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Determinations/Health as amended, taking into account amendments up to Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination (No.2) 2019
This determination prescribes a table of Medicare Benefits Schedule pathology items that can be provided to patients for specified genetic testing to determine eligibility for medications subsidised under the Pharmaceutical Benefits Scheme, known as co-dependent items.
Administered by: Health
Registered 26 Apr 2019
Start Date 01 Mar 2019
End Date 31 Oct 2019
Table of contents.

Commonwealth Coat of Arms of Australia

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

made under subsection 3C(1) of the

Health Insurance Act 1973

Compilation No. 4

Compilation date:                              1 March 2019

Includes amendments up to:            Health Insurance (Section 3C Co‑Dependent                                                            Pathology Services) Amendment Determination                                                       (No.2) 2019

 

About this compilation

This compilation

This is a compilation of the Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018 that shows the text of the law as amended and in force on 1 March 2019 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Editorial changes

For more information about any editorial changes made in this compilation, see the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.

Self‑repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

  

  

  


Contents

1.                            Name of Determination                                                                                     1

3.                            Authority                                                                                                                          1

5.                            Definitions                                                                                                                        1

6.                            Treatment of relevant services                                                                    1

Schedule 1 – Relevant Services                                                                                                   3

Endnotes                                                                                                                                                                 6

Endnote 1—About the endnotes                                                                                                        6

Endnote 2—Abbreviation key                                                                                                            7

Endnote 3—Legislation history                                                                                                         8

Endnote 4—Amendment history                                                                                                       9


1.       Name of Determination

This Determination is the Health Insurance (Section 3C Co‑Dependent Pathology Services) Determination 2018.

3.       Authority

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

5.       Definitions

(1)     In this Determination:

Act means the Health Insurance Act 1973.

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.

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 a Schedule to this Determination.

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

·         clinically relevant service

·         pathology services table

·         item

·         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.

6.       Treatment of relevant services

(1)     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 pathology service; and

(b)     there were an item in Groups P5 or P7 of the pathology services table that:

(i)  related to the service; and

(i)  specified for the service a fee in relation to each State, being the fee specified in Schedule 1 in relation to the service.


Schedule 1 – Relevant Services

 

Group P5—Tissue pathology

Item

Description

Fee ($)

72814

Immunohistochemical examination by immunoperoxidase or other labelled antibody techniques using the programmed cell death ligand 1 (PD‑L1) antibody of tumour material from a patient diagnosed with non‑small cell lung cancer, to determine if the requirements relating to PD‑L1 status for access to pembrolizumab under the Pharmaceutical Benefits Scheme are fulfilled.

    74.50

 

 

 

 

 

 

Group P7—Genetics

Item

Description

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

73332

An in situ hybridisation (ISH) test of tumour tissue from a patient with breast cancer 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 human epidermal growth factor receptor 2 (HER2) gene amplification for access to trastuzumab under the Pharmaceutical Benefits Scheme or the Herceptin Program are fulfilled.

315.40

73336

A test of tumour tissue from a patient with unresectable stage III or stage IV metastatic cutaneous melanoma, requested by, or on behalf of, a specialist or consultant physician, to determine if the requirements relating to BRAF V600 mutation status for access to dabrafenib or vemurafenib under the Pharmaceutical Benefits Scheme are fulfilled

230.95

73337

A test of tumour tissue from a patient diagnosed with non‑small cell lung cancer, shown to have non‑squamous histology or histology not otherwise specified, requested by, or on behalf of, a specialist or consultant physician, to determine if the requirements relating to epidermal growth factor receptor (EGFR) gene status for access to erlotinib, gefitinib or afatinib under the Pharmaceutical Benefits Scheme are fulfilled

397.35

73338

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 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.

362.60

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, ceritinib or alectinib under the Pharmaceutical Benefits Scheme are fulfilled.

400.00

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

73343

Detection of 17p chromosomal deletions by fluorescence in situ hybridisation, in a patient with relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma, on a peripheral blood or bone marrow sample, requested by a specialist or consultant physician, to determine if the requirements for access to idelalisib, ibrutinib or venetoclax under the Pharmaceutical Benefits Scheme are fulfilled.

230.95

73344

Fluorescence in situ hybridization (FISH) test of tumour tissue from a patient with locally advanced or metastatic non‑small‑cell lung cancer (NSCLC), which is of non‑squamous histology or histology not otherwise specified, with documented evidence of ROS proto‑oncogene 1 (ROS1)  immunoreactivity by immunohistochemical (IHC) examination giving a staining intensity score of 2+ or 3+; and with documented absence of both activating mutations of the epidermal growth factor receptor (EGFR) gene and anaplastic lymphoma kinase (ALK) immunoreactivity by IHC, requested by a specialist or consultant physician to determine if requirements relating to ROS1 gene rearrangement status for access to crizotinib under the Pharmaceutical Benefits Scheme are fulfilled.

400.00

73351

A test of tumour tissue that is derived from a new sample from a patient with locally advanced (Stage IIIb) or metastatic (Stage IV) non‑small cell lung cancer (NSCLC), who has progressed on or after treatment with an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI). The test is to be requested by a specialist or consultant physician, to determine if the requirements relating to EGFR T790M gene status for access to osimertinib under the Pharmaceutical Benefits Scheme are fulfilled.

397.35

 


Endnotes

Endnote 1—About the endnotes

The endnotes provide information about this compilation and the compiled law.

The following endnotes are included in every compilation:

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Abbreviation key—Endnote 2

The abbreviation key sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history—Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.

The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.

Editorial changes

The Legislation Act 2003 authorises First Parliamentary Counsel to make editorial and presentational changes to a compiled law in preparing a compilation of the law for registration. The changes must not change the effect of the law. Editorial changes take effect from the compilation registration date.

If the compilation includes editorial changes, the endnotes include a brief outline of the changes in general terms. Full details of any changes can be obtained from the Office of Parliamentary Counsel.

Misdescribed amendments

A misdescribed amendment is an amendment that does not accurately describe the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation “(md)” added to the details of the amendment included in the amendment history.

If a misdescribed amendment cannot be given effect as intended, the abbreviation “(md not incorp)” is added to the details of the amendment included in the amendment history.

 

Endnote 2—Abbreviation key

 

A = Act

o = order(s)

ad = added or inserted

Ord = Ordinance

am = amended

orig = original

amdt = amendment

par = paragraph(s)/subparagraph(s)

c = clause(s)

    /sub‑subparagraph(s)

C[x] = Compilation No. x

pres = present

Ch = Chapter(s)

prev = previous

def = definition(s)

(prev…) = previously

Dict = Dictionary

Pt = Part(s)

disallowed = disallowed by Parliament

r = regulation(s)/rule(s)

Div = Division(s)

Reg = Regulation/Regulations

exp = expires/expired or ceases/ceased to have

reloc = relocated

    effect

renum = renumbered

F = Federal Register of Legislative Instruments

rep = repealed

gaz = gazette

rs = repealed and substituted

LI = Legislative Instrument

s = section(s)/subsection(s)

LIA = Legislative Instruments Act 2003

Sch = Schedule(s)

(md) = misdescribed amendment can be given

Sdiv = Subdivision(s)

    effect

SLI = Select Legislative Instrument

(md not incorp) = misdescribed amendment

SR = Statutory Rules

    cannot be given effect

Sub‑Ch = Sub‑Chapter(s)

mod = modified/modification

SubPt = Subpart(s)

No. = Number(s)

underlining = whole or part not

 

    commenced or to be commenced

 

Endnote 3—Legislation history

 

Name

Registration

Commencement

Application, saving and transitional provisions

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

21 June 2018 (F2018L00810)

1 July 2018

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

26 October 2018 (F2018L01473)

1 November 2018

Health Insurance (Section 3C Co‑Dependent Pathology Services) Amendment Determination (No.2) 2018

30 October 2018 (F2018L01505)

1 November 2018

Health Insurance (Section 3C Co‑Dependent Pathology Services) Amendment Determination (No. 3) 2018

17 December 2018 (F2018L01776)

1 January 2019

Health Insurance (Section 3C Co‑Dependent Pathology Services) Amendment Determination 2019

17 January 2019 (F2019L00044)

1 February 2019

Health Insurance (Section 3C Co‑Dependent Pathology Services) Amendment Determination (No.2) 2019

22 February 2019 (F2019L00174)

1 March 2019

 

Endnote 4—Amendment history

 

Provision affected

How affected

s 2........................................

rep LA s 48D

s 4........................................

rep LA s 48C

s 6........................................

am F2018L01505

Schedule 1

 

Schedule 1...........................

ad F2018L01473

 

rs F2018L01505

 

am F2018L01776; F2019L00044; F2019L00174