{"id":"F2024L01331","name":"Statement of Principles concerning Merkel cell carcinoma (Reasonable Hypothesis) (No. 80 of 2024)","slug":"statement-of-principles-concerning-merkel-cell-carcinoma-reasonable-hypothesis-no-80-of-2024","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":442617,"registerId":"F2024L01331-fast-fetch-1775957585655","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Statement of Principles concerning Merkel cell carcinoma (Reasonable Hypothesis) (No. 80 of 2024)","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\n---\n\n?xml version=\"1.0\" encoding=\"utf-8\" standalone=\"no\"?>\n\n![RMA Australian Government Coat of Arms](image.001.jpeg)\n\n \n\nStatement of Principles\n\nconcerning\n\nMERKEL CELL CARCINOMA  (Reasonable Hypothesis)\n\n(No. 80 of 2024)\n\nThe Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(2) of the Veterans' Entitlements Act 1986.\n\n \n\nDated    18 October 2024.\n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\nProfessor Terence Campbell AM\n\nChairperson\n\nby and on behalf of\n\nThe Repatriation Medical Authority\n\n \n\n \n\n   \n\n\nContents\n\n1 Name\n\n2 Commencement\n\n3 Authority\n\n4 Repeal\n\n5 Application\n\n6 Definitions\n\n7 Kind of injury, disease or death to which this Statement of Principles relates\n\n8 Basis for determining the factors\n\n9 Factors that must exist\n\n10 Relationship to service\n\n11 Factors referring to an injury or disease covered by another Statement of Principles\n\nSchedule 1 - Dictionary\n\n1 Definitions\n\n \n\n \n\n\n\n\n1.                Name\n\n\nThis is the Statement of Principles concerning Merkel cell carcinoma (Reasonable Hypothesis) (No. 80 of 2024).\n\n1.                Commencement\n\n\n              This instrument commences on 19 November 2024.\n\n1.                Authority\n\n\nThis instrument is made under subsection 196B(2) of the Veterans' Entitlements Act 1986.\n\n1.                Repeal\n\n\nThe Statement of Principles concerning non-melanotic malignant neoplasm of the skin No. 7 of 2016 (Federal Register of Legislation No. F2016L00239) made under subsections 196B(2) and (8) of the VEA is repealed.\n\n1.                Application\n\n\nThis instrument applies to a claim to which section 120A of the VEA or section 338 of the Military Rehabilitation and Compensation Act 2004 applies.\n\n1.                Definitions\n\n\nThe terms defined in the Schedule 1 - Dictionary have the meaning given when used in this instrument.\n\n1.                Kind of injury, disease or death to which this Statement of Principles relates\n  1.           This Statement of Principles is about Merkel cell carcinoma and death from Merkel cell carcinoma.\n\n\nMeaning of Merkel cell carcinoma\n\n1.           For the purposes of this Statement of Principles, Merkel cell carcinoma means a primary cutaneous neuroendocrine carcinoma;\n2.           While Merkel cell carcinoma attracts ICD‑10‑AM codes C00.0, C00.1, C00.2, C00.6, C00.8, C00.9, C44, C51.0, C51.1, C51.2, C51.8, C51.9, C60.0, C60.1, C60.2, C60.8, C60.9, C63.2, D04, D07.1, D07.4., in applying this Statement of Principles the meaning of Merkel cell carcinoma is that given in subsection (2).\n3.           For subsection (3), a reference to an ICD-10-AM code is a reference to the code assigned to a particular kind of injury or disease in The International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Australian Modification (ICD-10-AM), Tenth Edition, effective date of 1 July 2017, copyrighted by the Independent Hospital Pricing Authority, ISBN 978-1-76007-296-4.\n\n\nDeath from Merkel cell carcinoma\n\n1.           For the purposes of this Statement of Principles, Merkel cell carcinoma, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's Merkel cell carcinoma.\n\n\nNote: terminal event is defined in the Schedule 1 – Dictionary.\n\n1.                Basis for determining the factors\n\n\nThe Repatriation Medical Authority is of the view that there is sound medical-scientific evidence that indicates that Merkel cell carcinoma and death from Merkel cell carcinoma can be related to relevant service rendered by veterans, members of Peacekeeping Forces, or members of the Forces under the VEA, or members under the MRCA.\n\nNote: MRCA, relevant service and VEA are defined in the Schedule 1 – Dictionary.\n\n1.                Factors that must exist\n\n\nAt least one of the following factors must as a minimum exist before it can be said that a reasonable hypothesis has been raised connecting Merkel cell carcinoma or death from Merkel cell carcinoma with the circumstances of a person's relevant service:\n\n1.           having sunlight exposure to unprotected skin for a cumulative period of at least 2,250 latitude equivalent hours before clinical onset;\n\n\nNote: latitude equivalent hours and unprotected skin are defined in the Schedule 1 dictionary.\n\n1.           having PUVA therapy, where:\n  1.           the first PUVA treatment commenced at least 5 years before clinical onset; and\n  2.           at least 50 PUVA treatments were administered before clinical onset;\n\n\nNote: PUVA therapy is defined in the Schedule 1 - Dictionary.\n\n1.           being infected with Merkel cell polyomavirus before clinical onset;\n2.           being infected with human immunodeficiency virus before clinical onset;\n3.           undergoing solid organ (excluding corneal transplant) or bone marrow transplantation at least 5 years before clinical onset;\n4.           having non-Hodgkin lymphoma before clinical onset;\n5.           having mature B-cell lymphoid leukaemia and small lymphocytic lymphoma before clinical onset;\n\n\nNote: Mature B-cell lymphoid leukaemia and small lymphocytic lymphoma is also known as chronic lymphocytic leukaemia/small cell lymphoma.\n\n1.           inability to obtain appropriate clinical management for Merkel cell carcinoma before clinical worsening.\n\n\n1.            Relationship to service\n  1.           The existence in a person of any factor referred to in section 9, must be related to the relevant service rendered by the person.\n  2.           The factor set out in subsection 9(8) applies only to material contribution to, or aggravation of, Merkel cell carcinoma where the person's Merkel cell carcinoma was suffered or contracted before or during (but did not arise out of) the person's relevant service.\n2.            Factors referring to an injury or disease covered by another Statement of Principles\n\n\nIn this Statement of Principles:\n\n1.           if a factor referred to in section 9 applies in relation to a person; and\n2.           that factor refers to an injury or disease in respect of which a Statement of Principles has been determined under subsection 196B(2) of the VEA;\n\n\nthen the factors in that Statement of Principles apply in accordance with the terms of that Statement of Principles as in force from time to time.\n\n \n\n \n\nSchedule 1 - Dictionary  \n\nNote:               See Section 6\n\n1               Definitions\n\nIn this instrument:\n\n                                latitude equivalent hours means hours of exposure multiplied by the appropriate latitude weighting factor as follows:\n\n(a)          For tropical latitudes (23.5° South to 23.5° North) multiply by 1.0\n\n(b)          For subtropical latitudes (23.6° - 35°) multiply by 0.75\n\n(c)          For warm temperate latitudes (35.1° - 45°)  multiply by 0.5\n\n(d)           For cool temperate latitudes (45.1° - 65°) multiply by 0.25.\n\nNote: sunlight exposure is calculated as the sum of sunlight exposure in each separate latitude, accounting for the different sunlight intensity in each latitude (weighting factor).\n\nSum of sunlight exposure = (hours spent in tropical latitude x tropical latitude weighting factor) + (hours spent in subtropical latitude x subtropical latitude weighting factor) + (hours spent in warm temperate latitude x warm temperate latitude weighting factor) + (hours spent in cool temperate latitude x cool temperate latitude weighting factor)\n\n                               Merkel cell carcinoma—see subsection 7(2).\n\n                               MRCA means the Military Rehabilitation and Compensation Act 2004.\n\n                               PUVA therapy means a combination treatment consisting of taking oral psoralen (P) (also known as methoxsalen) and exposing the skin to long-wave ultra-violet light (UVA).\n\n                               relevant service means:\n\n(a)          operational service under the VEA;\n\n(b)          peacekeeping service under the VEA;\n\n(c)          hazardous service under the VEA;\n\n(d)          British nuclear test defence service under the VEA;\n\n(e)          warlike service under the MRCA; or\n\n(f)           non-warlike service under the MRCA.\n\nNote: MRCA and VEA are defined in the Schedule 1 - Dictionary.\n\n                               terminal event means the proximate or ultimate cause of death and includes the following:\n\n(a)           pneumonia;\n\n(b)           respiratory failure;\n\n(c)           cardiac arrest;\n\n(d)           circulatory failure; or\n\n(e)           cessation of brain function.\n\n                               unprotected skin means skin that is directly exposed to the sun and is not protected by sunscreen, clothing or other physical barrier.\n\n                               VEA means the Veterans' Entitlements Act 1986.\n\n \n\n \n","sortOrder":0}],"analysis":{"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":true,"description":"This instrument narrows scope compared to the repealed instrument. The previous Statement of Principles (No. 7 of 2016) covered 'non-melanotic malignant neoplasm of the skin' broadly. This new instrument specifically isolates Merkel cell carcinoma as a standalone condition with its own specific risk factors, reflecting evolving medical understanding that this rare neuroendocrine carcinoma has distinct aetiology (Merkel cell polyomavirus, immunosuppression) compared to other skin cancers. The scope is now more targeted but medically precise."},"complexity_factors":["Specialised medical terminology requiring definitions (ICD-10-AM codes, PUVA therapy, Merkel cell polyomavirus, specific lymphoma subtypes)","Mathematical calculation required for sun exposure (latitude equivalent hours with four-tier weighting system: 1.0, 0.75, 0.5, 0.25)","Temporal conditions attached to factors (5-year latency periods for PUVA therapy and transplants)","Cross-referencing to other legislation (VEA and MRCA for service definitions, other Statements of Principles for linked conditions)","Dual application framework (applies to both VEA and MRCA claims with different service definitions)","Specific exclusion in factor 9(8) — inability to obtain clinical management only applies to worsening, not initial onset","Nested definitions (terminal event defined with five specific examples)"],"plain_english_summary":"This bill creates a tailored medical test under the \"reasonable hypothesis\" standard to link Merkel cell carcinoma (or death from it) to military service, replacing a broader skin-cancer rule. It establishes seven specific risk factors that, if proven, give a legal presumption the cancer is service-related.\n\nIt affects veterans, peacekeepers, and current/former Defence Force members claiming under the VEA or MRCA, and matters because it recognises military sun exposure (using a \"latitude equivalent hours\" measure) and other service-related risks."},"flash_summary":{"complexity_score":4,"scope_assessment":{"changed":true,"description":"This instrument narrows and clarifies scope compared with the repealed 2016 Statement (non‑melanotic malignant neoplasm of the skin). It replaces the broader category with a dedicated Merkel cell carcinoma definition (s7) and prescribes discrete, measurable service‑related factors (s9), while repealing the prior instrument (s4). The practical effect is a move from a broader skin cancer coverage to a disease‑specific test tied to enumerated exposures and thresholds."},"complexity_factors":["Defined medical and programmatic terms concentrated in Schedule 1 (eg. 'latitude equivalent hours', 'PUVA therapy', 'unprotected skin') increasing interpretive precision (Schedule 1; s6).","Numeric thresholds and latency periods that require factual calculation or medical timelines (eg. 2,250 latitude‑equivalent hours; ≥50 PUVA treatments; 5‑year latency) (s9(1), s9(2)).","Weighted sunlight calculation across multiple latitudes requiring reconstruction of service locations and hours (Schedule 1).","Cross‑references to other statutory instruments and ICD‑10‑AM codes, and application of other Statements of Principles where relevant, creating layered legal/medical sourcing (s7(2)–(3); s11).","Differential treatment of the 'inability to obtain appropriate clinical management' factor which only applies to material contribution/aggravation if pre‑existing (s9(8); s10(2)).","Requirement that any listed factor be 'related to the relevant service', introducing causation linkage between exposure/disease and types of service (s10(1)).","Repeal of the prior broader skin neoplasm Statement, shifting scope to a disease‑specific test and requiring claim assessors to apply the new instrument from commencement (s4; s2)."],"plain_english_summary":"This Statement of Principles sets the medical criteria the Repatriation Medical Authority will use to decide whether Merkel cell carcinoma (a primary cutaneous neuroendocrine carcinoma) can be reasonably linked to a person’s relevant service for claims under the VEA or MRCA. It lists specific risk factors — for example, cumulative unprotected sun exposure of at least 2,250 latitude‑equivalent hours; PUVA therapy with ≥50 treatments and a 5‑year latency; certain infections, transplants or lymphoid malignancies; or inability to obtain appropriate clinical management — any one of which may raise the reasonable hypothesis and affect entitlement decisions."}},"importantCases":[],"_links":{"self":"/api/acts/statement-of-principles-concerning-merkel-cell-carcinoma-reasonable-hypothesis-no-80-of-2024","history":"/api/acts/statement-of-principles-concerning-merkel-cell-carcinoma-reasonable-hypothesis-no-80-of-2024/history","analysis":"/api/acts/statement-of-principles-concerning-merkel-cell-carcinoma-reasonable-hypothesis-no-80-of-2024/analysis","conflicts":"/api/acts/statement-of-principles-concerning-merkel-cell-carcinoma-reasonable-hypothesis-no-80-of-2024/conflicts","importantCases":"/api/acts/statement-of-principles-concerning-merkel-cell-carcinoma-reasonable-hypothesis-no-80-of-2024/important-cases","documents":"/api/acts/statement-of-principles-concerning-merkel-cell-carcinoma-reasonable-hypothesis-no-80-of-2024/documents"}}