EXPLANATORY STATEMENT
HEALTH INSURANCE ACT 1973
SUBSECTION 23DNBA(4)
HEALTH INSURANCE (ELIGIBLE COLLECTION CENTRES) APPROVAL PRINCIPLES 2005
New arrangements for pathology specimen collection centres to replace the Licensed Collection Centre (LCC) Scheme were introduced under the Health Legislation Amendment (Medical Practitioners’ Qualifications and Other Measures) Act 2001. The new arrangements became known as the Approved Collection Centre Arrangements (ACC arrangements). The implementation date for these new arrangements was 1 December 2001.
A major focus of the ACC arrangements is an emphasis on the quality of pathology specimen collection facilities.
Subsection 23DNBA(4) of the Health Insurance Act 1973 (the Act) requires the Minister to determine, in writing, principles that apply to the granting of approvals for eligible pathology specimen collection centres. Approved pathology specimen collection centres are known as approved collection centres (ACCs).
In order for Medicare benefits to be payable, pathology specimens need to be collected in an approved collection centre, or in other specified circumstances.
The Health Insurance (Eligible Collection Centres) Approval Principles 2005 (the Principles) relate to the fifth and future years, and the full implementation, of the ACC arrangements and will replace the Health Insurance (Eligible Collection Centres) Approval Principles 2004. The Principles provide for a range of matters in relation to pathology specimen collection centres.
The Principles have been developed in consultation with the Australian Association of Pathology Practices, the Royal College of Pathologists of Australasia, the National Coalition of Public Pathology and the Health Insurance Commission.
Details of the Principles are set out in the Attachment.
ATTACHMENT
NOTES ON SECTIONS OF THE PRINCIPLES
Part 1 Introductory
Section 1 Name of Principles
This section provides that the Principles may be cited as the Health Insurance (Eligible Collection Centres) Approval Principles 2005.
Section 2 Commencement
This section specifies the commencement date of the Principles as the day after they are registered.
Section 3 Definitions
This section defines certain terms used in the Principles. This section also refers to the following documents that are incorporated in the instrument by reference:
- Health Insurance (Accredited Pathology Laboratories – Approval) Principles 2002 which are accessible on the Internet at http://www.health.gov.au/pathology/leg/index.htm
- Rural/Remote Areas Classification document published in January 1994 by the Department of Human Services and Health which is available, on request, from the Australian Government Department of Health and Ageing, Pathology Section, MDP 107, GPO Box 9848, Canberra, ACT 2600.
Part 2 General principles for applications
Section 4 Eligibility of premises for approval
This section specifies the criteria that the premises to be occupied by the specimen collection centre must meet before an application for approval of an eligible collection centre can be considered by the Minister.
Section 5 Application for approval
This section specifies the criteria to be met before an application for approval of an eligible collection centre can be considered by the Minister, for example that the applicant must be an approved pathology authority (APA) operating certain categories of accredited pathology laboratories. It also specifies the documentation to be provided in support of the application.
Section 6 Timing of application
This section specifies the timing of applications for approval of an eligible collection centre and the period for which the applications are applicable.
Section 7 Approvals
This section specifies the commencement and expiration dates of the approvals. It also specifies that the Minister will give written notice of the decision to grant, or not to grant, an approval and the applicant’s right to have the decision reconsidered.
Part 3 Principles determining maximum numbers of approvals
Section 8 Interpretation
This section provides an interpretation of the term “relevant financial year”.
Section 9 Maximum number of approvals
This section specifies that the maximum number of approvals that can be granted to an APA in a relevant financial year, will be determined in accordance with this Part of the Principles.
Section 10 Consequence of location of eligible collection centres.
This section outlines the ‘three approvals for one’ incentive that is applicable if an APA elects to operate eligible collection centres in locations specified as Rural Other or Remote Other statistical local areas in the Rural/Remote Areas Classification (defined in Section 3). The APA is not obliged to open three collection centres, it may open one, two or three. This section also specifies the circumstances in which this provision does not apply.
Section 11 Applicant operating, and sole owner of, category G pathology laboratory for 2 or more consecutive calendar years
This section specifies the circumstances under which the maximum number of approvals determined under this section may be granted. It also sets out the methodology for determining the maximum number of approvals that could be granted to these applicants after 1 July 2005.
Section 12 Applicant operating, and sole owner of, category G pathology laboratory for less than 2 consecutive calendar years
This section specifies the circumstances under which the maximum number of approvals determined under this section may be granted. It also specifies the methodology for determining the maximum number of approvals that could be granted to these applicants after 1 July 2005.
Section 13 Applicants relying on an arrangement with the owner of a category
G pathology laboratory and who operate collection centres in rural or remote areas
This section specifies the maximum number of approvals that may be granted to these applicants. These centres existed prior to the commencement of the Approved Collection Centre Arrangements and have been ‘grandfathered’ under the ACC arrangements. These centres are not transferable.
Section 14 Applicants operating a category S pathology laboratory who held
section 23DNB units
This section specifies the maximum number of approvals that may be granted to these applicants. These centres existed prior to the commencement of the Approved Collection Centre Arrangements and have been ‘grandfathered’ under the ACC arrangements. These centres are not transferable.
Section 15 Applicants operating a category S pathology laboratory who have
not held section 23DNB units
This section specifies the maximum number of approvals that may be granted to these applicants.
Part 4 Other Matters
Section 16 Effect of acquisition or disposal of APA business
This section specifies the circumstances in which an APA acquiring business from another APA to which an approval has been granted may have the approval transferred to the acquiring APA.
Section 17 Effect of merger of APA businesses
Where one APA merges with another APA, then section 11 or 12 may apply to the resulting merged APA. It also provides for the APA resulting from the merger to request the Minister to confirm that an approval held by the two merging APAs is now effectively held by the resulting merged APA.
Section 18 Compliance with the Collection Centre Guidelines
This section deals with the giving of an undertaking by the APA operating the collection centre(s) to inform the Health Insurance Commission of any failure to comply with the Collection Centre Guidelines and provide a reason for the non-compliance.
Section 19 Review of decisions
This section specifies the time-frame for the review of decisions made under the Principles. This section also refers to the Code of Practice created under section 27B of the Administrative Appeals Tribunal 1975, which is accessible at: http://www.scaleplus.law.gov.au/html/instruments/0/14/0/AATCode.htm
Section 20 Delegation of powers and functions
This section specifies that the Minister may delegate his/her powers and functions under these Principles to the Managing Director of the Health Insurance Commission.
Part 5 Transitional
Section 21 Transitional
This section specifies that the Health Insurance (Eligible Collection Centres) Approval Principles 2004, instead of these Principles, apply to an application for approval made in relation to the 2004/05 financial year.