{"id":"F2016L01374","name":"National Health Regulation 2016","slug":"national-health-regulation-2016","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":94960,"registerId":"commonwealth-F2016L01374-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"Part 1","sectionType":"part","heading":"Preliminary","content":"## Part 1—Preliminary","sortOrder":0},{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\n This is the National Health Regulation 2016.","sortOrder":1},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\n This instrument is made under the National Health Act 1953.","sortOrder":2},{"sectionNumber":"5","sectionType":"section","heading":"Definitions","content":"#### 5 Definitions\n\n In this instrument:\n\n> Act means the National Health Act 1953.\n\n> health practitioner means a person practising a profession that, under the Health Practitioner Regulation National Law, is regulated by a National Board.\n\n> Health Practitioner Regulation National Law means:\n\n (a) for a State or Territory other than Western Australia—the Health Practitioner Regulation National Law set out in the Schedule to the Health Practitioner Regulation National Law Act 2009 (Qld), as it applies (with or without modification) as a law of the State or Territory; or\n (b) for Western Australia—the Health Practitioner Regulation National Law (WA) Act 2010 (WA), so far as that Act corresponds to the Health Practitioner Regulation National Law set out in the Schedule to the Health Practitioner Regulation National Law Act 2009 (Qld).\n\n> insulin pump consumables includes the following equipment manufactured for use with an insulin pump:\n\n (a) cannulae;\n (b) tubing;\n (c) insulin reservoirs;\n (d) insulin cartridges, other than insulin cartridges that contain insulin when the cartridges are supplied.\n\n> National Board means any of the following:\n\n (a) the Aboriginal and Torres Strait Islander Health Practice Board of Australia;\n (b) the Chiropractic Board of Australia;\n (c) the Dental Board of Australia;\n (d) the Medical Board of Australia;\n (e) the Medical Radiation Practice Board of Australia;\n (f) the Nursing and Midwifery Board of Australia;\n (g) the Occupational Therapy Board of Australia;\n (h) the Optometry Board of Australia;\n (i) the Osteopathy Board of Australia;\n (j) the Pharmacy Board of Australia;\n (k) the Physiotherapy Board of Australia;\n (l) the Podiatry Board of Australia;\n (m) the Psychology Board of Australia.","sortOrder":3},{"sectionNumber":"Part 2","sectionType":"part","heading":"Prescribed medical or surgical aids etc.","content":"## Part 2—Prescribed medical or surgical aids etc.","sortOrder":4},{"sectionNumber":"6","sectionType":"section","heading":"Prescribed medical or surgical aids etc.","content":"#### 6 Prescribed medical or surgical aids etc.\n\n (1) For paragraph 9A(1)(a) of the Act, the medical or surgical aids, equipment and appliances specified in the following table are prescribed.\n\n```html\n

Prescribed medical or surgical aids, equipment and appliances

Item

Description

1

Haemodialysis machines

2

Medical or surgical aids, equipment and appliances used in conjunction with haemodialysis machines

3

Peritoneal dialysis machines

4

Medical or surgical aids, equipment and appliances used in conjunction with peritoneal dialysis machines

5

Stoma appliances

6

Medical or surgical aids, equipment and appliances used in conjunction with stoma appliances

7

Wheelchairs

8

Orthoses

9

Wigs

10

Mammary prostheses

11

Electrolarynxes

12

Aids for incontinence

13

Walking aids

14

Equipment and appliances for personal use

15

Insulin syringes and needles

16

Equipment used for testing and monitoring the diabetic condition

17

Dressings, bandages, padding and ancillary items

18

Needles for the delivery of injectable blood glucose lowering medications other than insulin

19

Insulin pump consumables

\n```\n\n (2) For subsection 9A(2) of the Act, the medical or surgical aids, equipment and appliances specified in items 1 to 4 of the table in subsection (1) of this section are prescribed.","sortOrder":5},{"sectionNumber":"Part 3","sectionType":"part","heading":"Payment for supply of benefits","content":"## Part 3—Payment for supply of benefits","sortOrder":6},{"sectionNumber":"7","sectionType":"section","heading":"Payment for supply of benefits—prescribed date","content":"#### 7 Payment for supply of benefits—prescribed date\n\n For subsection 99(7) of the Act, 1 May 2002 is prescribed.","sortOrder":7},{"sectionNumber":"Part 4","sectionType":"part","heading":"Procedure of Committees of Inquiry","content":"## Part 4—Procedure of Committees of Inquiry","sortOrder":8},{"sectionNumber":"8","sectionType":"section","heading":"Operation of this Part","content":"#### 8 Operation of this Part\n\n For section 121 of the Act, this Part makes provision for and in relation to the procedure of Committees of Inquiry.","sortOrder":9},{"sectionNumber":"9","sectionType":"section","heading":"Meetings","content":"#### 9 Meetings\n\n (1) A Committee of Inquiry must hold such meetings as are necessary for the efficient performance of its functions.\n (2) The Chairperson of a Committee of Inquiry may convene a meeting at any time.","sortOrder":10},{"sectionNumber":"10","sectionType":"section","heading":"Quorum","content":"#### 10 Quorum\n\n At a meeting of a Committee of Inquiry, a quorum is constituted by 3 members.","sortOrder":11},{"sectionNumber":"11","sectionType":"section","heading":"Record of proceedings","content":"#### 11 Record of proceedings\n\n A Committee of Inquiry must keep a record of its proceedings, including a transcript of all evidence given before the Committee.","sortOrder":12},{"sectionNumber":"Part 4A","sectionType":"part","heading":"Divulging information","content":"## Part 4A—Divulging information","sortOrder":13},{"sectionNumber":"11A","sectionType":"section","heading":"Treatment provided to veterans","content":"#### 11A Treatment provided to veterans\n\n For the purposes of paragraph 135A(3)(b) of the Act:\n (a) an APS employee in the Veterans’ Affairs Department who performs functions under any of the following laws in relation to treatment or medical treatment (within the meaning of those laws) is a prescribed person:\n (i) the Australian Participants in British Nuclear Tests and British Commonwealth Occupation Force (Treatment) Act 2006;\n (ii) Chapter 6 of the Military Rehabilitation and Compensation Act 2004;\n (iii) the Papua New Guinea (Members of the Forces Benefits) Act 1957;\n (iv) the Safety, Rehabilitation and Compensation (Defence‑related Claims) Act 1988;\n (v) the Treatment Benefits (Special Access) Act 2019;\n (vi) Part V of the Veterans’ Entitlements Act 1986; and\n (b) the information that may be provided to such an employee is information that would enable the employee to perform those functions.","sortOrder":14},{"sectionNumber":"11B","sectionType":"section","heading":"Complaints and investigations","content":"#### 11B Complaints and investigations\n\n (1) For the purposes of paragraph 135A(3)(b) of the Act:\n (a) each of the following authorities or persons is a prescribed authority or person:\n (i) the Australian Health Practitioner Regulation Agency;\n (ii) a National Board;\n (iii) each State or Territory Board of a National Board;\n (iv) the Health Care Complaints Commission of New South Wales;\n (v) the Office of the Health Ombudsman of Queensland;\n (vi) an APS employee mentioned in paragraph 11A(a); and\n (b) this section sets out the circumstances in which information may be provided to a prescribed authority or person and the kind of information that may be provided.\n Circumstances in which information may be provided\n (2) Information may be provided to an authority mentioned in any of subparagraphs (1)(a)(i) to (v) if:\n (a) a person has complained to the Chief Executive Medicare about a health practitioner; and\n (b) the Chief Executive Medicare reasonably believes that the complaint should be referred to the authority for possible investigation.\n (3) Information may be provided to an authority mentioned in any of subparagraphs (1)(a)(i) to (v) if the authority tells the Chief Executive Medicare that a person has made a complaint to the authority about a health practitioner.\n (4) Information may also be provided to a person mentioned in subparagraph (1)(a)(vi) in the circumstances mentioned in subsection (2) or (3).\n (5) Information may be provided to an authority or person mentioned in paragraph (1)(a) if a health practitioner is the subject of an investigation by the Chief Executive Medicare.\n (6) However, information may only be provided to a State or Territory authority under subsection (5) if:\n (a) the health practitioner is, was, or is applying to be, registered or licensed to practice in that State or Territory; or\n (b) the health practitioner is or was practising in that State or Territory.\n Information that may be provided\n (7) The following information may be provided in relation to a health practitioner who is the subject of a complaint or investigation mentioned in subsection (2), (3) or (5):\n (a) name;\n (b) the address of each location at which the health practitioner practises (including any former location at which the health practitioner practised in the period that is the subject of the complaint or investigation);\n (c) if the health practitioner has been allocated an identifying number by the Chief Executive Medicare or the Secretary (such as a provider number, requester number or pharmacy approval number)—the number;\n (d) whether the health practitioner has been the subject of an investigation by the Chief Executive Medicare, and if so, the status of the investigation.\n (8) Information relating to a service or to the supply of a pharmaceutical benefit or other goods may be provided if:\n (a) a health practitioner who is the subject of a complaint or investigation mentioned in subsection (2), (3) or (5):\n (i) provided the service or supplied the pharmaceutical benefit or other goods; or\n (ii) supervised the provision of the service or the supply of the pharmaceutical benefit or other goods; or\n (iii) requested the service or the supply of the pharmaceutical benefit or other goods; or\n (iv) claimed or received payment of fees in relation to the service or the supply of the pharmaceutical benefit or other goods; or\n (v) in the case of a service—was the assignee under an assignment or agreement, made or entered into in accordance with section 20A of the Health Insurance Act 1973, in relation to the medicare benefit in respect of the service; and\n (b) the Chief Executive Medicare reasonably believes that the service or the supply of the pharmaceutical benefit or other goods is relevant to the complaint or investigation.\n (9) The information mentioned in subsection (11) relating to a person may be provided if the person has made a complaint mentioned in subsection (2) or (3).\n (10) The information mentioned in subsection (11) relating to a person may also be provided if:\n (a) the person has received a service or been supplied a pharmaceutical benefit or other goods; and\n (b) a health practitioner who is the subject of a complaint or investigation mentioned in subsection (2), (3) or (5):\n (i) provided the service or supplied the pharmaceutical benefit or other goods; or\n (ii) supervised the provision of the service or the supply of the pharmaceutical benefit or other goods; or\n (iii) requested the service or the supply of the pharmaceutical benefit or other goods; or\n (iv) claimed or received payment of fees in relation to the service or the supply of the pharmaceutical benefit or other goods; or\n (v) in the case of a service—was the assignee under an assignment or agreement, made or entered into in accordance with section 20A of the Health Insurance Act 1973, in relation to the medicare benefit in respect of the service; and\n (c) the Chief Executive Medicare reasonably believes that the service or the supply of the pharmaceutical benefit or other goods is relevant to the complaint or investigation.\n (11) For the purposes of subsections (9) and (10), the information relating to the person is the following:\n (a) name;\n (b) contact information;\n (c) sex;\n (d) date of birth;\n (e) medicare number;\n (f) if the person is not a permanent Australian resident:\n (i) date of last entry into Australia; and\n (ii) expected date of departure from Australia; and\n (iii) name of country of residence.","sortOrder":15},{"sectionNumber":"11C","sectionType":"section","heading":"Professional disciplinary and regulatory bodies","content":"#### 11C Professional disciplinary and regulatory bodies\n\n For the purposes of subparagraph 135A(5C)(c)(i) of the Act, the bodies mentioned in subparagraphs 11B(1)(a)(i) to (v) of this instrument are prescribed.","sortOrder":16},{"sectionNumber":"Part 5","sectionType":"part","heading":"Fees and allowances for members of committees","content":"## Part 5—Fees and allowances for members of committees","sortOrder":17},{"sectionNumber":"12","sectionType":"section","heading":"Fees and allowances for members of committees","content":"#### 12 Fees and allowances for members of committees\n\n (1) For paragraph 140(a) of the Act, this section prescribes the fees and allowances payable to members of a committee established under the Act, other than:\n (a) the Drug Utilisation Sub‑Committee; and\n (b) the Economics Sub‑Committee.\n\n> Note: The sub‑committees mentioned in paragraphs (a) and (b) were established by the Pharmaceutical Benefits Advisory Committee under section 101A of the Act.\n\n Fees and allowances payable to Chairpersons\n (2) The fees and allowances payable to the Chairperson of a committee are the amounts payable to the Chairperson in accordance with a determination made by the Remuneration Tribunal, as in force from time to time.\n Fees and allowances payable to other members\n (3) The fees and allowances payable to a member (other than the Chairperson) of a committee are the amounts payable to a member (other than the Chairperson) of the committee in accordance with a determination made by the Remuneration Tribunal, as in force from time to time.\n References to Chairperson\n (4) In this section, a reference to Chairperson does not include a person elected to preside at a meeting of the committee.","sortOrder":18}],"analysis":{"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"},"flash_summary":{"complexity_score":5,"scope_assessment":{"changed":false,"description":"The instrument implements and fills detail within powers granted by the National Health Act 1953: it prescribes particular items, sets procedural rules for Committees of Inquiry, and authorises specific information disclosures and fee arrangements. The text does not itself expand or narrow statutory jurisdiction beyond the Act; it specifies operational detail and decision gates for existing statutory functions."},"complexity_factors":["Multiple cross‑references to the National Health Act 1953 and other statutes (e.g. Health Practitioner Regulation National Law) requiring statutory reading together.","Enumerated list of prescribed aids with potential operational and procurement implications for suppliers and claimants.","Information‑sharing rules with conditional gateways (e.g. 'reasonable belief', complaint referral, investigation status) that create discretionary decision points for Chief Executive Medicare.","Overlap of Commonwealth, State and Territory registration/licensing considerations when sharing information with State/Territory authorities (subsection 11B(6)).","Privacy and data content specifics (detailed personal identifiers) imposing compliance obligations when disclosures occur.","Procedural prescriptions for Committees of Inquiry (quorum, record keeping, transcript requirement) that impose administrative burdens.","Reference to external determinations for fees (Remuneration Tribunal), creating dependency on another decision‑maker for costs.","Defined terms (e.g. 'health practitioner', 'insulin pump consumables') that affect who is covered and how equipment is categorised."],"plain_english_summary":"This regulation, made under the National Health Act 1953, lists prescribed medical and surgical aids (e.g. dialysis machines, wheelchairs, insulin supplies), fixes a prescribed payment date, sets basic procedure for Committees of Inquiry (meetings, quorum, records), authorises specified disclosure of practitioner‑related information to named bodies, and ties committee member fees to Remuneration Tribunal determinations. It affects health practitioners, Medicare administration (Chief Executive Medicare), professional and complaints bodies, veterans’ treatment staff, committee members, and suppliers or users of the listed aids."},"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"The regulation appears consistent with its original purpose under the National Health Act 1953. It covers pharmaceutical benefits administration, medical equipment subsidies, and committee governance as expected. The addition of Part 4A (information sharing) reflects modern privacy and regulatory needs rather than scope creep."},"complexity_factors":["Multiple cross-references to the National Health Act 1953 and other legislation (Health Practitioner Regulation National Law, Health Insurance Act 1973, various veterans' affairs acts)","Nested conditional logic in Part 4A with multiple subsections setting out when information can be shared and with whom","Geographic variation in definitions (Western Australia treated differently for the Health Practitioner Regulation National Law)","Detailed table of 19 prescribed items with some items referring to 'equipment used in conjunction with' other items, creating interpretive dependencies","Exception clauses in section 12 excluding specific sub-committees from the general fee rules"],"plain_english_summary":"This regulation defines what medical aids and equipment the Pharmaceutical Benefits Scheme will subsidise, sets key payment rules, creates procedures and pay arrangements for oversight committees, and restricts when Medicare may share practitioner information with regulators and veterans’ officials. It affects patients needing subsidised equipment, health practitioners, Medicare staff, veterans, and professional regulators, shaping access, privacy, and oversight."}},"importantCases":[],"_links":{"self":"/api/acts/national-health-regulation-2016","history":"/api/acts/national-health-regulation-2016/history","analysis":"/api/acts/national-health-regulation-2016/analysis","conflicts":"/api/acts/national-health-regulation-2016/conflicts","importantCases":"/api/acts/national-health-regulation-2016/important-cases","documents":"/api/acts/national-health-regulation-2016/documents"}}