Health Insurance Legislation Amendment (Listing of Selpercatinib) Determination 2026

EXPLANATORY STATEMENT

Health Insurance Act 1973

Health Insurance Legislation Amendment (Listing of Selpercatinib) 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 pathology services table (the PST) shall, in specified circumstances and for specified statutory provisions, be treated as if it were specified in the PST.

The PST is set out in the regulations made under section 4A of the Act. The most recent version of the regulations is the Health Insurance (Pathology Services Table) Regulations 2020 (the PST Regulations).

Section 16A of the Act specifies certain requirements to be met for the payment of Medicare benefits in relation to pathology services, including the requirement for a pathology service to be requested (subsection 16A(3)). 

Pathologist-determinable services allow Medicare benefits to be paid for pathology services which are requested and performed by an approved pathology practitioner 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 may determine by legislative instrument that a particular pathology service, or pathology services included in a class of pathology services, are pathologist-determinable services, after consultation with the 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 that instrument in the same manner and subject to the same conditions.

Purpose

The purpose of Health Insurance Legislation Amendment (Listing of Selpercatinib) Determination 2026 (the Amendment Determination) is to introduce new Medicare Benefits Schedule (MBS) item 73331 from 1 August 2026 and provide that the service is a pathologist-determinable service by amending the:

• Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018 (the Co-Dependent Pathology Determination); and
• Health Insurance (Section 4BA - Pathologist-Determinable Services) Determination 2025 (the Pathologist-Determinable Determination).

The Amendment Determination will introduce new item 73331 into the Co-Dependent Pathology Determination. Item 73331 will provide for testing  of tumour tissue to detect RET proto-oncogene (RET) gene variant status in tumour tissue from patients with histologically confirmed medullary thyroid cancer, to determine patient eligibility for a relevant treatment listed on the Pharmaceutical Benefits Scheme (PBS), including selpercatinib. This means the item will provide for testing to determine eligibility for any treatment currently listed on the PBS, as well as any other relevant treatments which may in future be listed under the PBS for the same clinical indication. The new item commences on 1 August 2026, to coincide with the listing of the selpercatinib on the PBS, which is a relevant treatment for the clinical indication described in the new item 73331.

Additionally, the Amendment Determination will amend the Pathologist-Determinable Determination to enable item 73331 to be a pathologist-determinable service in specified circumstances.

At its 1 April 2026 meeting, the Medical Services Advisory Committee (MSAC) supported MSAC application 1804 for the creation of the new MBS item 73331. The Pharmaceutical Benefits Advisory Committee (PBAC) at its 11-13 March 2026 meeting supported PBS listing of selpercatinib. Policy authority was granted via the Minister’s delegation to approve certain MSAC recommendations outside a budget process.

Consultation

The following stakeholders were consulted and supported the introduction of item 73331 to the MBS:

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

The Amendment Determination commences on 1 August 2026.

Details of the Amendment Determination are set out in the Attachment.

Authority:     Subsection 3C(1) and section 4BA of the

 Health Insurance Act 1973

ATTACHMENT

Details of the Health Insurance Legislation Amendment (Listing of Selpercatinib) Determination 2026.

Section 1 – Name

Section 1 provides for the instrument to be referred to as the Health Insurance Legislation Amendment (Listing of Selpercatinib) Determination 2026 (the Amendment Determination).

Section 2 – Commencement

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

Section 3 – Authority

Section 3 provides that the Amendment Determination is made under subsection 3C(1) and section 4BA 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 Co-Dependent Pathology Services) Determination 2018

Item 1 introduces new Medicare Benefits Schedule (MBS) item 73331 for testing of tumour tissue to detect RET proto-oncogene (RET) gene variant status from patients with medullary thyroid cancer requested by, or on behalf of, a specialist or consultant physician to determine eligibility for a relevant treatment listed on the Pharmaceutical Benefits Scheme (PBS) from 1 August 2026. Item 73331 will be introduced to Group P7 - Genetics of the MBS, which is not subject to annual indexation.

Health Insurance (Section 4BA - Pathologist-Determinable Services) Determination 2025

Item 2 inserts reference to MBS item 73331 into item 1, column 1 of the table to section 7. This has the effect that item 73331 is a pathologist-determinable service where any of the items set out in item 1, column 2 to the table was the originally requested service.

Item 3 inserts reference to MBS item 73331 into the note under the table at section 7, which clarifies that item 73331 is specified in the Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018.

Statement of Compatibility with Human Rights

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

Health Insurance Legislation Amendment (Listing of Selpercatinib) 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 Health Insurance Legislation Amendment (Listing of Selpercatinib) Determination 2026 (the Amendment Determination) is to introduce new Medicare Benefits Schedule (MBS) item 73331 from 1 August 2026 and provide that the service is a pathologist-determinable service by amending the:

• Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018 (the Co-Dependent Pathology Determination); and
• Health Insurance (Section 4BA - Pathologist-Determinable Services) Determination 2025 (the Pathologist-Determinable Determination).

The Amendment Determination will introduce new item 73331 into the Co-Dependent Pathology Determination. Item 73331 will provide for RET proto-oncogene variant testing (RET variant testing) of tumour tissue from patients with histologically confirmed medullary thyroid cancer (MTC) to determine eligibility for a relevant treatment listed on the Pharmaceutical Benefits Scheme (PBS), including selpercatinib. This means the item will provide for testing to determine eligibility for any treatment currently listed on the PBS, as well as any other relevant treatments which may in future be listed under the PBS for the same clinical indication. The new item commences on 1 August 2026, to coincide with the listing of the selpercatinib on the PBS, which is a relevant treatment for the clinical indication described in the new item 73331.

Additionally, the Amendment Determination will amend the Pathologist-Determinable Determination to enable item 73331 to be a pathologist-determinable service in specified circumstances.

At its 1 April 2026 meeting, the Medical Services Advisory Committee (MSAC) supported MSAC application 1804 for the creation of the new MBS item 73331. The MSAC supported the decision to make item 73331 a pathologist-determinable service. Policy authority was granted via the Minister’s delegation to approve certain MSAC recommendations outside 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 reflects contemporary clinical practice by introducing a new subsidised pathology service for RET proto-oncogene variant testing of tumour tissue from patients with histologically confirmed medullary thyroid cancer to determine a patient’s eligibility for a relevant treatment under the PBS, including selpercatinib. The new listing of this service provides an access pathway for relevant treatments listed under the PBS to eligible patients. This, in turn, maintains the right to social security, the right of equality and non-discrimination, and promotes the right to health.

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