National Health Regulation 2016 (Cth)

National Health Regulation 2016

made under the

National Health Act 1953

Compilation No. 1

Compilation date:25 March 2020

Includes amendments up to:F2020L00294

Registered:14 April 2020

About this compilation

This compilation

This is a compilation of the National Health Regulation 2016 that shows the text of the law as amended and in force on 25 March 2020 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register ( The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Editorial changes

For more information about any editorial changes made in this compilation, see the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.

Self‑repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

Contents

Part 1Preliminary1Name

This is the National Health Regulation 2016.

3Authority

This instrument is made under the National Health Act 1953.

5Definitions

In this instrument:

Act means the National Health Act 1953.

health practitioner means a person practising a profession that, under the Health Practitioner Regulation National Law, is regulated by a National Board.

Health Practitioner Regulation National Law means:

1. (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

2. (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).

insulin pump consumables includes the following equipment manufactured for use with an insulin pump:

1. (a)

   cannulae;

2. (b)

   tubing;

3. (c)

   insulin reservoirs;

4. (d)

   insulin cartridges, other than insulin cartridges that contain insulin when the cartridges are supplied.

National Board means any of the following:

1. (a)

   the Aboriginal and Torres Strait Islander Health Practice Board of Australia;

2. (b)

   the Chiropractic Board of Australia;

3. (c)

   the Dental Board of Australia;

4. (d)

   the Medical Board of Australia;

5. (e)

   the Medical Radiation Practice Board of Australia;

6. (f)

   the Nursing and Midwifery Board of Australia;

7. (g)

   the Occupational Therapy Board of Australia;

8. (h)

   the Optometry Board of Australia;

9. (i)

   the Osteopathy Board of Australia;

10. (j)

    the Pharmacy Board of Australia;

11. (k)

    the Physiotherapy Board of Australia;

12. (l)

    the Podiatry Board of Australia;

13. (m)

    the Psychology Board of Australia.

Part 2Prescribed medical or surgical aids etc.6Prescribed medical or surgical aids etc.

1. (1)

   For paragraph 9A(1)(a) of the Act, the medical or surgical aids, equipment and appliances specified in the following table are prescribed.

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

1. (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.

Part 3Payment for supply of benefits7Payment for supply of benefits – prescribed date

For subsection 99(7) of the Act, 1 May 2002 is prescribed.

Part 4Procedure of Committees of Inquiry8Operation of this Part

For section 121 of the Act, this Part makes provision for and in relation to the procedure of Committees of Inquiry.

9Meetings

1. (1)

   A Committee of Inquiry must hold such meetings as are necessary for the efficient performance of its functions.

2. (2)

   The Chairperson of a Committee of Inquiry may convene a meeting at any time.

10Quorum

At a meeting of a Committee of Inquiry, a quorum is constituted by 3 members.

11Record of proceedings

A Committee of Inquiry must keep a record of its proceedings, including a transcript of all evidence given before the Committee.

Part 4ADivulging information11ATreatment provided to veterans

For the purposes of paragraph 135A(3)(b) of the Act:

1. (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:

   1. (i)

      the Australian Participants in British Nuclear Tests and British Commonwealth Occupation Force (Treatment) Act 2006;

   2. (ii)

      Chapter 6 of the Military Rehabilitation and Compensation Act 2004;

   3. (iii)

      the Papua New Guinea (Members of the Forces Benefits) Act 1957;

   4. (iv)

      the Safety, Rehabilitation and Compensation (Defence‑related Claims) Act 1988;

   5. (v)

      the Treatment Benefits (Special Access) Act 2019;

   6. (vi)

      Part V of the Veterans’ Entitlements Act 1986; and

2. (b)

   the information that may be provided to such an employee is information that would enable the employee to perform those functions.

11BComplaints and investigations

1. (1)

   For the purposes of paragraph 135A(3)(b) of the Act:

   1. (a)

      each of the following authorities or persons is a prescribed authority or person:

      1. (i)

         the Australian Health Practitioner Regulation Agency;

      2. (ii)

         a National Board;

      3. (iii)

         each State or Territory Board of a National Board;

      4. (iv)

         the Health Care Complaints Commission of New South Wales;

      5. (v)

         the Office of the Health Ombudsman of Queensland;

      6. (vi)

         an APS employee mentioned in paragraph 11A(a); and

   2. (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.

   Circumstances in which information may be provided

2. (2)

   Information may be provided to an authority mentioned in any of subparagraphs (1)(a)(i) to (v) if:

   1. (a)

      a person has complained to the Chief Executive Medicare about a health practitioner; and

   2. (b)

      the Chief Executive Medicare reasonably believes that the complaint should be referred to the authority for possible investigation.

3. (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.

4. (4)

   Information may also be provided to a person mentioned in subparagraph (1)(a)(vi) in the circumstances mentioned in subsection (2) or (3).

5. (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.

6. (6)

   However, information may only be provided to a State or Territory authority under subsection (5) if:

   1. (a)

      the health practitioner is, was, or is applying to be, registered or licensed to practice in that State or Territory; or

   2. (b)

      the health practitioner is or was practising in that State or Territory.

   Information that may be provided

7. (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):

   1. (a)

      name;

   2. (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);

   3. (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;

   4. (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.

8. (8)

   Information relating to a service or to the supply of a pharmaceutical benefit or other goods may be provided if:

   1. (a)

      a health practitioner who is the subject of a complaint or investigation mentioned in subsection (2), (3) or (5):

      1. (i)

         provided the service or supplied the pharmaceutical benefit or other goods; or

      2. (ii)

         supervised the provision of the service or the supply of the pharmaceutical benefit or other goods; or

      3. (iii)

         requested the service or the supply of the pharmaceutical benefit or other goods; or

      4. (iv)

         claimed or received payment of fees in relation to the service or the supply of the pharmaceutical benefit or other goods; or

      5. (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

   2. (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.

9. (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).

10. (10)

    The information mentioned in subsection (11) relating to a person may also be provided if:

    1. (a)

       the person has received a service or been supplied a pharmaceutical benefit or other goods; and

    2. (b)

       a health practitioner who is the subject of a complaint or investigation mentioned in subsection (2), (3) or (5):

       1. (i)

          provided the service or supplied the pharmaceutical benefit or other goods; or

       2. (ii)

          supervised the provision of the service or the supply of the pharmaceutical benefit or other goods; or

       3. (iii)

          requested the service or the supply of the pharmaceutical benefit or other goods; or

       4. (iv)

          claimed or received payment of fees in relation to the service or the supply of the pharmaceutical benefit or other goods; or

       5. (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

    3. (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.

11. (11)

    For the purposes of subsections (9) and (10), the information relating to the person is the following:

    1. (a)

       name;

    2. (b)

       contact information;

    3. (c)

       sex;

    4. (d)

       date of birth;

    5. (e)

       medicare number;

    6. (f)

       if the person is not a permanent Australian resident:

       1. (i)

          date of last entry into Australia; and

       2. (ii)

          expected date of departure from Australia; and

       3. (iii)

          name of country of residence.

11CProfessional disciplinary and regulatory bodies

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.

Part 5Fees and allowances for members of committees12Fees and allowances for members of committees

1. (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:

   1. (a)

      the Drug Utilisation Sub‑Committee; and

   2. (b)

      the Economics Sub‑Committee.

   Note: The sub‑committees mentioned in paragraphs (a) and (b) were established by the Pharmaceutical Benefits Advisory Committee under section 101A of the Act.

   Fees and allowances payable to Chairpersons

2. (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.

   Fees and allowances payable to other members

3. (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.

   References to Chairperson

4. (4)

   In this section, a reference to Chairperson does not include a person elected to preside at a meeting of the committee.

Endnotes

Endnote 1About the endnotes

The endnotes provide information about this compilation and the compiled law.

The following endnotes are included in every compilation:

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Abbreviation key—Endnote 2

The abbreviation key sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history—Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.

The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.

Editorial changes

The Legislation Act 2003 authorises First Parliamentary Counsel to make editorial and presentational changes to a compiled law in preparing a compilation of the law for registration. The changes must not change the effect of the law. Editorial changes take effect from the compilation registration date.

If the compilation includes editorial changes, the endnotes include a brief outline of the changes in general terms. Full details of any changes can be obtained from the Office of Parliamentary Counsel.

Misdescribed amendments

A misdescribed amendment is an amendment that does not accurately describe the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation “(md)” added to the details of the amendment included in the amendment history.

If a misdescribed amendment cannot be given effect as intended, the abbreviation “(md not incorp)” is added to the details of the amendment included in the amendment history.

Endnote 2Abbreviation key

ad = added or inserted	o = order(s)
am = amended	Ord = Ordinance
amdt = amendment	orig = original
c = clause(s)	par = paragraph(s)/subparagraph(s)
C[x] = Compilation No. x	/sub‑subparagraph(s)
Ch = Chapter(s)	pres = present
def = definition(s)	prev = previous
Dict = Dictionary	(prev…) = previously
disallowed = disallowed by Parliament	Pt = Part(s)
Div = Division(s)	r = regulation(s)/rule(s)
ed = editorial change	reloc = relocated
exp = expires/expired or ceases/ceased to have	renum = renumbered
effect	rep = repealed
F = Federal Register of Legislation	rs = repealed and substituted
gaz = gazette	s = section(s)/subsection(s)
LA = Legislation Act 2003	Sch = Schedule(s)
LIA = Legislative Instruments Act 2003	Sdiv = Subdivision(s)
(md) = misdescribed amendment can be given	SLI = Select Legislative Instrument
effect	SR = Statutory Rules
(md not incorp) = misdescribed amendment	Sub‑Ch = Sub‑Chapter(s)
cannot be given effect	SubPt = Subpart(s)
mod = modified/modification	underlining = whole or part not
No. = Number(s)	commenced or to be commenced

Endnote 3Legislation history

Name	Registration	Commencement	Application, saving and transitional provisions
National Health Regulation 2016	1 Sept 2016 (F2016L01374)	2 Sept 2016 (s 2(1) item 1)
Health Legislation Amendment (Permitted Information Disclosure) Regulations 2020	24 Mar 2020 (F2020L00294)	Sch 1 (items 13, 14): 25 Mar 2020 (s 2(1) item 1)	—

Endnote 4Amendment history

Provision affected	How affected
Part 1
s 2...........................................................	rep LA s 48D
s 4.............................................	rep LA s 48C
s 5.............................................	am F2020L00294
Part 4A
Part 4A....................................................	ad F2020L00294
s 11A.........................................	ad F2020L00294
s 11B.........................................	ad F2020L00294
s 11C.........................................	ad F2020L00294
Schedule 1..................................	rep LA s 48C