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PB 52 of 2020 Arrangements as amended, taking into account amendments up to National Health (Chemotherapy Prescribing) Consequential Amendments Special Arrangement 2021
Administered by: Health
Registered 10 Jan 2022
Start Date 01 Nov 2021

Commonwealth Coat of Arms of Australia

National Health (Chemotherapy Prescribing) Special Arrangement 2020

PB 52 of 2020

made under subsection 100(1) of the

National Health Act 1953

Compilation No. 1

Compilation date:                              1 November 2021

Includes amendments up to:            F2021L01492

Registered:                                         10 January 2022

About this compilation

This compilation

This is a compilation of the National Health (Chemotherapy Prescribing) Special Arrangement 2020 that shows the text of the law as amended and in force on 1 November 2021 (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 (www.legislation.gov.au). 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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

  

  

  


1  Name of Special Arrangement

             (1)  This Special Arrangement is the National Health (Chemotherapy Prescribing) Special Arrangement 2020.

             (2)  This Special Arrangement may also be cited as PB 52 of 2020.

3  Authority

This instrument is made under subsection 100(1) of the National Health Act 1953.

4  Simplified outline of this instrument

This instrument makes a special arrangement to make the supply of certain pharmaceutical benefits to patients who have been prescribed certain pharmaceutical benefits for the purposes of chemotherapy more efficient and convenient.

 

The instrument modifies arrangements for prescribing the supply of pharmaceutical benefits available for general supply, to enable them to be prescribed using a medication chart also used to prescribe the person an infusion or related chemotherapy benefit under the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011.

Note:          Part VII of the Act, and regulations or other instruments made for the purposes of that Part, have effect subject to this instrument (see subsection 100(3) of the Act).

5  Definitions

(1)  In this Special Arrangement:

Act means the National Health Act 1953.

authorised prescriber, for a pharmaceutical benefit, means a PBS prescriber (within the meaning of Part VII of the Act) authorised under section 9 or 9A of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 to write a prescription for the supply of the benefit.

authority prescription has the meaning given by section 5 of the Regulations.

chemotherapy medication chart - see section 8.

chemotherapy medication chart prescription - see section 8.

chemotherapy pharmaceutical benefit has the meaning given by the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011.

electronic chemotherapy medication chart prescription - see section 8.

electronic medication chart system means a software system that is used for prescribing and recording the administration of medicines to persons receiving treatment at or from a public or private hospital.   

eligible private hospital patient has the meaning given by the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011.

eligible public hospital patient has the meaning given by the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011.

infusion has the meaning given by the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011.

medication chart means a chart used for prescribing, and recording the administration of, pharmaceutical benefits to persons receiving treatment in, at or from a hospital, and includes a chart within an electronic medication chart system, whether or not the chart:

(a)  is used for any other purpose; or

(b)  contains any other information.

participating hospital authority has the meaning given by the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011.

related pharmaceutical benefit has the meaning given by the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011.

Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.

Note:          Terms used in this Special Arrangement have the same meaning as in the Act—see section 13 of the Legislation Act 2003.  These terms include:

·      approved hospital authority

·      approved pharmacist

·      approved supplier

·      Chief Executive Medicare

·      pharmaceutical benefit.

(2)  In this Special Arrangement, a reference to the supply of an infusion or a related pharmaceutical benefit refers to supply under the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011.

6  Pharmaceutical benefits covered by this Special Arrangement

(1)   This Special Arrangement applies to a pharmaceutical benefit that is generally available for supply under Part VII of the Act.

(2)   A pharmaceutical benefit is generally available for supply under Part VII if:

(a)   it does not contain a drug that is subject to a declaration under subsection 85(2A) of the Act; or

(b)   it is not subject to a determination under paragraph 85(8)(a) of the Act; or

(c)   for a pharmaceutical benefit in relation to which a determination under paragraph 85(8)(b) has been made about the circumstances in which the benefit can only be supplied under a special arrangement under section 100 - the supply is not in those circumstances.

(3)   This Special Arrangement does not apply to a pharmaceutical benefit that can only be supplied under Part VII of the Act in accordance with any other Special Arrangement under section 100 of the Act.

7  Application of Part VII of the Act

(1)   Each pharmaceutical benefit supplied in accordance with this Special Arrangement is supplied under Part VII of the Act.

(2)   A provision of Part VII of the Act, or of regulations or other instruments made for Part VII of the Act, applies subject to this Special Arrangement.

Note:  See subsection 100(3) of the Act.

8  Method of prescribing pharmaceutical benefits   

(1)  An authorised prescriber for a pharmaceutical benefit may only write a prescription for a pharmaceutical benefit under this Special Arrangement (a chemotherapy medication chart prescription):

(a)  for an eligible public hospital patient - by completing a section of a medication chart that also directs the supply of an infusion or a related pharmaceutical benefit to the patient, in accordance with section 41 of the Regulations as modified by this section; or

(b)  for eligible private hospital patient - by completing a section of a medication chart that also directs the supply of an infusion to the patient, in accordance with section 41 of the Regulations as modified by this section.

(2)  A medication chart referred to in subsection (1) (a chemotherapy medication chart) is not required to be in a form approved by the Secretary under subsection 41(5) of the Regulations.

(3)  For a prescription written using a chemotherapy medication chart in an electronic medication chart system (an electronic chemotherapy medication chart prescription):

(a)  paragraph 41(2)(c) of the Regulations does not apply to the completion of a section of the chart; and

(b)  the authorised prescriber must electronically approve the electronic chemotherapy medication chart prescription in the electronic medication chart system; and

(c)  the section of the chemotherapy medication chart must include each authority approval number (if any) for the prescription.

(4)  A prescription written in accordance with this section is taken to be written in accordance with section 41 of the Regulations and Parts 4 and 5 of the Regulations apply as if a reference to a medication chart prescription includes a reference to a prescription written in accordance with this section.

9  Authority required procedures for electronic chemotherapy medication charts

(1)      If a prescription would be an authority prescription, the authority required procedures set out in sections 11 to 15 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 apply with the modifications set out in this section.

(2)   A reference in those sections to a medication chart prescription includes a reference to a chemotherapy medication chart prescription.  

(3)   An electronic chemotherapy medication chart prescription directing the supply of a written authority required pharmaceutical benefit may be authorised as set out in subsections (4) to (8).

Written authority required procedures - submission of electronic chemotherapy medication chart prescription

(4)      The authorised prescriber may submit to the Chief Executive Medicare:

(a)      a copy of the electronic chemotherapy medication chart prescription; or

(b)     details of the prescription, by means of electronic communication to obtain an electronic authority, in accordance with subsection (3).

Note:    For an authority required prescription for a pharmaceutical benefit that is not a written authority required pharmaceutical benefit, the prescription may be submitted in accordance with the procedures set out in paragraph 12(1)(b), (c) or (d), as appropriate, of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012.

(5)   The details of the prescription submitted in accordance with paragraph (4)(b) must:

(a)      be given to the Chief Executive Medicare in writing; and

(b)     be given by means of an electronic communication; and

(c)      encrypted when given to the Chief Executive Medicare; and

(d)     be given in accordance with any other requirements that would need to be met in order for the requirements to give the information in writing to be taken to have been met under the Electronic Transactions Act 1999.

Written authority required procedures - authorisation of electronic chemotherapy medication chart prescription 

(6)   An electronic chemotherapy medication chart prescription submitted in accordance with paragraph (4)(a) may be authorised by the Chief Executive Medicare signing his or her authorisation on the copy of the prescription, and:

(a)   if the Chief Executive Medicare requires the authorised prescriber to alter the prescription — indicating this on the copy; and

(b)   returning the copy to the authorised prescriber for alteration; and

(c)   the authorised prescriber must enter the authorisation number into the electronic chemotherapy medication chart prescription.

(7)   An electronic chemotherapy medication chart prescription submitted in accordance with paragraph (4)(b) may be authorised by the Chief Executive Medicare sending his or her authorisation, by electronic communication, including computer automated electronic communication, to the authorised prescriber.

(8)   If the Chief Executive Medicare authorises a prescription under subsection (7):

(a)      the Chief Executive Medicare must tell the authorised prescriber, by telephone or electronic communication, the approval number that has been allotted to the electronic chemotherapy medication chart prescription; and

(b)     the authorised prescriber must enter that number into the electronic chemotherapy medication chart prescription.

10  Supply of pharmaceuticals under this Special Arrangement

(1)  A pharmaceutical benefit may be supplied under this Special Arrangement by:

(a)     a participating hospital authority to an eligible public hospital patient; or

(b)    an approved hospital authority for a private hospital to an eligible private hospital patient; or

(c)     an approved pharmacist to an eligible public hospital patient or eligible private hospital patient.

(2)  However, a participating hospital authority may not supply a related pharmaceutical benefit under this Special Arrangement.

(3)  Subsections 45(2) to (7) of the Regulations, section 47 and section 49 of the Regulations apply to a supply made under this Special Arrangement with the following modifications:

(a)  a reference to a medication chart prescription is taken to include a reference to a chemotherapy medication chart prescription;

(b)  a reference to a person receiving treatment in or at a hospital includes a reference to a person receiving treatment from a hospital; and

(c)  for an electronic chemotherapy medication chart prescription:

(i)   paragraph 45(2)(c) does not apply;

(ii)  the participating hospital authority, approved hospital authority for a private hospital or approved pharmacist must verify in the electronic chemotherapy medication chart prescription that the pharmaceutical benefit has been supplied and the date on which it was supplied; and

(iii) for section 51, a reference to writing “immediate supply necessary” on the prescription is taken to be a reference to including those words in the electronic chemotherapy medication chart prescription.

(4)  Section 53 the Regulations does not apply to a supply made under this Special Arrangement.

11  Electronic chemotherapy medication chart prescription records

(1)  If an approved hospital authority or approved pharmacist supplies a pharmaceutical benefit under this Special Arrangement, the supplier must keep the chemotherapy medication chart, or a copy of the chemotherapy medication chart, on which the supplier wrote:

(a)  the details required by subsection 45(2)(c) of the Regulations in relation to the prescription; or

(b)  for an electronic chemotherapy medication chart - the verification required by paragraph 10(3)(c) in relation to the prescription.

(2)  The chemotherapy medication chart or copy of the chemotherapy medication chart must be kept for a period of at least 2 years from the date the pharmaceutical benefit is supplied by the approved hospital authority or approved pharmacist.   

12  Modified application of legislative instruments

(1)  A reference to a medication chart prescription in the National Health (Pharmaceutical Benefit) (Condition of approval for approved pharmacists) Determination 2017 is to be taken as including a reference to a chemotherapy medication chart prescription.  

(2)  In the rules made by the Minister under subsection 99AAA(8) and subsection 98AC(4) of the Act:

(a)   a reference to a medication chart prescription is to be read as including a reference to a chemotherapy medication chart prescription; and

(b)   in item 28A of the table to item 1 of Schedule 1, the reference to a paper-based prescription that is a medication chart prescription is to be read as including a reference to an electronic chemotherapy medication chart prescription.


Endnotes

Endnote 1—About 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 2—Abbreviation 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 3—Legislation history

 

Name

Registration

Commencement

Application, saving and transitional provisions

National Health (Chemotherapy Prescribing) Special Arrangement 2020 (PB 52 of 2020)

20 Aug 2020 (F2020L01038)

21 Aug 2020 (s 2(1) item 1)

 

National Health (Chemotherapy Prescribing) Consequential Amendments Special Arrangement 2021 (PB 117 of 2021)

31 Oct 2021 (F2021L01492)

1 Nov 2021 (s 2(1) item 1)

 

Endnote 4—Amendment history

 

Provision affected

How affected

s 2.............................................

rep LA s 48D

s 5.............................................

am F2021L01492