Health Insurance (Section 3C – Lutetium Therapeutic Nuclear Medicine Treatments) Determination 2025

law://au/li/2025/f2025l00567@2026-11-15

Contents

1 Name #

This instrument is the Health Insurance (Section 3C – Lutetium Therapeutic Nuclear Medicine Treatments) Determination 2025.

3 Authority #

This instrument is made under subsection 3C(1) of the Health Insurance Act 1973.

4 Definitions #

(1)In this instrument:

Act means the Health Insurance Act 1973.

disease progression means, for items 16050 and 16055 only, either or both:

(a) a rise in PSA of >2ng/mL confirmed by two tests a minimum of two weeks apart, or

(b) evidence of new soft tissue or bone metastases on diagnostic imaging computed tomography as per established guidelines (such as the Response Evaluation Criteria in Solid Tumours criteria, as published by the European Organisation for Research and Treatment of Cancer, or the Response Evaluation Criteria in PSMA-Imaging Criteria.

formally convened neuroendocrine multidisciplinary board means a formal board of relevant practitioners, including specialists in medical oncology and nuclear medicine with experience in managing neuroendocrine neoplasms, endocrinology and surgery specialists, as well as medical practitioners from different areas of medical practice. The board must include at least one oncologist and one surgeon.

peptide receptor radionuclide therapy means a targeted form of radiation treatment that can be used to treat neuroendocrine neoplasms.

PET means positron emission tomography.

PSA means prostate-specific antigen

PSMA means prostate specific membrane antigen

nuclear medicine credentialled specialist means a specialist or consultant physician whose name is included in a register, given to the Chief Executive Medicare by the JNMCAC, of participants in the Joint Nuclear Medicine Specialist Credentialling Program of the JNMCAC.

relevant provisions means all provisions, of the Act and regulations made under the Act, and the National Health Act 1953 and regulations made under the National Health Act 1953, relating to medical services, professional services or items.

relevant service means a health service, as defined in subsection 3C(8) of the Act, that is specified in a Schedule.

report means a report prepared by a medical practitioner.

(R) has the meaning given by clause 1.2.15 of the diagnostic imaging services table.

Schedule means a Schedule to this instrument.

SPECT means single-photon emission computed tomography.

SUV means standardised uptake value.

Note: The following terms are defined in subsection 3(1) of the Act:

 clinically relevant service

 diagnostic imaging services table

 general medical services table

 item

 professional service

(2)Unless the contrary intention appears, a reference in this instrument to a provision of the Act or the National Health Act 1953 or regulations made under the Act or under the National Health Act 1953 as applied, adopted or incorporated in relation to specifying a matter is a reference to those provisions as in force from time to time and any other reference to provisions of an Act or regulations is a reference to those provisions as in force from time to time.

5 Treatment of relevant services #

For subsection 3C(1) of the Act, a relevant service, provided in accordance with this instrument and as a clinically relevant service, is to be treated, for the relevant provisions, as if:

(a) it were both a professional service and a medical service; and

(b) there were an item in the general medical services table or diagnostic imaging services table that:

(i) related to the service; and

(ii) specified for the service a fee in relation to each State, being the fee specified in the Schedule in relation to the service.

6 Application of provisions of the General Medical Services Table #

Clause 5.4.1 shall have effect as if the items listed in Schedule 1 of this Determination were also specified in clause 5.4.1 of the General Medical Services Table.

7 Application of provisions of the Diagnostic Imaging Services Table #

Clause 2.4.6 shall have effect as if the items listed in Schedule 2 of this Determination were also specified in subclause 2.4.6 of the Diagnostic Imaging Services Table.

7A Indexation #

(1)At the start of 1 July 2026 (the indexation time), each amount covered by subsection (2) is replaced by the amount worked out using the following formula:

Note: The indexed fees could in 2026 be viewed on the Department of Health, Disability and Ageing’s MBS Online website (www.mbsonline.gov.au).

(2)The amounts covered by this subsection are the fee for each item in Schedule 1 of this Determination, other than the fee for item 16060.

(3)An amount worked out under subsection (1) is to be rounded up or down to the nearest 5 cents (rounding down if the amount is an exact multiple of 2.5 cents).

8 Limitation of items listed in Schedule 2 #

An item listed in Schedule 2 of this instrument does not apply unless:

(a) the patient was referred by a specialist or consultant physician; and

(b) the service is provided by a nuclear medicine credentialled specialist.

9 Schedules #

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Category 3 – Therapeutic Procedures
GroupT3 -Therapeutic Nuclear Medicine
Subgroup 2 – Theranostics
Column 1Item	Column 2Description	Column 3Fee ($)
16050	Administration of Lutetium 177 PSMA, followed within 36 hours by whole body Lu-PSMA SPECT, for treatment of a patient with metastatic castrate resistant prostate cancer who is:(a) PSMA-positive as determined by PSMA PET (defined as SUVmax >15 at a single site of disease and SUVmax >10 at all sites of measurable disease) after disease progression and(b) prior treatment includes at least one taxane chemotherapy and at least one androgen receptor signalling inhibitor.Applicable once per cycle, up to a maximum of 2 cycles in the initial treatment phase.	8,000.00
16055	Administration of Lutetium 177 PSMA, followed within 36 hours by whole body Lu-PSMA SPECT, for treatment of a patient with metastatic castrate resistant prostate cancer, if:(a) a service to which item 16050 applies has been provided; and(b) the patient has not developed disease progression while receiving Lutetium 177 PSMA for this condition.Applicable once per cycle, up to a maximum of 4 cycles in the continuing treatment phase.	8,000.00
16060	¹⁷⁷Lutetium-DOTA-somatostatin receptor agonist treatment cycle for patients with histologically confirmed and inoperable neuroendocrine neoplasm (NEN), either locally advanced or metastatic, with documented disease progression or uncontrolled symptoms related to their NEN despite standard therapy who:(a) have high tumour somatostatin receptor expression demonstrated on whole body 68Ga DOTA somatostatin agonist PET study; and(b) are considered suitable for a course of 177Lutetium-DOTA-somatostatin receptor agonist therapy by a formally convened NEN multidisciplinary board.Includes the necessary patient preparation, administration and treatment, immediate patient aftercare required for the treatment cycle, consultation with the supervising specialist within 36 hours of treatment, and a post-infusion SPECT if performed.	9,999.95

Category 5 – Diagnostic Imaging Services
Group I4 – Nuclear Medicine Imaging
Subgroup 2 – PET
Column 1Item	Column 2Description	Column 3Fee ($)
61528	Whole body PSMA PET study, performed for the assessment of suitability for Lutetium 177 PSMA therapy in a patient with metastatic castrate resistant prostate cancer, after progressive disease has developed while undergoing prior treatment with at least one taxane chemotherapy and at least one androgen receptor signalling inhibitor.(R) (Anaes.)	1,300.00
61530	Whole body ⁶⁸Ga-DOTA-somatostatin receptor agonist PET study for:(a) staging of histologically confirmed neuroendocrine neoplasm (NEN) considered surgically incurable on conventional imaging, or(b) evaluation of somatostatin receptor expression of histologically confirmed and inoperable NEN, either locally advanced or metastatic, under consideration for peptide receptor radionuclide therapy (PRRT); or(c) evaluation of response to PRRT therapy; or(d) evaluation of suspected recurrent or metastatic disease in known somatostatin receptor positive NEN.(R) (Anaes.)	953.00

Sourced from the Federal Register of Legislation at legislation.gov.au, © Commonwealth of Australia, licensed under CC BY 4.0. Compilations may have been reformatted.

Health Insurance (Section 3C – Lutetium Therapeutic Nuclear Medicine Treatments) Determination 2025

Health Insurance (Section 3C – Lutetium Therapeutic Nuclear Medicine Treatments) Determination 2025

1 Name #

3 Authority #

4 Definitions #

5 Treatment of relevant services #

6 Application of provisions of the General Medical Services Table #

7 Application of provisions of the Diagnostic Imaging Services Table #

7A Indexation #

8 Limitation of items listed in Schedule 2 #

9 Schedules #

Defined terms · 15

Key facts

History · 1 version

Connections

1 Name #

3 Authority #

4 Definitions #

5 Treatment of relevant services #

6 Application of provisions of the General Medical Services Table #

7 Application of provisions of the Diagnostic Imaging Services Table #

7A Indexation #

8 Limitation of items listed in Schedule 2 #

9 Schedules #