EXPLANATORY STATEMENT
Health Insurance Act 1973
Health Insurance (Section 4BA - Pathologist-Determinable Services) Amendment (Administrative) Determination 2026
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.
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). A determination that a service is a pathologist-determinable service allows Medicare benefit to be paid for a pathology service in specified circumstances.
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 purpose of the Health Insurance (Section 4BA - Pathologist-Determinable Services) Amendment (Administrative) Determination 2026 (the Amendment Determination) is to make administrative amendments to the Health Insurance (Section 4BA - Pathologist-Determinable Services) Determination 2025 (the 2025 Determination).
The Amendment Determination amends the 2025 Determination to insert a definition of “necessary” into section 5 of the 2025 Determination to clarify that “necessary” has the same meaning in the 2025 Determination as in paragraph 16A(12)(b) of the Act. Additionally, the Amendment Determination removes the word “clinically” from the term “clinically necessary” in paragraph 9(b) of the 2025 Determination, clarifying that the relevant consideration is whether a service is “necessary”.
Consultation
Consultation was not required with persons affected as the Amendment Determination is administrative and machinery in nature and does not make any substantive changes to the 2025 Determination. This instrument retains the existing ability for specified services to be provided as pathologist-determinable services under the Medicare Benefits Schedule.
The Amendment Determination is a legislative instrument for the purposes of the Legislation Act 2003.
The Amendment Determination commences the day after the instrument is registered.
Details of the Amendment 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) Amendment (Administrative) Determination 2026
Section 1 – Name
Section 1 provides for the instrument to be referred to as the Health Insurance (Section 4BA - Pathologist-Determinable Services) Amendment (Administrative) Determination 2026 (the Amendment Determination).
Section 2 – Commencement
Section 2 provides for the Amendment Determination to commence the day after registration.
Section 3 – Authority
Section 3 provides that the Amendment Determination is made under section 4BA of the Health Insurance Act 1973 (the Act).
Section 4 – Schedules
Section 4 provides that each instrument that is specified in a Schedule to this Amendment Determination is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Amendment Determination has effect according to its terms.
Schedule 1 – Amendments
Health Insurance (Section 4BA - Pathologist-Determinable Services) Determination 2025
Item 1 inserts a definition for the term “necessary” into section 5 to provide that the word “necessary” has the meaning given by paragraph 16A(12)(b) of the Act. That is, a reference to determining that a service is necessary is a reference to determining that a service is reasonably necessary for the adequate medical care of the patient concerned.
Item 2 removes the word “clinically” at paragraph 9(b). This is because the words “clinically necessary” are intended to have the same meaning as the word “necessary” in the context of paragraph 9(b), as set out in the new definition of the word “necessary” being inserted by item 1 of the Amendment Determination.
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) Amendment (Administrative) Determination 2026
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 purpose of the Health Insurance (Section 4BA - Pathologist-Determinable Services) Amendment (Administrative) Determination 2026 (the Amendment Determination) is to make administrative amendments to the Health Insurance (Section 4BA - Pathologist-Determinable Services) Determination 2025 (the 2025 Determination).
The Amendment Determination amends the 2025 Determination to insert a definition of “necessary” into section 5 of the 2025 Determination to clarify that “necessary” has the same meaning in the 2025 Determination as in paragraph 16A(12)(b) of the Act. Additionally, the Amendment Determination removes the word “clinically” from the term “clinically necessary” in paragraph 9(b) of the 2025 Determination, clarifying that the relevant consideration is whether a service is “necessary”.
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 will reflect contemporary clinical practice to ensure that patients continue to have access to health and social security through relevant subsidised pathology services on the Medicare Benefits Schedule. 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 right to health and the right to social security and the right of 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