{"id":"C2007A00033","name":"Private Health Insurance (Medical Devices and Human Tissue Products Levy) Act 2007","slug":"private-health-insurance-medical-devices-and-human-tissue-products-levy-act-2007","collection":"act","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":"33 of 2007","makingDate":null,"administeringDepartment":null,"currentVersion":{"id":7980,"registerId":"commonwealth-C2007A00033-current","compilationNumber":null,"startDate":"2026-03-30","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Short title","content":"#### 1 Short title\n\n  This Act may be cited as the Private Health Insurance (Medical Devices and Human Tissue Products Levy) Act 2007.","sortOrder":0},{"sectionNumber":"2","sectionType":"section","heading":"Commencement","content":"#### 2 Commencement\n\n  This Act commences at the same time as the Private Health Insurance Act 2007 commences.","sortOrder":1},{"sectionNumber":"3","sectionType":"section","heading":"Definitions","content":"#### 3 Definitions\n\n  In this Act:\n\n> human tissue product has the same meaning as in the Private Health Insurance Act 2007.\n\n> listed item means a kind of medical device, or a kind of human tissue product, that is listed in the Private Health Insurance (Medical Devices and Human Tissue Products) Rules made under the Private Health Insurance Act 2007.\n\n> medical device has the same meaning as in the Private Health Insurance Act 2007.","sortOrder":2},{"sectionNumber":"4","sectionType":"section","heading":"Imposition of levy","content":"#### 4 Imposition of levy\n\n  (1) Levy is imposed for a financial year in respect of the ongoing listing of each listed item.\n  (2) Levy is imposed on each day specified as a levy imposition day in the Private Health Insurance (Medical Devices and Human Tissue Products Levy) Rules made under section 6.\n  (3) The amount of the levy imposed in respect of the ongoing listing of a listed item is the amount prescribed by the regulations.\n  (4) Before the Governor‑General makes regulations for the purposes of subsection (3) prescribing the amount of the levy for a financial year, the Minister must be satisfied that the amount is set at a level that is designed to recover no more than the Commonwealth’s likely costs in connection with the ongoing listing of all listed items for that financial year.","sortOrder":3},{"sectionNumber":"5","sectionType":"section","heading":"Matters relating to levy","content":"#### 5 Matters relating to levy\n\n  (1) The regulations may prescribe different amounts for the purposes of subsection 4(3) for different circumstances.\n  (2) Two or more amounts may be prescribed in relation to a single listed item, and a single amount may be prescribed in relation to 2 or more listed items.\n  (3) The regulations may prescribe an amount for the purposes of subsection 4(3) by:\n    (a) specifying an amount; or\n    (b) specifying a method for calculating the amount.\n  (4) The amount of a levy may be nil.\n  (5) The regulations may provide for exemptions from levy.\n\n> Note: Other matters relating to the levy, such as who is liable to pay, may be specified in Private Health Insurance (Levy Administration) Rules made under the Private Health Insurance Act 2007.","sortOrder":4},{"sectionNumber":"6","sectionType":"section","heading":"Private Health Insurance (Medical Devices and Human Tissue Products Levy) Rules","content":"#### 6 Private Health Insurance (Medical Devices and Human Tissue Products Levy) Rules\n\n  The Minister may, by legislative instrument, make Private Health Insurance (Medical Devices and Human Tissue Products Levy) Rules, providing for matters:\n    (a) required or permitted by this Act to be provided; or\n    (b) necessary or convenient to be provided in order to carry out or give effect to this Act.","sortOrder":5},{"sectionNumber":"7","sectionType":"section","heading":"Regulations","content":"#### 7 Regulations\n\n  The Governor‑General may make regulations prescribing matters:\n    (a) required or permitted by this Act to be prescribed by the regulations; or\n    (b) necessary or convenient to be prescribed for carrying out or giving effect to this Act.","sortOrder":6}],"analysis":{"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"},"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"The legislation remains tightly focused on its original purpose: imposing a levy to recover costs associated with listing medical devices and human tissue products for private health insurance purposes. No scope creep is evident."},"complexity_factors":["Only 3 defined terms, all referencing external legislation","Heavy reliance on delegated legislation (regulations and Rules) for substantive details — the Act itself doesn't specify levy amounts, imposition days, or who is liable to pay","Simple conditional structure with no nested exceptions","Cross-references limited to the parent Private Health Insurance Act 2007","Short length (7 sections) with straightforward operative provisions"],"plain_english_summary":"This law creates a **fee system** for private health insurers who want certain medical devices and human tissue products covered by Medicare. Here's what it does:\n\n**The basics**\n- Private health insurers can get medical devices and human tissue products \"listed\" (officially approved) so they're covered by insurance.\n- This Act charges those insurers an **annual levy** (fee) to keep those items on the approved list.\n\n**Who pays and when**\n- The fee is charged on specific days set out in rules made by the Minister.\n- The exact amount is set by regulations, but the Minister must ensure the total fees collected don't exceed what it costs the government to run the listing system.\n\n**Flexibility built in**\n- Different items can have different fees.\n- Some items might have no fee at all (nil).\n- Some items might be exempt entirely.\n- The fee can be a fixed amount or calculated using a formula.\n\n**Why it matters**\nThis ensures that the **costs of regulating medical devices and tissue products** are paid by the industry using the system, rather than by taxpayers generally. It creates a \"user pays\" approach to keeping the private health insurance product list up to date."},"flash_summary":{"complexity_score":4,"scope_assessment":{"changed":false,"description":"This Act does not change what private health insurance covers; it establishes a cost-recovery levy on the ongoing listing of specified medical devices and human tissue products and provides powers to make rules and regulations about levy timing, amounts and exemptions. Administrative liability details remain delegated to separate levy-administration rules."},"complexity_factors":["Delegation of key parameters to subordinate instruments (levy imposition days, methods and amounts): sections 4(2), 5 and 6","Ministerial satisfaction requirement limiting levy amounts to Commonwealth cost recovery creates an administrative judgment: section 4(4)","Flexible prescription options (fixed amounts, calculation methods, multiple amounts per item, nil amounts, exemptions) increase variation in application: section 5(1)–(4)","Separation of liability and administrative mechanics into different rules increases cross-referencing and compliance uncertainty (note in section 5 referencing Levy Administration Rules)","Regulations may vary amounts by circumstance and group items together, introducing aggregation and classification complexity for payers: section 5(1)–(3)"],"plain_english_summary":"This Act creates a levy to recover the Commonwealth’s costs for keeping certain medical devices and human tissue products on an official listing. The levy is charged for each listed item on specified levy days, with amounts set by regulation (and may be nil or exempted). The Minister and Governor‑General make rules about levy days, amounts and administration. It affects the parties who are liable under the levy-administration rules by creating a payment and compliance obligation for ongoing listings."},"issue_detection":{"absurdities":[{"type":"self_contradicting","section":"4(1) and 4(2)","severity":"medium","reasoning":"Section 4(1) frames the levy as a financial year imposition, suggesting an annual charge. Section 4(2) then reframes it as a per-day imposition on specified 'levy imposition days'. These two subsections create an unresolved tension: is the levy a single annual amount triggered by the financial year, or a per-day amount triggered by each levy imposition day? If it is per-day, the annual framing in s4(1) is redundant or misleading. If it is annual, s4(2) is superfluous. The interaction between the two is never resolved in the Act.","confidence":0.72,"description":"Levy is imposed simultaneously 'for a financial year' (s4(1)) and 'on each day specified as a levy imposition day' (s4(2)), creating an ambiguous and potentially contradictory temporal basis for the levy."},{"type":"impossible_compliance","section":"4(4)","severity":"low","reasoning":"The Minister's satisfaction must be based on 'likely costs' — a forward-looking estimate with no defined methodology, audit requirement, or accountability mechanism. The word 'likely' renders the constraint unenforceable: any estimate, however speculative, can satisfy the requirement. This makes the cost-recovery cap a procedural formality rather than a substantive constraint, undermining its apparent consumer-protection purpose.","confidence":0.65,"description":"The Minister must be satisfied the levy is designed to recover 'no more than' the Commonwealth's 'likely costs', but 'likely costs' is entirely prospective and unverifiable at the time of regulation-making, making the satisfaction requirement practically meaningless."},{"type":"other","section":"5(4)","severity":"low","reasoning":"Section 4 imposes a levy, and section 5(4) permits that levy to be nil. A nil levy is indistinguishable in practical effect from no levy at all, yet the statutory machinery of imposition, prescription by regulation, and ministerial satisfaction (s4(4)) must still be followed to arrive at a zero amount. This is logically absurd — it requires regulatory and ministerial activity to produce a null outcome. It also raises the question of whether a nil levy satisfies s4(4)'s cost-recovery requirement, since zero revenue recovers none of the Commonwealth's costs.","confidence":0.7,"description":"The Act expressly permits a levy amount of nil, meaning a levy can be lawfully 'imposed' that has no effect whatsoever, creating a meaningless legal act."},{"type":"other","section":"3 (definition of 'listed item') and 4(2)","severity":"medium","reasoning":"The definition of 'listed item' depends on the Private Health Insurance (Medical Devices and Human Tissue Products) Rules, while levy imposition days are set by the separate Private Health Insurance (Medical Devices and Human Tissue Products Levy) Rules. If an item is removed from the listing Rules between levy imposition days, it ceases to be a 'listed item' but the levy machinery in the Levy Rules may still reference it. Conversely, a newly listed item may not be captured until the Levy Rules are updated. The Act provides no synchronisation requirement or transitional mechanism.","confidence":0.62,"description":"The levy is imposed on 'levy imposition days' specified in the Levy Rules (s4(2)), but the listed items subject to levy are defined by reference to a separate instrument — the Medical Devices and Human Tissue Products Rules (s3). There is no mechanism in the Act ensuring these two instruments remain synchronised, potentially imposing levy on items no longer listed or failing to impose levy on newly listed items."},{"type":"impossible_compliance","section":"5(2)","severity":"medium","reasoning":"Section 5(2) permits multiple levy amounts to be prescribed for a single listed item. While s5(1) allows different amounts for 'different circumstances', there is no requirement that the circumstances be exhaustive, mutually exclusive, or even defined. A payer could face two applicable amounts simultaneously with no legislative rule to determine which prevails. The Act provides no tiebreaker, priority rule, or requirement that regulations resolve this conflict.","confidence":0.68,"description":"The provision that 'two or more amounts may be prescribed in relation to a single listed item' without any guidance on which amount applies in a given circumstance creates an unresolvable ambiguity about the operative levy amount."}],"contradictions":[{"severity":"low","section_a":"4(3)","section_b":"4(4)","confidence":0.58,"description":"Section 4(3) requires the levy amount to be prescribed by regulations, while section 4(4) requires ministerial satisfaction before the Governor-General makes those regulations — but the Act imposes no obligation on the Governor-General to act on the Minister's satisfaction, creating a gap where the precondition is met but the consequent action need never follow."},{"severity":"medium","section_a":"4(1)","section_b":"5(5)","confidence":0.75,"description":"Section 4(1) mandatorily imposes levy in respect of the ongoing listing of each listed item, while section 5(5) permits regulations to provide for exemptions from levy. An exemption for a listed item directly contradicts the mandatory imposition in s4(1), since the item remains listed but no levy is collected."},{"severity":"low","section_a":"4(4)","section_b":"5(4)","confidence":0.63,"description":"Section 4(4) requires the Minister to be satisfied the levy is set to recover no more than the Commonwealth's likely costs, implying a positive (non-zero) levy is contemplated. Section 5(4) permits a nil levy. A nil levy recovers none of the Commonwealth's costs, which is consistent with 'no more than' costs mathematically, but renders the cost-recovery framework in s4(4) purposively incoherent — the ministerial satisfaction requirement was plainly designed to prevent over-recovery, not to permit zero recovery with full regulatory process."}]},"summary":{"complexity_score":3,"scope_assessment":{"changed":false,"description":"The Act operates consistently within its stated purpose: imposing a cost-recovery levy on the ongoing listing of medical devices and human tissue products under the private health insurance framework. There is no evident scope creep or departure from original intent. The built-in ministerial satisfaction requirement (that the levy recover no more than actual Commonwealth costs) keeps the scope anchored to cost recovery."},"complexity_factors":["Relies heavily on external instruments — the actual levy amounts, exemptions, and liable parties are all defined in separate regulations and rules rather than in the Act itself, requiring cross-referencing multiple documents","Multiple layers of delegated legislation: Governor-General regulations, Minister's legislative instruments, and separate administration rules all interact","The definition of key terms ('medical device', 'human tissue product') is imported by reference from a separate parent Act","Flexible levy calculation mechanisms (specified amount or calculated amount, nil amounts, different amounts for different circumstances) add some interpretive nuance","Short and structurally simple — the Act itself is a thin enabling framework, keeping complexity relatively low"],"plain_english_summary":"This Act imposes a cost-recovery levy on manufacturers, suppliers or sponsors whose medical devices or human tissue products are listed under the private health insurance system, affecting those who seek insurer coverage for such products. \n\nThe levy is set by regulation, may vary (including being nil), can be exempted, and is limited to recovering the Commonwealth’s administrative costs of maintaining the approved-products list."}},"importantCases":[],"_links":{"self":"/api/acts/private-health-insurance-medical-devices-and-human-tissue-products-levy-act-2007","history":"/api/acts/private-health-insurance-medical-devices-and-human-tissue-products-levy-act-2007/history","analysis":"/api/acts/private-health-insurance-medical-devices-and-human-tissue-products-levy-act-2007/analysis","conflicts":"/api/acts/private-health-insurance-medical-devices-and-human-tissue-products-levy-act-2007/conflicts","importantCases":"/api/acts/private-health-insurance-medical-devices-and-human-tissue-products-levy-act-2007/important-cases","documents":"/api/acts/private-health-insurance-medical-devices-and-human-tissue-products-levy-act-2007/documents"}}