct the title of an accreditation standard that was incorporated into the Approval Principles on 13 July 2026. This is achieved by amending Schedule 1 (table item 4) to:
- Repeal the “Requirements for information, communication and reporting (Sixth Edition 2026)”; and
- Substitute the “Requirements for information communication and reporting (Sixth Edition 2026”.
The Approval Principles are made by the Minister under subsection 23DNA(1) of the Health Insurance Act 1973 (the Act) and will be applied in exercising the Minister’s powers to approve or refuse to approve, premises as an accredited pathology laboratory.
With the exception of some basic tests conducted by some medical practitioners within their own medical practice, Medicare benefits for pathology services are only payable when they are rendered by or on behalf of an approved pathology practitioner, in an accredited pathology laboratory operated by an approved pathology authority. The Approval Principles made under subsection 23DNA(1) of the Act operate to ensure that appropriate standards are met and maintained in pathology laboratories where Medicare eligible pathology services can be provided.
The Approval Principles set out the criteria for different categories of accredited pathology laboratories and specify the standards that must be met as part of the accreditation assessment for each category of laboratory and kinds of services provided in that laboratory. The objectives of the Approval Principles include promoting the delivery of reliable test results and reducing the risk of misdiagnosis in the provision of pathology services.
The Schedule to the Approval Principles specifies the accreditation materials that set out relevant standards against which applicants for accreditation are to be assessed. These documents are developed and maintained by the National Pathology Accreditation Advisory Council (NPAAC).
The NPAAC and the National Pathology Accreditation Scheme are supported by the Australian Commission on Safety and Quality in Health Care under an arrangement with the Department of Health, Disability and Ageing (Department). The Department holds policy and regulatory responsibilities for pathology accreditation, and the National Association of Testing Authorities, Australia (NATA) is the independent body that assesses the conformity of pathology laboratories with relevant accreditation standards.
Reviewing accreditation standards ensures that the requirements for the accreditation of pathology laboratories reflect contemporary clinical best practice and are responsive to the pathology sector’s operational requirements. They should be read in conjunction with the overarching NPAAC accreditation standard, the Requirements for Medical Pathology Services (Third Edition 2018) which sets out the core elements of good laboratory practice.
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 (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 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 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 advances the right to health and the right to social security. It achieves this by ensuring appropriate accreditation requirements are in place to maintain access to quality, safe, clinically relevant and cost-effective Medicare eligible pathology services.
Conclusion
This instrument is compatible with human rights because it does not raise any human rights issues.
Mary Warner
Assistant Secretary
Medicare Benefits and Digital Health Division
Health Resourcing Group
Department of Health, Disability and Ageing