Federal Register of Legislation - Australian Government

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Determinations/Health as made
This instrument amends the Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018 by introducing four new items, including three new items for fluorescence in-situ hybridisation (FISH) testing and one new item for next generation sequencing (NGS) testing, for the evaluation of neurotrophic receptor tyrosine kinase (NTRK) gene fusion status in paediatric patients and adult patients to determine the patient’s eligibility for treatment with larotrectinib under the Pharmaceutical Benefits Scheme.
Administered by: Health and Aged Care
Registered 30 Jun 2022
Tabling HistoryDate
Tabled HR26-Jul-2022
Tabled Senate26-Jul-2022
Date of repeal 26 Oct 2022
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003
Table of contents.

Commonwealth Coat of Arms of Australia

 

Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination (No. 3) 2022

I, Travis Haslam, delegate of the Minister for Health and Aged Care, make the following Determination.

Dated               29 June 2022

Travis Haslam

Acting First Assistant Secretary

Medical Benefits Division

Health Resourcing Group

Department of Health

 

 

 


Contents

1  Name........................................................................................................................................ 1

2  Commencement........................................................................................................................ 1

3  Authority.................................................................................................................................. 1

4  Schedules................................................................................................................................. 1

Schedule 1— Amendments.......................................................................................................... 2

 

 


1  Name

                        This instrument is the Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination (No. 3) 2022.

2  Commencement

(1)       Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  The whole of this instrument

1 July 2022.

 

                Note:        This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2)       Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

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

4  Schedules

                        Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.


 

Schedule 1— Amendments

Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018

1.     Schedule 1 (after item 73351)

Insert:

73430

Fluorescence in-situ hybridisation (FISH) test of tumour tissue from a patient with locally advanced or metastatic solid tumour, if:

(a)     the tumour is at risk of being caused by a neurotrophic receptor tyrosine kinase (NTRK) gene fusion as determined by either:

                       (i)        occurring in a child less than 18 years of age; or

                      (ii)        being mammary analogue secretory carcinoma of the salivary gland; or

                    (iii)        being secretory breast carcinoma; and

(b)     the test is requested by a specialist or consultant physician to determine if requirements relating to NTRK gene fusion status for access to a tropomyosin receptor kinase (Trk) inhibitor under the Pharmaceutical Benefits Scheme are fulfilled

This item cannot be claimed if item 73433 has been claimed for the same patient during the same cancer diagnosis

Applicable only once per cancer diagnosis

400.00

73431

Two tests described in item 73430

533.00

73432

Three or more tests described in item 73430

667.00

73433

Next generation sequencing (NGS) test for neurotrophic receptor tyrosine kinase (NTRK1, NTRK2, NTRK3) fusions by RNA or DNA in tumour tissue from a patient with locally advanced or metastatic solid tumour, if:

(a)     the tumour is at risk of being caused by an NTRK gene fusion as determined by either:

                       (i)        occurring in a child less than 18 years of age; or

                      (ii)        being mammary analogue secretory carcinoma of the salivary gland; or

                    (iii)        being secretory breast carcinoma;

(b)     the test is requested by a specialist or consultant physician to determine if requirements relating to NTRK gene fusion status for access to a tropomyosin receptor kinase (Trk) inhibitor under the Pharmaceutical Benefits Scheme are fulfilled

This item cannot be claimed if item 73430 has been claimed for the same patient during the same cancer diagnosis

Applicable only once per cancer diagnosis

1,000.00