REPLACEMENT EXPLANATORY STATEMENT
Health Insurance Act 1973
Health Insurance (Section 4BA - Pathologist-Determinable Services) Determination 2025
Section 16A of the Health Insurance Act 1973 (the Act) specifies the requirements that must be met for the payment of Medicare benefits in relation to pathology services. Subsection 16A(3) provides that a pathology service must be requested by the treating practitioner, unless it is a pathologist-determinable service. A pathologist-determinable service is a service which has not been requested by the treating practitioner.
The listing of pathologist-determinable services under section 4BA of the Act allows Medicare benefits to be paid for pathology services which are requested and performed by a pathologist for their own patients; or for certain tests which are not requested but are performed on the basis of information learned from an originally requested service. Section 4BA of the Act provides that the Minister for Health and Ageing may, by legislative instrument, determine that a particular pathology service, or pathology services included in a class of pathology services, are pathologist-determinable services, after consultation with Royal College of Pathologists of Australasia (RCPA).
This instrument is made pursuant to subsection 33(3) of the Acts Interpretation Act 1901, which provides that a power to make a legislative or administrative instrument includes the power to repeal, rescind, revoke, amend, or vary any such instrument in the same manner and subject to the same conditions.
Purpose
The Health Insurance (Section 4BA - Pathologist-Determinable Services) Determination 2025 (the 2025 Determination) repeals and remakes the Health Insurance (Pathologist-determinable Services) Determination 2015 (the 2015 Determination).
The 2025 Determination prescribes the services under the pathology services table that are pathologist-determinable services. Subject to the requirements in the 2025 Determination, a pathologist-determinable service is a service performed by a pathologist without being requested by a different provider.
The 2025 Determination does not make any substantive changes compared to the 2015 Determination. The 2015 Determination is being remade as it is due to sunset on 1 April 2026. The 2025 Determination makes exclusively administrative changes to update the structure of the instrument. No changes have been made to any of the listed pathologist-determinable services nor any of the associated specified conditions including the originally requested services.
The decisions that may be made under the 2025 Determination are considered not suitable for independent merits review. This is because these decisions have a limited impact as pathologist-determinable services are very targeted and consist of a small number of selected Medicare-funded tests for individual patients with targeted medical conditions. Further, the decision-making under the 2025 Determination is highly specialised, being based on approved pathology practitioner professional clinical judgement and expert technical knowledge about the tests.
Consultation
Consultation was not undertaken for the repeal and remake of the 2015 Determination. Consultation was not required with persons affected as the repeal and remake is administrative and machinery in nature and does not make any substantive changes compared to the 2015 Determination. This instrument retains the existing ability for specified services to be provided as pathologist-determinable services under the Medicare Benefits Schedule (MBS). The relevant consultation with affected parties was previously undertaken in relation to the 2015 Determination, including with the RCPA.
The 2025 Determination is a legislative instrument for the purposes of the Legislation Act 2003.
The 2025 Determination commences on 1 March 2026.
Details of the 2025 Determination are set out in the Attachment.
Authority: Section 4BA of the
Health Insurance Act 1973
ATTACHMENT
Details of the Health Insurance (Section 4BA - Pathologist-Determinable Services) Determination 2025
Section 1 – Name
Section 1 provides for the instrument to be referred to as the Health Insurance (Section 4BA - Pathologist-Determinable Services) Determination 2025 (the 2025 Determination).
Section 2 – Commencement
Section 2 provides for the 2025 Determination to commence on 1 March 2026.
Section 3 – Authority
Section 3 provides that the 2025 Determination is made under section 4BA of the Health Insurance Act 1973 (the Act).
Section 4 – Schedules
Section 4 of the 2025 Determination provides that each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
Section 5 – Definitions
Section 5 defines terms used in the 2025 Determination.
Section 6 – Services rendered to a patient of a pathologist
Section 6 provides that a pathology service in the pathology services table that is rendered by, or on behalf of, an approved pathology practitioner to a patient of that practitioner is a pathologist-determinable service.
Section 7 – Services rendered where a different service was originally requested
Section 7 provides that a pathology service that is rendered by, or on behalf of, an approved pathology practitioner is a pathologist-determinable service, in circumstances where that practitioner considers that service to be necessary on the basis of information learned from another service:
- that was rendered to the patient by, or on behalf of, that practitioner; and
- the request of which complied with paragraph 16A(4)(a) or (b) of the Act (i.e. the request is made in writing, or if the request was provided in a form other than writing, confirmed in writing within 14 days and the request is made in accordance with the regulations.
The originally requested services, and the corresponding pathologist-determinable services for the purposes of section 7, are specified in the table to paragraph (c).
The term “necessary” in paragraph 7(b) of this instrument is intended to be consistent with paragraph 16A(12)(b) of the Act, which is that a service is reasonably necessary for the adequate medical care of the patient concerned. The question of what factors may or must be taken into account in deciding whether a pathologist-determinable service is “necessary” is a matter of clinical professional judgement of whether that service is reasonably necessary for the adequate medical care of the patient based on that patient’s test result from the associated originally requested service.
For example, under item 6 of the table to paragraph 7(c), items 73411, 73412 and 73413 are pathologist-determinable services with item 73410 as the originally requested service. A medical practitioner treating a patient of reproductive age with suspected alpha thalassaemia (an inherited blood disorder that affects the production of haemoglobin, which carries oxygen in the blood) may request a genetic test to detect the deletion of HBA1 and HBA2 genes known to cause this disorder to confirm diagnosis under item 73410. If the test result is inconclusive, the approved pathology practitioner (APP) may determine, without another test request from the patient’s treating practitioner, that a subsequent test under either item 73411, 73412 and 73413 is necessary to confirm the diagnosis. The choice of which test to perform will be based on the APP’s professional clinical judgement of the initial test result (from item 73410) and expert technical knowledge of the types of genetic tests that would be most appropriate:
- item 73411 is for a test using gene sequencing if the test results from item 73410 were inconclusive and a less common or rare HBA1 or HBA2 gene variant is suspected,
- item 73412 is for another test to detect HBA1 and HBA2 genes deletion if the test results from item 73410 were inconclusive and a large deletion variant is suspected
- item 73413 is for non-deletion testing of HBA1 and HBA2 genes using a technique other than sequencing if the test results from item 73410 were inconclusive.
Section 8 – Services described in items 69316, 69317, 69319, 69494, 69495, 69496, 69497 and 69498
Section 8 provides that a pathology service that is described in items 69316, 69317, 69319, 69494, 69495, 69496, 69497 or 69498 is a pathologist-determinable service where:
- the service is rendered by, or on behalf of an approved pathology practitioner who is a recognised pathologist; and
- that practitioner considers it to be necessary on the basis of information provided by a treating practitioner, the nature or appearance of the specimen, or information learned from a pathology service described in items 69303, 69306, 69312, 69318, 69321 or 69345.
The term “necessary” in paragraph 8(b) has the same operation as in paragraph 7(b), as described above.
Section 9 – A service described in item 72860
Section 9 provides that a service described in item 72860 can be rendered as a pathologist-determinable service where the following are met.
- the initial service, which is a pathology service described in an item in Group P5 (other than item 72860), Group P6 or Group P7 of the pathology services table, was rendered in a patient episode for the patient, pursuant to a request that complied with paragraph 16A(4)(a) or (b) of the Act;
- following the initial service, the treating practitioner determines that a service described in an item in Group P7 (subsequent Group P7 service) is clinically necessary;
- following a request from the treating practitioner, the pathologist who rendered the initial service at an accredited laboratory determines that the laboratory is unable to perform the subsequent Group P7 service, and consequently determines that a service described under item 72860 is required to select appropriate tissue sample for referral to a different accredited pathology laboratory for testing;
- the subsequent Group P7 service and a service under item 72860 are rendered in a different accredited pathology laboratory, by or on behalf of, an approved pathology practitioner who is a recognised pathologist.
The term “clinically necessary” in paragraph 9(b) is intended to have the same meaning as the term “necessary” in paragraphs 7(b) and 8(b) of this instrument, consistent with paragraph 16A(12)(b) of the Act.
Schedule 1 – Repeals
Item 1 of Schedule 1 repeals the whole of the Health Insurance (Pathologist-determinable Services) Determination 2015.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Health Insurance (Section 4BA - Pathologist-Determinable Services) Determination 2025
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 Determination
The Health Insurance (Section 4BA - Pathologist-Determinable Services) Determination 2025 (the 2025 Determination) repeals and remakes the Health Insurance (Pathologist-determinable Services) Determination 2015 (the 2015 Determination).
The 2025 Determination prescribes the services under the pathology services table that are pathologist-determinable services. Subject to the requirements in the 2025 Determination, a pathologist-determinable service is a service performed by a pathologist without being requested by a different provider.
The 2025 Determination makes administrative changes to update the structure of the instrument. No changes have been made to any of the listed pathologist-determinable services nor any of the associated specified conditions including the originally requested services. The 2025 Determination does not make any substantive changes compared to the 2015 Determination. The 2015 Determination is being remade as it is due to sunset on 1 April 2026.
The decisions that may be made under the 2025 Determination are considered not suitable for independent merits review. This is because the decisions have a limited impact as pathologist-determinable services are very targeted and consist of a small number of selected Medicare-funded tests for individual patients with targeted medical conditions. Further, the decision-making under the 2025 Determination is highly specialised, being based on approved pathology practitioner professional clinical judgement and expert technical knowledge about the tests.
Human rights implications
This instrument engages Articles 2, 3, 9, 12, 16 and 26 of the International Covenant on Economic Social and Cultural Rights (ICESCR), specifically the rights to equality and non-discrimination, 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 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.
The Right of Equality and Non-Discrimination
The rights of equality and non-discrimination are contained in Articles 2, 16 and 26 of the International Covenant on Civil and Political Rights (ICCPR). Article 26 of the ICCPR requires that all persons are equal before the law, are entitled without any discrimination to the equal protection of the law and in this respect, the law shall prohibit any discrimination and guarantee to all persons equal and effective protection against discrimination on any ground such as race, colour, sex, language, religion, political or other opinion, national or social origin, property, birth or other status.
Analysis
This instrument reflects contemporary clinical practice to ensure that patients continue to have access to health and social security through relevant subsidised pathologist-determinable services on the MBS. The instrument will also maintain the right of equality and non‑discrimination, as a Medicare-eligible person (as defined in the Health Insurance Act 1973) continues to have access to all Medicare services based on clinical need consistent with a universal health insurance program.
Conclusion
This instrument is compatible with human rights as it maintains the rights to health, social security as well as equality and non-discrimination.
Mary Warner
Assistant Secretary
Diagnostic Imaging and Pathology Branch
Medicare Benefits and Digital Health Division
Health Resourcing Group
Department of Health, Disability and Ageing