EXPLANATORY STATEMENT
Health Insurance Act 1973
Health Insurance Legislation Amendment (Listing of Futibatinib) 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 for Health and Ageing 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 the Health Insurance Legislation Amendment (Listing of Futibatinib) Determination 2026 (the Amendment Determination) is to amend the Health Insurance (Section 3C Co‑Dependent Pathology Services) Determination 2018 (the Co-Dependent Pathology Determination) and the Health Insurance (Section 4BA - Pathologist-Determinable Services) Determination 2025 (the Pathologist-Determinable Determination) from 1 July 2026.
The Amendment Determination introduces new Medicare Benefits Schedule (MBS) item 73329 for a multi-gene panel test of tumour tissue to detect IDH1 gene variants and FGFR2 fusion or rearrangement status for patients with cholangiocarcinoma (CCA) for the purpose of determining eligibility for a relevant treatment under the Pharmaceutical Benefits Schedule (PBS) (with Futibatinib). This means the item will also provide testing for access to an already PBS listed treatment (Ivosidenib) for CCA patients with IDH1 alterations and any relevant treatments which may in future be listed under the PBS for the same clinical indication. The introduction of item 73329 to the MBS from 1 July 2026 will coincide with the relevant listing of Futibatinib on the PBS.
The introduction of MBS listing of this service was recommended by the Medical Services Advisory Committee (MSAC) under application 1779.1 in November 2025 and PBS listing of the treatment Futibatinib was supported by the Pharmaceutical Benefits Advisory Committee at the meeting held in November 2025. Policy authority was granted via the Minister’s delegation to approve certain MSAC recommendations outside a budget process.
Consultation
Consultation on the proposed service was undertaken with key stakeholders, including Australian Pathology (AP) and RCPA during the MSAC process. Further consultation occurred regarding implementation with AP, RCPA and Public Pathology Australia. These stakeholders support the change, but raised concerns about combining DNA and RNA testing into a single item. However, the MSAC had previously agreed that the new item 73329 should be for both genes (in this case requiring both a DNA and an RNA test) on the basis that a next generation sequencing panel test future-proofs the item (by enabling additional genes to be included as new evidence) and as targeted treatments emerge. On balance, the department considers that the item as currently drafted would ensure that patients with CCA are able to access a full range of DNA and RNA testing, rather than unnecessarily restricting testing options under the item for patients with CCA. Further the implementation of this item as currently drafted ensures alignment with the advice of the independent MSAC.
Some stakeholders provided input that the proposed item should not specify requested by a “specialist or consultant physician” due to concerns that it may not be clear that the item is also pathologist determinable. In response to this concern, the department will ensure the entry for item 73329 on the MBS Online website (https://www.mbsonline.gov.au/) includes a link to Pathology Note 1.2 (https://www9.health.gov.au/mbs/fullDisplay.cfm?type=note&q=PN.1.2&qt=noteID&criteria=PN.1.2) to more clearly indicate that the item is pathologist determinable.
The Amendment Determination is a legislative instrument for the purposes of the Legislation Act 2003.
The Amendment Determination commences on 1 July 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 Legislation Amendment (Listing of Futibatinib) Determination 2026
Section 1 – Name
Section 1 provides for the instrument to be referred to as the Health Insurance Legislation Amendment (Listing of Futibatinib) Determination 2026 (the Amendment Determination).
Section 2 – Commencement
Section 2 provides for the Amendment Determination to commence on 1 July 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 inserts new Medicare Benefits Schedule (MBS) item 73329 into existing Group P7 for Genetic Pathology. The new item is for a multi-gene panel test of tumour tissue to detect FGFR2 fusion or rearrangement and IDH1 gene variant status in tumour tissue from patients with cholangiocarcinoma, to determine eligibility for a relevant treatment listed under the Pharmaceutical Benefits Scheme.
Health Insurance (Section 4BA - Pathologist-Determinable Services) Determination 2025
Item 2 amends the table at paragraph 7(c) to insert reference to new item 73329 into the cell at table item 1, column 1. This provides that the service mentioned in item 73329 is a pathologist-determinable service, in relation to which the originally requested pathology service was an item in the pathology services table that is mentioned in column 2 of the table.
Item 3 inserts MBS item 73329 into the note under the table at paragraph 7(c), which clarifies the item 73329 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 Futibatinib) 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 Amendment (Listing of Futibatinib) Determination 2026 (the Amendment Determination) is to amend the Health Insurance (Section 3C Co‑Dependent Pathology Services) Determination 2018 (the Co-Dependent Pathology Determination) and the Health Insurance (Section 4BA - Pathologist-Determinable Services) Determination 2025 (the Pathologist-Determinable Determination) from 1 July 2026.
The Amendment Determination introduces new Medicare Benefits Schedule (MBS) item 73329 for a multi-gene panel test of tumour tissue to detect IDH1 gene variants and FGFR2 fusion or rearrangement status for patients with cholangiocarcinoma for the purpose of determining eligibility for a relevant treatment under the Pharmaceutical Benefits Scheme (PBS) (Futibatinib). This means the item will also provide testing for access to an already PBS listed treatment (Ivosidenib) for CCA patients with IDH1 alterations, and any relevant treatments which may in future be listed under the PBS for the same clinical indication. The introduction of item 73329 from 1 July 2026 to the MBS will coincide with the relevant listing of Futibatinib on the PBS.
The introduction of MBS listing of this service was recommended by the Medical Services Advisory Committee (MSAC) under application 1779.1 in November 2025 and PBS listing of the treatment. Futibatinib was supported by the Pharmaceutical Benefits Advisory Committee at the meeting held in November 2025. 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 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 reflects contemporary clinical practice by introducing a new subsidised pathology service for a multi-gene panel test of tumour tissue to detect FGFR2 fusions and rearrangments and IDH1 gene variants for patients with CCA, to determine eligibility for a relevant treatment under the PBS. The new MBS 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; it advances 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 and Aged Care