{"id":"F2025L00567","name":"Health Insurance (Section 3C – Lutetium Therapeutic Nuclear Medicine Treatments) Determination 2025","slug":"health-insurance-section-3c-lutetium-therapeutic-nuclear-medicine-treatments-determination-2025","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":106364,"registerId":"commonwealth-F2025L00567-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 – Lutetium Therapeutic Nuclear Medicine Treatments) Determination 2025.","sortOrder":0},{"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":1},{"sectionNumber":"4","sectionType":"section","heading":"Definitions","content":"#### 4 Definitions\n\n  (1) In this instrument:\n\n> Act means the Health Insurance Act 1973.\n\n> disease progression means, for items 16050 and 16055 only, either or both:\n\n> (a) a rise in PSA of >2ng/mL confirmed by two tests a minimum of two weeks apart, or\n\n> (b) evidence of new soft tissue or bone metastases on diagnostic imaging computed tomography as per established guidelines (such as the Response Evaluation Criteria in Solid Tumours criteria, as published by the European Organisation for Research and Treatment of Cancer, or the Response Evaluation Criteria in PSMA-Imaging Criteria.\n\n> formally convened neuroendocrine multidisciplinary board means a formal board of relevant practitioners, including specialists in medical oncology and nuclear medicine with experience in managing neuroendocrine neoplasms, endocrinology and surgery specialists, as well as medical practitioners from different areas of medical practice. The board must include at least one oncologist and one surgeon.\n\n> peptide receptor radionuclide therapy means a targeted form of radiation treatment that can be used to treat neuroendocrine neoplasms.\n\n> PET means positron emission tomography.\n\n> PSA means prostate‑specific antigen\n\n> PSMA means prostate specific membrane antigen\n\n> nuclear medicine credentialled specialist means a specialist or consultant physician whose name is included in a register, given to the Chief Executive Medicare by the JNMCAC, of participants in the Joint Nuclear Medicine Specialist Credentialling Program of the JNMCAC.\n\n> relevant 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\n> relevant service means a health service, as defined in subsection 3C(8) of the Act, that is specified in a Schedule.\n\n> report 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\n> Schedule means a Schedule to this instrument.\n\n> SPECT means single‑photon emission computed tomography.\n\n> SUV means standardised uptake value.\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 general medical 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","sectionType":"section","heading":"Treatment of relevant services","content":"#### 5 Treatment of relevant services\n\n> 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 medical service; and\n\n> (b) there were an item in the general medical services table or 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","sectionType":"section","heading":"Application of provisions of the General Medical Services Table","content":"#### 6 Application of provisions of the General Medical Services Table\n\n  Clause 5.4.1 shall have effect as if the items listed in Schedule 1 of this Determination were also specified in clause 5.4.1 of the General Medical Services Table.","sortOrder":4},{"sectionNumber":"7","sectionType":"section","heading":"Application of provisions of the Diagnostic Imaging Services Table","content":"#### 7 Application of provisions of the Diagnostic Imaging Services Table\n\n  Clause 2.4.6 shall have effect as if the items listed in Schedule 2 of this Determination were also specified in subclause 2.4.6 of the Diagnostic Imaging Services Table.","sortOrder":5},{"sectionNumber":"8","sectionType":"section","heading":"Limitation of items listed in Schedule 2","content":"#### 8 Limitation of items listed in Schedule 2\n\n  An item listed in Schedule 2 of this instrument does not apply unless:\n\n> (a) the patient was referred by a specialist or consultant physician; and\n\n> (b) the service is provided by a nuclear medicine credentialled specialist.","sortOrder":6},{"sectionNumber":"9","sectionType":"section","heading":"Schedules","content":"#### 9 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.","sortOrder":7}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":6,"scope_assessment":{"changed":false,"description":"The legislation remains tightly focused on its original purpose: establishing Medicare funding for specific Lutetium-based nuclear medicine treatments. The scope has not expanded beyond this therapeutic area."},"complexity_factors":["13 defined terms in section 4, including nested definitions (e.g., 'disease progression' only applies to specific items)","Cross-references to multiple external tables (General Medical Services Table, Diagnostic Imaging Services Table) and the Health Insurance Act 1973","Conditional eligibility criteria requiring specific clinical thresholds (PSA >2ng/mL, two tests minimum two weeks apart, specific imaging criteria)","Mandatory multidisciplinary board requirements with specific specialist composition (at least one oncologist and one surgeon)","External credentialing requirement — practitioners must be on a register maintained by the Joint Nuclear Medicine Specialist Credentialling Program (JNMCAC)","Dual scheduling structure — items split across Schedule 1 (General Medical Services) and Schedule 2 (Diagnostic Imaging Services) with different application rules","Section 8 imposes additional restrictions on Schedule 2 items (referral by specialist + credentialled provider)","Incorporation of evolving external standards (RECIST criteria, Response Evaluation Criteria in PSMA-Imaging Criteria)"],"plain_english_summary":"This Determination adds Medicare rebates for two Lutetium-177 radiopharmaceutical therapies: PSMA-targeted treatment for advanced prostate cancer and DOTATATE treatment for certain neuroendocrine tumours. \n\nIt affects eligible patients, credentialed nuclear medicine specialists and multidisciplinary teams, and hospitals/clinics providing these services — expanding access to treatments formerly limited or costly while keeping strict eligibility and provider requirements to ensure safe, appropriate use."},"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"},"flash_summary":{"complexity_score":5,"scope_assessment":{"changed":true,"description":"This instrument expands Medicare coverage scope by treating specified lutetium therapeutic nuclear medicine treatments as both professional and medical services and by specifying fee items to be inserted into the General Medical Services and Diagnostic Imaging tables (clause 5; clauses 6–7). It also narrows who may bill for certain imaging items by requiring specialist referral and provision by a nuclear medicine credentialled specialist (clause 8). The instrument operates under subsection 3C(1) of the Health Insurance Act 1973 (clause 3) and relies on external credentialling registers (clause 4)."},"complexity_factors":["Cross‑references to multiple statutes and tables (Health Insurance Act 1973, National Health Act 1953, General Medical Services Table, Diagnostic Imaging Services Table) increase interpretive complexity (clauses 3, 5–7).","Multiple technical medical definitions (e.g. disease progression, PSMA, PET, SUV, peptide receptor radionuclide therapy) require clinical understanding to apply eligibility criteria (clause 4).","Credentialling and register reliance: eligible providers must be on a JNMCAC register supplied to Chief Executive Medicare, creating administrative dependency on an external body (definition of nuclear medicine credentialled specialist in clause 4).","Conditional application of imaging items adds compliance burden: Schedule 2 items only apply with specialist referral and when provided by a credentialled specialist (clause 8).","Insertion of items into existing fee tables (clauses 5–7) requires coordination with Medicare billing systems and may affect provider billing practices and patient rebates.","Temporal drafting: references to provisions 'as in force from time to time' mean ongoing legal change must be tracked to maintain compliance (clause 4(2)).","Delegated procedural elements (Schedules amend or repeal other instruments) create chain‑of‑instruments complexity for lawyers and administrators (clause 9)."],"plain_english_summary":"This Determination adds specified lutetium therapeutic nuclear medicine services into the Medicare framework by treating those services as both medical and professional services and by inserting corresponding fee items into the General Medical Services and Diagnostic Imaging tables. It defines clinical and credentialling terms and sets delivery and eligibility rules.\n\nIt affects patients who may receive these treatments, the specialists and nuclear‑medicine credentialled practitioners who provide them, and Medicare administrators because it creates billing pathways, referral/credential requirements and reporting obligations."}},"importantCases":[],"_links":{"self":"/api/acts/health-insurance-section-3c-lutetium-therapeutic-nuclear-medicine-treatments-determination-2025","history":"/api/acts/health-insurance-section-3c-lutetium-therapeutic-nuclear-medicine-treatments-determination-2025/history","analysis":"/api/acts/health-insurance-section-3c-lutetium-therapeutic-nuclear-medicine-treatments-determination-2025/analysis","conflicts":"/api/acts/health-insurance-section-3c-lutetium-therapeutic-nuclear-medicine-treatments-determination-2025/conflicts","importantCases":"/api/acts/health-insurance-section-3c-lutetium-therapeutic-nuclear-medicine-treatments-determination-2025/important-cases","documents":"/api/acts/health-insurance-section-3c-lutetium-therapeutic-nuclear-medicine-treatments-determination-2025/documents"}}