Commonwealth legislation

Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018

In ForceCTH

Jurisdiction

Commonwealth

Collection

legislative instrument

Plain English Summary

6/10 complexity

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).

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What it does

This Determination, the Health Insurance (Section 3C Co‑Dependent Pathology Services) Determination 2018, is a statutory instrument made under subsection 3C(1) of the Health Insurance Act 1973 (see “3. Authority”). It prescribes how particular pathology and genetics tests, when provided as clinically relevant services, are to be treated for the purposes of the Health Insurance Act and related regulations. The core mechanical effect is in section 6: 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 it were both a professional service and a pathology service (s 6(1)(a)), and as if there were an item in Groups P2, P5 or P7 of the pathology services table that related to the service and specified a fee for each State equal to the fee listed in Schedule 1 (s 6(1)(b)(i)-(ii)).

Practically, the Determination: (a) identifies particular tests and assigns them pathology item numbers and fixed fees in Schedule 1; (b) imposes condition language within Schedule 1 that links many of those tests to a clinical purpose, commonly to determine eligibility for a Pharmaceutical Benefits Scheme (PBS) treatment; and (c) determines that, for the statutory “relevant provisions” (as defined in s 5(1)), those services are to be treated in law as if the items existed in the pathology services table and carried the Schedule 1 fees. The definition section (s 5(1)) clarifies that “relevant provisions” includes all provisions of the Health Insurance Act, its regulations, the National Health Act 1953 and its regulations that relate to medical services, professional services or items. Section 5(2) instructs that references to provisions of the Act or the National Health Act are to be read as those provisions are in force from time to time.

Schedule 1 itself is the operative list. It is organised under Group P2,Chemical, Group P5,Tissue pathology, and Group P7,Genetics. Items in the Schedule range from specific chemical assays (for example, item 66520, fibroblast growth factor 23 quantification, fee $90.00) to immunohistochemistry assays (for example, item 72814, PD‑L1 examination, fee $76.30) and a suite of genetics and molecular pathology items (including BRCA germline/tumour tests, various next generation sequencing and multi‑gene panel items, and other marker tests), with fees specified (for instance, item 73295, germline BRCA1/BRCA2 test, fee $1,200.00; item 73307, HRD testing item, fee $3,000.00). Many Schedule items expressly require the test to be “requested by a specialist or consultant physician” and state restrictions on frequency such as “Applicable once per lifetime”, “Applicable once per primary tumour diagnosis” or “Applicable only once per cancer diagnosis”. Some items state mutual exclusivity, for example that a given item cannot be claimed if another specified item has been claimed for the same patient during the same cancer diagnosis.

Current sections

Direct links to the current provisions in Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018.

1. Name of Determination

This Determination is the Health Insurance (Section 3C Co‑Dependent 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 P2, 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

Schedule 1 – Relevant Services

<table cellspacing="0" cellpadding="0" style="width:100%; border-collapse:collapse"><thead><tr><td colspan="4" style="border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; page-break-after:avoid; line-height:12pt"><span style="font-weight:bold">Group P2—Chemical</span></p></td></tr><tr><td style="width:16.22%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; page-break-after:avoid; line-height:12pt"><span style="font-weight:bold">Item</span></p></td><td style="width:63.18%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; page-break-after:avoid; line-height:12pt"><span style="font-weight:bold">Description</span></p></td><td colspan="2" style="border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; margin-left:29.7pt; page-break-after:avoid; line-height:12pt"><span style="font-weight:bold">Fee ($)</span></p></td></tr></thead><tbody><tr><td style="width:16.22%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p><span>66520</span></p></td><td style="width:63.18%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-bottom:12pt"><span>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</span></p></td><td style="width:20.52%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-left:1pt; text-align:right"><span>90.00</span></p></td><td style="border-top:1.5pt solid #000000; vertical-align:top"></td></tr><tr style="height:0pt"><td style="width:69.15pt"></td><td style="width:269.35pt"></td><td style="width:87.5pt"></td><td style="width:0.35pt"></td></tr></tbody></table>

<table cellspacing="0" cellpadding="0" style="width:100%; border-collapse:collapse"><thead><tr><td colspan="4" style="border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; page-break-after:avoid; line-height:12pt"><span style="font-weight:bold">Group P5—Tissue pathology</span></p></td></tr><tr><td style="width:16.22%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; page-break-after:avoid; line-height:12pt"><span style="font-weight:bold">Item</span></p></td><td style="width:63.18%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; page-break-after:avoid; line-height:12pt"><span style="font-weight:bold">Description</span></p></td><td colspan="2" style="border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; margin-left:29.7pt; page-break-after:avoid; line-height:12pt"><span style="font-weight:bold">Fee ($)</span></p></td></tr></thead><tbody><tr><td style="width:16.22%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p><span>72814</span></p></td><td style="width:63.18%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p><a id="_Hlk145140237"><span>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:</span></a></p><p class="Item" style="margin-left:17.8pt; text-indent:-17.8pt"><span>(a)</span><span style="width:5.59pt; text-indent:0pt; display:inline-block"> </span><span>non‑small cell lung cancer; or</span></p><p class="Item" style="margin-left:17.8pt; text-indent:-17.8pt"><span>(b)</span><span style="width:4.97pt; text-indent:0pt; display:inline-block"> </span><span>recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx; or</span></p><p class="Item" style="margin-left:17.8pt; text-indent:-17.8pt"><span>(c)</span><span style="width:5.59pt; text-indent:0pt; display:inline-block"> </span><span>locally recurrent unresectable or metastatic triple</span><span>‑</span><span>negative breast cancer.</span></p></td><td style="width:20.52%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-left:1pt; text-align:right"><span>76.30</span></p></td><td style="border-top:1.5pt solid #000000; vertical-align:top"></td></tr><tr style="height:0pt"><td style="width:69.15pt"></td><td style="width:269.35pt"></td><td style="width:87.5pt"></td><td style="width:0.35pt"></td></tr></tbody></table>

<table cellspacing="0" cellpadding="0" style="width:100%; border-collapse:collapse"><thead><tr><td colspan="3" style="border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; page-break-after:avoid; line-height:12pt"><span style="font-weight:bold">Group P7—Genetics</span></p></td></tr><tr><td style="width:15.38%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; page-break-after:avoid; line-height:12pt"><span style="font-weight:bold">Item</span></p></td><td style="width:64%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; page-break-after:avoid; line-height:12pt"><span style="font-weight:bold">Description</span></p></td><td style="width:20.62%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; margin-left:47.85pt; page-break-after:avoid; line-height:12pt"><span style="font-weight:bold">Fee ($)</span></p></td></tr></thead><tbody><tr><td style="width:15.38%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:3pt; margin-bottom:3pt; line-height:115%"><span>73295</span></p></td><td style="width:64%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p><a id="_Hlk183067664"><span>Detection of germline </span><span style="font-style:italic">BRCA1</span><span> or </span><span style="font-style:italic">BRCA2</span><span> 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:</span></a></p><p class="Item" style="margin-left:17.85pt; text-indent:-17.85pt"><span>(a)</span><span style="width:5.64pt; text-indent:0pt; display:inline-block"> </span><span>advanced (FIGO III</span><span>‑</span><span>IV) high</span><span>‑</span><span>grade serous or high</span><span>‑</span><span>grade epithelial ovarian, fallopian tube or primary peritoneal cancer for whom testing of tumour tissue is not feasible; or</span></p><p class="Item" style="margin-left:17.85pt; text-indent:-17.85pt"><span>(b)</span><span style="width:5.02pt; text-indent:0pt; display:inline-block"> </span><span>breast cancer.</span></p><p style="margin-top:14pt; margin-bottom:6pt; line-height:normal; background-color:#ffffff"><span>Applicable once per lifetime</span></p></td><td style="width:20.62%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:3pt; margin-left:8.85pt; margin-bottom:3pt; text-align:right; page-break-after:avoid; line-height:115%"><span>1,200.00</span></p></td></tr><tr><td style="width:15.38%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:3pt; margin-bottom:3pt; line-height:115%"><span>73301</span></p></td><td style="width:64%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-bottom:6pt; line-height:normal; background-color:#ffffff"><span>A test of tumour tissue from a patient with advanced (FIGO III</span><span>‑</span><span>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</span><span> </span><span style="font-style:italic">BRCA</span><span> </span><span>status for access to treatment with a poly (adenosine diphosphate [ADP]</span><span>‑</span><span>ribose) polymerase (PARP) inhibitor under the</span><span> </span><span>Pharmaceutical Benefits Scheme (PBS)</span></p><p style="margin-bottom:6pt; line-height:normal; background-color:#ffffff"><span>Applicable</span><span> </span><span>once per primary tumour diagnosis</span></p></td><td style="width:20.62%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:3pt; margin-left:8.85pt; margin-bottom:3pt; text-align:right; page-break-after:avoid; line-height:115%"><span>1,200.00</span></p></td></tr><tr><td style="width:15.38%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:3pt; margin-bottom:3pt; line-height:115%"><span>73302</span></p></td><td style="width:64%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-bottom:6pt; line-height:normal; background-color:#ffffff"><span>Characterisation of germline gene variants including copy number variants, in </span><span style="font-style:italic">BRCA1</span><span> or </span><span style="font-style:italic">BRCA2</span><span> 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</span><span> </span><span>73295, 73296 or 73297 applies, requested by a specialist or consultant physician</span></p><p style="margin-bottom:6pt; line-height:normal; background-color:#ffffff"><span>Applicable once per primary tumour diagnosis</span></p><p style="margin-bottom:6pt; line-height:normal; background-color:#ffffff"><span>Note: Items</span><span> </span><span>73296 and 73297 are in the pathology services table.</span></p></td><td style="width:20.62%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:3pt; margin-left:8.85pt; margin-bottom:3pt; text-align:right; page-break-after:avoid; line-height:115%"><span>400.00</span></p></td></tr><tr><td style="width:15.38%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p><span>73303</span></p></td><td style="width:64%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-bottom:6pt; line-height:normal; background-color:#ffffff"><span>A test of tumour tissue from a patient with metastatic castration</span><span>‑</span><span>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 </span><span style="font-style:italic">BRCA</span><span> status for access to a relevant treatment under the Pharmaceutical Benefits Scheme;</span></p><p style="margin-bottom:6pt; line-height:normal; background-color:#ffffff"><span>Applicable once per primary tumour diagnosis</span></p></td><td style="width:20.62%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-left:8.85pt; text-align:right; page-break-after:avoid"><span>1,000.00</span></p></td></tr><tr><td style="width:15.38%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p><span>73304</span></p></td><td style="width:64%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-bottom:6pt; line-height:normal; background-color:#ffffff"><span>Detection of germline </span><span style="font-style:italic">BRCA1</span><span> or </span><span style="font-style:italic">BRCA2</span><span> pathogenic or likely pathogenic gene variants, in a patient with metastatic castration</span><span>‑</span><span>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;</span></p><p style="margin-bottom:6pt; line-height:normal; background-color:#ffffff"><span>Applicable once per lifetime</span></p></td><td style="width:20.62%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-left:8.85pt; text-align:right; page-break-after:avoid"><span>1,000.00</span></p></td></tr><tr><td style="width:15.38%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p><span>73307</span></p></td><td style="width:64%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p><span>A test of tumour tissue from a patient with advanced (FIGO III</span><span>‑</span><span>IV), high</span><span>‑</span><span>grade serous or other high</span><span>‑</span><span>grade ovarian, fallopian tube or primary peritoneal carcinoma, requested by a specialist or consultant physician, if the test is:</span></p><p class="Item" style="margin-left:17.85pt; text-indent:-17.85pt"><span>(a)</span><span style="width:5.64pt; text-indent:0pt; display:inline-block"> </span><span>to determine eligibility with respect to homologous recombination deficiency (HRD) status, including </span><span style="font-style:italic">BRCA1 </span><span>or</span><span style="font-style:italic"> BRCA2 </span><span>status, to provide access to poly (adenosine diphosphate [ADP]</span><span>‑</span><span>ribose) polymerase (PARP) inhibitor therapy under the Pharmaceutical Benefits Scheme; and</span></p><p class="Item" style="margin-left:17.8pt; text-indent:-17.8pt"><span>(b)</span><span style="width:4.97pt; text-indent:0pt; display:inline-block"> </span><span>including a service described in item 73301</span></p><p style="margin-top:6pt; margin-bottom:6pt"><span style="vertical-align:-3pt">Applicable once per primary tumour diagnosis</span></p></td><td style="width:20.62%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="text-align:right"><span>3,000.00</span></p></td></tr><tr><td style="width:15.38%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p><span>73319</span></p></td><td style="width:64%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p><span>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.</span></p><p><span></span></p><p><span>Applicable only once per lifetime</span></p></td><td style="width:20.62%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="text-align:right"><span>340.00</span></p></td></tr><tr><td style="width:15.38%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; margin-bottom:3pt; line-height:115%"><span>73332</span></p></td><td style="width:64%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="line-height:12pt; background-color:#ffffff"><span>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.</span></p></td><td style="width:20.62%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; margin-left:8.85pt; margin-bottom:3pt; text-align:right; page-break-after:avoid; line-height:115%"><span>315.40</span></p></td></tr><tr><td style="width:15.38%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; margin-bottom:3pt; line-height:115%"><span>73336</span></p></td><td style="width:64%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="line-height:12pt; background-color:#ffffff"><span>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</span></p></td><td style="width:20.62%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; margin-left:8.85pt; margin-bottom:3pt; text-align:right; page-break-after:avoid; line-height:115%"><span>230.95</span></p></td></tr><tr><td style="width:15.38%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; margin-bottom:3pt; line-height:115%"><span>73337</span></p></td><td style="width:64%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p><span>A test of tumour tissue from a patient with a new diagnosis of non</span><span>‑</span><span>small cell lung cancer, requested by, or on behalf of, a specialist or consultant physician, if the test is:</span></p><p class="Item" style="margin-left:17.8pt; text-indent:-17.8pt"><span>(a)</span><span style="width:5.59pt; text-indent:0pt; display:inline-block"> </span><span>for epidermal growth factor receptor (EGFR) status to determine eligibility for a</span><span style="font-style:italic"> </span><span>relevant treatment under the Pharmaceutical Benefits Scheme; and</span></p><p class="Item" style="margin-left:17.8pt; text-indent:-17.8pt"><span>(b)</span><span style="width:4.97pt; text-indent:0pt; display:inline-block"> </span><span>not associated with a service to which item 73437 or 73438 applies</span></p></td><td style="width:20.62%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; margin-left:8.85pt; margin-bottom:3pt; text-align:right; page-break-after:avoid; line-height:115%"><span>397.35</span></p></td></tr><tr><td style="width:15.38%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; margin-bottom:3pt; line-height:115%"><span>73338</span></p></td><td style="width:64%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:6pt; line-height:12pt; background-color:#ffffff"><span>A test of tumour tissue from a patient with metastatic colorectal cancer (stage IV), requested by a specialist or consultant physician, to determine if:</span></p><p class="Item" style="margin-left:17.8pt; text-indent:-17.8pt"><span>(a)</span><span style="width:5.59pt; text-indent:0pt; display:inline-block"> </span><span>requirements relating to rat sarcoma oncogene (RAS) gene variant status for access to cetuximab or panitumumab under the Pharmaceutical Benefits Scheme are fulfilled, if:</span></p><p class="Item" style="margin-left:34.9pt; text-indent:-17.8pt"><span>(i)</span><span style="width:7.42pt; text-indent:0pt; display:inline-block"> </span><span>the test is conducted for all clinically relevant mutations on KRAS exons 2, 3 and 4 and NRAS exons 2, 3, and 4; or</span></p><p class="Item" style="margin-left:34.9pt; text-indent:-17.8pt"><span>(ii)</span><span style="width:4.36pt; text-indent:0pt; display:inline-block"> </span><span>a clinically</span><span>‑</span><span>relevant RAS variant is detected;</span></p><p style="margin-top:6pt; margin-left:17.8pt; line-height:12pt; background-color:#ffffff"><span>and, in cases where no RAS variant is detected:</span></p><p class="Item" style="margin-left:17.8pt; text-indent:-17.8pt"><span>(b)</span><span style="width:4.97pt; text-indent:0pt; display:inline-block"> </span><span>the requirements relating to BRAF V600 gene variant status for access to encorafenib under the Pharmaceutical Benefits Scheme are fulfilled.</span></p></td><td style="width:20.62%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; margin-left:8.85pt; margin-bottom:3pt; text-align:right; page-break-after:avoid; line-height:115%"><span>362.60</span></p></td></tr><tr><td style="width:15.38%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; margin-bottom:3pt; line-height:115%"><span>73341</span></p></td><td style="width:64%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p><span>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:</span></p><p class="Item" style="margin-left:17.1pt; text-indent:-17.1pt"><span>(a)</span><span style="width:4.89pt; text-indent:0pt; display:inline-block"> </span><span>for ALK gene rearrangement status to determine eligibility for a</span><span style="font-style:italic"> </span><span>relevant treatment under the Pharmaceutical Benefits Scheme; and</span></p><p class="Item" style="margin-left:17.1pt; text-indent:-17.1pt"><span>(b)</span><span style="width:4.27pt; text-indent:0pt; display:inline-block"> </span><span>not associated with a service to which item 73437 or 73439 applies</span></p></td><td style="width:20.62%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; margin-left:8.85pt; margin-bottom:3pt; text-align:right; page-break-after:avoid; line-height:115%"><span>400.00</span></p></td></tr><tr><td style="width:15.38%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; margin-bottom:3pt; line-height:115%"><span>73342</span></p></td><td style="width:64%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="line-height:12pt; background-color:#ffffff"><span>An in situ hybridisation (ISH) test of tumour tissue from a patient with metastatic adenocarcinoma of the stomach or gastro</span><span>‑</span><span>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.</span></p></td><td style="width:20.62%; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; margin-left:8.85pt; margin-bottom:3pt; text-align:right; page-break-after:avoid; line-height:115%"><span>315.40</span></p></td></tr><tr><td style="width:15.38%; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; margin-bottom:3pt; line-height:115%"><span>73344</span></p></td><td style="width:64%; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p><span>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:</span></p><p class="Item" style="margin-left:17.8pt; text-indent:-17.8pt"><span>(a)</span><span style="width:5.59pt; text-indent:0pt; display:inline-block"> </span><span>for ROS1 gene arrangement status to determine eligibility for a</span><span style="font-style:italic"> </span><span>relevant treatment under the Pharmaceutical Benefits Scheme; and</span></p><p class="Item" style="margin-left:17.8pt; text-indent:-17.8pt"><span>(b)</span><span style="width:4.97pt; text-indent:0pt; display:inline-block"> </span><span>not associated with a service to which item 73437 or 73439 applies</span></p></td><td style="width:20.62%; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; margin-left:8.85pt; margin-bottom:3pt; text-align:right; page-break-after:avoid; line-height:115%"><span>400.00</span></p></td></tr><tr><td style="width:15.38%; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; margin-bottom:3pt; line-height:115%"><span>73351</span></p></td><td style="width:64%; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="line-height:12pt; background-color:#ffffff"><span>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</span><span>‑</span><span>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 </span><span style="font-style:italic">EGFR</span><span> </span><span style="font-style:italic">T790M</span><span> gene status for access to osimertinib under the Pharmaceutical Benefits Scheme are fulfilled.</span></p></td><td style="width:20.62%; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; margin-left:8.85pt; margin-bottom:3pt; text-align:right; page-break-after:avoid; line-height:115%"><span>397.35</span></p></td></tr><tr style="height:1pt"><td style="width:15.38%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p><span>73430</span></p></td><td style="width:64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext1" style="margin-bottom:6pt; line-height:115%; font-size:11pt"><span style="font-family:'Times New Roman', serif">Fluorescence in</span><span style="font-family:'Times New Roman', serif">‑</span><span style="font-family:'Times New Roman', serif">situ hybridisation (FISH) test of tumour tissue from a patient with locally advanced or metastatic solid tumour, if:</span></p><p class="Tabletext1" style="margin-left:24.95pt; margin-bottom:0pt; text-indent:-17.85pt; line-height:115%; font-size:11pt"><span style="font-family:'Times New Roman', serif">(a)</span><span style="width:5.64pt; text-indent:0pt; font-family:'Times New Roman', serif; display:inline-block"> </span><span style="font-family:'Times New Roman', serif">the tumour is at risk of being caused by a neurotrophic receptor tyrosine kinase (</span><span style="font-family:'Times New Roman', serif; font-style:italic">NTRK</span><span style="font-family:'Times New Roman', serif">) gene fusion as determined by either:</span></p><p class="Tabletext1" style="margin-left:53.9pt; margin-bottom:0pt; text-indent:-11.35pt; line-height:115%; font-size:11pt"><span style="font-family:'Times New Roman', serif">(i)</span><span style="width:0.97pt; text-indent:0pt; font-family:'Times New Roman', serif; display:inline-block"> </span><span style="font-family:'Times New Roman', serif">occurring in a child less than 18 years of age; or</span></p><p class="Tabletext1" style="margin-left:53.9pt; margin-bottom:0pt; text-indent:-11.35pt; line-height:115%; font-size:11pt"><span style="font-family:'Times New Roman', serif">(ii)</span><span style="width:16.01pt; text-indent:0pt; font-family:'Times New Roman', serif; display:inline-block"> </span><span style="font-family:'Times New Roman', serif">being mammary analogue secretory carcinoma of the salivary gland; or</span></p><p class="Tabletext1" style="margin-left:53.9pt; margin-bottom:6pt; text-indent:-11.35pt; line-height:115%; font-size:11pt"><span style="font-family:'Times New Roman', serif">(iii)</span><span style="width:12.96pt; text-indent:0pt; font-family:'Times New Roman', serif; display:inline-block"> </span><span style="font-family:'Times New Roman', serif">being secretory breast carcinoma; and</span></p><p class="Tabletext1" style="margin-left:25.1pt; margin-bottom:6pt; text-indent:-18pt; line-height:115%; font-size:11pt"><span style="font-family:'Times New Roman', serif">(b)</span><span style="width:5.17pt; text-indent:0pt; font-family:'Times New Roman', serif; display:inline-block"> </span><span style="font-family:'Times New Roman', serif">the test is requested by a specialist or consultant physician to determine if requirements relating to </span><span style="font-family:'Times New Roman', serif; font-style:italic">NTRK</span><span style="font-family:'Times New Roman', serif"> gene fusion status for access to a tropomyosin receptor kinase (Trk) inhibitor under the Pharmaceutical Benefits Scheme are fulfilled</span></p><p class="Tabletext1" style="margin-bottom:6pt; line-height:115%; font-size:11pt"><span style="font-family:'Times New Roman', serif">This item cannot be claimed if item</span><span style="font-family:'Times New Roman', serif"> </span><span style="font-family:'Times New Roman', serif">73433 has been claimed for the same patient during the same cancer diagnosis</span></p><p class="Tabletext1" style="margin-bottom:6pt; line-height:115%; font-size:11pt"><span style="font-family:'Times New Roman', serif">Applicable only once per cancer diagnosis</span></p></td><td style="width:20.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext1" style="margin-bottom:6pt; text-align:right; line-height:115%; font-size:11pt"><span style="font-family:'Times New Roman', serif">400.00</span></p></td></tr><tr><td style="width:15.38%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p><span>73431</span></p></td><td style="width:64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext1" style="margin-bottom:6pt; line-height:115%; font-size:11pt"><span style="font-family:'Times New Roman', serif">Two tests described in item</span><span style="font-family:'Times New Roman', serif"> </span><span style="font-family:'Times New Roman', serif">73430</span></p></td><td style="width:20.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext1" style="margin-bottom:6pt; text-align:right; line-height:115%; font-size:11pt"><span style="font-family:'Times New Roman', serif">533.00</span></p></td></tr><tr><td style="width:15.38%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p><span>73432</span></p></td><td style="width:64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext1" style="margin-bottom:6pt; line-height:115%; font-size:11pt"><span style="font-family:'Times New Roman', serif">Three or more tests described in item</span><span style="font-family:'Times New Roman', serif"> </span><span style="font-family:'Times New Roman', serif">73430</span></p></td><td style="width:20.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext1" style="margin-bottom:6pt; text-align:right; line-height:115%; font-size:11pt"><span style="font-family:'Times New Roman', serif">667.00</span></p></td></tr><tr><td style="width:15.38%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p><span>73433</span></p></td><td style="width:64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext1" style="margin-bottom:6pt; line-height:115%; font-size:11pt"><span style="font-family:'Times New Roman', serif">Next generation sequencing (NGS) test for neurotrophic receptor tyrosine kinase (</span><span style="font-family:'Times New Roman', serif; font-style:italic">NTRK1</span><span style="font-family:'Times New Roman', serif">, </span><span style="font-family:'Times New Roman', serif; font-style:italic">NTRK2</span><span style="font-family:'Times New Roman', serif">, </span><span style="font-family:'Times New Roman', serif; font-style:italic">NTRK3</span><span style="font-family:'Times New Roman', serif">) fusions by RNA or DNA in tumour tissue from a patient with locally advanced or metastatic solid tumour, if:</span></p><p class="Tabletext1" style="margin-left:36pt; margin-bottom:0pt; text-indent:-18pt; line-height:115%; font-size:11pt"><span style="font-family:'Times New Roman', serif">(a)</span><span style="width:5.79pt; text-indent:0pt; font-family:'Times New Roman', serif; display:inline-block"> </span><span style="font-family:'Times New Roman', serif">the tumour is at risk of being caused by an </span><span style="font-family:'Times New Roman', serif; font-style:italic">NTRK </span><span style="font-family:'Times New Roman', serif">gene fusion as determined by either:</span></p><p class="Tabletext1" style="margin-left:53.85pt; margin-bottom:0pt; text-indent:-11.3pt; line-height:115%; font-size:11pt"><span style="font-family:'Times New Roman', serif">(i)</span><span style="width:0.92pt; text-indent:0pt; font-family:'Times New Roman', serif; display:inline-block"> </span><span style="font-family:'Times New Roman', serif">occurring in a child less than 18 years of age; or</span></p><p class="Tabletext1" style="margin-left:53.85pt; margin-bottom:0pt; text-indent:-11.3pt; line-height:115%; font-size:11pt"><span style="font-family:'Times New Roman', serif">(ii)</span><span style="width:16.01pt; text-indent:0pt; font-family:'Times New Roman', serif; display:inline-block"> </span><span style="font-family:'Times New Roman', serif">being mammary analogue secretory carcinoma of the salivary gland; or</span></p><p class="Tabletext1" style="margin-left:53.85pt; margin-bottom:6pt; text-indent:-11.3pt; line-height:115%; font-size:11pt"><span style="font-family:'Times New Roman', serif">(iii)</span><span style="width:12.96pt; text-indent:0pt; font-family:'Times New Roman', serif; display:inline-block"> </span><span style="font-family:'Times New Roman', serif">being secretory breast carcinoma;</span></p><p class="Tabletext1" style="margin-left:36pt; margin-bottom:6pt; text-indent:-18pt; line-height:115%; font-size:11pt"><span style="font-family:'Times New Roman', serif">(b)</span><span style="width:5.17pt; text-indent:0pt; font-family:'Times New Roman', serif; display:inline-block"> </span><span style="font-family:'Times New Roman', serif">the test is requested by a specialist or consultant physician to determine if requirements relating to </span><span style="font-family:'Times New Roman', serif; font-style:italic">NTRK</span><span style="font-family:'Times New Roman', serif"> gene fusion status for access to a tropomyosin receptor kinase (Trk) inhibitor under the Pharmaceutical Benefits Scheme are fulfilled</span></p><p class="Tabletext1" style="margin-bottom:6pt; line-height:115%; font-size:11pt"><span style="font-family:'Times New Roman', serif">This item cannot be claimed if item</span><span style="font-family:'Times New Roman', serif"> </span><span style="font-family:'Times New Roman', serif">73430 has been claimed for the same patient during the same cancer diagnosis</span></p><p class="Tabletext1" style="margin-bottom:6pt; line-height:115%; font-size:11pt"><span style="font-family:'Times New Roman', serif">Applicable only once per cancer diagnosis</span></p></td><td style="width:20.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext1" style="margin-bottom:6pt; text-align:right; line-height:115%; font-size:11pt"><span style="font-family:'Times New Roman', serif">1,000.00</span></p></td></tr><tr><td style="width:15.38%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p><span>73436</span></p></td><td style="width:64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p><span>A test of tumour tissue from a patient with a new diagnosis of non</span><span>‑</span><span>small cell lung cancer requested by, or on behalf of, a specialist or consultant physician, if the test is:</span></p><p style="margin-top:2pt; margin-left:17.15pt; margin-bottom:6pt; text-indent:-17.15pt; line-height:11.5pt"><span>(a)</span><span style="width:4.94pt; text-indent:0pt; display:inline-block"> </span><span>for MET proto-oncogene, receptor tyrosine kinase (MET) exon 14 skipping alterations (METex14sk) status to determine eligibility for access to a</span><span style="font-style:italic"> </span><span>relevant treatment under the Pharmaceutical Benefits Scheme; and</span></p><p style="margin-top:2pt; margin-left:17.15pt; margin-bottom:6pt; text-indent:-17.15pt; line-height:11.5pt"><span>(b)</span><span style="width:4.32pt; text-indent:0pt; display:inline-block"> </span><span>not associated with a service to which item 73437 or 73438 applies</span></p></td><td style="width:20.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext1" style="margin-bottom:6pt; text-align:right; line-height:115%; font-size:11pt"><span style="font-family:'Times New Roman', serif">397.35</span></p></td></tr><tr><td style="width:15.38%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:3pt; margin-bottom:3pt; line-height:115%"><span>73437</span></p></td><td style="width:64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:6pt; line-height:12pt"><span>A nucleic acid</span><span>‑</span><span>based multi</span><span>‑</span><span>gene panel test of tumour tissue from a patient with a new diagnosis of non</span><span>‑</span><span>small cell lung cancer requested by, or on behalf of, a specialist or consultant physician, if the test is:</span></p><p class="Item" style="margin-left:17.85pt; text-indent:-17.85pt"><span>(a)</span><span style="width:5.64pt; text-indent:0pt; display:inline-block"> </span><span>to detect variants in at least EGFR, BRAF, KRAS and MET exon 14 to determine eligibility for a</span><span style="font-style:italic"> </span><span>relevant treatment under the Pharmaceutical Benefits Scheme; and</span></p><p style="margin-top:4pt; margin-left:17.85pt; text-indent:-17.85pt; line-height:normal"><span>(b)</span><span style="width:5.02pt; text-indent:0pt; display:inline-block"> </span><span>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</span></p><p style="margin-top:4pt; margin-left:17.85pt; text-indent:-17.85pt; line-height:normal"><span>(c)</span><span style="width:5.64pt; text-indent:0pt; display:inline-block"> </span><span>not associated with a service to which item 73438, 73439, 73337, 73341, 73344, 73436 or 73351 applies</span></p></td><td style="width:20.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext1" style="margin-bottom:6pt; text-align:right; line-height:115%; font-size:11pt"><span style="font-family:'Times New Roman', serif">1,247.00</span></p></td></tr><tr><td style="width:15.38%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:3pt; margin-bottom:3pt; line-height:115%"><span>73438</span></p></td><td style="width:64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:6pt; line-height:12pt"><span>A DNA</span><span>‑</span><span>based multi</span><span>‑</span><span>gene panel test of tumour tissue from a patient with a new diagnosis of non</span><span>‑</span><span>small cell lung cancer requested by, or on behalf of, a specialist or consultant physician, if the test is:</span></p><p style="margin-top:4pt; margin-left:17.85pt; text-indent:-17.85pt; line-height:normal"><span>(a)</span><span style="width:5.64pt; text-indent:0pt; display:inline-block"> </span><span>to detect variants in at least EGFR, BRAF, KRAS and MET exon 14; and</span></p><p style="margin-top:4pt; margin-left:17.85pt; text-indent:-17.85pt; line-height:normal"><span>(b)</span><span style="width:5.02pt; text-indent:0pt; display:inline-block"> </span><span>to determine eligibility for a relevant treatment under the Pharmaceutical Benefits Scheme; and</span></p><p style="margin-top:4pt; margin-left:17.85pt; text-indent:-17.85pt; line-height:normal"><span>(c)</span><span style="width:5.64pt; text-indent:0pt; display:inline-block"> </span><span>not associated with a service to which item 73437, 73337, 73436 or 73351 applies</span></p></td><td style="width:20.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext1" style="margin-bottom:6pt; text-align:right; line-height:115%; font-size:11pt"><span style="font-family:'Times New Roman', serif">682.35</span></p></td></tr><tr><td style="width:15.38%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:3pt; margin-bottom:3pt; line-height:115%"><span>73439</span></p></td><td style="width:64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p style="margin-top:6pt; line-height:12pt"><span>A nucleic acid</span><span>‑</span><span>based multi</span><span>‑</span><span>gene panel test of tumour tissue from a patient with a new diagnosis of non</span><span>‑</span><span>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:</span></p><p style="margin-top:4pt; margin-left:17.85pt; text-indent:-17.85pt; line-height:normal"><span>(a)</span><span style="width:5.64pt; text-indent:0pt; display:inline-block"> </span><span>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</span></p><p style="margin-top:4pt; margin-left:17.85pt; text-indent:-17.85pt; line-height:normal"><span>(b)</span><span style="width:5.02pt; text-indent:0pt; display:inline-block"> </span><span>not associated with a service to which item 73437, 73341, 73344 or 73351 applies</span></p></td><td style="width:20.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext1" style="margin-bottom:6pt; text-align:right; line-height:115%; font-size:11pt"><span style="font-family:'Times New Roman', serif">682.35</span></p></td></tr></tbody></table>

Source text: opening excerpt

Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.

1. Name of Determination 1. Name of Determination

1. Name of Determination

This Determination is the Health Insurance (Section 3C Co‑Dependent Pathology Services) Determination 2018.

3. Authority 3. Authority

3. Authority

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

5. Definitions 5. Definitions

5. Definitions

(1) In this Determination:

Act means the Health Insurance Act 1973.

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

6. Treatment of relevant services 6. Treatment of relevant services

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 P2, 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.

Compliance with the Determination requires operational alignment across clinicians, pathology laboratories, billing teams and administrators. The following practical steps follow directly from the Determination’s text and the Schedule conditions.

Confirm service is a “relevant service” and clinically relevant. The statutory treatment in s 6 applies only to a “relevant service, provided in accordance with this Determination and as a clinically relevant service” (s 6(1)). Providers should ensure that the test requested meets the clinical purpose language in the relevant Schedule item, for example that it is intended “to determine eligibility for a relevant treatment under the Pharmaceutical Benefits Scheme” where that wording appears.
Ensure the requester is authorised. Where an item requires the test to be “requested by a specialist or consultant physician”, obtain and retain the signed or otherwise documented request from an appropriately credentialed specialist or consultant physician. Where the Schedule allows a request “on the advice of” a specialist who manages the patient, ensure that advice is recorded and linked to the request.
Check item‑specific conditions before claiming. For each patient, verify the relevant Schedule item number and its descriptive conditions, including pre‑requisites (for instance, whether tumour tissue testing is not feasible), gene lists to be tested, and whether the test is DNA‑ or RNA‑based, or an ISH/FISH/NGS assay. Align the laboratory method and report to the item’s technical description before lodging the claim.
Track frequency limits. Implement patient‑level tracking for items with limits such as “Applicable once per lifetime”, “Applicable once per primary tumour diagnosis”, or “Applicable only once per cancer diagnosis”. Billing systems should check a patient’s prior claim history for the same diagnosis before they accept a new claim under the item.
Reconcile cross‑item exclusivity. Where Schedule items are mutually exclusive for the same diagnosis (for example the NTRK FISH item 73430 and the NGS item 73433), establish pre‑claim checks to ensure that the claim is not disallowed because a mutually exclusive item has previously been claimed. This requires diagnosis episode linking and a consistent approach to diagnosis dates.
Map item numbers and fees into billing systems. Section 6 treats the Schedule items “as if” they were items in Groups P2, P5 or P7 with fees specified in Schedule 1 (s 6(1)(b)). Billing platforms must therefore map the Schedule item numbers and fees to the pathology services table processing logic used by Medicare claim systems. Note the Determination specifies a fee in Schedule 1 that is to be treated for each State (s 6(1)(b)(ii)), so billing rules should apply the Schedule fee uniformly across States.
Maintain documentary evidence to support claims. Although the Determination does not prescribe record‑keeping standards, providers will face audits under the Health Insurance Act’s “relevant provisions”. Keep copies of specialist requests, clinic letters showing PBS eligibility intent, pathology reports showing technical conformity with the item description, and a log of prior tests or claims pertinent to frequency limits.
Train clinical and administrative staff. Educate specialists, ordering clinicians, pathology staff and billing officers about the Determination’s conditions, the need for specialist requests, frequency limits, and mutual exclusivity rules. Misunderstandings at the ordering or billing stage are a common cause of improper claims.
Establish a process to reconcile clinical ambiguity. For items that hinge on clinical definitions (for example stage descriptors such as FIGO III‑IV), set up a review pathway so that claims with genuine clinical ambiguity are escalated to a named clinical reviewer who can document the clinical basis for the item claim.
Monitor legislative and PBS changes. Section 5(2) makes clear that references to other provisions are dynamic. Regularly monitor amendments to the Health Insurance Act, the pathology services table, and PBS listing or eligibility rules. Changes to PBS listings can alter whether a given test is being used to determine eligibility for a listed treatment, which in turn affects whether the Determination’s treatment applies.
Seek clarification where necessary. For areas of uncertainty , for example, how to treat hybrid situations where a test is partially for PBS eligibility and partially for other clinical reasons , engage with Medicare/Departmental advice channels before lodging high‑risk claims. A proactive clarification can reduce audit exposure.
Coordinate with external laboratories and referral centres. For genetic and multi‑gene panels, ensure the laboratory performing the assay understands the item criteria. If tests are performed by external referral labs, agreements should allocate responsibility for ensuring the assay method and reporting meet the item description, and for attaching the correct item number and fee to the claim.

These steps flow directly from the Determination’s operative provisions and the Schedule. Compliance is achieved by aligning clinical ordering practices, documentation, laboratory method and reporting, billing system mapping, and patient history checks with the specific item requirements found in Schedule 1 and the statutory treatment rule in s 6.

Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018

Plain English Summary

Deep Dive

What it does

Current sections

1. Name of Determination

1. Name of Determination

3. Authority

3. Authority

5. Definitions

5. Definitions

6. Treatment of relevant services

6. Treatment of relevant services

Relevant Services

Schedule 1 – Relevant Services

Source text: opening excerpt

1. Name of Determination 1. Name of Determination

1. Name of Determination

3. Authority 3. Authority

3. Authority

5. Definitions 5. Definitions

5. Definitions

6. Treatment of relevant services 6. Treatment of relevant services

6. Treatment of relevant services

Main concepts

Who it affects

Key duties and rights

Penalties and enforcement

How it interacts with other laws

Amendment history

Litigation history

Gotchas

How to comply

Schedule 1 Relevant Services

Schedule 1 – Relevant Services