Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination (No.2) 2018 (Cth)

Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination (No. 2) 2018

I, CELIA STREET, delegate of the Minister for Health, make the following determination.

Dated        30 October 2018

Celia Street

Assistant Secretary

Diagnostic Imaging and Pathology Branch

Medical Benefits Division

Department of Health

Contents

1.Name  3

2.Commencement  3

3.Authority  3

4.Schedules  3

Schedule      1 – Amendments   4

1. Name

This instrument is the Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination (No.2) 2018.

1. Commencement

(1)     Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information
Column 1	Column 2	Column 3
Provisions	Commencement	Date/Details
1.  The whole of this instrument	Immediately after the Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination 2018.

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

1. Authority

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

1. Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1 – Amendments

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

1. Paragraph (6)(b)

Repeal and substitute:

(b)   there were an item in Groups P5 or P7 of the pathology services table that:

(i)         related to the service; and

(ii)       specified for the service a fee in relation to each State, being the fee specified in Schedule 1 in relation to the service.

1. Schedule 1 (below the heading)

Repeal and substitute:

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 non-small cell lung cancer, to determine if the requirements relating to PD-L1 status for access to pembrolizumab under the Pharmaceutical Benefits Scheme are fulfilled.			74.50

Group P7—Genetics
Item	Description	Fee ($)
73295	Detection of germline BRCA1 or BRCA2 gene mutations, in a patient with platinum-sensitive relapsed ovarian, fallopian tube or primary peritoneal cancer with high grade serous features or a high grade serous component, and who has responded to subsequent platinum-based chemotherapy, requested by a specialist or consultant physician, to determine whether the eligibility criteria for olaparib under the Pharmaceutical Benefits Scheme are fulfilled. Maximum of one test per patient’s lifetime		1,200.00
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 unresectable 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 or vemurafenib under the Pharmaceutical Benefits Scheme are fulfilled		230.95
73337	A test of tumour tissue from a patient diagnosed with non-small cell lung cancer, shown to have non-squamous histology or histology not otherwise specified, requested by, or on behalf of, a specialist or consultant physician, to determine if the requirements relating to epidermal growth factor receptor (EGFR) gene status for access to erlotinib, gefitinib or afatinib under the Pharmaceutical Benefits Scheme are fulfilled		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 the requirements relating to rat sarcoma oncogene (RAS) gene mutation status for access to cetuximab or panitumumab under the Pharmaceutical Benefits Scheme are fulfilled, if: (a) the test is conducted for all clinically relevant mutations on KRAS exons 2, 3 and 4 and NRAS exons 2, 3, and 4; or (b) a RAS mutation is found.		362.60
73341	Fluorescence in situ hybridisation (FISH) test of tumour tissue from a patient with locally advanced or metastatic non-small cell lung cancer, which is of non-squamous histology or histology not otherwise specified, with documented evidence of anaplastic lymphoma kinase (ALK) immunoreactivity by immunohistochemical (IHC) examination giving a staining intensity score > 0, and with documented absence of activating mutations of the epidermal growth factor receptor (EGFR) gene, requested by a specialist or consultant physician to determine if requirements relating to ALK gene rearrangement status for access to crizotinib, ceritinib or alectinib under the Pharmaceutical Benefits Scheme are fulfilled.		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
73343	Detection of 17p chromosomal deletions by fluorescence in situ hybridisation, in a patient with relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma, on a peripheral blood or bone marrow sample, requested by a specialist or consultant physician, to determine if the requirements for access to idelalisib or ibrutinib under the Pharmaceutical Benefits Scheme are fulfilled.		230.95