Health Insurance (Eligible Collection Centres) Approval Principles 2001 (Cth)

Health Insurance (Eligible Collection Centres) Approval Principles 2001

as amended

made under subsection 23DNBA (4) of the

Health Insurance Act 1973

This compilation was prepared on 12 December 2001
taking into account amendments up to Health Insurance (Eligible Collection Centres — Approvals) Principles (Amendment number 2) 2001

Prepared by the Office of Legislative Drafting,
Attorney-General’s Department, Canberra

Contents

Page

Part 1                 Introductory

1  Name of Principles [see Note 1]   3

2  Commencement   3

3  Definitions   3

Part 2                 General principles for applications

4  Eligibility of premises for approval   4

5  Application for approval   4

6  Timing of application   5

7  Approvals   5

Part 3                 Principles determining maximum numbers of approvals

8  Maximum number of approvals   7

9  Consequence of location of eligible collection centre   7

10  Applicants holding section 23DNB units before 1 October 1999                   7

11  Applicants holding section 23DNB units on or after 1 October 1999             8

12  Applicants who have not held section 23DNB units   9

13  Applicants who have been recipients of a Health Program Grant                10

13A  Applicants who are not the sole proprietor of a category G laboratory who have collection centres in rural and remote areas   10

13B  Applicants who are the proprietors of a category S laboratory                    11

Part 4                 Other matters

14  Effect of acquisition or disposal of APA business   12

15  Effect of merger of APA businesses   12

16  Compliance with the Collection Centre Guidelines   13

17  Review of decisions   13

18  Delegation of powers and functions   13

Notes   14

Part 1                 Introductory

1. Name of Principles [see Note 1]

These Principles are the Health Insurance (Eligible Collection Centres) Approval Principles 2001.

1. Commencement

These Principles commence on 1 December 2001.

1. 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 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.

(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

1. 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.

1. 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:

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

(ii)    immediately before the commencement of item 31 of Schedule 1 to the Amendment Act was operating collection centres in locations that, in the document entitled ‘Rural/Remote Areas Classification’ published by the Department of Human Services and Health in January 1994, are:

(A)     Rural Major Statistical Local Areas; or

(B)     Rural Other Statistical Local Areas; or

(C)     Remote Major Statistical Local Areas; or

(D)     Remote Other Statistical Local Areas

and not located on hospital premises of a recognised hospital and is not the sole owner of a category G pathology laboratory but has entered into an arrangement with another APA for the use of an accredited pathology laboratory that is a category G pathology laboratory; or

(iii) is a Category S laboratory holding units of entitlement to operate a licenced collection centre that were allocated under section 23DNB of the Act, as in force immediately before the commencement of item 31 of Schedule 1 to the Amendment Act.

(b)     in writing and in the prescribed form.

Note   Prescribed forms may be obtained from the Health Insurance Commission.

(2)   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.

1. Timing of application

General rules

(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 1 May 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.  See, however, subsection 7 (3).

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

Applications relating to financial year ending on 30 June 2002

(3)   Despite subsection (1), an application relating to the financial year ending on 30 June 2002 may be made, whether by the holder of an existing approval or otherwise:

(a)    during that financial year; and

(b)    at any time following the commencement of these Principles and before that date.

Note 1   An application made later than 1 November 2001 may not be able to be processed in time for approval, if granted, to begin to take effect on 1 December 2001.

Note 2   An application made later than 1 May 2002 may not be able to be processed in time for approval, if granted, to begin to take effect before the end of the financial year.

Definition

(4)   For this section:

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

1. 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)   However, for an application made in the period beginning at the commencement of these Principles and ending on 30 June 2002:

(a)    an approval may be expressed to commence on an appropriate day later than 1 July 2001; and

(b)    subsection (2) does not apply.

(4)   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

1. 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   At present, this Part takes account only of operation of the collection centres approval scheme until 30 June 2002.  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 type="1">

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 document entitled ‘Rural/Remote Areas Classification’ published by the Department of Human Services and Health in January 1994, are:

(a)    Rural Other statistical local areas; or

(b)    Remote Other statistical local areas.

Note   The Rural/Remote Areas Classification document published by the Department of Human Services and Health in January 1994 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.

1. 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 held units of entitlement to operate a licensed collection centre that were issued under section 23DNB of the Act before 1 October 1999; and

(b)    it subsequently held units of entitlement to operate a licensed collection centre that were issued on or after that date, and continued to hold those units on 1 July 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 2000; 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

(c)    by applying subsection (3), (4) or (5) to the result, as the case requires; 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 1 July 2001, the maximum number of approvals that the APA may be granted is the number that is 10% higher than the number of units of entitlement so held.

(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 1 July 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 1 July 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 2002, 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.

1. 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 issued under section 23DNB of the Act on or after 1 October 1999, and continued to hold those units on 1 July 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 2000; 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

(c)    by halving the number resulting from paragraph (b); 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)    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 1 July 2001;

(c)    2.

(4)   For an APA that proposes to operate, in the financial year ending on 30 June 2002, 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.

1. Applicants who have not held section 23DNB units

(1)   An APA may be granted the maximum number of approvals determined under this section if 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 1 July 2001, business from another APA for which units of entitlement were issued under section 23DNB of the Act.

(2)   The maximum number is determined:

(a)    by dividing, by 14 200, the number of patient episodes for which the APA (or the APA from which the business was acquired) provided a pathology service, or services, during the calendar year 2000; 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

(c)    by halving the number resulting from paragraph (b); 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)    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.

(4)   For an APA that proposes to operate, in the financial year ending on 30 June 2002, 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.

(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:

(a) that were issued under section 23DNB of the Act; and

(b)    to which section 10 or 11 applies.

1. Applicants who have been recipients of a Health Program Grant

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

(a)    immediately before the commencement of item 31 of Schedule 1 to the Amendment Act, it has been the recipient of funding under a Health Program Grant administered by the Minister for Health and Aged Care; and

(b)    it continues to operate specimen collection centres that are located on hospital premises of a recognized hospital.

(2)   For the financial year ending on 30 June 2002, the maximum number is the number that is equal to the number of specimen collection centres that:

(a)    the APA was operating at the time when its provision of pathology services first entitled a person to payment of Medicare benefit; and

(b)    at that time, were not located on hospital premises of a recognized hospital.

13A         Applicants who are not the sole proprietor of a category G laboratory who have collection centres in rural and remote areas

The maximum number of approvals that may be granted to an APA to which subparagraph 5 (1) (a) (ii) applies is the number that is equal to the number of specimen collection centres collection centres not located on hospital premises of a recognised hospital that the APA was operating immediately before the commencement of item 31 of Schedule 1 to the Amendment Act.

13B         Applicants who are the proprietors of a category S laboratory

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

Part 4                 Other matters

1. 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

(c)    if the acquiring APA has disposed of business during the financial year to which the approval relates:

(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 2000.

(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.

1. Effect of merger of APA businesses

(1)   If, after 1 July 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.

1. Compliance with the Collection Centre Guidelines

An undertaking given by an applicant under paragraph 5 (2) (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.

1. 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 (2) (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 type="1">

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.

Notes to the Health Insurance (Eligible Collection Centres) Approval Principles 2001

Note 1

The Health Insurance (Eligible Collection Centres) Approval Principles 2001 (in force under subsection 23DNBA (4) of the Health Insurance Act 1973) as shown in this compilation is amended as indicated in the Tables below.

Table of Instruments

Title	Date of notification in Gazette	Date of commencement	Application, saving or transitional provisions
Health Insurance (Eligible Collection Centres) Approval Principles 2001	3 Oct 2001 (see Gazette 2001, No. GN39)	1 Dec 2001
Health Insurance (Eligible Collection Centres — Approvals) Principles 2001 (2001 No. 1) (a)	28 Nov 2001 (see Gazette 2001, No. GN47)	1 Dec 2001	—
Health Insurance (Eligible Collection Centres — Approvals) Principles (Amendment number 2) 2001	30 Nov 2001 (see Gazette 2001, No. S473)	1 Dec 2001	—

(a)    Clause 3 of the Health Insurance (Eligible Collection Centres — Approvals) Principles 2001 (2001 No. 1) provides as follows:

These Principles cease to have effect on the 30 June 2002.

Table of Amendments

ad. = added or inserted      am. = amended      rep. = repealed      rs. = repealed and substituted
Provision affected	How affected
C. 3 .........................................	am. 2001 No. 2
C. 5..........................................	am. 2001 Nos. 1 and 2
C. 13A.....................................	ad. 2001 No. 1
C. 13B.....................................	ad. 2001 No. 2