Health Insurance (Pharmacogenetic Testing – Human Epidermal Growth Factor Receptor 2) Determination 2015 (Cth)

Health Insurance (Pharmacogenetic Testing – Human Epidermal Growth Factor Receptor 2) Determination 2015

I, MARIA JOLLY, delegate of the Minister for Health, make this Determination under subsection 3C(1) of the Health Insurance Act 1973.

Dated         8 December 2015

__________________________

MARIA JOLLY
FIRST ASSISTANT SECRETARY
MEDICAL BENEFITS DIVISION

Contents

1.Name of Determination  3

2.Commencement  3

3.Authority  3

4.Interpretation  3

5.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 – Human Epidermal Growth Factor Receptor 2) Determination 2015.

1. Commencement

This Determination commences on 1 January 2016.

3.           Authority

This Determination is made under the Health Insurance Act 1973.

4.           Interpretation

(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 in the 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 the Schedule to this Determination.

NoteUnless 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 were 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

Item	Description	Fee($)
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