Health Insurance (Eligible Collection Centres) Approval Principles 2002

Legislation au C2004L06640 Not in force Legislative Instrument

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I, KAY CHRISTINE LESLEY PATTERSON, Minister for Health and Ageing, acting under subsection 23DNBA (4) of the Health Insurance Act 1973:

(a) subject to section 19 of the following principles, repeal the Health Insurance (Eligible Collection Centres) Approval Principles 2001; and

(b) make the following principles.

Dated 7 May 2002

KAY PATTERSON

Minister for Health and Ageing

Contents

Part 1 Introductory

1 Name of Principles

2 Commencement

3 Definitions

Part 2 General principles for applications

4 Eligibility of premises for approval

5 Application for approval

6 Timing of application

7 Approvals

Part 3 Principles determining maximum numbers of approvals

8 Maximum number of approvals

9 Consequence of location of eligible collection centre

10 Applicants holding section 23DNB units before 1 October 1999

11 Applicants holding section 23DNB units on or after 1 October 1999

12 Applicants who have not held section 23DNB units

13A Applicants relying on an arrangement with the owner of a category G pathology laboratory and who operate collection centres in rural or remote areas

13B Applicants operating a category S pathology laboratory who held section 23DNB units

13C Applicants operating a category S pathology laboratory who have not held section 23DNB units

Part 4 Other matters

14 Effect of acquisition or disposal of APA business

15 Effect of merger of APA businesses

16 Compliance with the Collection Centre Guidelines

17 Review of decisions

18 Delegation of powers and functions

Part 5 Transitional

19 Transitional

Part 1 Introductory

1 Name of Principles

These Principles are the Health Insurance (Eligible Collection Centres) Approval Principles 2002.

2 Commencement

These Principles commence on gazettal.

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, under the Health Insurance (Accredited Pathology Laboratories — Approval) Principles 1999, has accreditation as a category GX or category GY laboratory.

Note The Health Insurance (Accredited Pathology Laboratories — Approval) Principles 1999 is accessible on the Internet at http://scaleplus.law.gov.au/.

category S pathology laboratory means an accredited pathology laboratory that, under the Health Insurance (Accredited Pathology Laboratories — Approval) Principles 1999, has accreditation as a category S laboratory.

licensed collection centre has the meaning given in subsection 23DA (1) of the Act as in force immediately before 1 December 2001.

Note The definition of licensed collection centre has been repealed with effect from 1 December 2001.

patient episode has the meaning given in the pathology services table, and includes a patient episode in relation to a pathology service performed for the Department of Veterans’ Affairs.

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

Rural/Remote Areas Classification means the document of that name published in January 1994 by the Department of Human Services and Health, as in force on the date of commencement of these Principles.

unit of entitlement means a unit of entitlement allocated under section 23DNB of the Act, as in force before the commencement of item 31 of Schedule 1 to the Amendment Act.

(2) A word or expression used in these Principles that is defined in subsection 23DA (1) of the Act has the same meaning in these Principles as it has under that subsection.

Note See, for example, approval, Collection Centre Guidelines, eligible collection centre. 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, pathology services table and recognized hospital).

Part 2 General principles for applications

4 Eligibility of premises for approval

An application for approval of an eligible collection centre cannot 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 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.

5 Application for approval

(1) An application for approval of an eligible collection centre cannot 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 the Health Insurance Commission.

(2) For subsection (1), an eligible applicant:

(a) operates, and is the sole owner 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) Rural Other statistical local area; or

(D) Remote Other statistical local area; or

(i) operates, and is the sole owner of, an accredited pathology laboratory that is a category S pathology laboratory that is proposing to collect solely specimens within its speciality; and

(ii) immediately before the commencement of item 31 of Schedule 1 to the Amendment Act, was the holder of a unit of entitlement to operate a licensed collection centre; or

(d) operates, and is the sole owner of, an accredited pathology laboratory that is a category S pathology laboratory that:

(i) is proposing to collect solely specimens within its speciality; and

(ii) will be located on the same premises as the collection centre that is the subject of the application; and

(iii) received accreditation as a category S laboratory after the commencement of item 31 of Schedule 1 to the Amendment Act.

(3) An application must be supported by:

(a) all information reasonably required by the Minister to enable the application to be decided; and

(b) a written undertaking that the applicant will comply with the Collection Centre Guidelines in operating a 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.

6 Timing of application

(1) An application by the holder of an existing approval:

(a) must relate to the next following financial year; and

(b) should be lodged with the Minister before 3 June preceding the financial year to which the application relates.

Note The consequence of making a late application is that an approval, if granted, may begin to take effect later than 1 July in the financial year to which it relates.

(2) An application by an apa who is not the holder of an existing approval may be lodged with the Minister at any time.

7 Approvals

(1) An approval must be expressed:

(a) if the application complies with subsection 6 (1) — to commence on 1 July in the financial year for which it is granted; and

(b) in any case — to expire at the end of the financial year for which it is granted.

Note An approval could expire earlier if it is revoked or cancelled under the Act.

(2) An approval granted after the beginning of the financial year to which it relates may be expressed to commence at the beginning of the financial year if:

(a) the apa to which the approval is granted was the holder of an approval in relation to the eligible collection centre concerned in the preceding financial year; and

(b) the Minister is satisfied that special circumstances justify the backdating.

(3) The Minister must give to persons whose interests are affected by the making of the decision to grant, or not grant, an approval, written notice of:

(a) the decision; and

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

Part 3 Principles determining maximum numbers of approvals

8 Maximum number of approvals

(1) The maximum number of approvals that may be granted to a particular APA in respect of a financial year is determined in accordance with this Part.

(2) An applicant must be granted the maximum number of approvals to which the applicant is entitled under this Part.

Note This Part takes account only of operation of the collection centres approval scheme until 30 June 2003. Provision will be made for future years by amendments agreed with the Pathology Consultative Committee. For information about the implementation framework for the future arrangements, see the Internet website http://www.health.gov.au/haf/branch/dtb/pres.htm.

9 Consequence of location of eligible collection centre

(1) In this Part, a reference to an approval is taken, at the election of the holder, to be a reference to 2 or 3 approvals if those approvals are applied by the holder to the operation of eligible collection centres in locations that, in the Rural/Remote Areas Classification, are:

(a) Rural Other statistical local areas; or

(b) Remote Other statistical local areas.

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.

(2) Subsection (1) does not apply to an approval the grant of which is allowed by operation of subsection 10 (6), 11 (4) or 12 (4).

(3) Subsection (1) ceases to have effect if an approval applying to an eligible collection centre mentioned in that subsection is applied, by transfer or by any other circumstance, to a collection centre that is not a collection centre mentioned in that subsection.

10 Applicants holding section 23DNB units before 1 October 1999

(1) An APA may be granted the maximum number of approvals determined under this section if:

(a) it is an APA to which paragraph 5 (2) (a) applies; and

(b) it held units of entitlement to operate a licensed collection centre that were allocated before 1 October 1999; and

(c) it subsequently held units of entitlement to operate a licensed collection centre that were allocated on or after that date, and continued to hold those units on 30 November 2001.

(2) The maximum number is determined:

(a) by dividing, by 14 200, the number of patient episodes for which the APA provided a pathology service, or services, during the calendar year 2001; and

(b) if the result includes a fraction, by rounding the fraction to the nearest whole number and, in the event of the fraction being 0.5, by rounding up; and

(d) if subsection (6) applies to the APA, by adding, to the number arrived at under paragraph (c), the number given by operation of that subsection.

(3) If the result from subsection (2) is a number that is at least 10% higher than the number of units of entitlement held by the APA on 30 November 2001, the maximum number of approvals that the APA may be granted is:

(a) if the APA held 5 or more units of entitlement on 30 November 2001 — the number that is 10% higher than the number of units of entitlement so held; or

(b) if the APA held fewer than 5 units of entitlement on 30 November 2001 — the number that is equal to the number resulting from subsection (2).

(4) If the result from subsection (2) is a number that is higher, but less than 10% higher, than the number of units of entitlement held by the APA on 30 November 2001, the maximum number of approvals that the APA may be granted is the number that is equal to the number resulting from subsection (2).

(5) If the result from subsection (2) is a number that is lower than the number of units of entitlement held by the APA on 30 November 2001, the maximum number of approvals that the APA may be granted is the number that is equal to the number of units of entitlement so held.

(6) For an APA that proposes to operate, in the financial year ending on 30 June 2003, an eligible collection centre in the same premises as a category G pathology laboratory operated by the APA, the maximum number of approvals is increased to allow the grant of an approval for that collection centre, or each such collection centre, in addition to any approvals granted in accordance with the other provisions of this section.

11 Applicants holding section 23DNB units on or after 1 October 1999

(1) An APA may be granted the maximum number of approvals determined under this section if:

(a) it is not an APA to which section 10 applies; and

(b) it held units of entitlement to operate a licensed collection centre that were allocated on or after 1 October 1999, and continued to hold those units on 30 November 2001; and

(2) The maximum number is determined:

(a) by dividing, by 14 200, the number of patient episodes for which the APA provided a pathology service, or services, during the calendar year 2001; and

(b) if the result includes a fraction, by rounding the fraction to the nearest whole number and, in the event of the fraction being 0.5, by rounding up; and

(d) if the result from paragraph (c) includes a fraction, by rounding the fraction to the nearest whole number and, in the event of the fraction being 0.5, by rounding up; and

(e) by applying subsection (3) to the result; and

(f) if subsection (4) applies to the APA, by adding, to the number arrived at under paragraph (e), the number given by operation of that subsection.

(3) The maximum number of approvals that the APA may be granted is the highest of the following numbers:

(a) the number that is equal to the number resulting from paragraphs (2) (a), (b), (c) and (d);

(b) the number that is equal to the number of units of entitlement held by the APA on 30 November 2001;

(4) For an APA that proposes to operate, in the financial year ending on 30 June 2003, an eligible collection centre in the same premises as a category G pathology laboratory operated by the APA, the maximum number of approvals is increased to allow the grant of an approval for that collection centre, or each such collection centre, in addition to any approvals granted in accordance with the other provisions of this section.

Note Paragraph (3) (b) could be affected by section 15 of these Principles.

12 Applicants who have not held section 23DNB units

(1) An APA may be granted the maximum number of approvals determined under this section if it is an APA to which paragraph 5 (2) (a) applies and the APA:

(a) is not an APA to which section 10 or 11 applies; or

(b) whether or not paragraph (a) applies — has acquired, after 30 November 2001, business from another APA for which units of entitlement were allocated under section 23DNB of the Act; or

(c) immediately before the commencement of item 31 of Schedule 1 to the Amendment Act, had been the recipient of funding under a Health Program Grant administered by the Minister.

(2) The maximum number is determined:

(a) by dividing, by 14 200, the number of patient episodes for which the APA (and, if applicable, the APA from which the business was acquired) provided a pathology service, or services, during the calendar year 2001; and

(b) if the result includes a fraction, by rounding the fraction to the nearest whole number and, in the event of the fraction being 0.5, by rounding up; and

(d) if the result from paragraph (c) includes a fraction, by rounding the fraction to the nearest whole number and, in the event of the fraction being 0.5, by rounding up; and

(e) by applying subsection (3) to the result; and

(f) if subsection (4) applies to the APA, by adding, to the number arrived at under paragraph (e), the number given by operation of that subsection.

(3) The maximum number of approvals that the APA may be granted is the higher of:

(a) the number that is equal to the number resulting from subsection (2); and

(b) 2.

(5) In relation to an APA to which paragraph (1) (a) applies, this section does not apply if the APA, under another name, or constituted as a different kind of body, has held units of entitlement to which section 10 or 11 applies.

13A Applicants relying on an arrangement with the owner of a category G pathology laboratory and who operate collection centres in rural or remote areas

The maximum number of approvals that may be granted to an APA to which paragraph 5 (2) (b) applies is the number that is equal to the number of specimen collection centres that:

(a) the APA was operating immediately before the commencement of item 31 of Schedule 1 to the Amendment Act; and

(b) were not located on the hospital premises of a recognized hospital.

13B Applicants operating a category S pathology laboratory who held section 23DNB units

The maximum number of approvals that may be granted to an APA to which paragraph 5 (2) (c) applies is the number that is equal to the number of licensed collection centres that the APA was operating immediately before the commencement of item 31 of Schedule 1 to the Amendment Act.

13C Applicants operating a category S pathology laboratory who have not held section 23DNB units

The maximum number of approvals that may be granted to an APA to which paragraph 5 (2) (d) applies is 1 for each of the premises on which the APA operates a category S pathology laboratory of the kind described in paragraph 5 (2) (d).

Part 4 Other matters

14 Effect of acquisition or disposal of APA business

(1) If an APA (the acquiring APA) acquires business from another APA to which an approval has been granted, the acquiring APA may request the Minister to confirm the transfer of the approval to the acquiring APA from a specified date, not earlier than 2 weeks after the Minister receives the request.

(2) The request must be in writing, and state:

(a) the name of the APA from which the acquiring APA acquired business; and

(b) the nature and extent of the business acquired; and

(i) the name of each APA to which the acquiring APA has disposed of the business; and

(ii) the nature and extent of the business disposed of.

(3) The Minister may confirm the transfer of the approval to the acquiring APA, for so much of the financial year as remains from the specified date, if that action is consistent with the size of the business conducted by the APA as a result of the acquisition and disposition (if any).

(4) In making a decision under subsection (3), the Minister must have regard to the maximum number of approvals that could be granted to the acquiring APA under section 11, as if the APA had been providing the additional pathology service, or services, during the calendar year 2001.

(5) The Minister must not act in a way that increases the number of approvals held by an APA otherwise than:

(a) in accordance with this section; or

(b) to correct an error.

15 Effect of merger of APA businesses

(1) If, after 30 November 2001, an APA to which subsection 10 (1) or 11 (1) applies has merged business with another APA, section 10 or 11 (as appropriate) applies to the APA resulting from the merger as if it were the APA referred to in that subsection.

(2) If an APA to which an approval has been granted merges business with another APA, the merged business may request the Minister to confirm that the approval is effectively held by the APA resulting from the merger.

16 Compliance with the Collection Centre Guidelines

An undertaking given by an applicant under paragraph 5 (3) (b) must include an undertaking to give the Health Insurance Commission 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.

17 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) (b) 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 determined under section 27B of that Act (Gazette No. S 432, 7 December 1994), accessible on the Internet at http://scaleplus.law.gov.au/.

18 Delegation of powers and functions

The Minister may delegate the Minister’s powers and functions under these Principles to the Managing Director of the Health Insurance Commission.

Part 5 Transitional

19 Transitional

In relation to an application for approval made in relation to the financial year that ends on 30 June 2002, the Health Insurance (Eligible Collection Centres) Approval Principles 2001 have effect to the exclusion of these Principles.

Overview

The Health Insurance (Eligible Collection Centres) Approval Principles 2002 were introduced to streamline and regulate the approval process for eligible collection centres under the Health Insurance Act 1973. Enacted by Kay Patterson, the Minister for Health and Ageing, these principles address the need for a structured approach to approving collection centres that meet specific criteria for pathology specimen collection. The policy objective is to ensure that eligible collection centres operate within set guidelines, maintain a high standard of service, and are appropriately equipped and staffed, thereby enhancing the overall efficiency and effectiveness of pathology services provided under the Health Insurance Act. These principles repealed the previous Health Insurance (Eligible Collection Centres) Approval Principles 2001 to incorporate updated criteria and procedural requirements, ensuring that the approval process is both fair and reflective of current operational standards in the pathology sector.

Scope and Application

The Health Insurance (Eligible Collection Centres) Approval Principles 2002 governs the process by which eligible collection centres for pathology services can be approved and operated under the Health Insurance Act 1973. The Act applies to approved pathology authorities (APA) who seek to establish and operate eligible collection centres for the collection of pathology specimens. The Act sets out the criteria for the approval of premises, the process for making applications for approval, and the determination of maximum numbers of approvals granted to different categories of applicants, including those who have held units of entitlement under section 23DNB of the Act prior to certain dates and those who have not held such units. The Act also provides for the transfer of approvals in the event of the acquisition or disposal of APA business, and the merger of APA businesses. Furthermore, the Act requires that applicants comply with the Collection Centre Guidelines and mandates that they notify the Minister of any failures to comply. The Act applies nationally within Australia and is enforced by the Minister for Health and Ageing, who may delegate certain powers and functions to the Managing Director of the Health Insurance Commission. The Act does not specify any exclusions or exemptions, and its provisions may be extended or restricted through subordinate instruments.

Key Provisions

The Health Insurance (Eligible Collection Centres) Approval Principles 2002 (the Principles) set out the criteria and procedures for approving eligible collection centres for pathology services under the Health Insurance Act 1973. Section 4 specifies that an application for approval cannot be considered unless the premises meet specific criteria, including having the necessary equipment for specimen collection and preparation, and staff who are properly trained in these procedures. Section 5 outlines the requirements for an application, including that it must be made by an eligible applicant (defined in section 5(2)) in writing and in a prescribed form. Section 6 addresses the timing of applications, noting that existing approvals must relate to the next financial year and should be lodged by 3 June, while new applications can be made at any time. The Principles impose several obligations on applicants and approved pathology authorities (APA). Under section 8, the maximum number of approvals that can be granted to an APA is determined according to specific provisions outlined in Part 3 of the Principles. Section 16 requires applicants to provide an undertaking that they will comply with the Collection Centre Guidelines and to notify the Health Insurance Commission of any failure to comply within 24 hours. Additionally, section 17 mandates that the Minister must provide written notice of a decision to reconsider an application within 14 days, and applicants have the right to seek review by the Administrative Appeals Tribunal. Breaches of the provisions outlined in the Principles may have legal consequences. Although specific offences and penalties are not detailed within the Principles themselves, non-compliance with the Collection Centre Guidelines and failure to notify the Commission of such non-compliance (section 16) could potentially lead to revocation or cancellation of approvals under the Health Insurance Act 1973. Furthermore, any action by the Minister that increases the number of approvals held by an APA without following the provisions of section 15 could be considered an error and subject to correction. Legal action could also be taken under the Administrative Appeals Tribunal Act 1975 for decisions that affect an applicant’s rights.

Area of Law: Health Law
Instrument: Legislative Instrument
Concepts: Definitions & Interpretation; Commencement Provisions; Licensing & Registration; Review of decisions

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