EXPLANATORY STATEMENT
Health Insurance Act 1973
Health Insurance (Section 3C – Lutetium PSMA Treatment) Amendment (No. 2) Determination 2025
Subsection 3C(1) of the Health Insurance Act 1973 (the Act) enables the Minister to determine, by legislative instrument, that a health service not specified in an item in the general medical services table (the GMST), or the diagnostic imaging services table (the DIST) is to be treated as if it were listed, under specified circumstances and statutory provisions.
The GMST is established under the regulations made pursuant to subsection 4(1) of the Act. The current version of the GMST is the Health Insurance (General Medical Services Table) Regulations 2021.
The DIST is established under the regulations made pursuant to section 4AA of the Act. The current version of the DIST is the Health Insurance (Diagnostic Imaging Services Table) Regulations (No. 2) 2020.
This instrument is made under 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 3C – Lutetium PSMA Treatment) Amendment (No. 2) Determination 2025 (the Amendment Determination) is to amend the Health Insurance (Section 3C – Lutetium PSMA Treatment) Determination 2025 (the Principal Determination). The Amendment Determination expands the scope of the Principal Determination to enable the listing of two new Lutetium therapeutic nuclear medicine items on the Medicare Benefits Schedule (MBS). Currently, the Principal Determination provides for Lutetium PSMA treatments items. The Amendment Determination will facilitate the introduction of two new Lutetium MBS items from 1 November 2025.
New MBS item 16060 will be listed on the MBS to provide for treatment with the administration of 177Lutetium-DOTA-somatostatin receptor agonist treatment for patients with histologically confirmed, locally advanced or metastatic, and inoperable neuroendocrine neoplasm (NEN).
New MBS item 61530 will be listed on the MBS to provide a new diagnostic imaging service for whole body 68Ga-DOTA-somatostatin receptor agonist positron emission tomography to inform treatment pathways for inoperable NEN.
The Medical Services Advisory Committee (MSAC) supported funding for these services in November 2024. Approval to list the new items was granted by the Minister for Health and Ageing through the authority to approve certain MSAC recommendations outside of a budget process. This authority was announced in the 2025-26 Federal Budget under the Strengthening Medicare measure.
Consultation
Consultation on the two new MBS items was undertaken with medical and diagnostic imaging peak bodies, which were supportive of the services being added to the MBS. The following organisations were consulted with on the item descriptors and associated explanatory note:
- Australasian Association of Nuclear Medicine Specialists;
- Australian and New Zealand Society of Nuclear Medicine;
- Australian Diagnostic Imaging Association;
- Australian Society of Medical Imaging and Radiation Therapy;
- Rural Alliance in Nuclear Scintigraphy;
- The Royal Australian and New Zealand College of Radiologists;
- Australian College of Rural and Remote Medicine;
- Australian Medical Association;
- NeuroEndocrine Cancer Australia;
- Gastroenterological Society of Australia;
- Urological Society of Australia and New Zealand;
- Abdominal Radiology Group of Australia and New Zealand ;
- Rare Cancers Australia;
- Cancer Council Australia;
- Clinical Oncology Society of Australia;
- Medical Oncology Group of Australia;
- Australian Genomic Cancer Medicine Centre;
- Consumer Health Forum;
- Royal Australasian College of Physicians;
- Royal Australasian College of Surgeons;
- Royal Australian College of General Practitioners;
- Novartis; and
- Telix Pharmaceuticals.
The Amendment Determination is a legislative instrument for the purposes of the Legislation Act 2003.
The Amendment Determination commences on 1 November 2025.
Details of the Amendment Determination are set out in the Attachment.
Authority: Subsection 3C(1) of the
Health Insurance Act 1973
ATTACHMENT
Details of the Health Insurance (Section 3C – Lutetium PSMA Treatment) Amendment (No. 2) Determination 2025
Section 1 – Name
Section 1 provides for the instrument to be referred to as the Health Insurance (Section 3C – Lutetium PSMA Treatment) Amendment (No. 2) Determination 2025 (the Amendment Determination).
Section 2 – Commencement
Section 2 provides for the Amendment Determination to commence on 1 November 2025.
Section 3 – Authority
Section 3 provides that the Amendment Determination is made under subsection 3C(1) of the Health Insurance Act 1973.
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 3C – Lutetium PSMA Treatment) Determination 2025 (the Principal Determination)
Item 1 amends the title of the Principal Determination (currently, the Health Insurance (Section 3C – Lutetium PSMA Treatment) Determination 2025) to the Health Insurance (Section 3C – Lutetium Therapeutic Nuclear Medicine Treatments) Determination 2025
Item 2 amends the existing definition of “disease progression” in subsection 4(1) of the Principal Determination to limit this definition to only apply to items 16050 and 16055.
Item 3 inserts two new definitions into subsection 4(1) of the Principal Determination, defining the terms “formally convened neuroendocrine multidisciplinary board” and “peptide receptor radionuclide therapy”.
Item 4 amends section 6 of the Principal Determination to specify that clause 5.4.1 of the Health Insurance (General Medical Services Table) Regulations 2021 (the GMST) shall have effect as if all items listed in Schedule 1 of the Principal Determination were also specified in clause 5.4.1 of the GMST.
Item 5 amends section 7 of the Principal Determination to specify that clause 2.4.6 of the Health Insurance (Diagnostic Imaging Services Table) Regulations (No. 2) 2020 (the DIST) shall have effect as if all items listed in Schedule 2 of the Principal Determination were also specified in clause 2.4.6 of the DIST.
Item 6 repeals and substitutes the current section 8 of the Principal Determination to extend the provision to all items listed in Schedule 2 of the Principal Determination (existing Medicare Benefits Schedule (MBS) item 61530, which is being inserted by the Amendment Determination, and existing MBS item 61528).
Item 7 inserts new MBS item 16060 for 177Lutetium-DOTA-somatostatin receptor agonist treatment cycle into Schedule 1 of the Principal Determination.
Item 8 inserts new MBS item 61530 for whole body 68Ga-DOTA-somatostatin receptor agonist PET study into Schedule 2 of the Principal Determination.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Health Insurance (Section 3C – Lutetium PSMA Treatment) Amendment (No. 2) 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 purpose of the Health Insurance (Section 3C – Lutetium PSMA Treatment) Amendment (No. 2) Determination 2025 (the Amendment Determination) is to amend the Health Insurance (Section 3C – Lutetium PSMA Treatment) Determination 2025 (the Principal Determination). The Amendment Determination expands the scope of the Principal Determination to serve as the legislative mechanism for listing new Lutetium therapeutic nuclear medicine items on the Medicare Benefits Schedule (MBS). The Principal Determination currently provides for Lutetium PSMA treatments. The Amendment Determination will facilitate the introduction of two new Lutetium MBS items from 1 November 2025.
New MBS item 16060 will be listed in on the MBS to provide for treatment with the administration of 177Lutetium-DOTA-somatostatin receptor agonist treatment for patients with histologically confirmed, locally advanced or metastatic, and inoperable neuroendocrine neoplasm (NEN).
New MBS item 61530 will be listed on the MBS to provide a new diagnostic imaging service for whole body 68Ga-DOTA-somatostatin receptor agonist positron emission tomography to inform treatment pathways for inoperable NEN.
The Medical Services Advisory Committee (MSAC) supported funding for these services in November 2024. Approval to list the new items was granted by the Minister for Health and Ageing through the authority to approve certain MSAC recommendations outside of a budget process. This authority was announced in the 2025-26 Federal Budget under the Strengthening Medicare measure.
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 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 by introducing two new MBS items for the treatment of inoperable NEN. This will expand patient access to cancer treatment services, ensuring patients continue to have access to health and social security through relevant services on the Medicare Benefits Schedule.
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 Integrity Division
Health Resourcing Group
Department of Health, Disability and Ageing