Health Insurance (Section 3C – Lutetium Therapeutic Nuclear Medicine Treatments) Determination 2025
made under subsection 3C(1) of the
Health Insurance Act 1973
Compilation No. 2
Compilation date: 1 November 2025
Includes amendments: F2025L01031
About this compilation
This compilation
This is a compilation of the Health Insurance (Section 3C – Lutetium Therapeutic Nuclear Medicine Treatments) Determination 2025 that shows the text of the law as amended and in force on 1 November 2025 (the compilation date).
The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.
Uncommenced amendments
The effect of uncommenced amendments is not shown in the text of the compiled law. The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au).
Application, saving and transitional provisions
If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.
Editorial changes
For more information about any editorial changes made in this compilation, see the endnotes.
Presentational changes
The Legislation Act 2003 provides for First Parliamentary Counsel to make presentational changes to a compilation. Presentational changes are applied to give a more consistent look and feel to legislation published on the Register, and enable the user to more easily navigate those documents.
Modifications
If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. Any modifications affecting the law are accessible on the Register.
Self‑repealing provisions
If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.
Contents
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
8 Limitation of items listed in Schedule 2
9 Schedules
Schedule 1 – General medical services
Schedule 2 – Diagnostic imaging services
Endnotes
Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history
Endnote 5—Editorial changes
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.
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.
Schedule 1 – General medical services
Category 3 – Therapeutic Procedures |
GroupT3 ‑Therapeutic Nuclear Medicine |
Subgroup 2 – Theranostics |
Column 1 Item | Column 2 Description | Column 3 Fee ($) |
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 |
Schedule 2 – Diagnostic imaging services
Category 5 – Diagnostic Imaging Services |
Group I4 – Nuclear Medicine Imaging |
Subgroup 2 – PET |
Column 1 Item | Column 2 Description | Column 3 Fee ($) |
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 |
Endnotes
Endnote 1—About the endnotes
The endnotes provide information about this compilation and the compiled law.
The following endnotes are included in every compilation:
Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history
Abbreviation key—Endnote 2
The abbreviation key sets out abbreviations that may be used in the endnotes.
Legislation history and amendment history—Endnotes 3 and 4
Amending laws are annotated in the legislation history and amendment history.
The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.
The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.
Editorial changes
The Legislation Act 2003 authorises First Parliamentary Counsel to make editorial and presentational changes to a compiled law in preparing a compilation of the law for registration. The changes must not change the effect of the law. Editorial changes take effect from the compilation registration date.
If the compilation includes editorial changes, the endnotes include a brief outline of the changes in general terms. Full details of any changes can be obtained from the Office of Parliamentary Counsel.
Misdescribed amendments
A misdescribed amendment is an amendment that does not accurately describe how an amendment is to be made. If, despite the misdescription, the amendment can be given effect as intended, then the misdescribed amendment can be incorporated through an editorial change made under section 15V of the Legislation Act 2003.
If a misdescribed amendment cannot be given effect as intended, the amendment is not incorporated and “(md not incorp)” is added to the amendment history.
Endnote 2—Abbreviation key
ad = added or inserted | orig = original |
am = amended | p = page(s) |
amdt = amendment | para = paragraph(s)/subparagraph(s) |
C[x] = Compilation No. x | /sub‑subparagraph(s) |
ch = Chapter(s) | pres = present |
cl = clause(s) | prev = previous |
cont. = continued | (prev…) = previously |
def = definition(s) | pt = Part(s) |
Dict = Dictionary | r = regulation(s)/Court rule(s) |
disallowed = disallowed by Parliament | reloc = relocated |
div = Division(s) | renum = renumbered |
ed = editorial change | rep = repealed |
exp = expires/expired or ceases/ceased to have | rs = repealed and substituted |
effect | s = section(s)/subsection(s) |
gaz = gazette | /rule(s)/subrule(s)/order(s)/suborder(s) |
LA = Legislation Act 2003 | sch = Schedule(s) |
LIA = Legislative Instruments Act 2003 | SLI = Select Legislative Instrument |
(md) = misdescribed amendment can be given | SR = Statutory Rules |
effect | sub ch = Sub‑Chapter(s) |
(md not incorp) = misdescribed amendment | sub div = Subdivision(s) |
cannot be given effect | sub pt = Subpart(s) |
mod = modified/modification | underlining = whole or part not |
No. = Number(s) | commenced or to be commenced |
Ord = Ordinance | |
Endnote 3—Legislation history
Name | Registration | Commencement | Application, saving and transitional provisions |
Health Insurance (Section 3C – Lutetium PSMA Treatment) Determination 2025 | 9 May 2025 (F2025L00567) | 1 July 2025 (s 2(1) item 1) | |
Health Insurance (Section 3C – Lutetium PSMA Treatment) Amendment Determination 2025 | 4 June 2025 (F2025L00654) | 1 July 2025 (s 2(1) item 1) | — |
Health Insurance (Section 3C – Lutetium PSMA Treatment) Amendment (No. 2) Determination 2025 | 2 Sept 2025 (F2025L01031) | 1 Nov 2025 (s 2(1) item 1) | — |
Endnote 4—Amendment history
Provision affected | How affected |
s 1..................... | am F2025L01031 |
| ed C2 |
s 2..................... | rep LA s 48D |
s 4..................... | am F2025L01031 |
s 6..................... | am F2025L01031 |
s 7..................... | am F2025L01031 |
| ed C2 |
s 8..................... | rs F2025L01031 |
| ed C2 |
Schedule 1 | |
Schedule 1................ | am F2025L00654; F2025L01031 |
Schedule 2 | |
Schedule 2................ | am F2025L01031 |
Endnote 5—Editorial changes
In preparing this compilation for registration, the following kinds of editorial change(s) were made under the Legislation Act 2003.
Section 1
Kind of editorial change
Give effect to the misdescribed amendment as intended and change to typeface
Details of editorial change
Schedule 1 item 1 of the Health Insurance (Section 3C – Lutetium PSMA Treatment) Amendment (No. 2) Determination 2025 provides as follows:
1 Section 1
Omit “PSMA Treatment”, substitute “Therapeutic Nuclear Medicine Treatments”.
The text “PSMA Treatment” does not appear in section 1. However, the text “PSMA Treatment” does appear.
This compilation was editorially changed to omit “PSMA Treatment” and substitute “Therapeutic Nuclear Medicine Treatments” in section 1 to give effect to the misdescribed amendment as intended and to change the typeface to bring it into line with legislative drafting practice.
Section 7
Kind of editorial change
Changes to grammar, syntax or the use of conjunctives or disjunctives
Details of editorial change
Schedule 1 item 5 of the Health Insurance (Section 3C – Lutetium PSMA Treatment) Amendment (No. 2) Determination 2025 instructs to omit “Item 61528 of Schedule 2” and substitute “items listed in Schedule 2” in section 7.
After the amendment is applied, section 7 appears as follows:
Clause 2.4.6 shall have effect as if items listed in Schedule 2 of this Determination was also specified in subclause 2.4.6 of the Diagnostic Imaging Services Table.
This compilation was editorially changed to insert “the” after “as if”, and to omit “was” and substitute “were”, in section 7 to correct the grammatical errors.
Section 8
Kind of editorial change
Numbering or renumbering of provisions
Details of editorial change
Schedule 1 item 6 of the Health Insurance (Section 3C – Lutetium PSMA Treatment) Amendment (No. 2) Determination 2025 provides as follows:
6 Section 8
Repeal the section, substitute:
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.
The substituted heading does not contain the section number “8” at the beginning of the heading.
This compilation was editorially changed to reinsert the section number “8” at the beginning of the heading to section 8.