Health Insurance (Section 3C General Medical Services – Botox Injection) Amendment (Addition of Xeomin Injection) Determination 2025

Administered by Department of Health, Disability and Ageing

Legislation au F2025L01487 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

Health Insurance Act 1973

 

Health Insurance (Section 3C General Medical Services – Botox Injection) Amendment (Addition of Xeomin Injection) Determination 2025

 

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 general medical services table (the GMST) shall, in specified circumstances and for specified statutory provisions, be treated as if it were specified in the GMST.  

 

The GMST is set out in the regulations made under subsection 4(1) of the Act. The most recent version of the regulations is the Health Insurance (General Medical Services Table) Regulations 2021.

 

This instrument relies on 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 that instrument in the same manner and subject to the same conditions.

 

Purpose

The purpose of the Health Insurance (Section 3C General Medical Services – Botox Injection) Amendment (Addition of Xeomin Injection) Determination 2025 (the Amendment Determination) is to amend the Health Insurance (Section 3C General Medical Services – Botox Injection) Determination 2020 from 1 March 2026.

 

The Amendment Determination will enable the inclusion of IncobotulinumtoxinA (Xeomin) for the treatment of moderate to severe upper limb spasticity due to cerebral palsy for patients aged two years and older under Medicare Benefits Schedule (MBS) item 18361.

 

The amendment of MBS item 18361 was agreed to by the Minister for Health and Ageing on 8 October 2025 through the Minister’s authority to approve certain Medical Services Advisory Committee (MSAC) recommendations for new and amended MBS items outside of a budget process.

Consultation

At its meeting of 31 July 2025, MSAC supported the amendment of existing MBS item 18361 to include the injection of Xeomin for the treatment of upper limb spasticity in patients with cerebral palsy aged 2 years and older.

 

The Cerebral Palsy Alliance, the Rehabilitation Medicine Society of Australia and New Zealand and the Movement Disorder Society of Australia and New Zealand were consulted on the MSAC application and supported the amendment to MBS item 18361.

 

The Amendment Determination is a legislative instrument for the purposes of the Legislation Act 2003.

The Amendment Determination commences on 1 March 2026.

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 General Medical Services – Botox Injection) Amendment (Addition of Xeomin Injection) Determination 2025

 

Section 1 – Name

 

Section 1 provides for the instrument to be referred to as the Health Insurance (Section 3C General Medical Services – Botox Injection) Amendment (Addition of Xeomin Injection) Determination 2025 (the Amendment Determination).

 

Section 2 – Commencement

 

Section 2 provides for the Amendment Determination to commence on 1 March 2026.

 

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 the 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 the Amendment Determination has effect according to its terms.

 

Schedule 1 – Amendments

 

Item 1 repeals the Group T1 table and substitutes a new table to: add Xeomin for the treatment of cerebral palsy to the item descriptor for MBS item 18361; update the table Group from T1 to T11; add column numbers; and update the current MBS fee for the item.

 

 

 


Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

 

Health Insurance (Section 3C General Medical Services – Botox Injection) Amendment (Addition of Xeomin Injection) 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 General Medical Services – Botox Injection) Amendment (Addition of Xeomin Injection) Determination 2025 (the Amendment Determination) is to amend the Health Insurance (Section 3C General Medical Services – Botox Injection) Determination 2020 from 1 March 2026.

 

The Amendment Determination will enable the inclusion of IncobotulinumtoxinA (Xeomin) for the treatment of moderate to severe upper limb spasticity due to cerebral palsy for patients aged 2 years and older under Medicare Benefits Schedule (MBS) item 18361.

 

The amendment of MBS item 18361 was agreed to by the Minister for Health and Ageing on 8 October 2025 through the Minister’s authority to approve certain Medical Services Advisory Committee (MSAC) recommendations for new and amended MBS items outside of a budget process.

 

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 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 as it will enable an MBS benefit for Xeomin injection services for the treatment of upper and lower limb spasticity in patients with cerebral palsy aged two years and older.

 

 

Louise Riley

Assistant Secretary

MBS Policy and Reviews Branch

Medicare Benefits and Digital Health Division

Health Resourcing Group

Department of Health, Disability and Ageing

 

Overview

The Health Insurance (Section 3C General Medical Services – Botox Injection) Amendment (Addition of Xeomin Injection) Determination 2025 is an amendment to the Health Insurance Act 1973, designed to incorporate IncobotulinumtoxinA (Xeomin) for the treatment of moderate to severe upper limb spasticity due to cerebral palsy for patients aged two years and older under Medicare Benefits Schedule (MBS) item 18361. Enacted by the Australian Parliament, the amendment aims to address the gap in treatment options for patients with cerebral palsy by ensuring they have access to necessary medical services. The amendment was agreed upon by the Minister for Health and Ageing on 8 October 2025, following recommendations from the Medical Services Advisory Committee (MSAC), and will come into effect on 1 March 2026. The policy objective is to reflect contemporary clinical practice and uphold human rights by ensuring patients have access to health and social security through relevant subsidised services on the Medicare Benefits Schedule. This legislative instrument is compatible with human rights, engaging 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 amendment will ensure that patients with cerebral palsy have access to necessary health services, thereby supporting the right to health and social security and ensuring equality and non-discrimination. The addition of Xeomin to the MBS reflects a commitment to providing comprehensive and equitable healthcare services to those in need.

Scope and Application

The Health Insurance (Section 3C General Medical Services – Botox Injection) Amendment (Addition of Xeomin Injection) Determination 2025 amends the Health Insurance (Section 3C General Medical Services – Botox Injection) Determination 2020, effective from 1 March 2026. This amendment is made under subsection 3C(1) of the Health Insurance Act 1973 and involves the addition of IncobotulinumtoxinA (Xeomin) for the treatment of moderate to severe upper limb spasticity due to cerebral palsy in patients aged two years and older under Medicare Benefits Schedule (MBS) item 18361. The amendment was approved by the Minister for Health and Ageing on 8 October 2025 and follows recommendations by the Medical Services Advisory Committee (MSAC). The amendment was supported by relevant stakeholders, including the Cerebral Palsy Alliance, the Rehabilitation Medicine Society of Australia and New Zealand, and the Movement Disorder Society of Australia and New Zealand. This legislative instrument is compatible with human rights, particularly the rights to equality and non-discrimination, health, and social security as outlined in the International Covenant on Economic, Social and Cultural Rights and the International Covenant on Civil and Political Rights. It aims to provide equitable access to essential health services under the Medicare system. The Amendment Determination specifies that the changes will come into effect on 1 March 2026, with Schedule 1 detailing the amendments to MBS item 18361. This includes updating the table Group from T1 to T11, adding column numbers, and revising the current MBS fee for the item to reflect the inclusion of Xeomin for the treatment of cerebral palsy. This legislative instrument is made under the authority of the Health Insurance Act 1973 and is compatible with the human rights and freedoms recognised or declared in the international instruments listed in the Human Rights (Parliamentary Scrutiny) Act 2011. The changes align with the commitment to provide equitable access to essential health services, ensuring that patients with cerebral palsy have access to necessary treatments under the Medicare system.

Key Provisions

The main operative sections of the Health Insurance (Section 3C General Medical Services – Botox Injection) Amendment (Addition of Xeomin Injection) Determination 2025 (the Amendment Determination) include Section 1, which names the instrument, and Section 2, which specifies that the Amendment Determination will commence on 1 March 2026. Section 3 outlines the authority under which the Amendment Determination is made, and Section 4 details the schedules that will amend or repeal certain instruments. The primary change is outlined in Schedule 1, Item 1, which adds IncobotulinumtoxinA (Xeomin) for the treatment of moderate to severe upper limb spasticity due to cerebral palsy for patients aged two years and older under Medicare Benefits Schedule (MBS) item 18361. The Amendment Determination imposes obligations on the parties and entities it governs by ensuring that Xeomin injections for the specified condition and patient demographic are included under the MBS from 1 March 2026. This inclusion mandates that Medicare will cover the cost of these injections for eligible patients, aligning with the updated MBS fee as specified in the Amendment Determination. The determination also involves updating the MBS descriptors to reflect the new inclusion of Xeomin, ensuring that all relevant parties, such as healthcare providers and patients, are aware of the changes. Any breaches of the provisions set out in the Amendment Determination may result in civil or criminal consequences, depending on the nature and severity of the breach. The maximum penalties for contravening the terms of the Amendment Determination are not explicitly stated in the provided text, but typically, penalties for breaches of health-related legislation can include fines and, in severe cases, imprisonment. It is essential for all parties involved to adhere to the requirements and timelines set out in the Amendment Determination to avoid any legal repercussions.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.