EXPLANATORY STATEMENT
Health Insurance Act 1973
Health Insurance Legislation Repeal (Nuclear Medicine Imaging Services) Determination 2026
Subsection 3C(1) of the Health Insurance Act 1973 (the Act) provides that the Minister may, by legislative instrument, determine that a health service not specified in an item in the diagnostic imaging services table (the DIST) shall, in specified circumstances and for specified statutory provisions, be treated as if it were specified in the Table.
The DIST is set out in the regulations made under subsection 4AA of the Act. The most recent version of the regulations is the Health Insurance (Diagnostic Imaging Services Table) Regulations (No. 2) 2020.
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 of that instrument in the same manner and subject to the same conditions.
Purpose
The purpose of the Health Insurance Legislation Repeal (Nuclear Medicine Imaging Services) Determination 2026 (the Repeal Determination) is to repeal the Health Insurance (Section 3C Diagnostic Imaging Services – Conjunctive Gallium-67 Nuclear Medicine Imaging Service) Determination 2022 (the Gallium Determination) and the Health Insurance (Section 3C Diagnostic Imaging – Conjunctive Thallium-201 Nuclear Medicine Imaging Service) Determination 2023 (the Thallium Determination) from 1 July 2026.
The Gallium Determination introduced temporary Medicare Benefits Schedule (MBS) item 61477 on 8 November 2022 to assist in addressing additional costs associated with the procurement of the nuclear medicine radiopharmaceutical gallium-67. This was pursuant to the Medicare Benefits Schedule – new and amended listings measure in the October 2022-23 Budget. The temporary item had authority to be listed on the MBS until the end of 30 June 2023, however, was extended to 30 June 2024 under A Modern and Clinically Appropriate Medicare Benefits Schedule measure in the 2023-24 Budget.
The Thallium Determination introduced temporary MBS item 61470 on 1 July 2023 to assist in addressing increasing costs associated with the procurement of the nuclear medicine radiopharmaceutical thallium-201. This was pursuant to the A Modern and Clinically Appropriate Medicare Benefits Schedule measure in the 2023-24 Budget. The temporary item had authority to be listed on the MBS until the end of 30 June 2024.
Both temporary MBS items (61477 and 61470) were extended to 30 June 2026 as part of the Extend availability and increase the schedule fee for two temporary nuclear medicine items to continue to support the additional cost of the radiopharmaceuticals, thallium-201 and gallium-67 measure in the 2024-25 Budget.
The Repeal Determination repeals the Thallium Determination and the Gallium Determination to cease MBS items 61477 and 61470 from 1 July 2026, in accordance with policy authority.
Consultation
Key stakeholders in the nuclear medicine sector, including the Australasian Association of Nuclear Medicine Specialists and Global Medical Solutions, were supportive of the introduction of temporary MBS items 61470 and 61477 and made aware that these items would cease from 1 July 2026.
The Repeal Determination is a legislative instrument for the purposes of the Legislation Act 2003.
The Repeal Determination commences on 1 July 2026.
Details of the Repeal Determination are set out in the Attachment.
Authority: Subsection 3C(1) of the
Health Insurance Act 1973
ATTACHMENT
Details of the Health Insurance Legislation Repeal (Nuclear Medicine Imaging Services) Determination 2026
Section 1 – Name
Section 1 provides for the instrument to be referred to as the Health Insurance Legislation Repeal (Nuclear Medicine Imaging Services) Determination 2026 (the Repeal Determination).
Section 2 – Commencement
Section 2 provides for the Repeal Determination to commence on 1 July 2026.
Section 3 – Authority
Section 3 provides that the Repeal 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 the Repeal Determination is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to the Repeal Determination has effect according to its terms.
Schedule 1 – Repeals
Health Insurance (Section 3C Diagnostic Imaging Services – Conjunctive Gallium-67 Nuclear Medicine Imaging Service) Determination 2022
Item 1 of Schedule 1 repeals the Health Insurance (Section 3C Diagnostic Imaging Services – Conjunctive Gallium-67 Nuclear Medicine Imaging Service) Determination 2022.
Health Insurance (Section 3C Diagnostic Imaging – Conjunctive Thallium-201 Nuclear Medicine Imaging Service) Determination 2023
Item 2 of Schedule 1 repeals the Health Insurance (Section 3C Diagnostic Imaging – Conjunctive Thallium-201 Nuclear Medicine Imaging Service) Determination 2023.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Health Insurance Legislation Repeal (Nuclear Medicine Imaging Services) 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 Legislation Repeal (Nuclear Medicine Imaging Services) Determination 2026 (the Repeal Determination) is to repeal the Health Insurance (Section 3C Diagnostic Imaging Services – Conjunctive Gallium-67 Nuclear Medicine Imaging Service) Determination 2022 (the Gallium Determination) and the Health Insurance (Section 3C Diagnostic Imaging – Conjunctive Thallium-201 Nuclear Medicine Imaging Service) Determination 2023 (the Thallium Determination) from 1 July 2026.
The Gallium Determination introduced temporary Medicare Benefits Schedule (MBS) item 61477 on 8 November 2022 to assist in addressing additional costs associated with the procurement of the nuclear medicine radiopharmaceutical gallium-67. This was pursuant to the Medicare Benefits Schedule – new and amended listings measure in the October 2022-23 Budget. The temporary item had authority to be listed on the MBS until the end of 30 June 2023, however, was extended to 30 June 2024 under A Modern and Clinically Appropriate Medicare Benefits Schedule measure in the 2023-24 Budget.
The Thallium Determination introduced temporary MBS item 61470 on 1 July 2023 to assist in addressing increasing costs associated with the procurement of the nuclear medicine radiopharmaceutical thallium-201. This was pursuant to the A Modern and Clinically Appropriate Medicare Benefits Schedule measure in the 2023-24 Budget. The temporary item had authority to be listed on the MBS until the end of 30 June 2024.
Both temporary MBS items (61477 and 61470) were extended to 30 June 2026 as part of the Extend availability and increase the schedule fee for two temporary nuclear medicine items to continue to support the additional cost of the radiopharmaceuticals, thallium-201 and gallium-67 measure in the 2024-25 Budget.
The Repeal Determination repeals the Thallium Determination and the Gallium Determination to cease MBS items 61477 and 61470 from 1 July 2026, in accordance with policy authority.
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 is compatible with human rights as patient access to thallium-201 and gallium-67 base items will not be adversely affected. Items 61470 and 61477 are temporary “top-up” items that are claimed in addition to existing thallium-201 “base” items 61438, 61461 and 61325 and gallium-67 base items 61429, 61430, 61442, 61450 and 61453, respectively. The schedule fees for the permanent base items are being increased from 1 July 2026, subject to the passage of legislation. Therefore, increased schedule fees of the base items will ensure continued patient access to essential nuclear medicine imaging services using thallium-201 and gallium-67.
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