{"id":"F2018L00810","name":"Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018","slug":"health-insurance-section-3c-co-dependent-pathology-services-determination-2018","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":97476,"registerId":"commonwealth-F2018L00810-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1. Name of Determination","sectionType":"part","heading":"1. Name of Determination","content":"# 1. Name of Determination\n\nThis Determination is the Health Insurance (Section 3C Co‑Dependent Pathology Services) Determination 2018.","sortOrder":0},{"sectionNumber":"3. Authority","sectionType":"part","heading":"3. Authority","content":"# 3. Authority\n\nThis Determination is made under subsection 3C(1) of the Health Insurance Act 1973.","sortOrder":1},{"sectionNumber":"5. Definitions","sectionType":"part","heading":"5. Definitions","content":"# 5. Definitions\n\n(1) In this Determination:\n\nAct means the Health Insurance Act 1973.\n\nrelevant 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.\n\nrelevant service means a health service, as defined in subsection 3C(8) of the Act, that is specified in a Schedule.\n\nPathology services table means the table prescribed under subsection 4A(1) of the Act.\n\nPharmaceutical Benefits Scheme means the scheme for the supply of pharmaceutical benefits established under Part VII of the National Health Act 1953.\n\nSchedule means a Schedule to this Determination.\n\nNote: The following terms are defined in subsection 3(1) of the Act:\n\n clinically relevant service\n\n pathology services table\n\n item\n\n professional service\n\n(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.","sortOrder":2},{"sectionNumber":"6. Treatment of relevant services","sectionType":"part","heading":"6. Treatment of relevant services","content":"# 6. Treatment of relevant services\n\n(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:\n\n(a) it were both a professional service and a pathology service; and\n\n(b) there were an item in Groups P2, P5 or P7 of the pathology services table that:\n\n(i) related to the service; and\n\n(ii) specified for the service a fee in relation to each State, being the fee specified in Schedule 1 in relation to the service.","sortOrder":3},{"sectionNumber":"Schedule 1","sectionType":"part","heading":"Relevant Services","content":"# Schedule 1 – Relevant Services\n\n```html\n

Group P2—Chemical

Item

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

90.00

\n```\n\n```html\n

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 triple‑negative breast cancer.

76.30

\n```\n\n```html\n

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 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 lifetime

1,200.00

73301

A 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 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 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 diagnosis

1,000.00

73304

Detection 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 lifetime

1,000.00

73307

A 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 73301

Applicable once per primary tumour diagnosis

3,000.00

73319

Detection 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 lifetime

340.00

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 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 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 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.

362.60

73341

Fluorescence 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 applies

400.00

73342

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.

315.40

73344

Fluorescence 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 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) 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.

397.35

73430

Fluorescence 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 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 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 applies

397.35

73437

A 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 applies

1,247.00

73438

A 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 applies

682.35

73439

A 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 applies

682.35

\n```","sortOrder":4}],"analysis":{"flash_summary":{"complexity_score":6,"scope_assessment":{"changed":false,"description":"The Determination itself creates and specifies a set of services and fees but does not include any text comparing this list to previous lists or stating it expands or narrows prior scope. From the instrument alone one cannot determine whether it changes the prior statutory scope; no comparative or historical statement is provided here."},"complexity_factors":["Extensive, itemised Schedule 1 listing many different tests with different fees and applicability rules (Schedule 1).","Multiple conditional limits (e.g. 'Applicable once per lifetime', 'once per primary tumour diagnosis', 'only once per cancer diagnosis') that vary by item, increasing administrative tracking (Schedule 1 items 73295, 73301, 73302, 73307, 73319, 73430, etc.).","Inter-item exclusions and dependencies (items that cannot be claimed together or that refer to other items), requiring cross‑checking when claiming (Schedule 1, e.g. items 73430/73433 and 73431/73432 references).","Requirement that tests be 'requested by a specialist or consultant physician' for many items, creating a gatekeeping condition and evidentiary requirement for claims (Schedule 1 multiple items).","Interaction with the Pharmaceutical Benefits Scheme to determine eligibility for treatments — tests are payable only where used to determine PBS access, linking two statutory regimes (Definitions; Schedule 1 descriptions referencing PBS).","Statutory cross‑references and incorporation by reference to the Health Insurance Act and National Health Act provisions as in force, which imports external rules and potential future changes (s.5(2); Authority s.3C(1) citation).","Treatment-for-claiming mechanism: a listed service is treated as both a professional and a pathology service and deemed to have a pathology table item and State fee, which alters how services are classified and reimbursed (s.6).","State‑specific fee specification requirement (s.6(b)(ii) referencing Schedule 1 fees 'in relation to each State'), adding potential administrative variance by jurisdiction (s.6; Schedule 1)."],"plain_english_summary":"This Determination lists specific pathology and genetic tests (Schedule 1) and treats each listed ‘relevant service’, when clinically relevant and supplied as required, as both a professional service and a pathology service for health‑insurance claiming, with a pathology fee set for each State (s.6; Schedule 1). It affects specialist requesters, pathology providers and patients seeking PBS‑linked treatments because it fixes which tests can be claimed, the fee payable and claiming limits or frequency conditions in Schedule 1 (s.5, s.6)."},"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"},"kimi_summary":{"content_quality":"ok","complexity_score":6,"scope_assessment":{"changed":true,"description":"The original Section 3C power was a general mechanism to deem health services as 'professional services' for Medicare purposes. This Determination has significantly expanded in scope from its 2018 origins, growing from a handful of BRCA tests to cover 24 distinct items spanning lung, breast, ovarian, prostate, colorectal, melanoma, and rare paediatric cancers. The complexity has increased with multi-gene panel tests (items 73437-73439) that bundle multiple biomarkers, and sophisticated anti-duplication rules to prevent overlap with standalone items. The instrument has evolved from a simple BRCA-testing vehicle into a comprehensive precision oncology framework."},"complexity_factors":["Extensive cross-referencing to the Health Insurance Act 1973, National Health Act 1953, and their regulations","Multiple 'anti-duplication' clauses preventing claims when related items (73337, 73437, 73438, 73439, 73430/73433) have been used","Nested conditional logic: tests only qualify if requested by specific practitioner types AND for specific clinical indications AND to determine PBS eligibility","Temporal restrictions ('once per lifetime', 'once per primary tumour diagnosis', 'once per cancer diagnosis') requiring tracking across patient history","Technical medical terminology requiring external knowledge (EGFR T790M, METex14sk, HRD status, PARP inhibitors, Trk inhibitors)","Dual-structure items where germline vs somatic testing have different rules and fees","Incorporation by reference to external PBS listings that change independently of this instrument"],"plain_english_summary":"This Determination creates a Medicare-funded category of 24 “co‑dependent” pathology tests — specialised genetic/molecular assays paid by Medicare only when ordered to determine eligibility for specific PBS‑subsidised cancer drugs. It sets fixed fees and limits (often once per lifetime or per diagnosis), with anti‑duplication rules.\n\nIt affects patients with advanced cancers, treating specialists who must request tests, and pathology labs claiming rebates, ensuring taxpayer funding targets tests that directly enable access to targeted therapies."}},"importantCases":[],"_links":{"self":"/api/acts/health-insurance-section-3c-co-dependent-pathology-services-determination-2018","history":"/api/acts/health-insurance-section-3c-co-dependent-pathology-services-determination-2018/history","analysis":"/api/acts/health-insurance-section-3c-co-dependent-pathology-services-determination-2018/analysis","conflicts":"/api/acts/health-insurance-section-3c-co-dependent-pathology-services-determination-2018/conflicts","importantCases":"/api/acts/health-insurance-section-3c-co-dependent-pathology-services-determination-2018/important-cases","documents":"/api/acts/health-insurance-section-3c-co-dependent-pathology-services-determination-2018/documents"}}