Health Insurance (ALK Gene Testing) Determination 2017 (Cth)

Health Insurance (ALK Gene Testing) Determination 2017

I, MICHAEL RYAN, delegate of the Minister for Health and Aged Care, make this Determination under subsection 3C(1) of the Health Insurance Act 1973. 

Dated    17 January 2017

MICHAEL RYAN

ACTING ASSISTANT SECRETARY

MEDICAL SPECIALIST SERVICES BRANCH

MEDICAL BENEFITS DIVISION

DEPARTMENT OF HEALTH

Contents

1.           Name of Determination

2.           Commencement

3.           Authority

4.           Definitions

5.           Treatment of relevant services

Schedule 1 – relevant services

Schedule 2 – repeals

Part 1

1. Name of Determination

This Determination is the Health Insurance (ALK Gene Testing) Determination 2017.

1. Commencement

This Determination commences on 1 February 2017.

1. Authority

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

1. Definitions

1. In this Determination:

Act means the Health Insurance Act 1973.

Pharmaceutical Benefits Scheme means the scheme for the supply of pharmaceutical benefits established under Part VII of the National Health Act 1953.

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.

Schedule means a Schedule to this Determination.

Note:       The following terms are defined in subsection 3(1) of the Act:

·clinically relevant service

·item

·pathology services table

·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.

1. Treatment of relevant services

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 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 for the service a fee in relation to each State, being the fee specified in the Schedule in relation to the service.

Schedule 1 – relevant services

Group P7—Genetics
Item	Service	Fee ($)
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 or ceritinib under the Pharmaceutical Benefits Scheme (PBS) are fulfilled.	400.00

Schedule 2 – repeals

Health Insurance (ALK Gene Testing) Determination 2015

1. The whole of the regulation

Repeal the regulation.