Health Insurance (Section 3C Diagnostic Imaging Services – PET and Gallium-67 Services) Determination 2022

Administered by Department of Health, Disability and Ageing

Legislation au F2022L01003 In force Legislative Instrument

Legislation content

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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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

Item

Column 2

Description

Column 3

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

/subsubparagraph(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

SubCh = SubChapter(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

 

 

Overview

The Health Insurance (Section 3C Diagnostic Imaging Services – PET and Gallium-67 Services) Determination 2022, enacted under subsection 3C(1) of the Health Insurance Act 1973, was introduced to address gaps in the provision of certain diagnostic imaging services, specifically Positron Emission Tomography (PET) and Gallium-67 (Ga-67) services. This determination aims to ensure that these critical services are adequately provided and reimbursed under the Medicare system, particularly in circumstances where the standard Ga-67 supply is interrupted. The policy objective of this legislation is to facilitate the timely and effective provision of diagnostic imaging services by specifying the conditions under which PET services can be performed as a substitute when Ga-67 services are unavailable. This is achieved by setting out the requirements for the performance of PET services, the qualifications of practitioners, and the equipment standards, thereby ensuring that these services are both clinically relevant and professionally administered. The determination was made by the relevant authority under the Health Insurance Act 1973 and commenced on 1 August 2022.

Scope and Application

The Health Insurance (Section 3C Diagnostic Imaging Services – PET and Gallium-67 Services) Determination 2022 applies to services related to Positron Emission Tomography (PET) and Gallium-67 diagnostic imaging within the healthcare sector in Australia. This legislation is made under subsection 3C(1) of the Health Insurance Act 1973 and commenced on 1 August 2022. It specifies how certain PET services should be treated as clinical services under the Act and regulates the fees associated with these services as outlined in the accompanying Schedule. The Determination applies to services provided in comprehensive facilities and involves credentialled specialists or appropriately qualified medical practitioners. The Act also imposes certain requirements on the equipment used for PET services and mandates that the owner or operator of the equipment submit a statutory declaration to the Chief Executive Medicare. The legislation further provides for the treatment of services connected with PET nuclear scanning during interruptions in the supply of Gallium-67, specifying conditions under which such services can be justified and billed. Notably, this Determination does not extend its application to all PET services but specifically targets those that are substitutes due to the unavailability of Gallium-67.

Key Provisions

The Health Insurance (Section 3C Diagnostic Imaging Services – PET and Gallium-67 Services) Determination 2022, which commenced on 1 August 2022, establishes specific provisions for the treatment of relevant services concerning PET and Gallium-67 imaging services under the Health Insurance Act 1973. This determination outlines how these services are to be treated as both professional and diagnostic imaging services, with specific fees determined by the Schedule attached to the instrument. It also details that certain clauses of the diagnostic imaging services table apply as if the items in Schedule 1 were specified for those purposes, while excluding other clauses from application to these items. Entities and individuals governed by this determination must adhere to several specific obligations. For instance, they must ensure that PET nuclear scanning services are performed in comprehensive facilities by credentialed specialists or qualified medical practitioners under stringent conditions, including meeting specific experience and accreditation requirements. Equipment used for these services must comply with the Australian and New Zealand Society of Nuclear Medicine's accreditation standards. Additionally, the owner or operator of the equipment must provide a statutory declaration to the Chief Executive Medicare, detailing their qualifications, the facility's details, and the equipment specifications. Any changes to the information provided in the statutory declaration must be promptly reported to Medicare. Breaching the provisions of this determination can lead to significant consequences. While the determination itself does not explicitly state penalties, violations of health insurance regulations generally can result in substantial fines and potential criminal charges, depending on the severity and intent of the breach. The Health Insurance Act 1973 and related regulations outline penalties that can include fines of up to several thousand Australian dollars per offence, along with possible imprisonment for more serious breaches. These penalties are intended to ensure compliance and maintain the integrity of the health insurance system.

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