Commonwealth Coat of Arms of Australia

Health Insurance (Section 3C CoDependent Pathology Services) Determination 2018

made under subsection 3C(1) of the

Health Insurance Act 1973

Compilation No. 23

Compilation date: 1 January 2025

Includes amendments: F2024L01528

About this compilation

This compilation

This is a compilation of the Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018 that shows the text of the law as amended and in force on 1 January 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. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

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.

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. For more information on any modifications, see the Register for the compiled law.

Selfrepealing 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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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 of Determination

3. Authority

5. Definitions

6. Treatment of relevant services

Schedule 1 – Relevant Services

Endnotes

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

 

1. Name of Determination

This Determination is the Health Insurance (Section 3C CoDependent Pathology Services) Determination 2018.

3. Authority

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

5. Definitions

(1) In this Determination:

Act means the Health Insurance Act 1973.

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.

Pathology services table means the table prescribed under subsection 4A(1) of the Act.

Pharmaceutical Benefits Scheme means the scheme for the supply of pharmaceutical benefits established under Part VII of the National Health Act 1953.

Schedule means a Schedule to this Determination.

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

 clinically relevant service

 pathology services table

 item

 professional service

(2) Unless the contrary intention appears, a reference in this Determination 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.

6. Treatment of relevant services

(1) For subsection 3C(1) of the Act a relevant service, provided in accordance with this Determination 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 pathology service; and

(b) there were an item in Groups P5 or P7 of the pathology 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 Schedule 1 in relation to the service.

Schedule 1 – Relevant Services

 

Group P5—Tissue pathology

Item

Description

Fee ($)

72814

Immunohistochemical examination by immunoperoxidase or other labelled antibody techniques using the programmed cell death ligand 1 (PD‑L1) antibody of tumour material from a patient diagnosed with:

(a) non‑small cell lung cancer; or

(b) recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx; or

(c) locally recurrent unresectable or metastatic triplenegative breast cancer.

74.50

 

Group P7—Genetics

Item

Description

Fee ($)

73295

Detection of germline BRCA1 or BRCA2 pathogenic or likely pathogenic gene variants, requested by a specialist or consultant physician, to determine eligibility for a relevant treatment under the Pharmaceutical Benefits Scheme (PBS), in a patient with:

(a) advanced (FIGO IIIIV) highgrade serous or highgrade epithelial ovarian, fallopian tube or primary peritoneal cancer for whom testing of tumour tissue is not feasible; or

(b) breast cancer.

Applicable once per lifetime

1,200.00

73301

A test of tumour tissue from a patient with advanced (FIGO IIIIV), high grade serous or high grade epithelial ovarian, fallopian tube or primary peritoneal cancer, requested by a specialist or consultant physician, to determine eligibility relating to BRCA status for access to treatment with a poly (adenosine diphosphate [ADP]ribose) polymerase (PARP) inhibitor under the Pharmaceutical Benefits Scheme (PBS)

Applicable once per primary tumour diagnosis

1,200.00

73302

Characterisation of germline gene variants including copy number variants, in BRCA1 or BRCA2 genes, in a patient who has had a pathogenic or likely pathogenic variant identified in either gene by tumour testing and who has not previously received a service to which items 73295, 73296 or 73297 applies, requested by a specialist or consultant physician

Applicable once per primary tumour diagnosis

Note: Items 73296 and 73297 are in the pathology services table.

400.00

73303

A test of tumour tissue from a patient with metastatic castrationresistant prostate cancer, including subsequent characterisation of germline gene variants should tumour tissue testing undertaken during the same service be inconclusive, requested by a specialist or consultant physician, to determine eligibility relating to BRCA status for access to a relevant treatment under the Pharmaceutical Benefits Scheme;

Applicable once per primary tumour diagnosis

1,000.00

73304

Detection of germline BRCA1 or BRCA2 pathogenic or likely pathogenic gene variants, in a patient with metastatic castrationresistant prostate cancer, for whom testing of tumour tissue is not clinically feasible, requested by a specialist or consultant physician, to determine eligibility for a relevant treatment under the Pharmaceutical Benefits Scheme;

Applicable once per lifetime

1,000.00

73307

A test of tumour tissue from a patient with advanced (FIGO IIIIV), highgrade serous or other highgrade ovarian, fallopian tube or primary peritoneal carcinoma, requested by a specialist or consultant physician, if the test is:

(a) to determine eligibility with respect to homologous recombination deficiency (HRD) status, including BRCA1 or BRCA2 status, to provide access to poly (adenosine diphosphate [ADP]ribose) polymerase (PARP) inhibitor therapy under the Pharmaceutical Benefits Scheme; and

(b) including a service described in item 73301

Applicable once per primary tumour diagnosis

3,000.00

73332

An in situ hybridisation (ISH) test of tumour tissue from a patient with breast cancer requested by, or on the advice of, a specialist or consultant physician who manages the treatment of the patient to determine if the requirements relating to human epidermal growth factor receptor 2 (HER2) gene amplification for access to trastuzumab under the Pharmaceutical Benefits Scheme or the Herceptin Program are fulfilled.

315.40

73336

A test of tumour tissue from a patient with stage III or stage IV metastatic cutaneous melanoma, requested by, or on behalf of, a specialist or consultant physician, to determine if the requirements relating to BRAF V600 mutation status for access to dabrafenib, vemurafenib or encorafenib under the Pharmaceutical Benefits Scheme are fulfilled

230.95

73337

A test of tumour tissue from a patient with a new diagnosis of nonsmall cell lung cancer, shown to have nonsquamous histology or histology not otherwise specified, requested by, or on behalf of, a specialist or consultant physician, if the test is:

(a) to determine if requirements relating to epidermal growth factor receptor (EGFR) gene status for access to an immunotherapy listed under the Pharmaceutical Benefits Scheme (PBS) are fulfilled; and

(b) not associated with a service to which item 73437 or 73438 applies

397.35

73338

A test of tumour tissue from a patient with metastatic colorectal cancer (stage IV), requested by a specialist or consultant physician, to determine if:

(a) requirements relating to rat sarcoma oncogene (RAS) gene variant status for access to cetuximab or panitumumab under the Pharmaceutical Benefits Scheme are fulfilled, if:

(i) the test is conducted for all clinically relevant mutations on KRAS exons 2, 3 and 4 and NRAS exons 2, 3, and 4; or

(ii) a clinicallyrelevant RAS variant is detected;

and, in cases where no RAS variant is detected:

(b) the requirements relating to BRAF V600 gene variant status for access to encorafenib under the Pharmaceutical Benefits Scheme are fulfilled.

362.60

73341

Fluorescence in situ hybridisation (FISH) test of tumour tissue from a patient with a new diagnosis of locally advanced or metastatic nonsmall cell lung cancer, which is of nonsquamous histology or histology not otherwise specified, with documented evidence of anaplastic lymphoma kinase (ALK) immunoreactivity by immunohistochemical (IHC) examination giving a staining intensity score > 0, and with documented absence of activating mutations of the epidermal growth factor receptor (EGFR) gene, requested by a specialist or consultant physician, if the test is:

(a) to determine if requirements relating to ALK gene rearrangement status for access to an immunotherapy listed under the Pharmaceutical Benefits Scheme (PBS) are fulfilled; and

(b) not associated with a service to which item 73437 or 73439 applies

400.00

73342

An in situ hybridisation (ISH) test of tumour tissue from a patient with metastatic adenocarcinoma of the stomach or gastrooesophageal junction, with documented evidence of human epidermal growth factor receptor 2 (HER2) overexpression by immunohistochemical (IHC) examination giving a staining intensity score of 2+ or 3+ on the same tumour tissue sample, requested by, or on the advice of, a specialist or consultant physician who manages the treatment of the patient to determine if the requirements relating to HER2 gene amplification for access to trastuzumab under the Pharmaceutical Benefits Scheme are fulfilled.

315.40

73344

Fluorescence in situ hybridization (FISH) test of tumour tissue from a patient with a new diagnosis of locally advanced or metastatic nonsmall cell lung cancer, which is of nonsquamous histology or histology not otherwise specified, with documented evidence of ROS protooncogene 1 (ROS1) immunoreactivity by immunohistochemical (IHC) examination giving a staining intensity score of 2+ or 3+; and with documented absence of both activating mutations of the epidermal growth factor receptor (EGFR) gene and anaplastic lymphoma kinase (ALK) immunoreactivity by IHC, requested by a specialist or consultant physician, if the test is:

(a) to determine if requirements relating to ROS1 gene arrangement status for access to an immunotherapy listed under the Pharmaceutical Benefits Scheme (PBS) are fulfilled: and

(b) not associated with a service to which item 73437 or 73439 applies

400.00

73351

A test of tumour tissue that is derived from a new sample from a patient with locally advanced (Stage IIIb) or metastatic (Stage IV) nonsmall cell lung cancer (NSCLC), who has progressed on or after treatment with an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI). The test is to be requested by a specialist or consultant physician, to determine if the requirements relating to EGFR T790M gene status for access to osimertinib under the Pharmaceutical Benefits Scheme are fulfilled.

397.35

73430

Fluorescence insitu hybridisation (FISH) test of tumour tissue from a patient with locally advanced or metastatic solid tumour, if:

(a) the tumour is at risk of being caused by a neurotrophic receptor tyrosine kinase (NTRK) gene fusion as determined by either:

(i) occurring in a child less than 18 years of age; or

(ii) being mammary analogue secretory carcinoma of the salivary gland; or

(iii) being secretory breast carcinoma; and

(b) the test is requested by a specialist or consultant physician to determine if requirements relating to NTRK gene fusion status for access to a tropomyosin receptor kinase (Trk) inhibitor under the Pharmaceutical Benefits Scheme are fulfilled

This item cannot be claimed if item 73433 has been claimed for the same patient during the same cancer diagnosis

Applicable only once per cancer diagnosis

400.00

73431

Two tests described in item 73430

533.00

73432

Three or more tests described in item 73430

667.00

73433

Next generation sequencing (NGS) test for neurotrophic receptor tyrosine kinase (NTRK1, NTRK2, NTRK3) fusions by RNA or DNA in tumour tissue from a patient with locally advanced or metastatic solid tumour, if:

(a) the tumour is at risk of being caused by an NTRK gene fusion as determined by either:

(i) occurring in a child less than 18 years of age; or

(ii) being mammary analogue secretory carcinoma of the salivary gland; or

(iii) being secretory breast carcinoma;

(b) the test is requested by a specialist or consultant physician to determine if requirements relating to NTRK gene fusion status for access to a tropomyosin receptor kinase (Trk) inhibitor under the Pharmaceutical Benefits Scheme are fulfilled

This item cannot be claimed if item 73430 has been claimed for the same patient during the same cancer diagnosis

Applicable only once per cancer diagnosis

1,000.00

73436

A test of tumour tissue from a patient with a new diagnosis of locally advanced or metastatic nonsmall cell lung cancer requested by, or on behalf of, a specialist or consultant physician, if the test is:

(a) to determine if the requirements relating to MET protooncogene, receptor tyrosine kinase (MET) exon 14 skipping alterations (METex14sk) status for access to an immunotherapy listed under the Pharmaceutical Benefits Scheme (PBS) are fulfilled: and

(b) not associated with a service to which item 73437 or 73438 applies

397.35

73437

A nucleic acidbased multigene panel test of tumour tissue from a patient with a new diagnosis of nonsmall cell lung cancer requested by, or on behalf of, a specialist or consultant physician, if the test is:

(a) to detect variants in at least EGFR, BRAF, KRAS and MET exon 14 to determine access to specific therapies relevant to these variants listed on the Pharmaceutical Benefits Scheme (PBS); and

(b) to detect the fusion status of at least ALK, ROS1, RET, NTRK1, NTRK2 and NTRK3; and

(i) to determine access to specific therapies relevant to these variants listed on the PBS; or

(ii) determine if the requirements relating to EGFR, ALK and ROS1 status for access immunotherapies listed on the PBS are fulfilled; and

(c) not associated with a service to which item 73438, 73439, 73337, 73341, 73344, 73436 or 73351 applies

1,247.00

73438

A DNAbased multigene panel test of tumour tissue from a patient with a new diagnosis of nonsmall cell lung cancer requested by, or on behalf of, a specialist or consultant physician, if the test is:

(a) to detect variants in at least EGFR, BRAF, KRAS and MET exon 14; and

(b) to determine access to specific therapies relevant to these variants listed on the Pharmaceutical Benefits Scheme (PBS); or

(c) to determine if the requirements relating to EGFR status for access to immunotherapies listed on the PBS are fulfilled; and

(d) not associated with a service to which item 73437, 73337, 73436 or 73351 applies

682.35

73439

A nucleic acidbased multigene panel test of tumour tissue from a patient with a new diagnosis of nonsmall cell lung cancer and with documented absence of activating variants of the EGFR gene, KRAS, BRAF and MET exon14, requested by, or on behalf of, a specialist or consultant physician, if the test is:

(a) to determine the fusion status of at least ALK, ROS1, RET, NTRK1, NTRK2, and NTRK3 to determine access to specific therapies relevant to these variants listed on the Pharmaceutical Benefits Scheme (PBS) are fulfilled; or

(b) to determine if the requirements relating to ALK and ROS1 status for access to immunotherapies listed on the PBS are fulfilled; and

(c) not associated with a service to which item 73437, 73341, 73344 or 73351 applies

682.35

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

o = order(s)

am = amended

Ord = Ordinance

amdt = amendment

orig = original

c = clause(s)

par = paragraph(s)/subparagraph(s)

C[x] = Compilation No. x

/subsubparagraph(s)

Ch = Chapter(s)

pres = present

def = definition(s)

prev = previous

Dict = Dictionary

(prev…) = previously

disallowed = disallowed by Parliament

Pt = Part(s)

Div = Division(s)

r = regulation(s)/rule(s)

ed = editorial change

reloc = relocated

exp = expires/expired or ceases/ceased to have

renum = renumbered

effect

rep = repealed

F = Federal Register of Legislation

rs = repealed and substituted

gaz = gazette

s = section(s)/subsection(s)

LA = Legislation Act 2003

Sch = Schedule(s)

LIA = Legislative Instruments Act 2003

Sdiv = Subdivision(s)

(md) = misdescribed amendment can be given

SLI = Select Legislative Instrument

effect

SR = Statutory Rules

(md not incorp) = misdescribed amendment

SubCh = SubChapter(s)

cannot be given effect

SubPt = Subpart(s)

mod = modified/modification

underlining = whole or part not

No. = Number(s)

commenced or to be commenced

 

Endnote 3—Legislation history

 

Name

Registration

Commencement

Application, saving and transitional provisions

Health Insurance (Section 3C CoDependent Pathology Services) Determination 2018

21 June 2018 (F2018L00810)

1 July 2018

Health Insurance (Section 3C CoDependent Pathology Services) Amendment Determination 2018

26 October 2018 (F2018L01473)

1 November 2018

Health Insurance (Section 3C CoDependent Pathology Services) Amendment Determination (No.2) 2018

30 October 2018 (F2018L01505)

1 November 2018

Health Insurance (Section 3C CoDependent Pathology Services) Amendment Determination (No. 3) 2018

17 December 2018 (F2018L01776)

1 January 2019 (s 2)

Health Insurance (Section 3C CoDependent Pathology Services) Amendment Determination 2019

17 January 2019 (F2019L00044)

1 February 2019 (s 2)

Health Insurance (Section 3C CoDependent Pathology Services) Amendment Determination (No.2) 2019

22 February 2019 (F2019L00174)

1 March 2019 (s 2)

Health Insurance (Section 3C CoDependent Pathology Services) Amendment Determination (No. 3) 2019

30 October 2019 (F2019L01385)

1 November 2019 (s 2(1) item 1)

Health Insurance (Section 3C CoDependent Pathology Services) Amendment Determination (No. 1) 2020

25 March 2020 (F2020L00304)

1 April 2020 (s 2(1) item 1)

Health Insurance (Section 3C CoDependent Pathology Services) Amendment Determination (No. 4) 2020

30 April 2020 (F2020L00521)

1 May 2020 (s 2(1) item 1)

Health Insurance (Section 3C CoDependent Pathology Services) Amendment Determination (No. 5) 2020

23 July 2020 (F2020L00938)

1 August 2020 (s 2(1) item 1)

Health Insurance (Section 3C CoDependent Pathology Services) Amendment Determination (No. 6) 2020

27 August 2020 (F2020L01075)

1 September 2020 (s 2(1) item 1)

Health Insurance (Section 3C CoDependent Pathology Services) Amendment Determination (No. 7) 2020

18 December 2020 (F2020L01642)

1 January 2021 (s 2(1) item 1)

Health Insurance (Section 3C CoDependent Pathology Services) Amendment Determination 2021

16 September 2021 (F2021L01270)

1 November 2021 (s 2(1) item 1)

Health Insurance (Section 3C CoDependent Pathology Services) Amendment Determination (No. 1) 2022

17 January 2022 (F2022L00033)

1 January 2022 (s 2(1) item 2)

Health Insurance (Section 3C CoDependent Pathology Services) Amendment Determination (No. 2) 2022

31 March 2022 (F2022L00451)

1 April 2022 (s 2(1) item 1)

Health Insurance (Section 3C CoDependent Pathology Services) Amendment Determination (No. 3) 2022

30 June 2022 (F2022L00908)

1 July 2022 (s 2(1) item 1)

Health Insurance (Section 3C CoDependent Pathology Services) Amendment Determination (No. 4) 2022

22 August 2022 (F2022L01100)

1 September 2022 (s 2(1) item 1)

Health Insurance (Section 3C CoDependent Pathology Services) Amendment Determination (No. 5) 2022

26 September 2022 (F2022L01251)

1 October 2022 (s 2(1) item 1)

Health Insurance (Section 3C CoDependent Pathology Services) Amendment Determination (No. 6) 2022

17 October 2022 (F2022L01358)

1 November 2022 (s 2(1) item 1)

Health Insurance Legislation Amendment (2023 Measures No. 2) Determination 2023

7 June 2023 (F2023L00731)

Sch 3: 1 July 2023 (s 2(1) item 3)

Health Insurance (Section 3C CoDependant Pathology Services) Amendment Determination (No.1) 2023

24 August 2023 (F2023L01112)

1 September 2023 (s 2(1) item 1)

Health Insurance (Section 3C CoDependant Pathology) Amendment (No. 2) Determination 2023

22 September 2023 (F2023L01280)

1 November 2023 (s 2(1) item 1)

Health Insurance (Section 3C CoDependent Pathology) Amendment (No. 3) Determination 2023

14 December 2023 (F2023L01664)

1 January 2024 (s 2(1) item 1)

Health Insurance (Section 3C CoDependent Pathology Services) Amendment (No. 1) Determination 2024

20 May 2024 (F2024L00555)

1 July 2024 (s 2(1) item 1)

Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment (No. 2) Determination 2024

29 November 2024 (F2024L01528)

1 January 2025 (s 2(1) item 1)

 

Endnote 4—Amendment history

 

Provision affected

How affected

s 2.....................

rep LA s 48D

s 4.....................

rep LA s 48C

s 6.....................

am F2018L01505

Schedule 1

 

Schedule 1................

ad F2018L01473

 

rs F2018L01505

 

am F2018L01776; F2019L00044; F2019L00174; F2019L01385; F2020L00304; F2020L00521; F2020L00938; F2020L01075; F2020L01642; F2021L01270; F2022L00033; F2022L00451; F2022L00908; F2022L01100; F2022L01251; F2022L01358

 

ed C17

 

am F2023L00731; F2023L01112; F2023L01280; F2023L01664

 

ed C21

 

am F2024L00555; F2024L01528