{"id":"F2019L01195","name":"Health Insurance (Section 3C Diagnostic Imaging – Nuclear Medicine Services) Determination 2019","slug":"health-insurance-section-3c-diagnostic-imaging-nuclear-medicine-services-determination-2019","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":99793,"registerId":"commonwealth-F2019L01195-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1. Name","sectionType":"part","heading":"1. Name","content":"# 1. Name\n\nThis instrument is the Health Insurance (Section 3C Diagnostic Imaging – Nuclear Medicine Services) Determination 2019.","sortOrder":0},{"sectionNumber":"3. Authority","sectionType":"part","heading":"3. Authority","content":"# 3. Authority\n\nThis instrument is made under subsection 3C(1) of the Health Insurance Act 1973.","sortOrder":1},{"sectionNumber":"4. Definitions","sectionType":"part","heading":"4. Definitions","content":"# 4. Definitions\n\n(1) In this instrument:\n\nAct means the Health Insurance Act 1973.\n\ngeneral medical services table means the table prescribed under subsection 4(1) of the Act.\n\nPET means positron emission tomography.\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 the Schedule.\n\nreport means a report prepared by a medical practitioner.\n\n(R) has the meaning given by clause 1.2.15 of the diagnostic imaging services table.\n\nSchedule means the Schedule to this instrument.\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\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":2},{"sectionNumber":"5. Treatment of relevant services","sectionType":"part","heading":"5. Treatment of relevant services","content":"# 5. Treatment of relevant services\n\nFor 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 of the Act, the regulations, the National Health Act 1953 or the regulations under that Act, as if:\n\n(a) it were both a professional service and a medical service; and\n\n(b) there were an item in the diagnostic imaging services table that:\n\n(i) related to the service; and\n\n(ii) specified for the service a fee in relation to each State, being the fee specified in the Schedule in relation to the service.","sortOrder":3},{"sectionNumber":"6. Application of Items in Schedule 1","sectionType":"part","heading":"6. Application of Items in Schedule 1","content":"# 6. Application of Items in Schedule 1\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":4},{"sectionNumber":"7. Restriction on items — services conne","sectionType":"part","heading":"7. Restriction on items — services connected with provision of PET nuclear scanning during Technetium‑99m interruptions","content":"# 7. Restriction on items – services connected with provision of PET nuclear scanning during Technetium‑99m interruptions\n\n(1) Items 61333, 61336 and 61341 only apply 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 technetium‑99m 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 61348, 61402, 61421 or 61425 applies.","sortOrder":5},{"sectionNumber":"8. PET nuclear scanning services","sectionType":"part","heading":"8. PET nuclear scanning services","content":"# 8. PET nuclear scanning services\n\n(1) Items 61333, 61336 and 61341 apply 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 items apply only if the owner or operator of the equipment used to perform the service is not in breach of section 11.","sortOrder":6},{"sectionNumber":"9. PET nuclear scanning services—perform","sectionType":"part","heading":"9. 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.","sortOrder":7},{"sectionNumber":"10. PET nuclear scanning services—equipm","sectionType":"part","heading":"10. 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":8},{"sectionNumber":"11. PET nuclear scanning services—statut","sectionType":"part","heading":"11. 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 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":9},{"sectionNumber":"Schedule 1","sectionType":"part","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

61333

Lung ventilation study using Galligas and lung perfusion study using gallium‑68 macro aggregated albumin (68Ga‑MAA), with PET, if the service is performed because the service to which item 61348 applies cannot be performed due to unavailability of technetium‑99m (R)

443.35

61336

Cerebral study, with PET, if the service is performed because the service to which item 61402 applies cannot be performed due to unavailability of technetium‑99m (R)

605.05

61341

Bone study – whole body with PET, with delayed imaging when undertaken, if the service is performed because the services to which item 61421 or 61425 apply cannot be performed due to unavailability of technetium‑99m (R)

600.70

\n```","sortOrder":10}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":5,"scope_assessment":{"changed":false,"description":"The legislation appears tightly scoped to its original purpose. It addresses a specific contingency (technetium-99m supply interruptions) for three specific PET scan substitutes, with detailed eligibility and quality controls. There is no evidence of scope creep beyond this targeted technical fix."},"complexity_factors":["Multiple nested conditions: services only apply if (a) technetium-99m is unavailable AND (b) clinical urgency exists AND (c) report justifies substitution","Cross-references to external documents: incorporates by reference the 'Requirements for PET Accreditation (Instrumentation & Radiation Safety) 3rd Edition (2017)' as in force on 1 July 2020","Complex practitioner qualification requirements in section 9(1)(b) with four cumulative sub-conditions including historical reporting threshold (400+ studies before 1 November 2011)","Statutory declaration requirements with 7 specific information categories plus ongoing notification obligations","Incorporation by reference of multiple tables and clauses from the diagnostic imaging services table (clauses 1.2.15, 1.2.17, 2.4.2)","Dual statutory framework: operates under both Health Insurance Act 1973 and National Health Act 1953","Defined terms with layered meanings (e.g., 'relevant provisions' spans two Acts and their regulations)"],"plain_english_summary":"This law creates a temporary Medicare rebate pathway for three specific PET scans using gallium-68 as substitutes when technetium‑99m supplies are interrupted. It lets patients receive urgent lung, brain and whole‑body bone imaging without delay, while requiring medical urgency, documented justification, accredited comprehensive facilities, approved equipment, credentialed supervising doctors (or very experienced practitioners), and a facility statutory declaration to Medicare. It ensures continuity of critical diagnostic imaging with strict quality controls."},"flash_summary":{"complexity_score":4,"scope_assessment":{"changed":false,"description":"This instrument does not expand the Act's broad scope. It specifies three substitute PET items and the conditions under which Medicare will treat those services as both professional and medical services with set fees, limited to comprehensive facilities meeting equipment and supervision standards. It therefore narrows claimability to particular circumstances and adds compliance requirements rather than changing who falls within the Act generally."},"complexity_factors":["Cross-references to the Health Insurance Act 1973, the diagnostic imaging services table and National Health Act provisions, requiring readers to consult multiple instruments.","Conditional application tied to temporary technetium‑99m unavailability, requiring clinicians to justify substitutions in reports.","Detailed eligibility rules for practitioners (credentialling, fellowship, 400 prior PET reports, authorisation to prescribe/administer PET radiopharmaceuticals, with a pre‑2011 timing requirement).","Facility and equipment rules referencing an external technical standard (Requirements for PET Accreditation (Instrumentation & Radiation Safety) 3rd Edition (2017)) fixed as at 1 July 2020.","Statutory declaration and ongoing notification obligation placed on owner/operators, creating administrative compliance steps.","Explicit exclusion of certain diagnostic imaging table clauses (clause 2.4.2) and incorporation of items into clause 1.2.17, affecting how items operate within the broader fee schedule."],"plain_english_summary":"Adds three PET diagnostic imaging items to Medicare rules, treating specified PET services as both professional and medical services and attaching fixed fees when technetium‑99m‑based studies cannot be performed. The items apply only in defined circumstances and to services meeting equipment, supervision and facility requirements.\nAffects PET providers, facility owners/operators and credentialled specialists: Medicare pays the listed fees, while providers must meet accreditation/equipment standards, provide statutory declarations and include a written justification in reports — imposing compliance and reporting duties on providers."},"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-section-3c-diagnostic-imaging-nuclear-medicine-services-determination-2019","history":"/api/acts/health-insurance-section-3c-diagnostic-imaging-nuclear-medicine-services-determination-2019/history","analysis":"/api/acts/health-insurance-section-3c-diagnostic-imaging-nuclear-medicine-services-determination-2019/analysis","conflicts":"/api/acts/health-insurance-section-3c-diagnostic-imaging-nuclear-medicine-services-determination-2019/conflicts","importantCases":"/api/acts/health-insurance-section-3c-diagnostic-imaging-nuclear-medicine-services-determination-2019/important-cases","documents":"/api/acts/health-insurance-section-3c-diagnostic-imaging-nuclear-medicine-services-determination-2019/documents"}}