Health Insurance (Section 3C Pathology Services BRCA Gene Testing No.2) Determination 2017 (Cth)

Health Insurance (Section 3C Pathology Services – BRCA Gene Testing No.2) Determination 2017

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

Dated           27 September 2017

CELIA STREET

Assistant Secretary

Primary Care Analytics and Pathology Branch

Medical Benefits Division

Department of Health

Contents

1.           Name of Determination

2.           Commencement

3.           Authority

4.           Definitions

5.           Treatment of relevant services

6.           Repeal

Schedule 1 – relevant services

1. Name of Determination

This Determination is the Health Insurance (Section 3C Pathology Services - BRCA Gene Testing No.2) Determination 2017.

1. Commencement

This Determination commences on 1 November 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.

1. Repeal

This Determination repeals the Health Insurance (BRCA Gene Testing) Determination 2017.

Schedule 1 – relevant services

Group P7—Genetics
Item	Service	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
73296	Characterisation of germline gene mutations, requested by a specialist or consultant physician, including copy number variation in BRCA1 and BRCA2 genes and one or more of the following genes STK11, PTEN, CDH1, PALB2, or TP53 in a patient with breast or ovarian cancer for whom clinical and family history criteria, as assessed by the specialist or consultant physician who requests the service using a quantitative algorithm, place the patient at >10% risk of having a pathogenic mutation identified in one or more of the genes specified above.	1,200.00
73297	Characterisation of germline gene mutations, requested by a specialist or consultant physician, including copy number variation in BRCA1 and BRCA2 genes and one or more of the following genes STK11, PTEN, CDH1, PALB2, or TP53 in a patient who is a biological relative of a patient who has had a pathogenic mutation identified in one or more of the genes specified above, and has not previously received a service under item 73296.	400.00