Part 1 Preliminary
1 Name of Principles
These Principles are the Health Insurance (Eligible Collection Centres) Approval Principles 2010.
2 Commencement
These Principles commence on 1 July 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 it is made:
(a) by an APA who is an eligible applicant; and
(b) in writing and in the prescribed form.
Note Prescribed forms may be obtained from Medicare Australia.
(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 must be expressed to be valid for one year, 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