Health Insurance (Eligible Collection Centres) Approval Principles 2010

made under subsection 23DNBA(4) of the

Health Insurance Act 1973.

Compilation No. 3

Compilation date:    1 December 2018

Includes amendments up to: F2018L01358

Registered:    17 January 2019

About this compilation

This compilation

This is a compilation of the Health Insurance (Eligible Collection Centres) Approval Principles 2010 that shows the text of the law as amended and in force on 1 December 2018 (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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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

Part 1 Preliminary

1 Name of Principles

3 Definitions

Part 2 General principles for applications

4 Eligibility of premises for approval

5 Application for approval

6 Approvals

Part 3 Other matters

7 Compliance with the Collection Centre Guidelines

8 Review of decisions

Endnotes

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Part 1 Preliminary

1 Name of Principles

  These Principles are the Health Insurance (Eligible Collection Centres) Approval Principles 2010.

3 Definitions

 (1) In these Principles:

Act means the Health Insurance Act 1973.

Amendment Act means the Health Legislation Amendment (Medical Practitioners’ Qualifications and Other Measures) Act 2001.

APA means approved pathology authority.

category G pathology laboratory means an accredited pathology laboratory that has approval under section 23DN of the Act as a category GX or category GY accredited pathology laboratory.

category S pathology laboratory means an accredited pathology laboratory that has approval under section 23DN of the Act as a category S accredited pathology laboratory.

eligible applicant means an APA of a kind described in subsection 5(2).

prescribed, in relation to a form, means prescribed by the Minister.

recognized hospital has the same meaning as it did in the Act immediately before the commencement of item 31 of Schedule 1 to the Amendment Act.

Rural/Remote Areas Classification means the document of that name published in January 1994 by the Department of Human Services and Health.

Note   The Department of Human Services and Health publication ‘Rural/Remote Areas Classification’ should not be confused with a similar document published jointly by the Department of Human Services and Health and the Department of Primary Industries and Energy in November 1994.

Note   Item 31 of Schedule 1 to the Amendment Act commenced on 1 December 2001.

 (2) A word or expression used in these Principles that is defined in the Act has the same meaning in these Principles as it has in the Act.

Note   See, for example, the definition of the terms approval, Collection Centre Guidelines, and eligible collection centre in subsection 23DA(1) of the Act.  Also, several expressions used in these Principles have the meaning given in subsection 3 (1) of the Act (for example, accredited pathology laboratory, approved pathology authority and pathology services table).             

Part 2 General principles for applications

4 Eligibility of premises for approval

 (1) An application for approval of an eligible collection centre must not be considered by the Minister unless the premises to be occupied by the specimen collection centre meet the following criteria:

 (a) there is on the premises the necessary equipment for the collection and preparation of specimens for pathology procedures;

 (b) the staff at the premises:

 (i) are persons employed or engaged by the APA; and

 (ii) include persons properly trained in procedures for the collection and preparation of pathology specimens.

Note   These are secondary criteria for eligibility. For the primary criteria, see the definition of eligible collection centre in subsection 23DA (1) of the Act.

 (2) For the purposes of subparagraph (1)(b)(i), a person will be considered to be engaged by the APA only if the person is engaged directly or indirectly by the APA under a contract and, by virtue of that contract, acts under the general direction and control of the APA.

5 Application for approval

 (1) An application for approval of an eligible collection centre must not be considered by the Minister unless:

 (a) it is made:

 (i) by an APA who is an eligible applicant; and

 (ii) in writing and in the prescribed form; and

 (b) the application is complete.

 (1A) An application for approval of an eligible collection centre will be complete for the purposes of paragraph 5(1)(b) where the applicant has provided:

 (a) a response to each question asked in the prescribed form;

 (b) any information reasonably necessary to substantiate or explain each such response; and

 (c) any additional information required by the Minister under subsection 5(3) which is to be provided at the time of lodgement of the application.

Note   Prescribed forms may be obtained from the Department of Human Services.

 (2) An APA is an eligible applicant if the APA:

 (a) operates, and is the proprietor of, an accredited pathology laboratory that is a category G pathology laboratory; or

 (b) has entered into an arrangement with another APA for the use of an accredited pathology laboratory that is a category G pathology laboratory and, immediately before the commencement of item 31 of Schedule 1 to the Amendment Act, operated a collection centre that:

 (i) was not located on the hospital premises of a recognized hospital; and

 (ii) was in an area that, in the Rural/Remote Areas Classification, is:

 (A) a Rural Major statistical local area; or

 (B) a Rural Other statistical local area; or

 (C) a Remote Major statistical local area; or

 (D) a Remote Other statistical local area; or

 (c) is an APA who operates, and is the proprietor of, an accredited pathology laboratory that is a category S pathology laboratory that is proposing to collect solely specimens within its speciality.

 (3) An application must be supported by:

 (a) a written undertaking that the applicant will comply with the Collection Centre Guidelines in operating a specimen collection centre for which an approval is in force, except to the extent that, in a particular circumstance, the Minister accepts that compliance with some, or all, provisions of the Guidelines is not reasonably practicable; and

 (b) any additional information required by the Minister to enable the application to be decided.

6 Approvals

 (1) Subject to subsection (2), an approval takes effect on the day on which the Minister grants the approval under subsection 23DNBA(1) of the Act, or on such a day as is specified in the approval, not being a day earlier than the day on which the approval is granted.

 (2) An approval may be expressed to commence on a day earlier than the day the Minister grants the approval under subsection 23DNBA(1) of the Act if the Minister is satisfied that special circumstances justify the backdating.

 (3) An approval granted in respect of an application must be expressed to be valid for two years, inclusive of the day of commencement of the approval.

Note: An approval may be revoked or cancelled under the Act.

 (4) The Minister must give to an APA who applies for approval, written notice of:

 (a) the decision to grant or not grant approval; and

 (b) if the decision is to not grant approval, or to not backdate commencement as requested — their right to have the decision reconsidered by the Minister under section 23DO of the Act.

Part 3 Other matters

7 Compliance with the Collection Centre Guidelines

  An undertaking given by an applicant under paragraph 5 (3) (a) must include an undertaking to give to Medicare Australia written notice within 24 hours after a failure to comply with the Collection Centre Guidelines in operating an approved collection centre, including an explanation of the reason for the non‑compliance.

8 Review of decisions

 (1) Within 14 days after receiving an application for reconsideration under subsection 23DO(2DA) of the Act, the Minister must give the applicant written notice of the decision made under subsection 23DO(2DB).

 (2) An applicant for approval who is dissatisfied with a decision of the Minister under paragraph 5(3)(a) may apply to the Administrative Appeals Tribunal for review of the decision.

Note   Under section 27A of the Administrative Appeals Tribunal Act 1975, a decision‑maker must give to persons whose interests are affected by the decision notice of the decision and of their right to have the decision reviewed.  In giving notice, the Minister must have regard to the Code of Practice for Notification of Reviewable Decisions and Rights of Review determined under section 27B of that Act (Gazette No. S 432, 7 December 1994), accessible on the Internet at http://www.comlaw.gov.au

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 the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation “(md)” added to the details of the amendment included in the amendment history.

If a misdescribed amendment cannot be given effect as intended, the abbreviation “(md not incorp)” is added to the details of the amendment included in the amendment history.

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history