Health Insurance (Eligible Collection Centres) Approval Principles 2004 (Cth)
Health Insurance (Eligible Collection Centres) Approval Principles 2004
I, TONY ABBOTT, Minister for Health and Ageing, acting under subsection 23DNBA (4) of the Health Insurance Act 1973:
(a) subject to section 21 of the following Principles, repeal the Health Insurance (Eligible Collection Centres) Approval Principles 2003; and
(b) make the following Principles.
Dated 27 April 2004
TONY ABBOTT
Minister for Health and Ageing
Contents
Part 1Preliminary
1Name of Principles 2
2Commencement 2
3Definitions 2
Part 2General principles for applications
4Eligibility of premises for approval 2
5Application for approval 2
6Timing of application 2
7Approvals 2
Part 3Principles determining maximum numbers of approvals
8Maximum number of approvals 2
9Consequence of location of eligible collection centre 2
10Applicants holding section 23DNB units before 1 October 1999 2
11Applicants holding section 23DNB units on or after 1 October 1999 2
12Applicants who have not held section 23DNB units 2
13Applicants relying on an arrangement with the owner of a category G pathology laboratory and who operate collection centres in rural or remote areas 2
14Applicants operating a category S pathology laboratory who held section 23DNB units 2
15Applicants operating a category S pathology laboratory who have not held section 23DNB units 2
Part 4Other matters
16Effect of acquisition or disposal of APA business 2
17Effect of merger of APA businesses 2
18Compliance with the Collection Centre Guidelines 2
19Review of decisions 2
20Delegation of powers and functions 2
Part 5Transitional
21Transitional 2
Part 1 Preliminary
Name of Principles
These Principles are the Health Insurance (Eligible Collection Centres) Approval Principles 2004.
Commencement
These Principles commence on the date of their notification in the Gazette.
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 2002, has accreditation as a category GX or category GY laboratory.
Note The Health Insurance (Accredited Pathology Laboratories — Approval) Principles 2002 is accessible on the Internet at S pathology laboratory means an accredited pathology laboratory that, under the Health Insurance (Accredited Pathology Laboratories — Approval) Principles 2002, 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 was repealed on 1 December 2001.
patient episode means a pathology service or pathology services:
(a) that are provided in the circumstances mentioned in the definition of patient episode in the pathology services table; and
(b) for which benefits are payable:
(i) under medicare; or
(ii) by the Department of Veterans’ Affairs under a Repatriation Commission arrangement; or
(iii) by the Department of Health and Ageing under the contingency fund for former recipients of health program grants for the provision of rural and remote pathology services.
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.
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 subsection 23DA (1) of the Act has the same meaning in these Principles as it has in 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
Eligibility of premises for approval
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 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.
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 the Health Insurance Commission.
(2) For subsection (1), an APA is an eligible applicant if the APA:
(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) 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:
(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.
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 1 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.
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 a 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 by the Minister under section 23DO of the Act.
Part 3 Principles determining maximum numbers of approvals
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 2005. 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:
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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 (5), 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.
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) Subject to subsection (5), the maximum number of approvals that the APA may be granted under this section is worked out as follows:
(a) if the number determined under subsection (4) is greater, by 10% or more, than the maximum number that applied to the APA for the previous financial year, and the maximum number for the previous financial year was 5 or more — the whole number nearest to the number that is 10% greater than the maximum number for the previous financial year;
(b) if the number determined under subsection (4) is greater, by 10% or more, than the maximum number that applied to the APA for the previous financial year, and the maximum number for the previous financial year was less than 5 — the number determined under subsection (4);
(c) if the number determined under subsection (4) is greater, by less than 10%, than the maximum number that applied to the APA for the previous financial year — the number determined under subsection (4);
(d) if the number determined under subsection (4) is less, by 10% or more, than the maximum number that applied to the APA for the previous financial year — the whole number nearest to the number that is 10% less than the maximum number of approvals for the previous financial year;
(e) if the number determined under subsection (4) is less, by less than 10%, than the maximum number that applied to the APA for the previous financial year — the number determined under subsection (4).
(3) For paragraphs (2) (a) and (d), if the number that is 10% greater or less, as the case may be, than the maximum number that applied to the APA for the previous financial year is equidistant from 2 whole numbers, the higher of those whole numbers is taken to be the nearest whole number.
(4) For subsection (2), the 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 2003; and
(b) if the result includes a fraction, by rounding it to the nearest whole number and, in the event of the fraction being 0.5, by rounding up.
(5) For an APA that proposes to operate an eligible collection centre in the same premises as it operates a category G pathology laboratory in the financial year ending on 30 June 2005, the maximum number of approvals is increased by one for each eligible collection centre that it proposes to operate in the same premises as it operates a category G pathology laboratory.
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 an APA to which paragraph 5 (2) (a) applies; and
(b) it is not an APA to which section 10 applies; and
(c) 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.
(2) Subject to subsection (4), the maximum number of approvals that the APA may be granted under this section is the higher of the following:
(a) the number worked out under subsection (3);
(b) 2.
(3) For paragraph (2) (a), the 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 2003; 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.
(4) For an APA that proposes to operate an eligible collection centre in the same premises as it operates a category G pathology laboratory in the financial year ending on 30 June 2005, the maximum number of approvals is increased by one for each eligible collection centre that it proposes to operate in the same premises as it operates a category G pathology laboratory.
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:
(a) it is not an APA to which section 10 or 11 applies; or
(b) whether or not paragraph (a) applies — it 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, it had been the recipient of funding under a Health Program Grant administered by the Minister.
(2) Subject to subsection (4), the maximum number of approvals that the APA may be granted under this section is the higher of the following:
(a) the number worked out under subsection (3);
(b) 2.
(3) For paragraph (2) (a), the 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 2003; 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.
(4) For an APA that proposes to operate an eligible collection centre in the same premises as it operates a category G pathology laboratory in the financial year ending on 30 June 2005, the maximum number of approvals is increased by one for each eligible collection centre that it proposes to operate in the same premises as it operates a category G pathology laboratory.
(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.
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.
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.
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 one 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
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 2003.
(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.
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.
Compliance with the Collection Centre Guidelines
An undertaking given by an applicant under paragraph 5 (3) (b) must include an undertaking to give to 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.
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:
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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
Transitional
In relation to an application for approval made in relation to the financial year that ends on 30 June 2004, the Health Insurance (Eligible Collection Centres) Approval Principles 2003 have effect instead of these Principles.
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