1 Name

(1) This instrument is the National Health (Efficient Funding of Chemotherapy) Amendment (COVID-19 Simplified Prescribing) Special Arrangement 2020.

(2) This Special Arrangement may also be cited as PB 53 of 2020.

(1) Each provision of this instrument 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
The whole of the instrument	On the day after this instrument is registered

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3 Authority

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

4 Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1—Amendments

National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011

1 Section 3

Before “In this Special Arrangement:” insert “(1)”.

2 Section 3

Insert:

chemotherapy medication chart prescription means a section of medication chart directing the supply of an infusion or a related pharmaceutical benefit.

electronic chemotherapy medication chart prescription means a chemotherapy medication chart directing the supply of an infusion or a related pharmaceutical benefit, prepared in an electronic medication chart system.

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

3 Section 3 (definition of infusion medication chart prescription)

Repeal the definition.

4 Section 3 (definition of medication chart prescription)

Repeal the definition.

5 At the end of section 3 (after the note)

Add:

(2) Subject to a contrary intention, in this Special Arrangement, a reference to a chemotherapy medication chart prescription includes a reference to an electronic chemotherapy medication chart prescription.

6 Subsection 14(1)

Repeal the subsection, substitute:

(1) An authorised prescriber may prescribe a chemotherapy pharmaceutical benefit under this Special Arrangement by:

(a) writing an infusion prescription for an infusion that includes the chemotherapy drug in the chemotherapy pharmaceutical benefit, in accordance with section 40 of the Regulations as modified by section 15 of this Special Arrangement; or

(b) preparing a chemotherapy medication chart prescription for an infusion that includes the chemotherapy drug in the chemotherapy pharmaceutical benefit, in accordance with section 41 of the Regulations as modified by section 16 of this Special Arrangement.

7 Subsection 14(2)

Omit “an infusion medication chart prescription”, substitute “a chemotherapy medication chart prescription directing the supply of an infusion”.

8 Subsection 14(3)

Repeal the subsection.

9 Subsection 14(4)

Repeal the subsection, substitute:

(4) Where an infusion prescription is written in accordance with section 40 of the Regulations as modified by section 15, the prescription is taken to be written in accordance with section 40 of the Regulations.

(5) Where a chemotherapy medication chart prescription is written in accordance with section 41 of the Regulations as modified by section 16, the prescription 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 included a reference to a chemotherapy medication chart prescription.

10 Section 15 (heading)

Omit “infusion medication chart prescriptions”, substitute “chemotherapy medication chart prescription directing the supply of an infusion”.

11 Section 16 (heading)

Omit “infusion medication chart prescription”, substitute “chemotherapy medication chart prescription directing the supply of an infusion”.

12 Section 16

Repeal the section (including the note, not including the heading), substitute:

(1) For paragraph 14(1)(b), this section modifies the requirements of section 41 of the Regulations.

(2) A medication chart used to write a chemotherapy medication chart prescription directing the supply of an infusion is not required to be in a form approved by the Secretary under section 41(5) of the Regulations.

(3) A completed section of a chemotherapy medication chart prescription directing the supply of an infusion must include the following information:

(a) the name of each chemotherapy drug included in the infusion; and

(b) for each chemotherapy drug – the dose, the frequency of administration and the route of administration.

(4) However, a completed section of a chemotherapy medication chart prescription directing the supply of an infusion does not need to include the form of the chemotherapy drug to be supplied.

(5) Section 41 of the Regulations applies as if references to a person receiving treatment in or at a hospital includes a reference to a person receiving treatment from a hospital.

(6) For 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.

Note: If the medication chart includes information about the form or brand of a chemotherapy drug to be supplied, or the quantity, number of units or number of repeats of a particular pharmaceutical benefit to be supplied, a supplier is not required to follow the prescriber's directions except if they relate to the method of administering the chemotherapy drug - see section 33.

13 Paragraph 17(1)(b)

Omit “an infusion medication chart prescription”, substitute “a chemotherapy medication chart prescription”.

14 Subsection 17(2)

Repeal the subsection, substitute:

(2) A reference in section 30 of the Regulations to:

(a) a determination in force under paragraph 85A(2)(a) of the Act is to be read as a reference to the maximum amount of the chemotherapy drug as described in section 9;

(b) compliance with subsection 41(2) of the Regulations is to be read as a reference to subsection 41(2) as modified by section 16;

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

(d) an electronic prescription is to be read as reference to an electronic chemotherapy medication chart.

15 Paragraph 17(3)(b)

Omit “an infusion medication chart prescription”, substitute “a chemotherapy medication chart prescription”.

16 Subsection 17(4)

Repeal the subsection, substitute:

(4) A reference in section 30 of the Regulations to:

(a) a determination in force under paragraph 85A(2)(b) of the Act is to be read as a reference to the maximum number of repeats for a chemotherapy drug as described in section 11;

(b) compliance with subsection 41(2) of the Regulations is to be read as a reference to subsection 41(2) as modified by section 16;

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

(d) an electronic prescription is to be read as reference to an electronic chemotherapy medication chart.

17 Section 19

Repeal the section (including the note, not including the heading), substitute:

(1) An authorised prescriber may prescribe a related pharmaceutical benefit under this Special Arrangement by:

(a) writing a prescription for the related pharmaceutical benefit in accordance with section 40 of the Regulations; or

(b) writing a chemotherapy medication chart prescription for the related pharmaceutical benefit in accordance with section 41 of the Regulations as modified by section 20.

(2) Where a chemotherapy medication chart prescription is written in accordance with section 41 of the Regulations as modified by section 20, it 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 chemotherapy medication chart prescription.

Note: Related pharmaceutical benefits can only be supplied under this Special Arrangement by a participating hospital authority to an eligible public hospital patient - see section 32.

18 After section 19

Insert:

20 Modified requirements for prescribing of related pharmaceutical benefits

(1) For paragraph 19(1)(b), this section modifies the requirements of section 41 of the Regulations.

(2) A medication chart used to write a chemotherapy medication chart prescription directing the supply of a related pharmaceutical benefit is not required to be in a form approved by the Secretary under subsection 41(5) of the Regulations.

(3) Section 41 of the Regulations applies as if references to a person receiving treatment in or at a hospital includes a reference to a person receiving treatment from a hospital.

(4) For 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.

19 Subsection 22(1)

Omit “infusion medication chart prescription”, insert “chemotherapy medication chart prescription used to direct the supply of an infusion”.

20 Subsection 22(1)

Omit “; (v) Compliance with modified Written Authority Required procedures".

21 Subsection 22(2)

After “including a”, insert “chemotherapy”.

22 Subsection 22(2)

Omit “; (v) Compliance with modified Written Authority Required procedures”.

23 Subsection 22(3)

Repeal the subsection, substitute:

(3) The authority required procedures set out in sections 11 to 15 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, with the modifications set out in this section, are to be followed.

Note: See section 14 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 for Streamlined Authority Code.

(4) A reference to a medication chart prescription in sections 11 to 15 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 includes a reference to a chemotherapy medication chart prescription.

(5) An electronic chemotherapy medication chart prescription directing the supply of a written authority required pharmaceutical benefit may be authorised as set out in subsections (6) to (10).

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

(6) 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 (7).

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.

(7) The details of the prescription submitted in accordance with paragraph (6)(b) must:

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

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

(8) An electronic chemotherapy medication chart prescription submitted in accordance with paragraph (6)(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.

(9) An electronic chemotherapy medication chart prescription submitted in accordance with paragraph (6)(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.

(10) If the Chief Executive Medicare authorises a prescription under subsection (9):

(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.

24 Subsection 22(4)

Repeal the subsection (including the example).

25 Subsection 31(3)

Omit “infusion medication chart prescription”, insert “infusion directed to be supplied under a chemotherapy medication chart prescription”.

26 Section 34 (after the heading)

Omit "Infusions".

27 Subsection 34(3)

Repeal the subsection (including the note), substitute:

(3) Subsections 45(2) to (7) of the Regulations apply as if a reference to a person receiving treatment in or at a hospital includes a reference to a person receiving treatment from a hospital.

(3A) Section 49 of the Regulations does not apply in relation to the writing of an infusion prescription.

Note: Section 49 of the Regulations does not apply in relation to the writing of a chemotherapy medication chart prescription because of section 14.

(3B) Section 53 of the Regulations does not apply to the supply of an infusion on the basis of an infusion prescription.

Note: Section 53 of the Regulations does not apply to supplies on the basis of a chemotherapy medication chart prescription because of section 14.

(3C) For an electronic chemotherapy medication chart prescription:

(a) paragraph 45(2)(c) of the Regulations does not apply;

(b) the approved supplier or public hospital authority must verify in the electronic chemotherapy medication chart prescription that the pharmaceutical benefit has been supplied and the date on which is was supplied; and

(c) for section 51 of the Regulations, 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.

28 Subsection 37(1)

After paragraph (a), insert:

(ab) a reference to a medication chart prescription includes a reference to a chemotherapy medication chart prescription;

29 Section 48

Omit “divided by”, substitute “÷”.

30 Section 48

Omit “mark-up for maximum multiple”, substitute “mark-up for maximum multiple”.

31 After Part 5

Insert:

Part 5A − Record keeping

59A Keeping documents - chemotherapy medication chart prescriptions

(1) If an approved supplier or public hospital authority supplies an infusion or a related pharmaceutical benefit under this Special Arrangement on the basis of a chemotherapy medication chart prescription, 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 paragraph 45(2)(c) of the Regulations; or

(b) for an electronic chemotherapy medication chart - the verification required by subsection 34(3C) 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 infusion or related pharmaceutical benefit is supplied by the approved supplier or public hospital authority.

Note 1: The chemotherapy medication chart, or a copy of the chemotherapy medication chart, may be kept in an electronic form (see subsection 12(2) of the Electronic Transactions Act 1999).

Note 2: Requirements to keep documents in relation to the supply of an infusion or a related pharmaceutical benefit on the basis of an infusion prescription are in section 59 of the Regulations.

32 Section 60

Repeal the section (not including the heading), substitute:

(1) This section applies where, before the commencement time, an authorised prescriber has written an infusion medication chart prescription or a medication chart prescription directing the supply of a related pharmaceutical benefit, in accordance with this Special Arrangement as in force immediately before that time (a relevant existing prescription).

(2) This Special Arrangement as in force immediately before commencement time continues to apply to:

(a) the prescribing of chemotherapy pharmaceutical benefits or related pharmaceutical benefits using the same chart used to write the relevant existing prescription, during the chart's period of validity under subsection 45(4) of the Regulations; and

(b) the supply of a chemotherapy pharmaceutical benefit or related pharmaceutical benefit made on the basis of that prescription and claims, payment and provisions of under co-payment data in relation to such a supply.

(3) In this section:

commencement time means the commencement of the National Health (Efficient Funding of Chemotherapy) Amendment (COVID-19 Simplified Prescribing) Special Arrangement 2020.

infusion medication chart prescription has the meaning given by the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 as in force immediately before the commencement time.

medication chart prescription has the meaning given by the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 as in force immediately before the commencement time.

33 Amendments of listed provisions

Further amendments
Item	Provision	Omit	Substitute
1	Subsections 9(2) and 11(2)	infusion medication chart prescription	chemotherapy medication chart prescription
2	Subsection 14(5) (note)	infusion medication chart prescriptions	chemotherapy medication chart prescriptions
3	Subsections 18(1), 18(3), 33(1), 33(2), 33(3) and 33(7)	infusion medication chart prescription	chemotherapy medication chart prescription