Shorter claim window for bulk‑billed services: The time limit to make claims for bulk‑billed dental and Medicare services is reduced from 2 years to 1 year (Dental Benefits Act 2008; Health Insurance Act 1973). (Schedule 1, Part 1: items 1–8)
Stronger Medicare investigative and recovery powers: The Act revises the definition of what counts as a "relevant offence" involving Medicare/dental/pharmaceutical claims; it expands departmental investigative tools (including evidence handling rules) and creates a clear statutory route to recover overpayments as debts. It also creates a new notice power allowing Chief Executive Medicare to require people to give information or documents (with a minimum 21‑day compliance period) and attaches strict liability and civil penalties for non‑compliance. (Schedule 1, Part 2: item 9; Schedule 4, Part 1: items 1–2, 3–10)
Changes to pharmacist approval processes: Timeframes and procedures for requests to the Minister about pharmacy approvals are altered (Minister must decide or be taken to have decided within 4 months of a request; limits on repeat requests for the same premises — 12 months between requests; and procedural changes for notices). (Schedule 1, Part 3: items 14–23)
Therapeutic Goods Act changes (big package): Vaping goods are brought explicitly within the Therapeutic Goods Act framework in several places; additional enforcement tools and procedural changes are added (authorised persons may use assistants; broadened grounds and notice requirements for enforceable directions; delegation of certain powers; expanded definitions and tests for shortages so foreseeable shortages count; fees must be paid before some consents will be considered). The Act also creates new criminal offences and civil penalties for breaching conditions of exemptions, approvals or authorities relating to therapeutic goods (new sections 32CP and 32CQ). (Schedule 2, Parts 1–9: many items; see particularly Part 7 items 78–80)
The Health Legislation Amendment (Improved Medicare Integrity and Other Measures) Act 2025 amends multiple statutes to tighten Medicare claims processes, strengthen investigative and recovery powers, streamline pharmacy approvals, enhance therapeutic goods regulation including vaping and shortages management, clarify tobacco advertising rules, and introduce new administrative and immunity provisions. Schedule 1 Part 1 shortens the timeframe for claims relating to bulk-billed Medicare services and dental benefits from two years to one year. Division 1 amends subsection 15(2) of the Dental Benefits Act 2008 to substitute one year for two years, applying to services rendered on or after 5 September 2025. Divisions 2 and 3 make corresponding changes to paragraphs 20B(1)(c) and 20B(2)(b) of the Health Insurance Act 1973, with contingent commencement tied to the Health Insurance Legislation Amendment (Assignment of Medicare Benefits) Act 2024. Part 2 updates the definition of relevant offence in section 3A of the Human Services (Medicare) Act 1973 to encompass offences under the Health Insurance Act 1973, National Health Act 1953, Dental Benefits Act 2008 and related Criminal Code provisions concerning claims, indemnity payments and Commonwealth contributions. It also removes the 60-day limit in subsection 8U(1) and revises data disposal options in paragraphs 8ZG(3)(d) and 8ZGA(3)(d) to allow return or destruction of reproductions. Part 3 amends the National Health Act 1953 by repealing subsections 90A(5) and 90B(4), extending the Minister's decision timeframe in subsection 90B(5) to four months from receipt of a request, inserting new subsection 90C(3) to bar repeat requests within 12 months, and adjusting review and appointment provisions in sections 90C, 90D, 105AE and 99N. Schedule 2 Part 1 extends multiple provisions of the Therapeutic Goods Act 1989 to vaping goods, including sections 9J, 9K, 9L, 41QB, 41QC, 41QD, 41RB, 41RC, 42AD, 42DZK and 52G, while removing certain public health and safety satisfaction requirements and adding fee provisions. Parts 2 to 5 insert section 48AAA on persons assisting authorised persons, update warrant execution and assistance obligations in sections 48AA and 48FA, broaden forfeiture under section 52AAA to Part 6-2 seizures, adjust enforceable directions thresholds in section 42YT to interests of public health or safety, and expand delegation in subsection 57(1A). Part 6 amends shortage substitution provisions in sections 19A, 32CO, 41H and 41HD to cover goods that may in the reasonably foreseeable future become unavailable. Part 7 replaces offences and civil penalties in sections 32CH, 32CI and related provisions with new Subdivision F containing sections 32CP and 32CQ for breaches of conditions on exemptions, approvals and authorities for biologicals, with penalties up to five years imprisonment or 4000 penalty units. Part 8 repeals subsection 7(2) and paragraph 60(1)(a) of the definition of initial decision, ending applications for declarations that goods are or are not therapeutic goods. Part 9 adds fee requirements before the Secretary must consider consents in sections 14, 14A, 32BF and new section 41MAB, updates section 63 on incorporation of instruments, and clarifies information release in section 61. Schedule 3 amends the Public Health (Tobacco and Other Products) Act 2023 to repeal sections 47, 53 to 55 and 57 to 59, insert exceptions for exempt advertisements and authorisations under the Therapeutic Goods Act, extend sponsorship prohibitions to all persons rather than individuals, and add Division 1A with sections 120A to 120D enabling phasing-in and phasing-out provisions for health warnings, inserts and product appearance requirements. Schedule 4 Part 1 inserts section 129AACA allowing the Chief Executive Medicare to require relevant material by notice with at least 21 days to comply, creates strict liability offences and civil penalties in section 129AACB for non-compliance, expands recovery under new subsection 129AAK(1) for overpayments where entitlement did not exist or assignments were invalid, and adjusts review and interest provisions in sections 129AAJ and 129AED. Part 2 amends section 106ZPQ to provide use and derivative use immunity for documents produced under subsections 89B(2) and 105A(2), with limited exceptions for criminal proceedings, Committee matters and recovery actions, while allowing admission in National Law proceedings via appropriate bodies. Part 3 authorises the Minister to make transitional rules by legislative instrument. Most provisions commence on 5 September 2025, the day after royal assent on 4 September 2025, with specific contingent timing for certain Medicare claim amendments.
Official source available
Zoe has indexed the source text for search and analysis. Use the official register for the original document and download formats.
Amends the: Dental Benefits Act 2008 and Health Insurance Act 1973 to change the timeframe for making claims relating to bulk-billed Medicare and dental services from 2 years to 1 year; Human Services (Medicare) Act 1973 to update investigative powers in relation to Medicare fraud offences; National Health Act 1953 to streamline pharmacy approval processes; Therapeutic Goods Act 1989 to: enable the department to manage and alleviate the consequences of therapeutic goods shortages; and support compliance and enforcement activities undertaken in relation to unlawful therapeutic and vaping goods; and Public Health (Tobacco and Other Products) Act 2023 to clarify the intended operation of certain provisions.
Parliamentary progress
Progress
Senate
Introduced and read a first time
23 Jul 2025
Second reading moved
23 Jul 2025
Second reading debate
24 Jul 2025
Second reading debate
28 Jul 2025
Second reading agreed to
28 Jul 2025
Committee of the Whole debate
28 Jul 2025
Committee of the Whole debate
29 Jul 2025
Third reading agreed to
29 Jul 2025
House of Representatives
Introduced and read a first time
29 Jul 2025
Second reading moved
25 Aug 2025
Second reading debate
25 Aug 2025
Second reading debate
01 Sep 2025
Second reading agreed to
01 Sep 2025
Third reading agreed to
01 Sep 2025
Finally passed both Houses
01 Sep 2025
Assent
Act no: 38
Year: 2025
04 Sep 2025
Notes
Documents and transcripts
Text of bill
First reading
As passed by both Houses
Explanatory memoranda
Advertising and tobacco law tweaks: The Public Health (Tobacco and Other Products) Act is adjusted so that advertisements for e‑cigarette products that are regulated by the Therapeutic Goods Act may be treated under the TGA rules; the Act also adds rules allowing later regulations to phase‑in or phase‑out product packaging, warnings and other appearance requirements. (Schedule 3, Parts 1 and 3: items 1–5, 9–14)
Additional technical and review changes: The Act alters some review and transitional processes (for example, how certain TGA review pathways operate and saving provisions for applications in progress), and allows the regulations to adopt external instruments by reference. (Schedule 2, Parts 8–9, and Schedule 4, Part 3)
Who is affected
Medical and dental practitioners, and pharmacies: shorter claim windows and strengthened recovery powers mean these providers bear more timing and documentation risk, and may face faster debt recovery if claims are incorrect. (Schedule 1; Schedule 4)
Pharmacists seeking approvals: changes to decision timeframes and limits on re‑applications affect the administrative pathway and commercial timing for pharmacy supply of pharmaceutical benefits. (Schedule 1, Part 3)
Therapeutic goods and vaping manufacturers, importers, suppliers and advertisers: bringing vaping goods explicitly into the Therapeutic Goods Act, adding criminal and civil penalties for breaching conditions of exemptions/approvals/authorities, and new enforcement powers increase compliance obligations and legal risk. (Schedule 2, Part 1 and Part 7)
Publishers, advertisers and those handling e‑cigarette marketing: advertising exemptions and cross‑references between the TGA and the Public Health (Tobacco and Other Products) Act change which rules apply and where authorisations are required. (Schedule 3, Part 1)
Individuals and third parties from whom Medicare may seek documents or information: Chief Executive Medicare gains a formal notice power requiring production of relevant material; failure to comply carries a strict liability offence and civil penalties. (Schedule 4, Part 1: new section 129AACA and 129AACB)
Why the government says it matters (official purpose claims)
The stated aims are: to improve Medicare integrity (reduce fraud, recover erroneous payments), to streamline and clarify pharmacy approval processes, to equip the department to manage therapeutic goods shortages, and to strengthen enforcement against unlawful therapeutic and vaping goods, including clearer controls on advertising.
Testing those claims against costs, incentives and trade‑offs (practical impacts and risks)
Who pays and who benefits: The immediate fiscal beneficiary is the Commonwealth (improved ability to recover overpayments and deter fraud). Costs fall in concentrated ways on regulated parties: medical/dental providers (who must lodge claims faster and keep records aligned to shorter deadlines), pharmacists (who face new administrative timing rules), and therapeutic/goods/vaping businesses (who face higher compliance costs, fees and criminal/civil risk). The Act creates a direct enforcement incentive for the regulator to pursue recoveries and compliance actions (Schedule 4: 129AAK and related recovery provisions).
Compliance burden: New criminal penalties (up to 5 years and large penalty units for some therapeutic goods breaches — Schedule 2, Part 7: new section 32CP) and civil penalties raise compliance costs for manufacturers, sponsors and suppliers. Requiring payment of prescribed fees before processing consents (Schedule 2, Part 9 items 86–91) shifts processing costs onto applicants and may reduce the regulator’s processing load but raises barriers (and cash flow costs) for smaller operators.
Bureaucratic discretion and decision‑making: Several provisions broaden Secretary/Minister discretion — e.g. enforceable directions must be given where "in the interests of public health or safety" (Schedule 2, Part 4 items 45–49), and the Secretary need not consider a consent application until fees are paid (Schedule 2, Part 9). These expand administrative control but also concentrate discretionary power in departmental hands, increasing scope for internal policy choices and potential administrative delay.
Market effects and private choice: Bringing vaping goods into the Therapeutic Goods Act and tightening advertising controls changes the regulatory environment for e‑cigarette products. That raises barriers for new entrants and may change marketing, packaging and pricing strategies. Pharmacy approval timing and restrictions on reapplications can affect local pharmacy competition and access to PBS supply in a locality (Schedule 1, Part 3).
Enforcement vs service delivery trade‑off: The Act prioritises enforcement tools (expanded offences, recovery powers, seizure/forfeiture and enforceable directions) and greater administrative reach. That imposes opportunity costs: resources used to investigate, litigate and enforce will not be available for other administrative tasks unless the department receives additional resourcing.
Legal and implementation risks: The Act introduces strict liability offences and broad civil penalties (Schedule 2, Part 7; Schedule 4: 129AACB). Those provisions may prompt legal challenges, disputes about retrospective effect (the Act includes some transitional saving clauses), and require clear administrative guidance to avoid inconsistent enforcement. Conditional commencement clauses (for example, some Health Insurance Act amendments commence only once an assignment‑of‑benefits measure has come into effect) add implementation complexity (Commencement table and Schedule 1, Part 1 Division 2–3).
Concentrated benefits, diffuse costs: The fiscal benefit (recoverable amounts) is concentrated in government revenue; costs are often dispersed across many small providers, manufacturers, advertisers and consumers (e.g. increased fees, compliance costs and possible price effects).
Key sections to check in the Act text (examples)
Shorter claims window: Schedule 1, Part 1 (Dental Benefits Act 2008, item 1; Health Insurance Act 1973, items 3 and 7)
New "relevant offence" and data handling: Schedule 1, Part 2 (item 9 and items 11–12)
Pharmacist approvals: Schedule 1, Part 3 (items 16–23)
Vaping goods under TGA and advertising cross‑references: Schedule 2, Part 1 (multiple items) and Schedule 3, Part 1
New therapeutic goods offences and civil penalties: Schedule 2, Part 7 (new sections 32CP and 32CQ — item 78)
Chief Executive Medicare notice power and penalties for non‑compliance: Schedule 4, Part 1 (new sections 129AACA and 129AACB — item 1)
Recovery of overpayments as debts: Schedule 4, Part 1 (new section 129AAK — item 6)
Bottom line (mechanical effects): The Act tightens time limits and recovery tools for Medicare payments, expands and clarifies TGA powers (including bringing vaping goods into the TGA scheme and creating new offences/civil penalties), alters pharmacist approval procedures, and increases administrative information and enforcement powers. These changes shift legal and financial risk onto providers, suppliers and applicants, while expanding departmental discretion and enforcement capability. The official aims emphasise integrity, safety and regulatory clarity; concretely, implementation will require updated departmental processes, stakeholder compliance efforts, and close attention to transitional rules and commencement linkages.
Main concepts
The Act centres on Medicare integrity through shortened claim periods, expanded investigative reach and overpayment recovery. The one-year timeframe for bulk-billed claims replaces the previous two-year period under amended subsection 15(2) of the Dental Benefits Act 2008 and paragraphs 20B(1)(c) and 20B(2)(b) of the Health Insurance Act 1973. Relevant offence is redefined in section 3A of the Human Services (Medicare) Act 1973 to capture a broader list of health and Criminal Code offences linked to claims, dental services, pharmaceutical benefits and indemnity payments. Pharmacy approval processes are streamlined by removing certain ministerial discretions, setting a four-month decision window in subsection 90B(5) of the National Health Act 1953 and imposing a 12-month bar on repeat requests under new subsection 90C(3). Therapeutic goods concepts include extension of advertising, shortage and enforcement rules to vaping goods, authorisation of persons assisting in warrant executions under new section 48AAA, adjustment of forfeiture and direction powers, and new criminal offences and civil penalties in sections 32CP and 32CQ for breaching conditions of biologicals exemptions and approvals. Shortage management now explicitly covers goods that may become unavailable in the reasonably foreseeable future. Tobacco concepts involve alignment of e-cigarette advertisement exceptions with Therapeutic Goods Act authorisations, extension of sponsorship rules to all persons, and mechanisms for phasing health warnings and product features during regulatory transitions. Additional integrity measures introduce administrative notice powers in section 129AACA of the Health Insurance Act 1973 requiring production of material relevant to Act administration, broader debt recovery under subsection 129AAK(1) for payments made without entitlement or invalid assignments, and use and derivative use immunity protections in amended section 106ZPQ for documents produced in Professional Services Review processes. Fee requirements are imposed before the Secretary considers certain consents, and transitional rule-making power is granted to the Minister.
Who it affects
Medical practitioners, dentists and allied health providers who bulk bill Medicare services face a reduced one-year window to lodge claims, affecting billing cycles and record-keeping practices. Patients and providers must now submit claims within one year of service under the amended Dental Benefits Act 2008 and Health Insurance Act 1973 provisions. Pharmacists seeking approval to supply pharmaceutical benefits encounter revised request processes, a four-month ministerial decision period and a 12-month restriction on resubmitting requests for the same premises under the National Health Act 1953. Therapeutic goods sponsors, manufacturers and suppliers of vaping goods are subject to extended advertising controls, shortage notification obligations and new condition breach offences under the Therapeutic Goods Act 1989. Importers and possessors of unlawful therapeutic or vaping goods face updated enforcement including forfeiture and enforceable directions. Biologicals licence holders and applicants for exemptions or approvals must comply with new criminal and civil penalty regimes for condition breaches. Tobacco product manufacturers, importers and retailers are affected by clarified e-cigarette advertisement exceptions, extended sponsorship prohibitions applying to all persons, and future phasing provisions for health warnings and packaging requirements under the Public Health (Tobacco and Other Products) Act 2023. The Chief Executive Medicare gains powers to issue notices requiring information relevant to administration, while persons receiving such notices face strict liability offences and civil penalties for non-compliance. Practitioners under Professional Services Review gain use and derivative use immunity for certain produced documents, limiting their use in subsequent criminal or civil proceedings except for specific recovery and compliance matters. Departmental employees and authorised persons receive expanded assistance and delegation authorities during inspections and enforcement. The Department of Health and Aged Care and Services Australia implement the new timeframes, investigative procedures and recovery mechanisms. Administrative Review Tribunal processes are adjusted for pharmacy approval reviews.
What people will want to know
Patients and providers should note that claims for bulk-billed Medicare professional services and dental benefits must now be lodged within one year of the service date rather than two years, with the change applying to services rendered on or after 5 September 2025. Failure to meet the deadline may result in loss of entitlement to benefits. Pharmacists considering applications for new premises approvals should be aware of the four-month decision timeframe and the prohibition on lodging a further request for the same premises within 12 months of a previous request. Vaping goods businesses need to understand that advertising and generic information rules now align more closely with Therapeutic Goods Act requirements, with certain authorisations providing exceptions from tobacco advertising prohibitions. Persons in possession of seized therapeutic goods should know that forfeiture provisions have been broadened beyond search warrants to any seizure under Part 6-2 of the Therapeutic Goods Act 1989. Biologicals manufacturers and sponsors must comply with conditions of exemptions and approvals or face new offences carrying up to five years imprisonment or 4000 penalty units for serious breaches that cause harm, alongside civil penalties up to 50000 penalty units for bodies corporate. Individuals or companies receiving a notice under new section 129AACA of the Health Insurance Act 1973 to produce information relevant to Medicare administration have at least 21 days to respond and may face 30 penalty unit strict liability offences or 150 penalty unit civil penalties for bodies corporate if they fail to comply without reasonable excuse. Overpayments made where no entitlement existed or assignments were invalid can now be recovered directly as debts, including from the person who rendered the service in certain circumstances. Practitioners involved in Professional Services Review should understand that documents they produce receive use and derivative use immunity, preventing their use against them in most criminal or civil proceedings except recovery actions and specific compliance matters. Tobacco retailers should monitor future regulations that may phase in new health warnings or product appearance requirements over prescribed periods.
Status and what happens next
The Bill received royal assent on 4 September 2025 and became Act No. 38 of 2025. Most provisions, including Schedules 2, 3 and 4 and Schedule 1 Parts 2 and 3, commenced on 5 September 2025. Schedule 1 Part 1 Division 1 commenced on 5 September 2025. Division 2 commenced on the same day unless the assignment of benefits amendments had already commenced. Division 3 commences on the later of 5 September 2025 or immediately after the commencement of Schedule 1 to the Health Insurance Legislation Amendment (Assignment of Medicare Benefits) Act 2024. An electronic version of the Act is available on the Federal Register of Legislation. The Senate Standing Committee for the Scrutiny of Bills considered the Bill in Scrutiny Digest 4 of 2025. Proposed amendments from the Australian Greens, Senator Thorpe, Senator Roberts and Senator Hanson were listed but no schedules of amendments were ultimately adopted. Implementation now rests with the Department of Health and Aged Care, Services Australia and the Therapeutic Goods Administration to update claims processing systems, issue guidance on new notice and recovery powers, develop any necessary regulations for phasing provisions and fees, and apply the revised investigative and enforcement frameworks. Practitioners and businesses should review updated administrative guidelines and fee schedules as they are published.
Powers, duties and rights created
The Chief Executive Medicare gains power under new section 129AACA of the Health Insurance Act 1973 to issue written notices requiring persons reasonably suspected of holding relevant material to provide it to specified APS employees, with a minimum 21-day compliance period that may be extended. Failure to comply creates a strict liability offence and civil penalty liability under section 129AACB. The Commonwealth gains new rights to recover overpayments under subsection 129AAK(1) from the recipient or, in specified cases, from the practitioner who rendered the service, where payment was made without entitlement or following an invalid assignment. The Minister gains power to make legislative instruments containing transitional rules for Schedule 4 amendments. Authorised persons under the Therapeutic Goods Act 1989 may be assisted by other persons in exercising powers, with actions of assistants attributed to the authorised person under new section 48AAA. The Secretary may give enforceable directions where it is in the interests of public health or safety rather than a stricter necessity test. New criminal offences and civil penalties are created in sections 32CP and 32CQ for breaching conditions of biologicals exemptions, approvals and authorities, with graduated penalties depending on whether harm results. The Secretary is relieved of any duty to consider consent applications until prescribed fees are paid under amended sections 14, 14A, 32BF and new section 41MAB. Use and derivative use immunity is conferred on persons producing documents in Professional Services Review processes, limiting admissibility in subsequent proceedings except for listed exceptions. Pharmacy applicants gain a right to written advice of ministerial decisions and review rights are preserved with adjusted timeframes. Later regulations may include phasing-in provisions that temporarily disapply conduct rules during transitions to new health warnings or product features.
Money, penalties and enforcement
New strict liability offences carry 30 penalty units for individuals failing to comply with administrative information notices under section 129AACB of the Health Insurance Act 1973, with corresponding civil penalties of 30 penalty units for individuals and 150 penalty units for bodies corporate. Breaches of biologicals conditions under section 32CP attract up to five years imprisonment or 4000 penalty units where harm results, 12 months or 1000 penalty units for basic breaches, and 100 penalty units for strict liability offences. Civil penalties under section 32CQ reach 5000 penalty units for individuals and 50000 penalty units for bodies corporate. Recovery of overpayments occurs as debts due to the Commonwealth, with interest provisions adjusted to 45 days in some review contexts. Application fees are now required before the Secretary considers consents for import, export or supply of goods that do not comply with standards. The Minister may prescribe fees for vaping goods applications and consents. Enforcement is supported by broadened forfeiture powers, updated warrant assistance obligations, and expanded delegation to cover information and document powers. Transitional rules may address application of new recovery and penalty provisions to past conduct in limited circumstances.
Pressure points and controversies
The shortening of claim timeframes from two years to one year creates a policy trade-off between improved Medicare integrity and potential administrative burden on providers and patients who may miss deadlines due to delayed invoicing or record retrieval. Expanded recovery powers for overpayments where services did not meet requirements or assignments were invalid may increase financial exposure for practitioners even where they acted in good faith. Introduction of administrative notice powers with strict liability consequences raises questions about the balance between efficient information gathering and procedural fairness for recipients. Extension of vaping goods regulation and new condition breach offences for biologicals strengthen enforcement but require sponsors to maintain rigorous compliance systems. Phasing provisions for tobacco product requirements allow regulatory flexibility during transitions yet depend on future regulations whose content is not yet known. Proposed amendments from cross-bench senators were considered during parliamentary debate but did not result in changes to the text as passed. The Scrutiny of Bills Committee examined the Bill, focusing on matters including delegation and strict liability provisions. Trade-offs also arise in the removal of certain public health and safety satisfaction tests for directions and the broadening of shortage substitution criteria to foreseeable future unavailability, which may facilitate faster regulatory responses at the cost of reduced thresholds for intervention.
What changes if it passes
Since the Act received royal assent, Medicare claims for bulk-billed services and dental benefits rendered on or after 5 September 2025 must be made within one year. Investigative officers may exercise updated powers in relation to a wider definition of relevant offences and may dispose of data reproductions by return or destruction. Pharmacy approval requests are subject to a four-month decision period and a 12-month bar on repeat applications for the same premises. Vaping goods are explicitly covered by multiple therapeutic goods advertising, shortage and enforcement provisions, with new offences applying to breaches of biologicals conditions. Overpayments may be recovered in additional circumstances including invalid assignments, supported by new administrative inquiry powers. Practitioners producing documents in Professional Services Review matters receive statutory use and derivative use immunity. Tobacco advertising exceptions now reference Therapeutic Goods Act authorisations, sponsorship rules apply to all persons, and future regulations may phase new packaging and warning requirements. Implementation has commenced with systems updates required across Services Australia and the Therapeutic Goods Administration.
Social post angles
Health Legislation Amendment (Improved Medicare Integrity and Other Measures) Bill 2025: what changes if it passes. A plain-English angle on the powers, duties and institutions the bill would create or change.
The practical question in this royal assent bill. Focus on who would need to act differently if Parliament passes it.
What the bill actually says, not the political noise. Pull out the main operational changes and point readers back to the clauses.
The compliance angle. Explain which agencies, regulated entities or decision-makers would carry new obligations.
The next-step angle. Use the bill's current status to explain what still has to happen before the changes become law.
Why this bill is worth watching. Tie the hook to: The bill received royal assent on 4 September 2025 and is now Act No. 38 of 2025.
Explanatory memorandum
Transcript of speeches
All second reading speeches
Minister's second reading speech
Proposed amendments
Senate
2R - Australian Greens [sheet 3360]
STEELE-JOHN, Sen Jordon
2R - Independent [sheet 3375]
THORPE, Sen Lidia
CW - Independent [sheet 3374]
THORPE, Sen Lidia
CW - Independent [sheet 3372]
THORPE, Sen Lidia
CW - Pauline Hanson's One Nation [sheet 3379]
ROBERTS, Sen Malcolm
CW - Pauline Hanson's One Nation [sheet 3373]
HANSON, Sen Pauline
Schedules of amendments
No documents at present
Notes
Considered by scrutiny committee (27/08/2025): Senate Standing Committee for the Scrutiny of Bills; Scrutiny Digest 4 of 2025
An electronic version of this Act is available on the Federal Register of Legislation (www.legislation.gov.au)
Health Legislation Amendment (Improved Medicare Integrity and Other Measures) Act 2025
No. 38, 2025
An Act to amend the law relating to health, and for related purposes
Contents
1 Short title 1
2 Commencement 2
3 Schedules 3
Schedule 1,Medicare integrity amendments 4
Part 1,Amendments relating to timeframe for bulk‑billed claims 4
Division 1,Amendments commencing the day after Royal Assent 4
Dental Benefits Act 2008 4
Division 2,Contingent amendments if amendments relating to assignment of medicare benefits have not yet commenced 4
Health Insurance Act 1973 4
Division 3,Amendments commencing when Division 1 and amendments relating to assignment of medicare benefits have both commenced 5
Health Insurance Act 1973 5
Part 2,Amendments relating to criminal offences 6
Human Services (Medicare) Act 1973 6
Part 3,Amendments relating to approvals of pharmacists 9
Division 1,Requests for Minister to approve pharmacists 9
National Health Act 1953 9
Division 2,Other amendments 11
National Health Act 1953 11
Schedule 2,Therapeutic goods amendments 12
Part 1,Vaping measures 12
Therapeutic Goods Act 1989 12
Part 2,Persons assisting 16
Therapeutic Goods Act 1989 16
Part 3,Forfeiture 19
Therapeutic Goods Act 1989 19
Part 4,Enforceable directions 20
Therapeutic Goods Act 1989 20
Part 5,Delegation 21
Therapeutic Goods Act 1989 21
Part 6,Therapeutic goods shortages 22
Therapeutic Goods Act 1989 22
Part 7,Biologicals and breaching conditions of exemptions, approvals or authorities 24
Therapeutic Goods Act 1989 24
Part 8,Review of decisions 29
Therapeutic Goods Act 1989 29
Part 9,Other amendments 30
Therapeutic Goods Act 1989 30
Schedule 3,Public health tobacco amendments 32
Part 1,Advertisements of e‑cigarette products that are vaping goods 32
Public Health (Tobacco and Other Products) Act 2023 32
Part 2,Sponsorship 34
Public Health (Tobacco and Other Products) Act 2023 34
Part 3,Phasing‑in and phasing‑out of tobacco product requirements 35
Public Health (Tobacco and Other Products) Act 2023 35
Part 4,Appointment of authorised officers 40
Public Health (Tobacco and Other Products) Act 2023 40
Schedule 4,Additional amendments to improve medicare integrity 41
Part 1,Amendments relating to administrative inquiries and recovery of overpayments 41
Division 1,Administrative inquiries 41
Health Insurance Act 1973 41
Division 2,Recovery of overpayments 44
Health Insurance Act 1973 44
Part 2,Use and derivative use immunity 47
Health Insurance Act 1973 47
Part 3,Transitional rules for amendments made by this Schedule 50
Health Legislation Amendment (Improved Medicare Integrity and Other Measures) Act 2025
No. 38, 2025
An Act to amend the law relating to health, and for related purposes
[Assented to 4 September 2025]
The Parliament of Australia enacts:
1 Short title
This Act is the Health Legislation Amendment (Improved Medicare Integrity and Other Measures) Act 2025.
2 Commencement
(1) Each provision of this Act 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.
Commencement information
Column 1
Column 2
Column 3
Provisions
Commencement
Date/Details
Sections 1 to 3 and anything in this Act not elsewhere covered by this table
The day this Act receives the Royal Assent.
4 September 2025
Schedule 1, Part 1, Division 1
The day after this Act receives the Royal Assent.
5 September 2025
Schedule 1, Part 1, Division 2
At the same time as the provisions covered by table item 2.
However, the provisions do not commence at all if Schedule 1 to the Health Insurance Legislation Amendment (Assignment of Medicare Benefits) Act 2024 commences before that time.
5 September 2025
Schedule 1, Part 1, Division 3
The later of:
(a) the commencement of the provisions covered by table item 2; and
(b) immediately after the commencement of Schedule 1 to the Health Insurance Legislation Amendment (Assignment of Medicare Benefits) Act 2024.
Schedule 1, Parts 2 and 3
The day after this Act receives the Royal Assent.
5 September 2025
Schedules 2 to 4
The day after this Act receives the Royal Assent.
5 September 2025
Note: This table relates only to the provisions of this Act as originally enacted. It will not be amended to deal with any later amendments of this Act.
(2) Any information in column 3 of the table is not part of this Act. Information may be inserted in this column, or information in it may be edited, in any published version of this Act.
3 Schedules
Legislation that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.
Schedule 1,Medicare integrity amendments
Part 1,Amendments relating to timeframe for bulk‑billed claims
Division 1,Amendments commencing the day after Royal Assent
Dental Benefits Act 2008
1 Subsection 15(2)
Omit “2 years”, substitute “1 year”.
2 Application provision
The amendment of subsection 15(2) of the Dental Benefits Act 2008 made by this Division applies in relation to a claim for a dental benefit in respect of a dental service that is rendered on or after the commencement of this Division.
Division 2,Contingent amendments if amendments relating to assignment of medicare benefits have not yet commenced
Health Insurance Act 1973
3 Paragraph 20B(2)(b)
Omit all the words after “within”, substitute:
the following period after the rendering of the professional service, or such further period as is allowed in accordance with subsection (3A):
(i) if the claim is for a medicare benefit the right to the payment of which has been assigned under subsection 20A(2A),2 years;
(ii) otherwise,1 year.
4 Subsection 20B(3A)
Omit “lodging the claim than the period of 2 years referred to in paragraph (1)(b) or (2)(b)”, substitute “making the claim”.
5 Subsection 20B(3B)
Omit “lodging”, substitute “making”.
6 Application provision
The amendment of paragraph 20B(2)(b) of the Health Insurance Act 1973 made by this Division applies in relation to a claim for a medicare benefit in respect of a professional service that is rendered on or after the commencement of this Division.
Division 3,Amendments commencing when Division 1 and amendments relating to assignment of medicare benefits have both commenced
Health Insurance Act 1973
7 Paragraph 20B(1)(c)
Repeal the paragraph, substitute:
(c) within the following period after the rendering of the service, or such further period as is allowed in accordance with subsection (3A):
(i) if the claim is for a medicare benefit the right to the payment of which would be taken to have been assigned under subsection 20A(2),2 years;
(ii) otherwise,1 year.
8 Application provision
Paragraph 20B(1)(c) of the Health Insurance Act 1973, as inserted by this Division, applies in relation to a claim for a medicare benefit in respect of a professional service that is rendered on or after the commencement of this Division.
Part 2,Amendments relating to criminal offences
Human Services (Medicare) Act 1973
9 Section 3A
Repeal the section, substitute:
3A Definition of relevant offence
(1) For the purposes of this Act, a relevant offence is any of the following:
(a) an offence against the Health Insurance Act 1973;
(b) an offence against the National Health Act 1953;
(c) an offence against the Health and Other Services (Compensation) Act 1995;
(d) an offence against the Medical Indemnity Act 2002;
(e) an offence against the Dental Benefits Act 2008;
(f) an offence against the Midwife Professional Indemnity (Commonwealth Contribution) Scheme Act 2010;
(g) an offence against Division 134, 135, 136, 137, 141, 142, 144, 145, 372 or 400 of the Criminal Code, that relates to:
(i) a claim for payment in respect of a professional service, dental service or supply or purported supply of pharmaceutical benefits; or
(ii) an indemnity scheme payment; or
(iii) a Commonwealth contribution (within the meaning of the Midwife Professional Indemnity (Commonwealth Contribution) Scheme Act 2010);
(h) an offence against section 6 of the Crimes Act 1914, or section 11.1, 11.2, 11.2A, 11.3, 11.4 or 11.5 of the Criminal Code, that relates to an offence mentioned in another paragraph of this subsection.
(2) In this section:
dental service has the same meaning as in the Dental Benefits Act 2008.
indemnity scheme payment has the same meaning as in the Medical Indemnity Act 2002.
professional service has the same meaning as in the Health Insurance Act 1973.
10 Subsection 8U(1)
Omit “within the previous 60 days”.
11 Paragraph 8ZG(3)(d)
Repeal the paragraph, substitute:
(d) the disposal, by either of the following means, of any other reproduction of the data in the control of a Departmental employee:
(i) returning the reproduction to a person who is the occupier of the premises at that time;
(ii) destroying the reproduction.
12 Paragraph 8ZGA(3)(d)
Repeal the paragraph, substitute:
(d) the disposal, by either of the following means, of any other reproduction of the data in the control of a Departmental employee:
(i) returning the reproduction to a person who is the occupier of the premises at that time;
(ii) destroying the reproduction.
13 Application provisions
(1) The definition of relevant offence under section 3A of the Human Services (Medicare) Act 1973, as inserted by this Part, applies in relation to conduct that:
(a) constitutes or may constitute an offence; and
(b) occurs before, on or after the commencement of this Part.
(2) Paragraphs 8ZG(3)(d) and 8ZGA(3)(d) of the Human Services (Medicare) Act 1973, as inserted by this Part, apply in relation to a reproduction of data if:
(a) the reproduction is created as a result of entry to premises under a warrant issued under that Act; and
(b) the warrant is issued on or after the commencement of this Part.
Part 3,Amendments relating to approvals of pharmacists
Division 1,Requests for Minister to approve pharmacists
National Health Act 1953
14 Subsection 90A(5)
Repeal the subsection.
15 Subsection 90B(4)
Repeal the subsection.
16 Subsection 90B(5)
Omit “If the Minister decides to consider a request under subsection (1), the Minister must, within three months after making that decision”, substitute “The Minister must, within 4 months after the day a request is received under subsection (1)”.
17 Subsection 90B(6)
Repeal the subsection, substitute:
(6) The Secretary must, by notice in writing, advise the pharmacist of the decision made, or taken to have been made, by the Minister under subsection (5).
18 Before subsection 90C(1)
Insert:
Proceedings before the Administrative Review Tribunal or a federal court
19 Subsection 90C(2)
Omit “subsection 90B(4) or (if applicable)”.
20 At the end of section 90C
Add:
Previous requests in relation to premises
(3) If a pharmacist makes a request (the previous request) under subsection 90B(1) in relation to a decision of the Secretary under section 90 rejecting the pharmacist’s application to supply pharmaceutical benefits at particular premises, the pharmacist must not make a further request under subsection 90B(1), in relation to the premises, unless at least 12 months have passed since the day the previous request was made.
21 Subsection 90D(1)
Omit “to consider a request made by a pharmacist under subsection 90B(1) or whether to exercise the power under subsection 90A(2) in relation to such a request”, substitute “to exercise the power under subsection 90A(2) in relation to a request made by a pharmacist under subsection 90B(1)”.
22 Paragraph 105AE(1)(c)
Repeal the paragraph, substitute:
(c) the Minister decides, or is taken to have decided, not to exercise the Minister’s power under subsection 90A(2) in respect of the Secretary’s decision.
23 Application provision
(1) The amendments of the National Health Act 1953 made by this Part apply in relation to requests made by a pharmacist under section 90B(1) of that Act on or after the commencement of this item (subject to subitem (2)).
(2) Subsection 90C(3) of the National Health Act 1953 applies where the previous request referred to in that subsection is made on or after the commencement of this item.
Division 2,Other amendments
National Health Act 1953
24 Paragraph 6(1)(ab)
Omit “sections 90A and 90B”, substitute “section 90A and subsection 90B(5)”.
25 Subsection 99N(5)
Omit “2”, substitute “3”.
26 Application provision
The amendment of section 99N of the National Health Act 1953 made by this Part applies in relation to an appointment that is:
(a) made on or after the commencement of this item; or
(b) in force immediately before the commencement of this item.
Note: For reappointment, see section 33AA of the Acts Interpretation Act 1901.
Schedule 2,Therapeutic goods amendments
Part 1,Vaping measures
Therapeutic Goods Act 1989
1 Chapter 2A (heading)
After “therapeutic goods”, insert “or vaping goods”.
2 Section 9J
After “therapeutic goods” (wherever occurring), insert “or vaping goods”.
3 Section 9K (heading)
After “therapeutic goods”, insert “or vaping goods”.
4 Subsection 9K(1) (heading)
After “therapeutic goods”, insert “or vaping goods”.
5 Subsection 9K(1)
After “therapeutic goods” (wherever occurring), insert “or vaping goods”.
6 Subsection 9K(3) (heading)
After “therapeutic goods”, insert “or vaping goods”.
7 Subsection 9K(3)
After “therapeutic goods” (wherever occurring), insert “or vaping goods”.
8 Paragraphs 9L(1)(a) and (2)(a)
After “therapeutic goods” (wherever occurring), insert “or vaping goods”.
9 Subparagraph 41QB(6)(b)(ii)
After “determination by the Secretary”, insert “under the regulations”.
10 Subparagraph 41QB(6)(b)(ii)
Omit “because the Secretary is satisfied that the supply of the goods compromises public health and safety or the goods do not conform with a standard applicable to the goods”.
11 Subparagraph 41QB(9)(b)(ii)
After “determination by the Secretary”, insert “under the regulations”.
12 Subparagraph 41QB(9)(b)(ii)
Omit “because the Secretary is satisfied that the supply of the goods compromises public health and safety or the goods do not conform with a standard applicable to the goods”.
13 Subparagraph 41QC(13)(b)(ii)
After “determination by the Secretary”, insert “under the regulations”.
14 Subparagraph 41QC(13)(b)(ii)
Omit “because the Secretary is satisfied that the supply of the goods compromises public health and safety or the goods do not conform with a standard applicable to the goods”.
15 Subparagraph 41QD(7)(b)(ii)
After “determination by the Secretary”, insert “under the regulations”.
16 Subparagraph 41QD(7)(b)(ii)
Omit “because the Secretary is satisfied that the supply of the goods compromises public health and safety or the goods do not conform with a standard applicable to the goods”.
17 At the end of subsection 41RB(2)
Add “and be accompanied by the fee (if any) prescribed by the regulations”.
18 After paragraph 41RC(1)(a)
Insert:
(aa) the application is accompanied by the fee (if any) prescribed by the regulations for the purposes of subsection 41RB(2); and
19 Section 42AD (heading)
After “advertisements”, insert “or generic information”.
20 At the end of subsection 42AD(1)
Add:
Note: Part 5‑1A deals with advertisements about vaping goods.
21 Subsection 42AD(2)
Repeal the subsection, substitute:
(2) This Part does not apply in relation to generic information in relation to vaping goods.
Note: Part 5‑1A deals with generic information in relation to vaping goods.
(3) In this section:
generic information, in relation to vaping goods, has the same meaning as in Part 5‑1A.
22 Subsection 42DZK(2)
Omit “If, in”, substitute “In”.
23 Subsection 42DZK(2)
Omit “the Secretary is satisfied that there has been a contravention of this Act or the regulations,”.
24 Subsection 42DZK(2)
After “do one or more of the following”, insert “if the Secretary is satisfied that it is in the interests of public health or safety to give the person the direction”.
25 Subsections 52G(1) and (2)
After “therapeutic goods”, insert “or vaping goods”.
26 After paragraph 52G(3)(o)
Insert:
(oa) an instrument under section 41R;
(ob) a consent under section 41RC;
27 Application provisions
(1) The amendments made by items 10 and 12 apply in relation to the supply of vaping goods on or after the commencement of this item.
(2) The amendments made by items 14 and 16 apply in relation to the possession of a quantity of a kind of vaping goods on or after the commencement of this item.
(3) The amendments of sections 41RB and 41RC of the Therapeutic Goods Act 1989 made by this Part apply in relation to an application made on or after the commencement of this item.
(4) The amendments of section 42DZK of the Therapeutic Goods Act 1989 made by this Part apply in relation to the dissemination of generic information on or after the commencement of this item.
Part 2,Persons assisting
Therapeutic Goods Act 1989
28 Section 45A
Insert:
person assisting, in relation to an authorised person: see subsection 48AAA(2).
29 After section 48
Insert:
48AAA Persons assisting authorised persons
Authorised persons may be assisted by other persons
(1) An authorised person may be assisted by other persons in exercising powers or performing functions or duties under this Part, if that assistance is necessary and reasonable.
(2) A person providing such assistance is a person assisting an authorised person.
Powers, functions and duties of a person assisting
(3) A person assisting an authorised person:
(a) may enter premises; and
(b) may exercise the powers and perform the functions or duties that an authorised person may exercise or perform under this Part; and
(c) must do so only in accordance with a direction given to the person assisting by the authorised person.
(4) A power exercised by a person assisting an authorised person as mentioned in subsection (3) is taken for all purposes to have been exercised by the authorised person.
(5) A function or duty performed by a person assisting an authorised person as mentioned in subsection (3) is taken for all purposes to have been performed by the authorised person.
(6) If a direction is given under paragraph (3)(c) in writing, the direction is not a legislative instrument.
30 Subsection 48AA(1)
Omit “an authorised person who is”, substitute “all authorised persons, and all persons assisting the authorised persons, who are”.
31 Subsection 48AA(1)
Omit “ceases its execution and leaves”, substitute “cease its execution and leave”.
32 Subsection 48AA(2)
Omit “The authorised person”, substitute “One or more of the authorised persons, and the persons assisting the authorised persons,”.
33 Paragraph 48AA(2)(b)
Omit “the authorised person is”, substitute “the authorised persons, and the persons assisting the authorised persons, are”.
34 Subsection 48AA(3)
After “An authorised person”, insert “, or a person assisting the authorised person,”.
35 Paragraph 48AA(3)(b)
After “the authorised person” (wherever occurring), insert “or person assisting the authorised person”.
36 Subsection 48AA(4)
After “the authorised person”, insert “or person assisting the authorised person”.
37 Subsection 48FA(1)
Omit all the words after “represents the occupier,”, substitute:
must provide:
(a) an authorised person executing the warrant; and
(b) any person assisting the authorised person;
with all reasonable facilities and assistance for the effective exercise of the powers of both the authorised person and the person assisting the authorised person.
38 Application provisions
(1) Section 48AAA of the Therapeutic Goods Act 1989, as inserted by this Part, applies in relation to an entry to premises:
(a) if the entry is under a warrant,under a warrant that is issued or signed on or after the commencement of this Part; and
(b) otherwise,on or after the commencement of this Part.
(2) The amendments of sections 48AA and 48FA of the Therapeutic Goods Act 1989 made by this Part apply in relation to a warrant that is issued or signed on or after the commencement of this Part.
Part 3,Forfeiture
Therapeutic Goods Act 1989
39 Section 52AAA (heading)
Omit “under search warrant”.
40 Paragraph 52AAA(1)(a)
Omit “a warrant issued under section 50”, substitute “Part 6‑2”.
41 Paragraph 52AAA(3)(b)
Repeal the paragraph, substitute:
(b) the provision of Part 6‑2 under which the thing was seized and the grounds on which the thing was seized;
42 Subsection 54(5) (note)
Omit “under a warrant”.
43 Subsection 57(1A)
Omit “under search warrant”.
44 Application provision
The amendments of section 52AAA of the Therapeutic Goods Act 1989 made by this Part apply in relation to a thing seized on or after the day on which this item commences.
Part 4,Enforceable directions
Therapeutic Goods Act 1989
45 Section 42YS
Omit:
(b) it is necessary to exercise powers under this Part to protect the health and safety of humans;
substitute:
(b) it is in the interests of public health or safety to give the person directions under this Part;
46 Paragraph 42YT(1)(b)
Repeal the paragraph, substitute:
(b) it is in the interests of public health or safety to give the person directions under this section.
47 Subsection 42YT(1) (note)
Repeal the note.
48 Paragraphs 42YT(2)(a) and (b)
Omit “in compliance with this Act or the instrument”.
49 After subsection 42YT(2)
Insert:
(2A) A notice given under subsection (2) must set out the Secretary’s reasons for giving the notice.
50 Application provision
The amendments of section 42YT of the Therapeutic Goods Act 1989 made by this Part apply in relation to directions given under that section on or after the day on which this item commences.
Part 5,Delegation
Therapeutic Goods Act 1989
51 Subsection 57(1A)
After “(enforcement),”, insert “section 45AB (Secretary may require information or documents), section 45AF (Secretary may inspect and copy documents), section 45AG (Secretary may retain documents),”.
Part 6,Therapeutic goods shortages
Therapeutic Goods Act 1989
52 Paragraph 19A(1)(a)
Repeal the paragraph, substitute:
(a) registered goods that could act as a substitute for the goods:
(i) are unavailable or are in short supply; or
(ii) may, in the reasonably foreseeable future, become unavailable or be in short supply; and
53 Paragraph 19A(1A)(a)
Repeal the paragraph, substitute:
(a) registered goods that could act as a substitute for the goods:
(i) are unavailable or are in short supply; or
(ii) may, in the reasonably foreseeable future, become unavailable or be in short supply; and
54 Paragraph 32CO(1)(c)
Repeal the paragraph, substitute:
(c) therapeutic goods included in the Register that could act as a substitute for the biological:
(i) are unavailable or are in short supply; or
(ii) may, in the reasonably foreseeable future, become unavailable or be in short supply; and
55 Paragraph 32CO(1A)(c)
Repeal the paragraph, substitute:
(c) therapeutic goods included in the Register that could act as a substitute for the biological:
(i) are unavailable or are in short supply; or
(ii) may, in the reasonably foreseeable future, become unavailable or be in short supply; and
56 Section 41H
Omit:
(d) medical devices exempted if substitutes are unavailable or in short supply.
substitute:
(d) medical devices exempted if substitutes are unavailable or in short supply or may, in the reasonably foreseeable future, become unavailable or be in short supply.
57 Section 41HD (heading)
Omit “or in short supply”, substitute “etc.”.
58 Paragraph 41HD(1)(c)
Repeal the paragraph, substitute:
(c) the kinds of medical devices included in the Register that could act as a substitute for the medical device:
(i) are unavailable or are in short supply; or
(ii) may, in the reasonably foreseeable future, become unavailable or be in short supply; and
59 Paragraph 41HD(1A)(c)
Repeal the paragraph, substitute:
(c) the kinds of medical devices included in the Register that could act as a substitute for the medical device:
(i) are unavailable or are in short supply; or
(ii) may, in the reasonably foreseeable future, become unavailable or be in short supply; and
Part 7,Biologicals and breaching conditions of exemptions, approvals or authorities
Therapeutic Goods Act 1989
60 At the end of subsection 32CA(3)
Add:
Note: There are criminal offences and a civil penalty related to the breach of a condition of an exemption: see sections 32CP and 32CQ.
61 Subsection 32CA(4)
Repeal the subsection.
62 Section 32CC (note 1)
Omit “32CH and 32CI”, substitute “32CP and 32CQ”.
63 Sections 32CH and 32CI
Repeal the sections.
64 At the end of subsections 32CK(6) and (8)
Add:
Note: There are criminal offences and a civil penalty related to the breach of a condition of an approval: see sections 32CP and 32CQ.
65 Subsection 32CK(9)
Repeal the subsection.
66 Subsection 32CL(1)
Omit “(1) The”, substitute “The”.
67 At end of subsection 32CL(1)
Add:
Note: There are criminal offences and a civil penalty related to the breach of a condition applicable under regulations made for the purposes of this section: see sections 32CP and 32CQ.
68 Subsection 32CL(2)
Repeal the subsection.
69 At the end of subsections 32CM(2) and (3)
Add:
Note: There are criminal offences and a civil penalty related to the breach of a condition of an authority: see sections 32CP and 32CQ.
70 Paragraph 32CN(1)(c)
Omit “any”, substitute “either”.
71 Subparagraphs 32CN(1)(c)(ii) and (e)(ii)
Repeal the subparagraphs.
72 Paragraph 32CN(4)(c)
Omit “any”, substitute “either”.
73 Subparagraph 32CN(4)(c)(ii)
Repeal the subparagraph.
74 Paragraph 32CN(4A)(c)
Omit “any”, substitute “either”.
75 Subparagraph 32CN(4A)(c)(ii)
Repeal the subparagraph.
76 At the end of subsection 32CO(7)
Add:
Note: There are criminal offences and a civil penalty related to the breach of a condition of an approval under subsection (1), (1A) or (2): see sections 32CP and 32CQ.
77 Subsection 32CO(8)
Repeal the subsection.
78 At the end of Division 3 of Part 3‑2A
Add:
Subdivision F,Offences and civil penalties relating to breaching conditions of exemptions, approvals or authorities
32CP Offences for breaching a condition of an exemption, approval or authority
(1) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches:
(i) a condition of an exemption applicable under regulations made for the purposes of subsection 32CA(3); or
(ii) a condition of an exemption under section 32CB; or
(iii) a condition of an approval under section 32CK; or
(iv) a condition applicable under regulations made for the purposes of section 32CL; or
(v) a condition of an authority under section 32CM; or
(vi) a condition of an approval under subsection 32CO(1), (1A) or (2); and
(c) the act or omission:
(i) except for a breach of a condition referred to in subparagraph (b)(ii),has resulted in, will result in, or is likely to result in harm or injury to any person; or
(ii) for a breach of a condition referred to in subparagraph (b)(ii),has caused, will cause, or is likely to cause a serious risk to public health.
Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (2) instead: see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
(2) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches:
(i) a condition of an exemption applicable under regulations made for the purposes of subsection 32CA(3); or
(ii) a condition of an exemption under section 32CB; or
(iii) a condition of an approval under section 32CK; or
(iv) a condition applicable under regulations made for the purposes of section 32CL; or
(v) a condition of an authority under section 32CM; or
(vi) a condition of an approval under subsection 32CO(1), (1A) or (2).
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
(3) A person commits an offence of strict liability if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches:
(i) a condition of an exemption applicable under regulations made for the purposes of subsection 32CA(3); or
(ii) a condition of an exemption under section 32CB; or
(iii) a condition of an approval under section 32CK; or
(iv) a condition applicable under regulations made for the purposes of section 32CL; or
(v) a condition of an authority under section 32CM; or
(vi) a condition of an approval under subsection 32CO(1), (1A) or (2).
Penalty: 100 penalty units.
32CQ Civil penalty for breaching a condition of an exemption, approval or authority
A person contravenes this section if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches:
(i) a condition of an exemption applicable under regulations made for the purposes of subsection 32CA(3); or
(ii) a condition of an exemption under section 32CB; or
(iii) a condition of an approval under section 32CK; or
(iv) a condition applicable under regulations made for the purposes of section 32CL; or
(v) a condition of an authority under section 32CM; or
(vi) a condition of an approval under subsection 32CO(1), (1A) or (2).
(1) The amendments of the Therapeutic Goods Act 1989 made by this Part apply in relation to acts or omissions that occur on or after the commencement of this Part.
(2) Regulations made for the purposes of subsection 32CL(1) of the Therapeutic Goods Act 1989 that are in force immediately before the commencement of this item are taken, on and after that commencement, to have been made for the purposes of section 32CL of that Act.
Part 8,Review of decisions
Therapeutic Goods Act 1989
82 Subsection 7(2)
Repeal the subsection.
83 Subsection 60(1) (paragraph (a) of the definition of initial decision)
Repeal the paragraph.
84 Transitional,applications for declaration that goods are or are not therapeutic goods
(1) If:
(a) an application had been made under subsection 7(2) of the Therapeutic Goods Act 1989 before the commencement of this item (the commencement time); and
(b) no decision on the application had been made on the application before the commencement time;
the Secretary must make a decision on the application, and notify the applicant of the decision, in writing, as soon as practicable after the commencement time.
(2) Despite the repeal of paragraph (a) of the definition of initial decision in subsection 60(1) of the Therapeutic Goods Act 1989 by this Part, section 60 of that Act continues to apply, as if that repeal had not happened, in relation to:
(a) an initial decision referred to in that paragraph that was made before the commencement time; and
(b) a decision made under subitem (1) of this item after the commencement time.
Part 9,Other amendments
Therapeutic Goods Act 1989
85 Subsection 3(3)
Repeal the subsection.
86 At the end of section 14
Add:
(16) The Secretary is not required to consider giving an applicant a consent unless the applicant has paid the fee that is prescribed by the regulations for the processing of the applicant’s application for a consent.
87 At the end of section 14A
Add:
(6) The Secretary is not required to consider giving an applicant a consent unless the applicant has paid the fee that is prescribed by the regulations for the processing of the applicant’s application for a consent.
88 Subsection 19(8)
After “paragraph (1)(a)”, insert “, or an authority under subsection (5),”.
89 Paragraph 30(1)(b)
Omit “become”, substitute “are”.
90 At the end of section 32BF
Add:
(10) The Secretary is not required to consider giving an applicant a consent mentioned in subsection (6) unless the applicant has paid the fee (if any) that is prescribed by the regulations for the processing of the applicant’s application for such a consent.
91 After section 41MAA
Insert:
41MAB Giving of consent by Secretary
The Secretary is not required to consider giving a consent mentioned in section 41MA or 41MAA to a person unless the person has paid the fee that is prescribed by the regulations for the person’s application for such a consent.
92 At the end of section 61
Add:
(16) To avoid doubt, this section does not limit any other lawful release, disclosure or use of information held by the Department (including information that has been, or may be, released, disclosed or used under this section).
93 Subsection 63(4)
Repeal the subsection, substitute:
(4) Despite subsection 14(2) of the Legislation Act 2003, the regulations may make provision in relation to a matter by applying, adopting or incorporating, with or without modification, any matter contained in an instrument or other writing as in force or existing from time to time.
94 Application and saving provisions
(1) The amendments of sections 14, 14A and 32BF of the Therapeutic Goods Act 1989, and the insertion of section 41MAB of that Act, made by this Part apply in relation to an application made on or after the commencement of this item.
(2) The amendment of section 63 of the Therapeutic Goods Act 1989 made by this Part does not affect the validity of regulations in force under that Act immediately before the commencement of this item.
Schedule 3,Public health tobacco amendments
Part 1,Advertisements of e‑cigarette products that are vaping goods
Public Health (Tobacco and Other Products) Act 2023
1 Section 18
Omit “A person who contravenes these prohibitions may commit an offence or be liable for a civil penalty.”, substitute “A person who contravenes these prohibitions may commit an offence or be liable for a civil penalty. The Therapeutic Goods Act also contains advertising offences and civil penalties in relation to therapeutic goods and vaping goods.”.
2 Section 47
Repeal the section.
3 Sections 53 to 55
Repeal the sections, substitute:
53 Exception,exempt advertisements under the Therapeutic Goods Act
(1) An advertisement for an e‑cigarette product does not constitute an e‑cigarette advertisement if:
(a) the e‑cigarette product is a vaping good within the meaning of the Therapeutic Goods Act; and
(b) Part 5‑1A of that Act (about regulation of advertising etc. for vaping goods) does not apply to the advertisement because of section 42DZA of that Act.
(2) An advertisement for an e‑cigarette product does not constitute an e‑cigarette advertisement to the extent that:
(a) the e‑cigarette product is a vaping good within the meaning of the Therapeutic Goods Act; and
(b) an authorisation under section 42DZC of that Act is in force in relation to the advertising of that vaping good; and
(c) the advertisement complies with any conditions specified in the authorisation.
4 Sections 57 to 59
Repeal the sections.
5 Application provision
The amendments made by this Part apply in relation to the publishing of material on or after the day on which this item commences.
Part 2,Sponsorship
Public Health (Tobacco and Other Products) Act 2023
6 Subsection 39(1)
Omit “individual”, substitute “person”.
7 Subsection 66(1)
Omit “individual”, substitute “person”.
8 Application provision
The amendments made by this Part apply in relation to a contribution (whether financial or otherwise) made on or after the day on which this item commences.
Part 3,Phasing‑in and phasing‑out of tobacco product requirements
Public Health (Tobacco and Other Products) Act 2023
9 Section 8
Insert:
conduct rule means subsection (1) of each of the following provisions:
(a) sections 94 to 100;
(b) sections 102 to 105;
(c) sections 108 to 114;
(d) sections 116 to 119.
10 At the end of section 78
Add:
(4) Subsection (3) has effect subject to subsection 120A(2).
11 At the end of section 82
Add:
(5) Subsection (4) has effect subject to subsection 120B(2).
12 At the end of section 86
Add:
(7) Subsection (6) has effect subject to subsections 120C(2) and 120D(2).
13 Subsection 120(1)
Repeal the subsection, substitute:
(1) This section applies in relation to each conduct rule.
14 After Division 1 of Part 3.6
Insert:
Division 1A,Phasing‑in and phasing‑out of health warnings, health promotion inserts and appearance and physical features
120A Phasing‑in and phasing‑out of health warnings
(1) If:
(a) provisions (the existing provisions) of regulations prescribing images or a combination of images (if any) are in force for the purposes of subsection 78(1); and
(b) later regulations are made that contain provisions (the new provisions) amending the existing provisions;
then the later regulations may contain provisions (the phasing‑in provisions) that provide that a prescribed conduct rule, to the extent that it relates to subsection 78(1), does not apply to prescribed conduct engaged in:
(c) by persons in relation to a tobacco product if the retail packaging of that product displays the images or combination of images (if any) that will be prescribed for the purposes of subsection 78(1) on the day on which the new provisions commence; and
(d) during one or more prescribed periods.
(2) Subsection 78(3) does not apply to the phasing‑in provisions of the later regulations.
Note: Subsection 78(3) applies to the new provisions of the later regulations.
(3) This section does not limit the application, saving or transitional provisions that may be made by the later regulations in relation to the new provisions.
Note: For example, the later regulations may contain application provisions relating to the phasing out of the current health warnings on the retail packaging of tobacco products.
120B Phasing‑in and phasing‑out of health promotion inserts
(1) If:
(a) provisions (the existing provisions) of regulations prescribing health promotion inserts are in force for the purposes of paragraph 82(1)(a); and
(b) later regulations are made that contain provisions (the new provisions) amending the existing provisions;
then the later regulations may contain provisions (the phasing‑in provisions) that provide that a prescribed conduct rule, to the extent that it relates to paragraph 82(1)(a) and health promotion inserts, does not apply to prescribed conduct engaged in:
(c) by persons in relation to a tobacco product if the retail packaging, referred to in subsection 82(1), of that product includes the health promotion inserts that will be prescribed for the purposes of paragraph 82(1)(a) on the day on which the new provisions commence; and
(d) during one or more prescribed periods.
(2) Subsection 82(4) does not apply to the phasing‑in provisions of the later regulations.
Note: Subsection 82(4) applies to the new provisions of the later regulations.
(3) This section does not limit the application, saving or transitional provisions that may be made by the later regulations in relation to the new provisions.
Note: For example, the later regulations may contain application provisions relating to the phasing out of the current health promotion inserts on the retail packaging of tobacco products.
120C Phasing‑in and phasing‑out of appearance requirements
(1) If:
(a) provisions (the existing provisions) of regulations prescribing an image or text are in force for the purposes of subsection 86(3); and
(b) later regulations are made that contain provisions (the new provisions) amending the existing provisions;
then the later regulations may contain provisions (the phasing‑in provisions) that provide that a prescribed conduct rule, to the extent that it relates to subsection 86(3) and images or text, does not apply to prescribed conduct engaged in:
(c) by persons in relation to a tobacco product if the appearance of that product complies with the requirements, relating to images or text, that will be prescribed for the purposes of subsection 86(3) on the day on which the new provisions commence; and
(d) during one or more prescribed periods.
(2) Subsection 86(6) does not apply to the phasing‑in provisions of the later regulations.
Note: Subsection 86(6) applies to the new provisions of the later regulations.
(3) This section does not limit the application, saving or transitional provisions that may be made by the later regulations in relation to the new provisions.
Note: For example, the later regulations may contain application provisions relating to the phasing out of the current appearance requirements of a tobacco product.
120D Phasing‑in and phasing‑out of physical features requirements
(1) If:
(a) provisions (the existing provisions) of regulations prescribing an image or text are in force for the purposes of subsection 86(4); and
(b) later regulations are made that contain provisions (the new provisions) amending the existing provisions;
then the later regulations may contain provisions (the phasing‑in provisions) that provide that a prescribed conduct rule, to the extent that it relates to subsection 86(4) and images or text, does not apply to prescribed conduct engaged in:
(c) by persons in relation to a tobacco product if the physical features of that product comply with the requirements, relating to images or text, that will be prescribed for the purposes of subsection 86(4) on the day on which the new provisions commence; and
(d) during one or more prescribed periods.
(2) Subsection 86(6) does not apply to the phasing‑in provisions of the later regulations.
Note: Subsection 86(6) applies to the new provisions of the later regulations.
(3) This section does not limit the application, saving or transitional provisions that may be made by the later regulations in relation to the new provisions.
Note: For example, the later regulations may contain application provisions relating to the phasing out of the current physical features requirements of a tobacco product.
Part 4,Appointment of authorised officers
Public Health (Tobacco and Other Products) Act 2023
15 Paragraph 150(1)(a)
Omit “in the Department”.
Schedule 4,Additional amendments to improve medicare integrity
Part 1,Amendments relating to administrative inquiries and recovery of overpayments
Division 1,Administrative inquiries
Health Insurance Act 1973
1 After section 129AAC
Insert:
129AACA Notice to give information etc. relevant to Act administration
Chief Executive Medicare may require person to give information etc.
(1) If the Chief Executive Medicare reasonably suspects that a person has relevant material, the Chief Executive Medicare may, by notice in writing, require the person to give the relevant material:
(a) if the relevant material contains clinical details relating to an individual,to a specified APS employee in the Department who is a medical practitioner; or
(b) otherwise,to a specified APS employee in the Department.
Content of notice
(2) The notice must:
(a) specify all of the following:
(i) the relevant material;
(ii) the grounds on which the Chief Executive Medicare suspects that the person has the relevant material;
(iii) how the relevant material is to be given;
(iv) each person to whom the relevant material is to be given;
(v) the contact details of an APS employee in the Department who may be contacted in relation to the notice;
(vi) the period within which the person is required to give the relevant material; and
(b) contain a statement about the effect of section 129AACB (consequences of failure to give information etc. relevant to Act administration).
Period to comply with notice
(3) The period specified for the purposes of subparagraph (2)(a)(vi) must be a period ending at least 21 days after the day on which the notice is given.
(4) The Chief Executive Medicare may, in writing, extend the period within which the person is required to give the relevant material. The Chief Executive Medicare may do so before or after the end of the period.
Section not limited
(5) This section is not limited by:
(a) any other provision of this Act; or
(b) any provision of the Human Services (Medicare) Act 1973 or any other Act;
that relates to powers to require information, a document or a thing to be given.
Meaning of relevant material
(6) In this section, relevant material means information, a document or a thing that is relevant to the administration of this Act and includes information, a document or a thing that relates to:
(a) compliance with a requirement under this Act or an instrument made under this Act; or
(b) an amount paid under this Act; or
(c) a person’s entitlement to a benefit or payment under this Act.
129AACB Consequences of failure to give information etc. relevant to Act administration
(1) A person contravenes this subsection if:
(a) the person is given a notice under subsection 129AACA(1) requiring the person to give information, a document or a thing; and
(b) the person fails to comply with the requirement within:
(i) if the Chief Executive Medicare has, under subsection 129AACA(4), extended the period specified in the notice,the extended period; or
(ii) otherwise,the period specified in the notice.
Strict liability offence
(2) A person commits an offence of strict liability if the person contravenes subsection (1).
Penalty: 30 penalty units.
Civil penalty
(3) A person is liable for a civil penalty if the person contravenes subsection (1).
Civil penalty:
(a) for an individual,30 penalty units; and
(b) for a body corporate,150 penalty units.
(4) Subsection (3) does not apply if:
(a) the contravention is brought about by:
(i) another person over whom the defendant has no control; or
(ii) a non‑human act or event over which the defendant has no control; and
(b) the defendant could not reasonably be expected to guard against the contravention.
Note: A person who wishes to rely on this subsection in proceedings for a civil penalty order bears an evidential burden in relation to the matter in this subsection (see section 130H).
2 Section 129AAD (heading)
Repeal the heading, substitute:
129AAD Notice to produce documents relating to professional services
Division 2,Recovery of overpayments
Health Insurance Act 1973
3 Subsection 129AAI(1)
After “or (8)”, insert “, 129AAK(1)”.
4 Subsection 129AAJ(3)
Omit “28”, substitute “45”.
5 Subsection 129AAJ(4)
After “must”, insert “, unless the application has been withdrawn by the applicant”.
6 After section 129AAJ
Insert:
129AAK Recovery of amounts,overpayments in general
Amounts recoverable under this subsection
(1) An amount is recoverable under this subsection, as a debt due to the Commonwealth, if:
(a) the amount was paid purportedly under this Act in respect of a professional service to a person who was not entitled to be paid the amount under this Act in respect of that professional service; or
(b) the amount was paid purportedly by way of benefit or payment under this Act to a person who was not entitled to be paid the amount under this Act by way of that benefit or payment; or
(c) the amount was paid purportedly by way of benefit or payment under this Act, and the benefit or the right to the payment was assigned other than in accordance with section 20A.
From whom the amount may be recovered
(2) The amount may be recovered from:
(a) if subsection (3) applies to the amount,the person mentioned in paragraph (3)(b), or the estate of that person; or
(b) otherwise,the person to whom the amount was paid, or the estate of that person.
(3) This subsection applies to the amount if:
(a) the amount was paid, purportedly by way of benefit or payment under this Act, in respect of a professional service; and
(b) a person:
(i) rendered or purportedly rendered the service; or
(ii) is identified, in a claim for benefit or payment under this Act, as having rendered the service; and
(c) the amount was not in fact payable in respect of the service because:
(i) at the time the service was rendered or purportedly rendered, the person, the service, or the rendering or purported rendering of the service, did not meet a requirement under this Act or an instrument made under this Act; or
(ii) the person, the service, or the rendering or purported rendering of the service, breached a contract between the person and the Commonwealth; or
(iii) the service was rendered or purportedly rendered by a person who was, at the time, partly or fully disqualified under this Act or an instrument or agreement made under this Act.
Note: For the purposes of paragraph (c), an example of an amount not in fact payable in respect of a professional service is a medical benefit that, in accordance with section 19AA, is not payable because the service was rendered by a medical practitioner who did not meet the requirements under that section.
Recovery does not preclude other enforcement actions
(4) The recovery, by the Commonwealth, of an amount recoverable under subsection (1) does not preclude any other action being taken under this Act or any other Act in relation to any non‑compliance with a requirement under this Act, or an instrument made under this Act, that resulted in the amount being recoverable under subsection (1).
7 Section 129AC (heading)
Repeal the heading, substitute:
129AC Recovery of amounts,false or misleading information, failure to produce document etc.
8 Subsection 129AED(3)
After “section”, insert “129AAK or”.
9 After paragraph 129AEF(1)(a)
Insert:
(aaaa) an amount under subsection 129AAK(1) where any rights of review by the CEO under section 129AAJ have been exhausted or have expired;
10 Subsection 129AEG(1)
After “(a),”, insert “(aaaa),”.
Part 2,Use and derivative use immunity
Health Insurance Act 1973
11 At the end of subsection 106ZPQ(1)
Add:
Note: Under subsections 89B(2) and 105A(2), a person may be required to produce documents relevant to the Director’s review of the provision of services by a person, and documents relevant to the referral made to the Committee.
12 Before subsection 106ZPQ(2)
Insert:
Use and derivative use immunity
13 Subsection 106ZPQ(2)
Omit all the words after “evidence against”, substitute:
the person in any criminal or civil proceedings (including proceedings for the purposes of the National Law) other than the following:
(a) proceedings for an offence against subsection 106ZPN(1) (failing to produce documents or give information) or section 106ZPP (false or misleading documents);
(b) proceedings before a Committee or the Determining Authority;
(c) proceedings to recover an amount that is:
(i) recoverable under this Part as a debt due to the Commonwealth; or
(ii) otherwise required by or under this Part to be repaid to the Commonwealth;
(d) any other proceedings in relation to compliance with a requirement under this Part.
Note: For the purposes of subparagraph (c)(ii), an example of an amount required by or under this Part to be repaid to the Commonwealth is an amount that is to be repaid to the Commonwealth in accordance with a final determination under section 106TA.
14 At the end of section 106ZPQ
Add:
Admissibility of information passed on under certain provisions
(3) Subsection (2) does not prevent information, a document or other thing being admitted in evidence in proceedings against the person if:
(a) the information, document or other thing is obtained by:
(i) an appropriate person or body for the person (within the meaning of subsection 106XA(4)); or
(ii) the appropriate body, or one of the appropriate bodies, referred to in subsection 106XB(3) in relation to the person; and
(b) the information, document or other thing is obtained under subsection 106XA(2) or (3) or subsection 106XB(2); and
(c) the proceedings are for the purposes of the National Law.
Admissibility of certain derivative materials
(4) Subsection (2) does not prevent information, a document or other thing being admitted in evidence in proceedings against the person if the information, document or other thing:
(a) is not a document produced under subsection 89B(2) or 105A(2); but
(b) is, as a result of the production of a document under subsection 89B(2) or 105A(2), created or obtained by:
(i) an appropriate person or body for the person (within the meaning of subsection 106XA(4)); or
(ii) the appropriate body, or one of the appropriate bodies, referred to in subsection 106XB(3) in relation to the person.
15 Application provision
The amendments made by this Part to section 106ZPQ of the Health Insurance Act 1973 apply in relation to the admission of the following in any criminal or civil proceedings instituted on or after the commencement of this Part:
(a) a document produced before, on or after that commencement under subsection 89B(2) or 105A(2) of that Act;
(b) information, a document or other thing created or obtained before, on or after that commencement as a result of the production of a document before, on or after that commencement under subsection 89B(2) or 105A(2) of that Act.
Part 3,Transitional rules for amendments made by this Schedule
16 Transitional rules
(1) The Minister may, by legislative instrument, make rules prescribing matters of a transitional nature (including prescribing any saving or application provisions) relating to the amendments or repeals made by this Schedule.
(2) To avoid doubt, the rules may not do the following:
(a) create an offence or civil penalty;
(b) provide powers of:
(i) arrest or detention; or
(ii) entry, search or seizure;
(c) impose a tax;
(d) set an amount to be appropriated from the Consolidated Revenue Fund under an appropriation in this Act or the Health Insurance Act 1973;
(e) directly amend the text of this Act or the Health Insurance Act 1973.
(3) This Schedule (other than subitem (2)) does not limit the rules that may be made for the purposes of subitem (1).