{"id":"F2020L01179","name":"Health Insurance (Approvals for Eligible Collection Centres) Principles 2020","slug":"health-insurance-approvals-for-eligible-collection-centres-principles-2020","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":440601,"registerId":"F2020L01179-fast-fetch-1775956171088","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Health Insurance (Approvals for Eligible Collection Centres) Principles 2020","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\nmeta-generator: Aspose.Words for .NET 22.10.0\n---\n\n?xml version=\"1.0\" encoding=\"utf-8\" standalone=\"no\"?>\n\n![Commonwealth Coat of Arms of Australia](image.001.jpeg)\n\n \n\nHealth Insurance (Approvals for Eligible Collection Centres) Principles 2020\n\nI, Paul McBride, as delegate of the Minister for Health, make the following principles.\n\nDated 14 September 2020\n\nPaul McBride\n\nFirst Assistant Secretary  Medical Benefits Division  Department of Health\n\n \n\n \n\n \n\n \n\nContents\n\nPart 1—Preliminary\n\n1 Name\n\n2 Commencement\n\n3 Authority\n\n4 Schedules\n\n5 Definitions\n\nPart 2—Granting approvals for eligible collection centres\n\nDivision 1—Prerequisites for grant of approval\n\nSubdivision A—General\n\n6 Prerequisites\n\nSubdivision B—Requirements for application\n\n7 Applicant\n\n8 Form and content of application\n\nSubdivision C—Requirements for premises where centre is conducted\n\n9 Requirements for premises\n\nDivision 2—Notice of decision on granting of approval\n\n10 Giving notice to applicant\n\nDivision 3—Duration of approval\n\n11 Duration of approval\n\nPart 3—Application, saving and transitional provisions\n\nDivision 1—Provisions for this instrument as originally made\n\n12 Continuation of approvals\n\n13 Continuation of form until new form approved\n\nSchedule 1—Repeals\n\nHealth Insurance (Eligible Collection Centres) Approval Principles 2010\n\nPart 1—Preliminary\n\n \n\n1  Name\n\n  This instrument is the Health Insurance (Approvals for Eligible Collection Centres) Principles 2020.\n\n2  Commencement\n\n (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.\n\n \n\n- Commencement information\n- Column 1 Column 2 Column 3\n- Provisions Commencement Date/Details\n- 1. The whole of this instrument 1 October 2020. 1 October 2020\n\n\nNote: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.\n\n (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.\n\n3  Authority\n\n  This instrument is made under subsection 23DNBA(4) of the Health Insurance Act 1973.\n\n4  Schedules\n\n  Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.\n\n5  Definitions\n\nNote: A number of expressions used in this instrument are defined in the Act, including the following:\n\n(a) accredited pathology laboratory;\n\n(b) approved pathology authority.\n\n  In this instrument:\n\nAct means the Health Insurance Act 1973.\n\nAPA means approved pathology authority.\n\napproval, for an eligible collection centre, has the meaning given by subsection 23DA(1) of the Act.\n\ncategory G pathology laboratory means an accredited pathology laboratory the premises of which are approved under section 23DN of the Act as a category GX or category GY accredited pathology laboratory.\n\ncategory S pathology laboratory means an accredited pathology laboratory the premises of which are approved under section 23DN of the Act as a category S accredited pathology laboratory.\n\nCollection Centre Guidelines has the meaning given by subsection 23DA(1) of the Act.\n\neligible collection centre has the meaning given by subsection 23DA(1) of the Act.\n\nPart 2—Granting approvals for eligible collection centres\n\nDivision 1—Prerequisites for grant of approval\n\nSubdivision A—General\n\n6  Prerequisites\n\n  The Minister must not grant an approval for an eligible collection centre unless:\n\n (a) an application for the approval has been made and meets the requirements of Subdivision B; and\n\n (b) the requirements of Subdivision C are met for the premises on which the eligible collection centre is, or is to be, conducted.\n\nSubdivision B—Requirements for application\n\n7  Applicant\n\n (1) The application must be made by an APA who is covered by one of subsections (2), (3) and (4).\n\nOperator and proprietor of category G pathology laboratory\n\n (2) This subsection covers an APA who operates, and is the proprietor of, an accredited pathology laboratory that is a category G pathology laboratory.\n\nAPA with arrangement for use of category G pathology laboratory\n\n (3) This subsection covers an APA who:\n\n (a) has entered into an arrangement with another APA for the use of an accredited pathology laboratory that is a category G pathology laboratory; and\n\n (b) before the commencement of this instrument, had an approval for an eligible collection centre granted in accordance with the Health Insurance (Eligible Collection Centres) Approval Principles 2010 because the APA was an eligible applicant because of paragraph 5(2)(b) of that instrument.\n\nOperator and proprietor of category S pathology laboratory\n\n (4) This subsection covers 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 only specimens for the kind of pathology services in respect of which the premises of the laboratory are approved under section 23DN of the Act.\n\n8  Form and content of application\n\n (1) The application must be in writing and in a form approved by the Minister.\n\n (2) The application must include:\n\n (a) a response to each question in the approved form; and\n\n (b) information (if any) that is reasonably necessary to substantiate or explain each response; and\n\n (c) additional information (if any) that is required by the Minister to be provided at the time of lodgement of the application to allow the application to be decided; and\n\n (d) a written undertaking that the applicant:\n\n (i) will comply with the Collection Centre Guidelines in operating the eligible collection centre while the approval is in force, except so far as the Minister accepts that compliance with some, or all, provisions of the Guidelines is not reasonably practicable in particular circumstances; and\n\n (ii) will, within 24 hours after a failure to comply with the Collection Centre Guidelines in operating the eligible collection centre while the approval is in force, give the Chief Executive Medicare written notice of the failure and the reason for the failure.\n\nSubdivision C—Requirements for premises where centre is conducted\n\n9  Requirements for premises\n\n (1) This section applies to the premises where the eligible collection centre is, or is to be, conducted.\n\n (2) On the premises there must be the equipment necessary for the collection and preparation of specimens for pathology procedures.\n\n (3) The staff at the premises must:\n\n (a) include persons trained in procedures for the collection and preparation of pathology specimens; and\n\n (b) be persons who are either:\n\n (i) employed by the APA who has made the application for the approval; or\n\n (ii) engaged directly or indirectly by the APA under a contract that gives the APA power to generally direct or control the work of the persons on the premises.\n\nDivision 2—Notice of decision on granting of approval\n\n10  Giving notice to applicant\n\n  The Minister must give an APA who applies for approval for an eligible collection centre written notice of:\n\n (a) the decision to grant or not grant the approval; and\n\n (b) if the decision is to not grant the approval—the applicant’s right under subsection 23DO(2DA) of the Act to apply to the Minister for reconsideration of the decision.\n\nDivision 3—Duration of approval\n\n11  Duration of approval\n\n (1) An approval for an eligible collection centre has effect for 2 years starting on the day it comes into force, subject to:\n\n (a) section 23DNG of the Act (revocation of approval on the Minister’s initiative); and\n\n (b) section 23DNH of the Act (cancellation of approval on request).\n\n (2) An approval for an eligible collection centre comes into force:\n\n (a) on the day it is granted; or\n\n (b) on the day specified in the notice of the approval, which must not be a day before the approval was granted, unless the Minister is satisfied that special circumstances justify specifying an earlier day.\n\nPart 3—Application, saving and transitional provisions\n\nDivision 1—Provisions for this instrument as originally made\n\n12  Continuation of approvals\n\n  To avoid doubt, the repeal of the Health Insurance (Eligible Collection Centres) Approval Principles 2010 by this instrument does not affect the period for which an approval for an eligible collection centre granted before that repeal is in force.\n\n13  Continuation of form until new form approved\n\n (1) This section has effect for the purposes of subsection 8(1) and applications made before the Minister approves a form for the purposes of that subsection.\n\n (2) The form that was prescribed by the Minister for the purposes of the Health Insurance (Eligible Collection Centres) Approval Principles 2010 immediately before 1 October 2020 has effect as if it were approved by the Minister for the purposes of subsection 8(1) of this instrument.\n\n (3) The form has effect as if:\n\n (a) the first declaration in section 30 of the form were an undertaking described in subparagraph 8(2)(d)(i) of this instrument; and\n\n (b) the first and second understandings in section 30 of the form were an undertaking described in subparagraph 8(2)(d)(ii) of this instrument.\n\nSchedule 1—Repeals\n\n \n\nHealth Insurance (Eligible Collection Centres) Approval Principles 2010\n\n1  The whole of the instrument\n\nRepeal the instrument.\n\n \n","sortOrder":0}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"This instrument appears to be a straightforward re-enactment and update of the 2010 Approval Principles. It maintains the same core purpose — setting approval requirements for eligible collection centres — with modernised drafting and transitional arrangements. There is no evidence of scope creep beyond the original intent of regulating pathology collection centre approvals."},"complexity_factors":["Moderate cross-referencing to the Health Insurance Act 1973 (definitions like 'eligible collection centre' and 'approval' are defined externally in the parent Act)","Conditional eligibility requirements for applicants — three separate categories in subsections 7(2), 7(3), and 7(4) with specific preconditions","Transitional provisions (sections 12-13) that preserve existing approvals and forms from the repealed 2010 instrument","Nested conditions in section 8(2)(d) requiring undertakings about compliance with separate Collection Centre Guidelines","13 defined terms or external references in the interpretation section (section 5), including category G and category S pathology laboratory definitions that themselves reference other sections of the Act"],"plain_english_summary":"This instrument updates the rules for who can get government approval to run eligible collection centres — where patients give blood or other pathology samples — replacing 2010 requirements. It limits applications to approved pathology authorities (Category G or S), sets application, staffing and equipment expectations, and makes approvals time-limited.\n\nIt affects pathology companies, patients accessing collection services (and Medicare coverage), and the Minister who grants approvals, ensuring centres meet safety and operational standards."},"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":false,"description":"This instrument repeals the 2010 Approval Principles and replaces them with largely equivalent procedural rules for approvals (see Schedule 1). It preserves approvals granted under the prior instrument and the previously prescribed form until a new form is approved (ss12–13), so the practical scope of who may be approved and the approval duration (2 years, s11) is maintained rather than broadened or narrowed materially."},"complexity_factors":["Relies on multiple external definitions and powers in the Health Insurance Act 1973 (authority at s3; defined terms referenced throughout).","Different eligibility paths for applicants (operators/proprietors of category G labs, APAs with arrangements, and some category S operators) increase procedural nuance (see s7).","Detailed application content and undertakings, including an obligation to comply with Collection Centre Guidelines and 24‑hour breach reporting, create ongoing compliance burdens (s8(2)(d)).","Premises and staffing rules require demonstrable equipment and staff either employed by or contractually controlled by the APA, which affects contracting and HR arrangements (s9(2)–(3)).","Ministerial decision-making and notice obligations are prescribed but the instrument preserves statutory revocation/cancellation powers in the Act (s10; s11 cross-referring to ss23DNG/23DNH of the Act).","Transitional and saving provisions maintaining prior approvals and the old form until replaced add administrative continuity but require agencies to track legacy approvals (ss12–13; Schedule 1).","Dependency on external Collection Centre Guidelines (not reproduced here) means substantive operational rules sit outside this instrument, increasing interpretive complexity."],"plain_english_summary":"This instrument replaces the 2010 approval principles and sets the rules for granting, holding and ending Medicare approvals for eligible collection centres. It specifies who may apply (approved pathology authorities operating or using category G labs, or certain category S lab operators), the information and written undertakings required in an application, premises and staff requirements, and that approvals run for two years.\n\nThe Minister decides and must give written notice of decisions. Applicants must follow the Collection Centre Guidelines and notify Medicare within 24 hours of any guideline breach. Transitional clauses preserve existing approvals and the prior application form until replaced."},"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"}},"importantCases":[],"_links":{"self":"/api/acts/health-insurance-approvals-for-eligible-collection-centres-principles-2020","history":"/api/acts/health-insurance-approvals-for-eligible-collection-centres-principles-2020/history","analysis":"/api/acts/health-insurance-approvals-for-eligible-collection-centres-principles-2020/analysis","conflicts":"/api/acts/health-insurance-approvals-for-eligible-collection-centres-principles-2020/conflicts","importantCases":"/api/acts/health-insurance-approvals-for-eligible-collection-centres-principles-2020/important-cases","documents":"/api/acts/health-insurance-approvals-for-eligible-collection-centres-principles-2020/documents"}}