Contents
2 Commencement#
| Commencement information | ||
|---|---|---|
| Column 1 | Column 2 | Column 3 |
| Provisions | Commencement | Date/Details |
| 1. The whole of this instrument | 1 December 2026 | 1 December 2026 |
Note: This table relates only to the provisions of this instrument as originally made.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.
3 Authority#
This instrument is made under subsection 23DB(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Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
5 Definitions#
Words in this instrument have, unless they are otherwise defined, the same meaning as in the Health Insurance Act 1973.
6 Approval of forms of undertaking#
Approved form—approved pathology practitioners
Approved form—approved pathology authorities
Note: The form contained in this Schedule is the approved form of undertaking to be given by persons who wish to become approved pathology practitioners for the purposes of subsection 23DB(1) of the Health Insurance Act 1973
1 Interpretation#
Note: A number of expressions used in this undertaking are defined in the Act, including the following:
(a) accredited pathology laboratory
(b) approved pathology authority
(c) approved pathology practitioner
(d) medical practitioner
(e) participating midwife
(f) participating nurse practitioner
(g) pathology service
(h) relevant civil contravention
(i) relevant offence
(j) relevant person
(k) treating practitioner
APP means an approved pathology practitioner.
APL means an accredited pathology laboratory.
Assistant Secretary in the Benefits Integrity Division of the Department of Health, Disability and Ageing means any person from time to time holding, acting in, or performing the duties of the position titled Assistant Secretary in the Benefits Integrity Division within the Department of Health, Disability and Ageing.
Chief Executive Medicare means the person for the time being holding the position titled Chief Executive Medicare in the Human Services (Medicare) Act 1973 and includes an officer holding a valid delegation to make a particular decision in place of the Chief Executive Medicare.
Director, Pathology and Diagnostic Imaging means the person from time to time holding, acting in, or performing the duties of the position of Director, Pathology and Diagnostic Imaging within Services Australia.
independent body has the same meaning as in the Health Insurance (Accredited Laboratories—Approval) Principles 2017, or any legislation made in substitution for those Principles.
laboratory means an accredited pathology laboratory, given approval under section 23DN of the Act.
quality assurance program means a program offered for the purpose of testing proficiency in the testing of pathology specimens.
scientist means a person who possesses one of the following qualifications:
service means:
workday means, in respect of a laboratory, a calendar day during which the laboratory provides pathology services.
3 Personal supervision#
and no person in the above groups is physically present in the laboratory, then I must be physically present in the laboratory and closely supervise the rendering of the service;
7 Request and use of information#
makes a written request, I undertake to provide any relevant information specified in the request relating to services provided by or on my behalf, including any matter arising out of this undertaking.
12 Time and method of complying with undertakings#
Health Insurance Act 1973
Health Insurance Regulations 2018
Human Services (Medicare) Act 1973
Human Services (Medicare) Regulations 2017
Health Insurance (Approved Pathology Specimen Collection Centres) Tax Act 2000
Health Insurance (Pathology Services Table) Regulations 2020
Health Insurance (Accredited Pathology Laboratories – Approval) Principles 2017
Health Insurance (Approvals for Eligible Collection Centres) Principles 2020
Health Insurance (Section 4BA - Pathologist-Determinable Services) Determination 2025
Health Insurance (Permitted Benefits-Pathology Services) Determination 2018
Health Insurance (Prescribed Pathology Services) Determination 2021
Health Insurance (Eligible Pathology Laboratories) Determination 2026
Note: In general, these are items which can only be used for the collection of specimens for pathology testing or, if other uses are possible, when supplied by APPs or APAs to requesters, will only be used for collection purposes. These are mostly single use items employed in the collection of pathology specimens. These are the only items or services an APP or APA may supply free of charge, discounted or on a non-commercial basis, to a practitioner who requests or intends to request, pathology services. There is no obligation for a pathologist to supply any of the accepted items to a requesting practitioner.
Blood collection
Cervical cytology collection materials
Histology
Microbiological specimens
Non cervical cytology
Appropriate containers and media for urine, sputum and other body fluid cytology and cytology samples collected directly from tissues by the procedure of fine needle aspiration (FNA);
Biochemistry
Stationery/Instruction Sheets
Other
Note: Paragraphs 3(1)(a) to (f) and subsection 3(2) of Part 1 of this Schedule do not apply where a laboratory is limited to services (and associated equipment for those services) as detailed in this Part. These services will be updated from time to time in consultation with the Royal College of Pathologists of Australasia.
I ____________________________________________________
(full name in block letters)
a medical practitioner who is or wishes to become an approved pathology practitioner, hereby give the undertaking recorded in this Schedule. I acknowledge that a breach of this undertaking may be referred to a Medicare Participation Review Committee (MPRC) in accordance with the Act and, pursuant to section 124FB of the Act, the MPRC may make a number of determinations including that Medicare benefits should not be payable for up to 5 years.
Signature:
Date:
Address:
Note: The form contained in this Schedule is the approved form of undertaking to be given by persons who wish to become approved pathology authorities for the purposes of subsection 23DB(1) of the Health Insurance Act 1973
1 Interpretation#
Note: A number of expressions used in this undertaking are defined in the Act, including the following:
(a) accredited pathology laboratory
(b) approved collection centre
(c) approved pathology authority
(d) approved pathology practitioner
(e) medical practitioner
(f) participating midwife
(g) participating nurse practitioner
(h) pathology service
(i) relevant offence
(j) relevant person
ACC means an approved collection centre.
APP means an approved pathology practitioner.
APL means an accredited pathology laboratory.
approved premises means any premises approved under section 23DN (a laboratory) or section 23DNBA (a collection centre) of the Act.
Assistant Secretary in the Benefits Integrity Division of the Department of Health, Disability and Ageing means any person from time to time holding, acting in, or performing the duties of the position titled Assistant Secretary in the Benefits Integrity Division within the Department of Health, Disability and Ageing.
Chief Executive Medicare means the person for the time being holding the position titled Chief Executive Medicare in the Human Services (Medicare) Act 1973 and includes an officer holding a valid delegation to make a particular decision in place of the Chief Executive Medicare.
Director, Pathology and Diagnostic Imaging means the person from time to time holding, acting in, or performing the duties of the position of Director, Pathology and Diagnostic Imaging within Services Australia.
independent body has the same meaning as in the Health Insurance (Accredited Laboratories—Approval) Principles 2017 or as in any instrument made in substitution for those Principles.
laboratory means accredited pathology laboratory, given approval under section 23DN of the Act.
occupier of premises means:
proprietor as defined under the Act.
quality assurance program means a program offered for the purpose of testing proficiency in the testing of pathology specimens.
service means:
scientist means a person who possesses one of the following qualifications:
senior scientist means a scientist who has had not less than 10 years full-time relevant laboratory experience and who possesses one of the following qualifications:
12 Request and use of information#
makes a written request to the Authority to provide any relevant information specified in the request relating to the premises or the services rendered by the Authority, including any matter arising out of this undertaking, the Authority undertakes to provide that information to the Director, Pathology and Diagnostic Imaging or the Assistant Secretary in the Benefits Integrity Division of the Department of Health, Disability and Ageing.
17 Provision of information to prospective vendor or lessor of premises on or from which ACC to be operated#
18 Time and method of complying with undertakings#
Health Insurance Act 1973
Health Insurance Regulations 2018
Human Services (Medicare) Act 1973
Human Services (Medicare) Regulations 2017
Health Insurance (Approved Pathology Specimen Collection Centres) Tax Act 2000
Health Insurance (Pathology Services Table) Regulations 2020
Health Insurance (Accredited Pathology Laboratories – Approval) Principles 2017
Health Insurance (Approvals for Eligible Collection Centres) Principles 2020
Health Insurance (Section 4BA – Pathologist-Determinable Services) Determination 2025
Health Insurance (Permitted Benefits - Pathology Services) Determination 2018
Health Insurance (Prescribed Pathology Services) Determination 2021
Health Insurance (Eligible Pathology Laboratories) Determination 2026
Note: In general, these are items which can only be used for the collection of specimens for pathology testing or, if other uses are possible, when supplied by APPs or APAs to requesters, will only be used for collection purposes. These are mostly single use items employed in the collection of pathology specimens. These are the only items or services an APP or APA may supply free of charge, discounted or on a non-commercial basis, to a practitioner who requests or intends to request, pathology services. There is no obligation for a pathologist to supply any of the accepted items to a requesting practitioner.
Blood collection
Cervical cytology collection materials
Histology
Microbiological specimens
Non cervical cytology
Appropriate containers and media for urine, sputum and other body fluid cytology and cytology samples collected directly from tissues by the procedure of fine needle aspiration (FNA);
Biochemistry
Stationery/Instruction Sheets
Other
I/We* ____________________________________________________
(* name of applicant – as detailed on page 1)
apply to become an approved pathology authority and hereby give the undertaking recorded in this Schedule to the Minister. I/we acknowledge that a breach of this undertaking may be referred to a Medicare Participation Review Committee (MPRC) in accordance with the Act and, pursuant to section 124FB of the Act, the MPRC may make a number of determinations including that Medicare payments should not be payable for up to 5 years.
Name: ________________________ Name: ________________________
Position: ________________________ Position: ________________________
Signature: ________________________ Signature: ________________________
Date: ________________________ Date: ________________________
Address: ________________________ Address: ________________________
Partnership
Name, ABN and signature of each partner and date signed.
_________________, ___________________, ________________, ______.
(name in block letters) (ABN) (signature) (date)
_________________, ___________________, ________________, ______.
(name in block letters) (ABN) (signature) (date)
_________________, ___________________, ________________, ______.
(name in block letters) (ABN) (signature) (date)
_________________, ___________________, ________________, ______.
(name in block letters) (ABN) (signature) (date)
_________________, ___________________, ________________, ______.
(name in block letters) (ABN) (signature) (date)
_________________, ___________________, ________________, ______.
(name in block letters) (ABN) (signature) (date)
_________________, ___________________, ________________, ______.
(name in block letters) (ABN) (signature) (date)
_________________, ___________________, ________________, ______.
(name in block letters) (ABN) (signature) (date)
_________________, ___________________, ________________, ______.
(name in block letters) (ABN) (signature) (date)
_________________, ___________________, ________________, ______.
(name in block letters) (ABN) (signature) (date)
_________________, ___________________, ________________, ______.
(name in block letters) (ABN) (signature) (date)
_________________, ___________________, ________________, ______.
(name in block letters) (ABN) (signature) (date)
_________________, ___________________, ________________, ______.
(name in block letters) (ABN) (signature) (date)
_________________, ___________________, ________________, ______.
(name in block letters) (ABN) (signature) (date)
_________________, ___________________, ________________, ______.
(name in block letters) (ABN) (signature) (date)
All partners to sign. If insufficient space, this page can be copied and signed. If a partner is a corporation, show company name and position held by natural person authorised and signing on behalf of the company.
Health Insurance (Approved Pathology Undertakings) Approval 2017
1 The whole of the instrument
Repeal the instrument.
Sourced from the Federal Register of Legislation at legislation.gov.au, © Commonwealth of Australia, licensed under CC BY 4.0. Compilations may have been reformatted.