Health Insurance (Pharmacogenetic Testing – RAS (KRAS and NRAS)) Determination 2014
I, KIRSTY FAICHNEY, delegate of the Minister for Health, make this Determination under subsection 3C(1) of the Health Insurance Act 1973.
Dated 17 December 2014
ACTING FIRST ASSISTANT SECRETARY
MEDICAL BENEFITS DIVISION
1. Name of Determination 3
2. Commencement 3
3. Authority 3
4. Revocation 3
5. Interpretation 3
6. Treatment of a relevant service 4
SCHEDULE – SPECIFIED HEALTH SERVICES 5
Part 1 Preliminary
1. Name of Determination
This Determination is the Health Insurance (Pharmacogenetic Testing – RAS (KRAS and NRAS)) Determination 2014.
This Determination commences on 1 January 2015.
This Determination is made under the Health Insurance Act 1973.
The Health Insurance (Pharmacogenetic Testing Kirsten ras (KRAS)) Determination 2014 is revoked.
(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.
6. 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 ($)
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 (PBS) 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.
Note Subsection 3C(7) of the Act deems an internal territory to form part of the State of New South Wales.