Health Insurance (Approvals for Eligible Collection Centres) Principles 2020

Administered by Department of Health, Disability and Ageing

Legislation au F2020L01179 In force Legislative Instrument

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EXPLANATORY STATEMENT

 

Health Insurance Act 1973

 

Health Insurance (Approvals for Eligible Collection Centres) Principles 2020

 

Authority

Subsection 23DNBA(4) of the Health Insurance Act 1973 (the Act) requires the Minister to determine principles to be applied by the Minister in granting approvals for eligible pathology specimen collection centres under subsection 23DNBA(1) of the Act.

Under subsection 16A(5AA) of the Act, in order for Medicare benefits to be payable for pathology services rendered, pathology specimens must be collected at an approved eligible collection centre (ACC), or in other specified circumstances. The arrangements for ACCs are set out in the Health Insurance (Approvals for Eligible Collection Centres) Principles 2020 (the Principles). 

Subsection 33(3) of the Acts Interpretation Act 1901, provides that where an Act confers a power to make, grant or issue any instrument of a legislative or administrative character (including rules, regulations or by-laws), the power shall be construed as including a power exercisable in the like manner and subject to the like conditions (if any) to repeal, rescind, revoke, amend, or vary any such instrument.

Purpose

 

The Health Insurance (Eligible Collections Centres) Approval Principles 2020 (the Principles) prescribe the prerequisites for the granting of approvals for ACCs, notice requirements and the duration of approval.

Background 

 

The Principles repeal and remake the Health Insurance (Eligible Collection Centres) Approval Principles 2010 (previous Principles), due to sunset on 1 October 2020.

A Medicare benefit is payable for a pathology service only where the pathology specimen is collected from the patient at a type of location specified in subsection 16A(5AA) of the Act.  One of these locations is an ‘approved collection centre’, being a specimen collection centre approved by the Minister under section 23DNBA of the Act. 

Under section 23DNBA of the Act, the Minister may grant an approval to an Approved Pathology Authority (APA) to operate an ‘eligible collection centre’ on premises owned, leased or otherwise occupied by the APA. An eligible collection centre is a collection centre on premises owned, leased or sub-leased by an APA that is also the sole proprietor of at least one eligible pathology laboratory. 

The Principles do not change the operation of the Instrument. As part of the review, there have some administrative amendments to the granting approvals process for eligible collection centres and transition provision for clarification purposes and updates to the definitions to ensure consistency in terminology reflected in the Health Insurance Act 1973 and to update references to legislation regulating the provision of pathology services. The Principles make no changes to the operation of matters such as requirements for an application or prerequisites to be considered an eligible collection centre or duration of approval.

As part of National Pathology Accreditation Program, all Approved Pathology Collection Centres must meet the accreditation standard titled Guidelines for Approved Pathology Collection Centres (Requirements for Medical Pathology Specimen Collection). The accreditation standard is amongst the suite of accreditation materials referenced in the Health Insurance (Accredited Pathology Laboratories-Approval) Principles 2017 that are in force from time to time and are available from https://www1.health.gov.au/internet/main/publishing.nsf/Content/health-npaac-publication.htm

Consultation

 

Services Australia, which shares the responsibility for administering the application process for Approved Pathology Collection Centres with the Department of Health, was consulted on the review of the Principles. Key pathology professional and representative stakeholder organisations were consulted on the remake of the sunsetting legislative instrument that was in substantially the same form, and no submissions were received. Given the remade instrument is substantially the same as the previous instrument, it is considered that stakeholders were consulted on the revised instrument.

 

The Office of Best Practice Regulation has confirmed that given the instrument has been operating effectively and has been remade without any materially significant changes, a Regulation Impact Statement is not required nor a sunsetting letter for the remaking of this Instrument (OPBR ID 43051).

 

The Principles commence on 1 October 2020.

 

Details of the Principles are set out in Attachment A.

 

The Principles is a legislative instrument for the purposes of the Legislative Instruments Act 2003.


ATTACHMENT A

 

Details of the Health Insurance (Approvals for Eligible Collection Centres) Principles 2020

Section 1  Name

This section provides that the name of this instrument is the Health Insurance (Approvals for Eligible Collection Centres) Principles 2020.

Section 2  Commencement

This section provides that this instrument commences on 1 October 2020.

Section 3  Authority

This section provides that this instrument is made under subsection 23DNBA(4) of the Health Insurance Act 1973.

Section 4  Schedules

This section provides that the instrument specified in the Schedule to this instrument is repealed.

Section 5  Definitions

This section defines key terms used in the instrument. Unless otherwise defined they have the same meaning as in the Health Insurance Act 1973. This incorporation is permitted by section 14 of the Legislation Act 2003, and that the provisions of the Act are incorporated as in force from time to time.

Section 6  Prerequisites

This section provides the requirements that the eligible specimen collection centre must meet before an application for approval of an eligible collection centre can be approved by the Minister.

Section 7  Applicant

This section provides criteria for Authorised Pathology Authorities (APA’s) making an application for an eligible collection centre approval.

Section 8  Form and content of application

This section sets out the requirements of the form and content that an application in order to be considered for approval to the Minister.

Acceptance by the Minister of the impracticality of compliance with some or all provisions of the Collection Centre Guidelines in particular circumstances, as envisaged in subparagraph 8(2)(d)(i) of the instrument is intended to be an administrative action that is not dependent on the instrument. The Principles refer to the acceptance (in describing the content of an undertaking that an applicant has power to give apart from the Principles), and are not the source of the Minister’s power to accept the impracticability of compliance.

Section 9  Requirements for premises

This section provides the requirements for an eligible collection premises, including premises equipment and staff training and employment status.

Section 10  Giving notice to applicant

This section provides the requirements for notification of a decision by the Minister to grant approval or not to grant approval for an eligible collection centre. Applicants can seek the Minister’s reconsideration of a decision.

Section 10(b) of the Health Insurance (Approvals for Eligible Collection Centres) Principles 2020 requires the Minister to give an approved pathology authority written notice of their right to request reconsideration if a decision is made not to grant approval for an eligible collection centre.  

The decision to grant (or not to grant) approval for an eligible collection centre is made by the Minister under subsection 23DNBA(1) of the Health Insurance Act 1973.  Reconsideration decisions are made by the Minister under subsection 23DO(2DA) of the Health Insurance Act 1973 and are subject to merits review by the Administrative Appeals Tribunal (paragraph 23DO(5)(c) of the Health Insurance Act 1973).

Section 11  Duration of approval

This section provides for the duration and commencement date of an approval once granted.

Section 12  Continuation of approvals

This section provides transitional arrangements for any applications in the current form until such time a new form is approved.

Section 13  Continuation of form until new form approved

This section outlines that the existing application form continues to apply until such time a new application form is approved.

Schedule 1 – Repeals

Health Insurance (Eligible Collection Centres) Approval Principles 2010

1          The whole of the instrument

This Schedule repeals the Health Insurance (Eligible Collection Centres) Approval Principles 2010.

 

Overview

The Health Insurance (Approvals for Eligible Collection Centres) Principles 2020 were enacted to address the need for updated and streamlined guidelines for the approval of eligible pathology specimen collection centres under the Health Insurance Act 1973. The Act was introduced by the Parliament of Australia to ensure that the approval process for eligible collection centres remains consistent and efficient, thereby maintaining the integrity of the Medicare benefits system for pathology services. The primary objective of these Principles is to clearly outline the prerequisites for granting approvals, establish notice requirements for applicants, and specify the duration of such approvals. By repealing and replacing the previous Health Insurance (Eligible Collection Centres) Approval Principles 2010, these new principles aim to incorporate administrative amendments and updates to definitions to ensure consistency with the Health Insurance Act 1973 and relevant legislation. This legislative instrument is designed to support the effective operation of the National Pathology Accreditation Program, ensuring that all approved pathology collection centres meet the required accreditation standards.

Scope and Application

The Health Insurance (Approvals for Eligible Collection Centres) Principles 2020, which are made under subsection 23DNBA(4) of the Health Insurance Act 1973, detail the prerequisites, procedures, and requirements for granting approvals for eligible pathology specimen collection centres, ensuring these centres meet the necessary standards to qualify for Medicare benefits. These principles apply to Approved Pathology Authorities (APAs) seeking to operate eligible collection centres on premises they own, lease, or otherwise occupy, which are also the sole proprietors of at least one eligible pathology laboratory. The provisions set out in the principles govern the criteria for approval, the form and content of the application, the requirements for the premises, and the duration of approval. The principles apply nationally and do not specify exclusions but are subject to administrative actions and merits review under the Health Insurance Act 1973. The principles, which commenced on 1 October 2020, replace the previous Health Insurance (Eligible Collection Centres) Approval Principles 2010 and include administrative amendments without materially changing the operation of the approval process. The principles also incorporate definitions from the Health Insurance Act 1973 and require compliance with the Guidelines for Approved Pathology Collection Centres as part of the National Pathology Accreditation Program.

Key Provisions

The Health Insurance (Approvals for Eligible Collection Centres) Principles 2020, which commenced on 1 October 2020, outline the prerequisites and procedures for the Minister to approve eligible pathology specimen collection centres (ACCs) under the Health Insurance Act 1973 (the Act). Section 6 of the Principles details the requirements that must be met by an eligible specimen collection centre before an application for approval can be considered. Section 7 sets forth the criteria for Authorised Pathology Authorities (APAs) who apply for ACC approval. Section 8 specifies the form and content that an application must include. Section 9 provides the requirements for the premises, including equipment and staff training and employment status. Section 10 outlines the notification requirements for applicants regarding the Minister's decision on approval and the right to request reconsideration if approval is denied. Section 11 details the duration and commencement date of an approval once granted. The Principles impose several obligations on the parties involved. The Minister must assess applications for ACC approval based on the requirements set out in Sections 6 to 9. APAs must ensure their collection centres meet the prerequisites specified in Section 6 and submit a compliant application as outlined in Section 8. Approved Pathology Authorities must also comply with the notification requirements in Section 10(b) and may request reconsideration if their application is denied. Additionally, approved centres must adhere to the accreditation standards set by the National Pathology Accreditation Program. Any breaches of the provisions outlined in the Principles can result in civil or criminal consequences. Although specific penalties are not detailed within the text, under the Health Insurance Act 1973, failure to comply with the requirements for ACCs could lead to penalties for the APA, including fines and potential revocation of approval. The Act also provides for merits review by the Administrative Appeals Tribunal for reconsideration decisions.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.