Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018made under subsection 3C(1) of theHealth Insurance Act 1973Compilation No. 28Compilation date: 1 November 2026Includes amendments: F2026L01048About this compilationThis compilationThis 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 November 2026 (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 amendmentsThe 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 provisionsIf 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 changesFor more information about any editorial changes made in this compilation, see the endnotes.Presentational changesThe 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.ModificationsIf 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affecting the law are accessible on the Register.Self-repealing provisionsIf a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.Contents1. Name of Determination3. Authority5. Definitions5A. Indexation6. Treatment of relevant servicesSchedule 1 – Relevant ServicesEndnotesEndnote 1—About the endnotesEndnote 2—Abbreviation keyEndnote 3—Legislation historyEndnote 4—Amendment history
Group P2—ChemicalItem | Description | Fee ($)66520 | Fibroblast growth factor 23 quantification in serum or plasma, requested by a specialist or consultant physician to determine eligibility for a relevant treatment listed on the Pharmaceutical Benefits Scheme | 90.00Group P5—Tissue pathologyItem | Description | Fee ($)72814Immunohistochemical 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 triple-negative breast cancer.76.30Group P7—GeneticsItem | Description | Fee ($)73295Detection 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 III-IV) high-grade serous or high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer for whom testing of tumour tissue is not feasible; or(b) breast cancer.Applicable once per lifetime1,200.0073301A test of tumour tissue from a patient with advanced (FIGO III-IV), 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 diagnosis1,200.0073302Characterisation 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 physicianApplicable once per primary tumour diagnosisNote: Items 73296 and 73297 are in the pathology services table.400.0073303A test of tumour tissue from a patient with metastatic castration-resistant 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 diagnosis1,000.0073304Detection of germline BRCA1 or BRCA2 pathogenic or likely pathogenic gene variants, in a patient with metastatic castration-resistant 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 lifetime1,000.0073307A test of tumour tissue from a patient with advanced (FIGO III-IV), high-grade serous or other high-grade 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 73301Applicable once per primary tumour diagnosis3,000.0073319Detection in tumour tissue of isocitrate dehydrogenase 1 (IDH1) variant status, in a patient with histologically confirmed cholangiocarcinoma, to determine eligibility for a relevant treatment listed under the Pharmaceutical Benefits Scheme.Applicable only once per lifetime340.0073329A nucleic acid-based multi-gene panel test of tumour tissue from a patient with cholangiocarcinoma requested by, or on behalf of, a specialist or consultant physician, if the test is to:(a) detect at least IDH1 variant status, and(b) detect the fusion or rearrangement status of at least FGFR2; and(c) determine eligibility for a relevant treatment under the Pharmaceutical Benefits Schemeincluding a service described in item 73319.Applicable once per lifetime800.0073331A test of tumour tissue from a patient with histologically confirmed medullary thyroid cancer requested by, or on behalf of, a specialist or consultant physician if the test is:(a) to detect variants relating to at least the RET gene activating variant status, and(b) to determine eligibility for a relevant treatment listed on the Pharmaceutical Benefits Scheme400.0073332 | 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. | 315.4073336 | 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 | 230.9573337A test of tumour tissue from a patient with a new diagnosis of non-small cell lung cancer, requested by, or on behalf of, a specialist or consultant physician, if the test is:(a) for epidermal growth factor receptor (EGFR) status to determine eligibility for a relevant treatment under the Pharmaceutical Benefits Scheme; and(b) not associated with a service to which item 73437 or 73438 applies397.3573338A 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 clinically-relevant 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.362.6073341Fluorescence in situ hybridisation (FISH) test of tumour tissue from a patient with a new diagnosis of non-small cell lung cancer, requested by a specialist or consultant physician, if the test is:(a) for ALK gene rearrangement status to determine eligibility for a relevant treatment under the Pharmaceutical Benefits Scheme; and(b) not associated with a service to which item 73437 or 73439 applies400.0073342 | An in situ hybridisation (ISH) test of tumour tissue from a patient with metastatic adenocarcinoma of the stomach or gastro-oesophageal 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. | 315.4073344Fluorescence in situ hybridization (FISH) test of tumour tissue from a patient with a new diagnosis of non-small cell lung cancer, requested by a specialist or consultant physician, if the test is:(a) for ROS1 gene arrangement status to determine eligibility for a relevant treatment under the Pharmaceutical Benefits Scheme; and(b) not associated with a service to which item 73437 or 73439 applies400.0073351 | A test of tumour tissue that is derived from a new sample from a patient with locally advanced (Stage IIIb) or metastatic (Stage IV) non-small 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. | 397.3573430Fluorescence in-situ 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 fulfilledThis item cannot be claimed if item 73433 has been claimed for the same patient during the same cancer diagnosisApplicable only once per cancer diagnosis400.0073431 | Two tests described in item 73430 | 533.0073432 | Three or more tests described in item 73430 | 667.0073433Next generation sequencing 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; or(iv) being glioma, glioneuronal tumour or glioblastoma; and(b) the test is requested by a specialist or consultant physician for NTRK gene fusion status to determine eligibility for a relevant treatment under the Pharmaceutical Benefits SchemeThis item cannot be claimed if item 73430, 73431 or 73432 has been claimed for the same patient during the same cancer diagnosisApplicable only once per cancer diagnosis1,000.0073436A test of tumour tissue from a patient with a new diagnosis of non-small cell lung cancer requested by, or on behalf of, a specialist or consultant physician, if the test is:(a) for MET proto-oncogene, receptor tyrosine kinase (MET) exon 14 skipping alterations (METex14sk) status to determine eligibility for access to a relevant treatment under the Pharmaceutical Benefits Scheme; and(b) not associated with a service to which item 73437 or 73438 applies397.3573437A nucleic acid-based multi-gene panel test of tumour tissue from a patient with a new diagnosis of non-small 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 eligibility for a relevant treatment under the Pharmaceutical Benefits Scheme; and(b) to detect the fusion status of at least ALK, ROS1, RET, NTRK1, NTRK2 and NTRK3 to determine eligibility for a relevant treatment under the PBS; and(c) not associated with a service to which item 73438, 73439, 73337, 73341, 73344, 73436 or 73351 applies1,247.0073438A DNA-based multi-gene panel test of tumour tissue from a patient with a new diagnosis of non-small 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 eligibility for a relevant treatment under the Pharmaceutical Benefits Scheme; and(c) not associated with a service to which item 73437, 73337, 73436 or 73351 applies682.3573439A nucleic acid-based multi-gene panel test of tumour tissue from a patient with a new diagnosis of non-small 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) for fusion status of at least ALK, ROS1, RET, NTRK1, NTRK2, and NTRK3 to determine eligibility for a relevant treatment under the Pharmaceutical Benefits Scheme; and(b) not associated with a service to which item 73437, 73341, 73344 or 73351 applies682.35