Health Insurance (Section 3C Pathology Services— Cystic fibrosis gene testing) Determination 2018 (Cth)
Health Insurance (Section 3C Pathology Services—Cystic fibrosis gene testing) Determination 2018
made under subsection 3C(1) of the
Health Insurance Act 1973
Compilation No. 1
Compilation date: 1 January 2020
Includes amendments up to: F2019L01484
Registered: 16 January 2020
About this compilation
This compilation
This is a compilation of the Health Insurance (Section 3C Pathology Services—Cystic fibrosis gene testing) Determination 2018 that shows the text of the law as amended and in force on 1 January 2020 (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 ( 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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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
3. Authority
4. Definitions
5. Treatment of relevant services
6. Application of provisions
Schedule 1 – relevant services
Endnotes
Endnote 3—Legislation history
Endnote 4—Amendment history
1. Name of Determination
This Determination is the Health Insurance (Section 3C Pathology Services— Cystic fibrosis gene testing) Determination 2018.
3. Authority
This Determination is made under subsection 3C(1) of the Health Insurance Act 1973.
4. Definitions
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 that Act, relating to pathology services, professional services or items.
relevant service means a health service, as defined in subsection 3C(8) of the Act, that is specified in the Schedule.
Schedule means the 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.
5. Treatment of relevant services
For subsection 3C(1) of the Act:
(a) 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:
(i)it were both a professional service and a pathology service; and
(ii)there were an item in Group P7 of the pathology services table that:
(A)related to the service; and
(B)specified for the service a fee in relation to each State, being the fee specified in the Schedule in relation to the service.
6. Application of provisions
For any particular patient, item 73345, 73347, 73348 and 73349 is applicable not more than once in a lifetime.
For any particular patient, item 73346 and 73350 is applicable not more than once in a pregnancy.
The testing laboratory used to undertake tests for items 73345, 73346, 73347, 73348, 73349 and 73350 must use a cystic fibrosis transmembrane conductance regulator methodology appropriate to the clinical setting with:
(a) sufficient diagnostic range and sensitivity to detect at least 95% of pathogenic cystic fibrosis transmembrane conductance regulator variants likely to be present in the patient; and
(b) with at least 25 of the most frequently encountered cystic fibrosis transmembrane conductance regulator variants in the Australian population.
Schedule 1 – relevant services
| Group P7—Genetics | ||
| Item | Service | Fee ($) |
| 73345 | Testing of a patient for pathogenic cystic fibrosis transmembrane conductance regulator variants for the purpose of investigating, making or excluding a diagnosis of cystic fibrosis or a cystic fibrosis transmembrane conductance regulator related disorder when requested by a specialist or consultant physician who manages the treatment of the patient, not being a service associated with a service to which item 73347, 73348, or 73349 applies. The patient must have clinical or laboratory findings suggesting there is a high probability suggestive of cystic fibrosis or a cystic fibrosis transmembrane conductance regulator related disorder. | 500.00 |
| 73346 | Testing of a pregnant patient whose carrier status for pathogenic cystic fibrosis transmembrane conductance regulator variants, as well as their reproductive partner carrier status is unknown, for the purpose of determining whether pathogenic cystic fibrosis transmembrane conductance regulator variants are present in the fetus, in order to make or exclude a diagnosis of cystic fibrosis or a cystic fibrosis transmembrane conductance regulator related disorder in the fetus when requested by a specialist or consultant physician who manages the treatment of the patient, not being a service associated with a service to which item 73350 applies. The fetus must have ultrasonic findings of echogenic gut, with unknown familial cystic fibrosis transmembrane conductance regulator variants. | 500.00 |
| 73347 | Testing of a prospective parent for pathogenic cystic fibrosis transmembrane conductance regulator variants for the purpose of determining the risk of their fetus having pathogenic cystic fibrosis transmembrane conductance regulator variants. This is indicated when the fetus has ultrasonic evidence of echogenic gut when requested by a specialist or consultant physician who manages the treatment of the patient, not being a service associated with a service to which item 73345, 73348, or 73349 applies. | 500.00 |
| 73348 | Testing of a patient with a laboratory-established family history of pathogenic cystic fibrosis transmembrane conductance regulator variants, for the purpose of determining whether the patient is an asymptomatic genetic carrier of the pathogenic cystic fibrosis transmembrane conductance regulator variants that have been laboratory established in the family history, not being a service associated with a service to which item 73345, 73347, or 73349 applies. The patient must have a positive family history, confirmed by laboratory findings of pathogenic cystic fibrosis transmembrane conductance regulator variants, with a personal risk of being a heterozygous genetic carrier of at least 6%. (This includes family relatedness of: parents, children, full-siblings, half-siblings, grand-parents, grandchildren, aunts, uncles, first cousins, and first cousins once-removed, but excludes relatedness of second cousins or more distant relationships). | 250.00 |
| 73349 | Testing of a patient for pathogenic cystic fibrosis transmembrane conductance regulator variants for the purpose of determining the reproductive risk of the patient with their reproductive partner because their reproductive partner is already known to have pathogenic cystic fibrosis transmembrane conductance regulator variants requested by a specialist or consultant physician who manages the treatment of the patient, not being a service associated with a service to which item 73345, 73347, or 73348 applies. | 500.00 |
| 73350 | Testing of a pregnant patient, where one or both prospective parents are known to be a genetic carrier of pathogenic cystic fibrosis transmembrane conductance regulator variants for the purpose of determining whether pathogenic cystic fibrosis transmembrane conductance regulator variants are present in the fetus in order to make or exclude a diagnosis of cystic fibrosis or a cystic fibrosis transmembrane conductance regulator related disorder in the fetus, when requested by a specialist or consultant physician who manages the treatment of the patient, not being a service associated with a service to which item 73346 applies. The fetus must be at 25% or more risk of cystic fibrosis or a cystic fibrosis transmembrane conductance regulator related disorder because of known familial cystic fibrosis transmembrane conductance regulator variants. | 250.00 |
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
| ad = added or inserted | o = order(s) |
| am = amended | Ord = Ordinance |
| amdt = amendment | orig = original |
| c = clause(s) | par = paragraph(s)/subparagraph(s) |
| C[x] = Compilation No. x | /sub‑subparagraph(s) |
| Ch = Chapter(s) | pres = present |
| def = definition(s) | prev = previous |
| Dict = Dictionary | (prev…) = previously |
| disallowed = disallowed by Parliament | Pt = Part(s) |
| Div = Division(s) | r = regulation(s)/rule(s) |
| ed = editorial change | reloc = relocated |
| exp = expires/expired or ceases/ceased to have | renum = renumbered |
| effect | rep = repealed |
| F = Federal Register of Legislation | rs = repealed and substituted |
| gaz = gazette | s = section(s)/subsection(s) |
| LA = Legislation Act 2003 | Sch = Schedule(s) |
| LIA = Legislative Instruments Act 2003 | Sdiv = Subdivision(s) |
| (md) = misdescribed amendment can be given | SLI = Select Legislative Instrument |
| effect | SR = Statutory Rules |
| (md not incorp) = misdescribed amendment | Sub‑Ch = Sub‑Chapter(s) |
| cannot be given effect | SubPt = Subpart(s) |
| mod = modified/modification | underlining = whole or part not |
| No. = Number(s) | commenced or to be commenced |
Endnote 3—Legislation history
| Name | Registration | Commencement | Application, saving and transitional provisions |
| Health Insurance (Section 3C Pathology Services—Cystic fibrosis gene testing) Determination 2018 | 12 June 2018 (F2018L00757) | 1 July 2018 (s 2) | |
| Health Insurance (Section 3C Pathology Services – Cystic fibrosis gene testing) Amendment Determination 2019 | 20 Nov 2019 (F2019L01484) | 1 Jan 2020 (s 2(1) item 1) | — |
Endnote 4—Amendment history
| Provision affected | How affected |
| s 2........................................... | rep LA 48D |
| Schedule 1 | |
| Schedule 1.............................. | am F2019L01484 |
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