Health Insurance (ALK Gene Testing) Determination 2015
I, CATHERINE RULE, delegate of the Minister for Health, make this Determination under subsection 3C(1) of the Health Insurance Act 1973.
Dated 4 June 2015
FIRST ASSISTANT SECRETARY
MEDICAL BENEFITS DIVISION
1. Name of Determination 3
2. Commencement 3
3. Authority 3
4. Interpretation 3
5. Treatment of a relevant service 3
SCHEDULE – SPECIFIED HEALTH SERVICES 4
Part 1 Preliminary
1. Name of Determination
This Determination is the Health Insurance (ALK Gene Testing) Determination 2015.
This Determination commences on 1 July 2015.
This Determination is made under the Health Insurance Act 1973.
(1) In this Determination:
Act means the Health Insurance Act 1973.
relevant provision means a provision of the Act or of regulations made under the Act, or a provision of the National Health Act 1953 or of regulations made under that Act, that relates to professional services, medical services or items.
relevant service means a health service, as defined in subsection 3C(8)
of the Act, that is specified the Schedule to this Determination.
Note Unless the contrary intention appears, expressions used in this determination have the same meanings as in the Act—see section 13 of the Legislative Instruments Act 2003.
(2) Unless the contrary intention appears, in this Determination a reference to a provision of the Act or regulations made under the Act or the National Health Act 1953 or regulations made 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.
5. Treatment of a relevant service
A relevant service specified in the Schedule shall, for the purposes of each relevant provision, be treated as if:
(a) it were both a professional service and a medical service; and
(b) there was an item in Group P7 of the pathology services table that:
i. related to the service; and
ii. specified in respect of the service a fee in relation to each State being the fee specified in the Schedule.
SCHEDULE – SPECIFIED HEALTH SERVICES
Fee for all States ($)
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 under the Pharmaceutical Benefits Scheme (PBS) are fulfilled.
Note Subsection 3C(7) of the Act deems an internal territory to form part of the State of New South Wales.