{"id":"F2022L01003","name":"Health Insurance (Section 3C Diagnostic Imaging Services – PET and Gallium-67 Services) Determination 2022","slug":"health-insurance-section-3c-diagnostic-imaging-services-pet-and-gallium-67-services-determination-20","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":102535,"registerId":"commonwealth-F2022L01003-current","compilationNumber":null,"startDate":"2026-04-03","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\n This instrument is the Health Insurance (Section 3C Diagnostic Imaging Services – PET and Gallium-67 Services) Determination 2022","sortOrder":0},{"sectionNumber":"2","sectionType":"section","heading":"Commencement","content":"#### 2 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```html\n

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1. The whole of this instrument

1 August 2022

\n```\n\n Note: This table relates only to the provisions of this instrument as originally made.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 (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.","sortOrder":1},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\n This instrument is made under subsection 3C(1) of the Health Insurance Act 1973","sortOrder":2},{"sectionNumber":"4","sectionType":"section","heading":"Definitions","content":"#### 4 Definitions\n\n (1) In this instrument:\n\nAct means the Health Insurance Act 1973.\n\nPET means positron emission tomography.\n\n(R) has the meaning given by clause 1.2.15 of the diagnostic imaging services table.\n\nrelevant provisions means all provisions, of the Act and regulations made under the Act, and the National Health Act 1953 and regulations made under the National Health Act 1953, relating to medical services, professional services or items.\n\nrelevant service means a health service, as defined in subsection 3C(8) of the Act, that is specified in a Schedule.\n\nreport means a report prepared by a medical practitioner.\n\nSchedule means a Schedule to this instrument.\n\n \n\nNote: The following terms are defined in subsection 3(1) of the Act:\n\n clinically relevant service;\n\n diagnostic imaging services table;\n\n item; and\n\n professional service.\n\n(2) Unless the contrary intention appears, a reference in this instrument to a provision of the Act or the National Health Act 1953 or regulations made under the Act or under the National Health Act 1953 as applied, adopted or incorporated in relation to specifying a matter is a reference to those provisions as in force from time to time and any other reference to provisions of an Act or regulations is a reference to those provisions as in force from time to time.","sortOrder":3},{"sectionNumber":"5","sectionType":"section","heading":"Treatment of relevant services","content":"#### 5 Treatment of relevant services\n\n(1) For subsection 3C(1) of the Act, a relevant service, provided in accordance with this instrument and as a clinically relevant service, is to be treated, for the relevant provisions, as if:\n\n(a) it were both a professional service and a diagnostic imaging service; and\n\n(b) there were an item in the diagnostic imaging services table that:\n\ni. related to the service; and\n\nii. specified for the service a fee in relation to each State, being the fee specified in the Schedule in relation to the service.","sortOrder":4},{"sectionNumber":"6","sectionType":"section","heading":"Application of provisions of the diagnostic imaging services table","content":"#### 6 Application of provisions of the diagnostic imaging services table\n\n(1) Clause 1.2.17 of the diagnostic imaging services table shall have effect as if the items in Schedule 1 of this instrument were specified for the purpose of that clause.\n\n(2) Clause 2.4.2 of the diagnostic imaging services table does not apply to the items in Schedule 1 of this instrument.","sortOrder":5},{"sectionNumber":"7","sectionType":"section","heading":"Restriction on items — services connected with provision of PET nuclear scanning during Gallium-67 interruptions","content":"#### 7 Restriction on items – services connected with provision of PET nuclear scanning during Gallium-67 interruptions\n\n(1) An item in Schedule 1 of this instrument only applies to a service described in the item, if:\n\n(a) the patient’s clinical condition requires the service to be performed before the resumption of normal gallium-67 (Ga-67) supply is anticipated by the practitioner who provides the service; and\n\n(b) the report of the service performed includes a justification for the substitute service, which describes the unavailability of a service to which item 61429, 61430, 61442, 61450 or 61453 applies.","sortOrder":6},{"sectionNumber":"8","sectionType":"section","heading":"PET nuclear scanning services","content":"#### 8 PET nuclear scanning services\n\n(1) Item 61527 applies only if the service is performed on a person:\n\n(a) in a comprehensive facility; and\n\n(b) in accordance with sections 9 and 10.\n\n(2) Also, the item applies only if the owner or operator of the equipment used to perform the service is not in breach of section 11.","sortOrder":7},{"sectionNumber":"9","sectionType":"section","heading":"PET nuclear scanning services—performance under personal supervision","content":"#### 9 PET nuclear scanning services—performance under personal supervision\n\n(1) For the purposes of section 8, the service must be performed on a person by or under the personal supervision of:\n\n(a) a credentialled specialist; or\n\n(b) a medical practitioner other than the requesting practitioner if the medical practitioner:\n\n(i) is a Fellow of the RACP or RANZCR; and\n\n(ii) has reported 400 or more studies forming part of PET services for which a medicare benefit was payable; and\n\n(iii) is authorised under State or Territory law to prescribe and administer to humans the PET radiopharmaceuticals that are to be administered to the person; and\n\n(iv) met the requirements of subparagraphs (i), (ii) and (iii) before 1 November 2011.\n\nNote: For the purposes of this section, RACP means The Royal Australasian College of Physicians; and RANZCR means The Royal Australian and New Zealand College of Radiologists.","sortOrder":8},{"sectionNumber":"10","sectionType":"section","heading":"PET nuclear scanning services—equipment","content":"#### 10 PET nuclear scanning services—equipment\n\n(1) For the purposes of section 8, the service must be performed on a person using equipment that meets the requirements set out in Requirements for PET Accreditation (Instrumentation & Radiation Safety) 3rd Edition (2017), issued by the Australian and New Zealand Society of Nuclear Medicine Inc, as existing on 1 July 2020.\n\nNote: The Requirements for PET Accreditation (Instrumentation & Radiation Safety) 3rd Edition (2017) could in 2020 be viewed on the website of the Society ([https://www.anzsnm.org.au](https://www.anzsnm.org.au)).","sortOrder":9},{"sectionNumber":"11","sectionType":"section","heading":"PET nuclear scanning services—statutory declaration","content":"#### 11 PET nuclear scanning services—statutory declaration\n\n(1) The owner or operator mentioned in subsection 8(2) must have given a statutory declaration to the Chief Executive Medicare that includes the following information:\n\n(a) whether the owner or operator is a credentialed specialist or a medical practitioner who satisfies the requirements mentioned in subparagraphs 9(1)(b)(i) to (iv);\n\n(b) whether the place where the owner or operator provides the service is in a comprehensive facility;\n\n(c) whether the equipment meets the requirements mentioned in section 10;\n\n(d) the facility’s address;\n\n(e) the provider number for the facility given by the Chief Executive Medicare;\n\n(f) the location specific practice number for the facility given by the Minister;\n\n(g) the models, serial numbers and manufacturers of the equipment.\n\n(2) If the matters declared in the statutory declaration change, the owner or operator must give the Chief Executive Medicare written notice of the change as soon as the owner or operator knows about the change.","sortOrder":10},{"sectionNumber":"Schedule 1","sectionType":"section","heading":"Relevant services","content":"#### Schedule 1 — Relevant services\n\n```html\n

Group I4 – Nuclear Medicine Imaging

Column 1

Item

Column 2

Description

Column 3

Fee ($)

Subgroup 2– PET

61527

Whole body study using PET, if the service is performed because the services to which items 61429, 61430, 61442, 61450 or 61453 apply cannot be performed due to unavailability of gallium-67 (R)

752.35

\n```","sortOrder":11}],"analysis":{"flash_summary":{"complexity_score":6,"scope_assessment":{"changed":true,"description":"This instrument expands Medicare coverage by creating a new diagnostic imaging item for PET scans used as substitutes during gallium‑67 supply interruptions and treating those services as both professional and diagnostic imaging services (cl 5; Schedule 1). It limits application to specified clinical circumstances (cl 7) and adds substantive eligibility and compliance conditions—facility type, supervision, equipment standard, reporting and statutory declarations (cls 8–11)—thereby changing which services and providers are within the Act’s payable scope."},"complexity_factors":["Cross‑references to primary legislation and the diagnostic imaging services table (authority under s3C(1); treatment rule in cl 5; application changes in cl 6).","Conditional entitlement tied to an external supply interruption (substitution only when Ga‑67 services are unavailable; cl 7).","Multiple operational eligibility tests: facility type, personal supervision and practitioner credentials (cls 8–9).","Technical equipment standard specified by an external document and a fixed historical version date (Requirements for PET Accreditation (2017) as at 1 July 2020; cl 10).","Administrative compliance demands on owners/operators: statutory declaration content, provider and practice numbers, notification duties (cl 11).","Reporting burden on clinicians: service report must justify substitution and describe unavailability of specific Ga‑67 items (cl 7).","A single, high-value fee set in the Schedule (item 61527, $752.35) concentrates financial effects and incentive to comply precisely with conditions (Schedule 1).","Explicit exclusion of an existing diagnostic imaging clause for these items (cl 6(2)), which changes how other table rules apply.","Dependence on defined terms and external accrediting bodies (definitions in cl 4; references to RACP/RANZCR in cl 9).","Temporal and commencement detail that could affect retrospective application and administrative implementation (cl 2)."],"plain_english_summary":"This instrument adds an MBS diagnostic imaging item (61527) that treats certain PET whole‑body studies as Medicare‑payable diagnostic imaging professional services with a specified fee when gallium‑67 services are unavailable. It affects medical practitioners, facility owners/operators and Medicare administration by imposing supervision, equipment accreditation, reporting and statutory‑declaration requirements that determine entitlement to the $752.35 fee."},"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"},"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"This instrument maintains its original narrow purpose. It was always intended to provide a temporary substitute pathway for PET scans during gallium-67 shortages, and it continues to serve that specific function without expansion into broader diagnostic imaging services."},"complexity_factors":["Multiple nested conditions: item 61527 only applies if 5 separate conditions are met (sections 7, 8, 9, 10, and 11)","Cross-references to external documents: incorporates by reference the 'Requirements for PET Accreditation (Instrumentation & Radiation Safety) 3rd Edition (2017)'","Historical qualification cutoff: section 9 requires practitioners to have met requirements before 1 November 2011, creating a grandfathering clause","Dual statutory framework: operates under both the Health Insurance Act 1973 and National Health Act 1953","Defined terms rely on external tables: 'diagnostic imaging services table' and 'item' are defined in the parent Act, not this instrument","Specific exclusion: clause 2.4.2 of the diagnostic imaging services table explicitly does not apply to these items"],"plain_english_summary":"Medicare will cover a single full‑body PET scan as a substitute only when gallium‑67 is unavailable, provided the clinician documents why waiting for gallium‑67 wasn’t possible. Coverage requires the scan be done in a comprehensive facility, meet 2017 equipment/safety standards, be personally supervised by an approved or pre‑Nov 2011 specialist, and include a statutory declaration from the facility owner. This affects patients facing gallium supply delays, nuclear‑medicine specialists, and PET-capable facilities."}},"importantCases":[],"_links":{"self":"/api/acts/health-insurance-section-3c-diagnostic-imaging-services-pet-and-gallium-67-services-determination-20","history":"/api/acts/health-insurance-section-3c-diagnostic-imaging-services-pet-and-gallium-67-services-determination-20/history","analysis":"/api/acts/health-insurance-section-3c-diagnostic-imaging-services-pet-and-gallium-67-services-determination-20/analysis","conflicts":"/api/acts/health-insurance-section-3c-diagnostic-imaging-services-pet-and-gallium-67-services-determination-20/conflicts","importantCases":"/api/acts/health-insurance-section-3c-diagnostic-imaging-services-pet-and-gallium-67-services-determination-20/important-cases","documents":"/api/acts/health-insurance-section-3c-diagnostic-imaging-services-pet-and-gallium-67-services-determination-20/documents"}}