Health Insurance (Section 3C Diagnostic Imaging Services – PET and Gallium-67 Services) Determination 2022 made under subsection 3C(1) of the Health Insurance Act 1973 Compilation No. 1 Compilation date: 24 September 2022 Includes amendments up to: F2022L01239 Registered: 13 October 2022 About this compilation This compilation This is a compilation of the Health Insurance (Section 3C Diagnostic Imaging Services – PET and Gallium-67 Services) Determination 2022 that shows the text of the law as amended and in force on 24 September 2022 (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 Self-repealing provisions If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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 2 Commencement 3 Authority 4 Definitions 5 Treatment of relevant services 6 Application of provisions of the diagnostic imaging services table 7 Restriction on items – services connected with provision of PET nuclear scanning during Gallium-67 interruptions 8 PET nuclear scanning services 9 PET nuclear scanning services—performance under personal supervision 10 PET nuclear scanning services—equipment 11 PET nuclear scanning services—statutory declaration Schedule 1 — Relevant services Endnotes Endnote 1—About the endnotes Endnote 2—Abbreviation key Endnote 3—Legislation history Endnote 4—Amendment history 1 Name This instrument is the Health Insurance (Section 3C Diagnostic Imaging Services – PET and Gallium-67 Services) Determination 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 August 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 Definitions (1) In this instrument: Act means the Health Insurance Act 1973. PET means positron emission tomography. (R) has the meaning given by clause 1.2.15 of the diagnostic imaging services table. 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. report means a report prepared by a medical practitioner. Schedule means a Schedule to this instrument. Note: The following terms are defined in subsection 3(1) of the Act:  clinically relevant service;  diagnostic imaging services table;  item; and  professional service. (2) Unless the contrary intention appears, a reference in this instrument 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 (1) For subsection 3C(1) of the Act, a relevant service, provided in accordance with this instrument 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 diagnostic imaging service; and (b) there were an item in the diagnostic imaging 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. 6 Application of provisions of the diagnostic imaging services table (1) Clause 1.2.17 of the diagnostic imaging services table shall have effect as if the items in Schedule 1 of this instrument were specified for the purpose of that clause. (2) Clause 2.4.2 of the diagnostic imaging services table does not apply to the items in Schedule 1 of this instrument. 7 Restriction on items – services connected with provision of PET nuclear scanning during Gallium-67 interruptions (1) An item in Schedule 1 of this instrument only applies to a service described in the item, if: (a) the patient's clinical condition requires the service to be performed before the resumption of normal gallium-67 (Ga-67) supply is anticipated by the practitioner who provides the service; and (b) the report of the service performed includes a justification for the substitute service, which describes the unavailability of a service to which item 61429, 61430, 61442, 61450 or 61453 applies. 8 PET nuclear scanning services (1) Item 61527 applies only if the service is performed on a person: (a) in a comprehensive facility; and (b) in accordance with sections 9 and 10. (2) Also, the item applies only if the owner or operator of the equipment used to perform the service is not in breach of section 11. 9 PET nuclear scanning services—performance under personal supervision (1) For the purposes of section 8, the service must be performed on a person by or under the personal supervision of: (a) a credentialled specialist; or (b) a medical practitioner other than the requesting practitioner if the medical practitioner: (i) is a Fellow of the RACP or RANZCR; and (ii) has reported 400 or more studies forming part of PET services for which a medicare benefit was payable; and (iii) is authorised under State or Territory law to prescribe and administer to humans the PET radiopharmaceuticals that are to be administered to the person; and (iv) met the requirements of subparagraphs (i), (ii) and (iii) before 1 November 2011. Note: For the purposes of this section, RACP means The Royal Australasian College of Physicians; and RANZCR means The Royal Australian and New Zealand College of Radiologists. 10 PET nuclear scanning services—equipment (1) For the purposes of section 8, the service must be performed on a person using equipment that meets the requirements set out in Requirements for PET Accreditation (Instrumentation & Radiation Safety) 3rd Edition (2017), issued by the Australian and New Zealand Society of Nuclear Medicine Inc, as existing on 1 July 2020. Note: The Requirements for PET Accreditation (Instrumentation & Radiation Safety) 3rd Edition (2017) could in 2020 be viewed on the website of the Society (https://www.anzsnm.org.au). 11 PET nuclear scanning services—statutory declaration (1) The owner or operator mentioned in subsection 8(2) must have given a statutory declaration to the Chief Executive Medicare that includes the following information: (a) whether the owner or operator is a credentialed specialist or a medical practitioner who satisfies the requirements mentioned in subparagraphs 9(1)(b)(i) to (iv); (b) whether the place where the owner or operator provides the service is in a comprehensive facility; (c) whether the equipment meets the requirements mentioned in section 10; (d) the facility's address; (e) the provider number for the facility given by the Chief Executive Medicare; (f) the location specific practice number for the facility given by the Minister; (g) the models, serial numbers and manufacturers of the equipment. (2) If the matters declared in the statutory declaration change, the owner or operator must give the Chief Executive Medicare written notice of the change as soon as the owner or operator knows about the change. Schedule 1 — Relevant services Group I4 – Nuclear Medicine Imaging Column 1 Column 2 Column 3 Item Description Fee ($) Subgroup 2– PET 61527 Whole body study using PET, if the service is performed because the services to which items 61429, 61430, 61442, 61450 or 61453 apply cannot be performed due to unavailability of gallium-67 (R) 752.35 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 how an amendment is to be made. If, despite the misdescription, the amendment can be given effect as intended, then the misdescribed amendment can be incorporated through an editorial change made under section 15V of the Legislation Act 2003. If a misdescribed amendment cannot be given effect as intended, the amendment is not incorporated and "(md not incorp)" is added to 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 Diagnostic Imaging Services – PET and Gallium-67 Services) Determination 2022 21 July 2022 (F2022L01003) 1 Aug 2022 (s 2(1) item 1) Health Insurance (Section 3C Diagnostic Imaging Services – PET and Gallium-67 Services) Amendment (No. 1) Determination 2022 23 Sept 2022 (F2022L01239) 24 Sept 2022 (s 2(1) item 1) — Endnote 4—Amendment history Provision affected How affected s 2..................... rep LA s 48D s 6..................... am F2022L01239 s 8..................... ad F2022L01239 s 9..................... ad F2022L01239 s 10.................... ad F2022L01239 s 11.................... ad F2022L01239