Part 1—General
Division 1—Preliminary
1 Name of Special Arrangement
(1) This Special Arrangement is the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011.
(2) This Special Arrangement may also be cited as PB 79 of 2011.
3 Definitions
(1) In this Special Arrangement:
ABN has the same meaning as in the A New Tax System (Australian Business Number) Act 1999.
Act means the National Health Act 1953.
additional TGA licensed compounding fee, for the compounding of a dose of a chemotherapy drug for an infusion by a TGA licensed compounder – an amount of $20.
authorised prescriber means:
(a) for a chemotherapy pharmaceutical benefit—a kind of person identified by a prescriber code mentioned in the column in Part 1 of Schedule 1 headed ‘Authorised Prescriber’ for the benefit; or
(b) for a related pharmaceutical benefit—a kind of person identified by a prescriber code mentioned in the column in Schedule 2 headed ‘Authorised Prescriber’ for the benefit.
authority prescription means a prescription that has been authorised:
(a) in accordance with section 30 of the Regulations as modified by this Special Arrangement; or
(b) in accordance with Division 3 of Part 2 of this Special Arrangement.
benefit card means any of the following:
(a) a PBS Entitlement Card;
(b) a PBS Safety Net Concession Card;
(c) a Pensioner Concession Card;
(d) a Health Care Card (including Low Income Health Care Card and Foster Child Health Care Card);
(e) a Commonwealth Seniors Health Card;
(f) a cleft lip and cleft palate identification card;
(g) a DVA Gold Card;
(h) a DVA White Card;
(i) a DVA Orange Card;
(j) War Widow/Widower Transport Card;
(k) a card or voucher approved by the Chief Executive Medicare for this paragraph.
chemotherapy drug, means a drug that is mentioned in the column in Part 1 of Schedule 1 headed ‘Listed Drug’ for one or more chemotherapy pharmaceutical benefits.
Note: Each chemotherapy drug is also mentioned in Part 2 of Schedule 1.
chemotherapy medication chart prescription means a section of medication chart directing the supply of an infusion or a related pharmaceutical benefit.
chemotherapy pharmaceutical benefit means a pharmaceutical benefit that is mentioned in Part 1 of Schedule 1.
circumstances code means the letter ‘C’ followed by a number.
compounder means an entity (including a person, pharmacy, hospital or a body corporate) who undertakes and is responsible for the compounding of an infusion, so the infusion may be supplied by an approved supplier under this Special Arrangement.
compounder ID means the identification number allocated to a compounder by the Chemotherapy Compounding Payment Scheme Administration Agency in respect of a compounding site.
Note: Australian Healthcare Associates Pty Ltd is currently the Chemotherapy Compounding Payment Scheme Administration Agency.
diluent fee means an amount of $5.44.
dispensing fee means an amount of $7.74.
distribution fee means an amount of $27.45.
dose, for a chemotherapy drug, means the quantity of the drug contained in an infusion, including unit of use, such as international units, grams, micrograms, or milligrams.
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.
eligible patient means a person who:
(a) is, or is to be treated as, an eligible person within the meaning of the Health Insurance Act 1973; and
(b) is receiving treatment from an authorised prescriber.
eligible private hospital patient means an eligible patient who is receiving treatment at or from a private hospital.
eligible public hospital patient means an eligible patient who is receiving treatment at, or from, a public hospital as a non‑admitted patient, day admitted patient or patient on discharge.
entitlement number, for an eligible patient, means the number listed on the patient’s benefit card.
HSD hospital authority means a public hospital authority approved under section 52 of the National Health (Highly specialised drugs program) Special Arrangement 2010.
Human Services Department means the Department administered by the Human Services Minister.
infusion means a single treatment for a patient that is made from one or more chemotherapy pharmaceutical benefits.
infusion prescription means a prescription directing the supply of an infusion.
National Health Reform Agreement has the meaning given in the Federal Financial Relations Act 2009.
other Special Arrangement means another Special Arrangement under section 100 of the Act.
participating hospital authority means an approved hospital authority for a public hospital that is participating in a Pharmaceutical Reform Arrangement within the meaning of the National Health Reform Agreement.
preparation fee means an amount of $85.78.
Note: The preparation fee includes $40 for compounding the dose of chemotherapy drug in the infusion, which is not indexed annually. Where a TGA licensed compounder has compounded the dose of a chemotherapy drug, an additional TGA licensed compounding fee of $20 is payable to that TGA licensed compounder ‑ see section 46B.
prescriber code means any of the following codes identifying the kind of person mentioned for the code:
(a) MP—medical practitioner;
(b) PDP—participating dental practitioner;
(c) AO—authorised optometrist;
(d) MW—authorised midwife;
(e) NP—authorised nurse practitioner.
purposes code means the letter ‘P’ followed by a number.
Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.
related pharmaceutical benefit means a pharmaceutical benefit mentioned in Schedule 2.
residential care service has the meaning given by the Regulations.
supplier means a person who may supply an infusion or related pharmaceutical benefit under Part 3 of this Special Arrangement.
TGA licensed compounder means a compounder who holds a license issued under the Therapeutic Goods Act 1989 for aseptic compounding of sterile cytotoxic preparations.
under co‑payment data means information in relation to the supply under this Special Arrangement of:
(a) an infusion by an approved pharmacist, approved medical practitioner, approved hospital authority, or HSD hospital authority; or
(b) a related pharmaceutical benefit by a participating hospital authority;
where a claim is not payable as the dispensed price for the supply under this Special Arrangement does not exceed the amount that the supplier was entitled to charge under subsection 54(2) or 55(2) for supply of an infusion, or under subsection 57(2) for supply of a related pharmaceutical benefit.
Note: Terms used in this Special Arrangement have the same meaning as in the Act—see section 13 of the Legislative Instruments Act 2003. These terms include:
approved hospital authority
approved medical practitioner
approved pharmacist
approved supplier
pharmaceutical benefit
pharmaceutical item
public hospital authority.
(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.
Division 2—Pharmaceutical benefits
4 Pharmaceutical benefits covered by this Special Arrangement
(1) This Special Arrangement applies to each pharmaceutical benefit mentioned in Part 1 of Schedule 1 or in Schedule 2.
(2) Each pharmaceutical benefit to which this Special Arrangement applies is a brand of a listed drug mentioned in Part 1 of Schedule 1 or in Schedule 2:
(a) in the form mentioned in Part 1 of Schedule 1 or in Schedule 2 for the listed drug; and
(b) with the manner of administration mentioned in Part 1 of Schedule 1 or in Schedule 2 for the form of the listed drug.
Note: Each listed drug mentioned in Part 1 of Schedule 1 or in Schedule 2 has been declared by the Minister under subsection 85(2) of the Act. The form, manner of administration and brand mentioned in Part 1 of Schedule 1 or in Schedule 2 have been determined by the Minister under subsections 85(3), (5) and (6) of the Act respectively.
5 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.
Note: Under this Special Arrangement, pharmaceutical benefits listed in Part 1 of Schedule 1 are supplied as an infusion made from one or more pharmaceutical benefits.
(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.
6 Responsible person
(1) If a code is mentioned in the column in Part 1 of Schedule 1 or in Schedule 2 headed ‘Responsible Person’ for a brand of a pharmaceutical item, the person mentioned in paragraph (2)(a) is the responsible person for the brand of the pharmaceutical item.
(2) For subsection (1):
(a) the person is the person mentioned in Schedule 3 for the code, with the ABN, if any, mentioned in Schedule 3 for the person; and
(b) the pharmaceutical item is the listed drug mentioned in Part 1 of Schedule 1 or in Schedule 2:
(i) in the form mentioned in Part 1 of Schedule 1 or in Schedule 2 for the listed drug; and
(ii) with the manner of administration mentioned in Part 1 of Schedule 1 or in Schedule 2 for the form of the listed drug.
Note: A person identified by a code in the column in Part 1 of Schedule 1 or in Schedule 2 headed ‘Responsible Person’ has been determined by the Minister, under section 84AF of the Act, to be the responsible person for the brand of the pharmaceutical item.
7 Authorised prescriber
(1) Only an authorised prescriber for a chemotherapy pharmaceutical benefit may prescribe the supply of an infusion that includes the chemotherapy drug in the chemotherapy pharmaceutical benefit to an eligible patient.
(2) Only an authorised prescriber for a related pharmaceutical benefit may prescribe the supply of the related pharmaceutical benefit to an eligible patient.
Note: Each person mentioned in the column in Part 1 of Schedule 1 or in Schedule 2 headed ‘Authorised Prescriber’ is authorised by subsection 88(1) of the Act, or has been authorised by the Minister under section 88 of the Act, to prescribe the pharmaceutical benefit.
8 Prescription circumstances
(1) If at least one circumstances code is mentioned in the column in Part 1 of Schedule 1 headed ‘Circumstances’ for a chemotherapy pharmaceutical benefit, the circumstances in Schedule 4 for a code are circumstances in which the supply of an infusion that includes the chemotherapy drug in the chemotherapy pharmaceutical benefit may be prescribed.
(2) If each chemotherapy pharmaceutical benefit that has the same chemotherapy drug has at least one circumstances code, then the supply of an infusion that includes the chemotherapy drug may only be prescribed in circumstances mentioned for a circumstances code.
(3) If at least one circumstances code is mentioned in the column in Schedule 2 headed ‘Circumstances’ for a related pharmaceutical benefit:
(a) the circumstances mentioned in Schedule 4 for a code are circumstances in which the related pharmaceutical benefit may be prescribed; and
(b) the related pharmaceutical benefit may only be prescribed in circumstances mentioned for a circumstances code.
Note: Circumstances for a code mentioned in the column in Part 1 of Schedule 1 or in Schedule 2 headed ‘Circumstances’ have been determined by the Minister under paragraph 85(7)(b) of the Act, except for circumstances in relation to chemotherapy pharmaceutical benefits containing trastuzumab or fluorouracil.
9 Maximum amount—chemotherapy drug
(1) This section applies subject to section 17.
(2) The maximum amount of a chemotherapy drug that an authorised prescriber may direct to be included in an infusion in one infusion prescription or chemotherapy medication chart prescription is the amount mentioned in the column in Part 2 of Schedule 1 headed ‘Maximum Amount’ for the chemotherapy drug.
(3) If at least one purposes code is mentioned in the column in Part 2 of Schedule 1 headed ‘Purposes’ for a chemotherapy drug, the amount mentioned in the column headed ‘Maximum Amount’ is the maximum for the particular purposes mentioned in Schedule 4 for each code.
(4) If no purposes code is mentioned in the column in Part 2 of Schedule 1 headed ‘Purposes’, the amount mentioned in the column headed ‘Maximum Amount’ is the maximum for all purposes, other than a purpose for which a different maximum is mentioned for the same chemotherapy drug.
10 Maximum quantity—related pharmaceutical benefit
(2) The maximum quantity or number of units of the pharmaceutical item in a related pharmaceutical benefit that an authorised prescriber may direct to be supplied in one prescription is the quantity or number of units mentioned in the column in Schedule 2 headed ‘Maximum Quantity’ for the pharmaceutical benefit.
(3) If at least one purposes code is mentioned in the column in Schedule 2 headed ‘Purposes’ for a related pharmaceutical benefit, the quantity or number of units mentioned in the column headed ‘Maximum Quantity’ is the maximum for the particular purposes mentioned in Schedule 4 for each code.
(4) If no purposes code is mentioned in the column in Schedule 2 headed ‘Purposes’, the quantity or number of units mentioned in the column headed ‘Maximum Quantity’ is the maximum for all purposes, other than a purpose for which a different maximum is mentioned for the same related pharmaceutical benefit.
(5) For subsection (2), the pharmaceutical item is the listed drug mentioned in Schedule 2:
(a) in the form mentioned in Schedule 2 for the listed drug; and
(b) with the manner of administration mentioned in Schedule 2 for the form of the listed drug.
Note: The maximum quantities and numbers of units mentioned in the column in Schedule 2 headed ‘Maximum quantity’ have been determined by the Minister under paragraph 85A(2)(a) of the Act.
11 Maximum number of repeats—chemotherapy drug
(1) This section applies subject to section 17.
(2) The maximum number of occasions an authorised prescriber may, in one infusion prescription or chemotherapy medication chart prescription, direct that the supply of an infusion containing a chemotherapy drug be repeated is the number in the column in Part 2 of Schedule 1 headed ‘Number of Repeats’ for the chemotherapy drug.
(3) If at least one purposes code is mentioned in the column in Part 2 of Schedule 1 headed ‘Purposes’ for the chemotherapy drug, the number of repeats mentioned in the column headed ‘Number of Repeats’ is the maximum number for the particular purposes mentioned in Schedule 4 for each code.
(4) If no purposes code is mentioned in the column in Part 2 of Schedule 1 headed ‘Purposes’, the number of repeats mentioned in the column headed ‘Number of Repeats’ is the maximum number for all purposes, other than a purpose for which a different maximum is mentioned for the same chemotherapy drug.
(5) If an infusion contains more than one chemotherapy drug, the maximum number of repeats for the infusion is the smallest maximum number that applies in relation to one of the chemotherapy drugs.
12 Maximum number of repeats—related pharmaceutical benefit
(2) The maximum number of occasions an authorised prescriber may, in one prescription, direct that the supply of a related pharmaceutical benefit be repeated is the number in the column in Schedule 2 headed ‘Number of Repeats’ for the related pharmaceutical benefit.
(3) If at least one purposes code is mentioned in the column in Schedule 2 headed ‘Purposes’ for the related pharmaceutical benefit, the number of repeats mentioned in the column headed ‘Number of Repeats’ is the maximum number for the particular purposes mentioned in Schedule 4 for each code.
(4) If no purposes code is mentioned in the column in Schedule 2 headed ‘Purposes’, the number of repeats mentioned in the column headed ‘Number of Repeats’ is the maximum number for all purposes, other than a purpose for which a different maximum is mentioned for the same related pharmaceutical benefit.
Note: The numbers of repeats mentioned in the column in Schedule 2 headed ‘Number of Repeats’ have been determined by the Minister under paragraph 85A(2)(b) of the Act.
13 Section 100 only supply
(1) If the letter ‘D’ is mentioned in the column in Part 1 of Schedule 1 or in Schedule 2 headed ‘Section 100 only’ for a listed drug, the listed drug may be supplied only in accordance with this Special Arrangement and any other Special Arrangement relating to the listed drug.
(2) A pharmaceutical benefit that has a drug mentioned in subsection (1) is not available for general supply on the Pharmaceutical Benefits Scheme.
Note: The Minister has declared, under subsection 85(2A) of the Act, that the listed drug can only be supplied under a section 100 Special Arrangement.
(3) If the letters ‘PB’ are mentioned in the column in Part 1 of Schedule 1 or in Schedule 2 headed ‘Section 100 only’ for a pharmaceutical benefit, the pharmaceutical benefit may be supplied only in accordance with this Special Arrangement and any other Special Arrangement relating to the pharmaceutical benefit.
(4) A pharmaceutical benefit mentioned in subsection (3) is not available for general supply on the Pharmaceutical Benefits Scheme.
Note: The Minister has determined, under paragraph 85(8)(a) of the Act, that this pharmaceutical benefit can only be supplied under a section 100 Special Arrangement.
(5) If the letter ‘C’ is mentioned in the column in Part 1 of Schedule 1 or in Schedule 2 headed ‘Section 100 only’ for a pharmaceutical benefit and a code is mentioned in the column headed ‘Circumstances’, the pharmaceutical benefit may be supplied in the circumstances signified by the code only in accordance with this Special Arrangement and any other Special Arrangement relating to the pharmaceutical benefit.
(6) A pharmaceutical benefit mentioned in subsection (5) is not available in the circumstances mentioned in subsection (5) for general supply on the Pharmaceutical Benefits Scheme.
Note: The Minister has determined, under paragraph 85(8)(b) of the Act, that one or more of the circumstances in which a prescription for the supply of the pharmaceutical benefit may be written are circumstances in which the benefit can only be supplied under a section 100 Special Arrangement.
Part 2—Prescription
Division 1—Chemotherapy pharmaceutical benefits
14 Methods of prescribing chemotherapy pharmaceutical benefit
(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.
(2) However, a chemotherapy medication chart prescription directing the supply of an infusion may only be prepared for an eligible public hospital patient or eligible private hospital patient.
(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.
(4A) 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.
(5) Paragraph 40(3)(a) of the Regulations does not apply to an infusion prescription.
Note: Section 41 of the Regulations does not prohibit same day prescribing for chemotherapy medication chart prescriptions.
15 Information to be included in infusion prescription, other than chemotherapy medication chart prescription directing the supply of an infusion
(1) For paragraph 14(1)(a), this section modifies the requirements of section 40 of the Regulations.
(2) An infusion prescription must include the following information:
(a) the name of each chemotherapy drug included in the infusion;
(b) the dose of each chemotherapy drug;
(c) if supply of the infusion is to be repeated—the number of times it is to be repeated.
(3) An infusion prescription does not need to include the following information:
(a) the form of a chemotherapy drug to be supplied;
(b) the quantity or number of units of a pharmaceutical benefit to be supplied;
(c) the number of times supply of a pharmaceutical benefit is to be repeated.
Note: If the prescription does include this information, a supplier is not required to follow the prescriber’s directions—see section 33.
16 Information to be included in chemotherapy medication chart prescription directing the supply of an infusion
(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.
17 Dose or number of repeats greater than maximum
(1) If an authorised prescriber prescribes a dose of a chemotherapy drug that is greater than the maximum amount permitted under section 9, then:
(a) for an infusion prescription written in accordance with paragraph 14(1)(a); or
(b) for a chemotherapy medication chart prescription written in accordance with paragraph 14(1)(b),
the prescription must be authorised in accordance with the procedures set out in section 30 of the Regulations as modified by subsection (2).
(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.
(3) If an authorised prescriber directs that the supply of an infusion be repeated more times than the maximum number of repeats permitted under section 11 for one or more of the chemotherapy drugs included in the infusion, then:
(a) for an infusion prescription written in accordance with paragraph 14(1)(a); or
(b) for a chemotherapy medication chart prescription written in accordance with paragraph 14(1)(b),
the prescription must be authorised in accordance with the procedures set out in section 30 of the Regulations as modified by subsection (4).
(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.
18 Direction to vary dose of chemotherapy drug in infusion
(1) An authorised prescriber may direct a supplier to increase or decrease the dose of a chemotherapy drug in a prescribed infusion, without writing a new infusion prescription or chemotherapy medication chart prescription, if the new dose of the drug is between 90% and 110% of the dose that was originally prescribed.
(2) A new dose directed under subsection (1) that is greater than the maximum amount for the chemotherapy drug does not require approval under section 17.
(3) If a supplier receives a direction in accordance with subsection (1), the supplier must record on the infusion prescription or chemotherapy medication chart prescription:
(a) the name of the authorised prescriber who gave the direction; and
(b) the means by which the supplier was notified of the direction (for example, by phone or by fax); and
(c) the date and time the supplier was notified.
Division 2—Related pharmaceutical benefits
19 Methods of prescribing related pharmaceutical benefit
(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.
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.
Division 3—Authority required procedures
22 Authority required procedures to be followed
(1) This section applies to an infusion prescription or chemotherapy medication chart prescription used to direct the supply of an infusion if:
(a) a circumstances code is mentioned in Part 1 of Schedule 1 for a chemotherapy pharmaceutical benefit that has a chemotherapy drug included in the infusion; and
(b) the supply of the infusion is prescribed in the circumstances mentioned in Schedule 4 for the code; and
(c) the circumstances include one of the following statements:
(i) Compliance with Authority Required procedures;
(ii) Compliance with Written Authority Required procedures;
(iii) Compliance with Telephone Authority Required procedures;
(iv) Compliance with Written or Telephone Authority Required procedures.
Note: If at least one circumstances code is mentioned in Part 1 of Schedule 1 for each chemotherapy pharmaceutical benefit that has the same chemotherapy drug, supply of an infusion containing the chemotherapy drug may only be prescribed in one of the circumstances to which a code relates—see subsections 8(1) and (2).
(1A) If the circumstances mentioned in Schedule 4 include ‘Compliance with Telephone Authority Required procedures’ or ‘Compliance with Written or Telephone Authority Required procedures’ then treat as if the words used are ‘Compliance with Authority Required Procedures’.
(2) This section applies to a prescription (including a chemotherapy medication chart prescription) for a related pharmaceutical benefit if:
(a) a circumstances code is mentioned in Schedule 2 for the related pharmaceutical benefit; and
(b) the related pharmaceutical benefit is prescribed in the circumstances mentioned in Schedule 4 for the code; and
(c) the circumstances include one of the following statements:
(i) Compliance with Authority Required procedures;
(ii) Compliance with Written Authority Required procedures;
(iii) Compliance with Telephone Authority Required procedures;
(iv) Compliance with Written or Telephone Authority Required procedures.
Note: If at least one circumstances code is mentioned in Schedule 2, the related pharmaceutical benefit may only be prescribed in one of the circumstances to which the code relates—see subsection 8(3).
(2A) If the circumstances mentioned in Schedule 4 include ‘Compliance with Telephone Authority Required procedures’ or ‘Compliance with Written or Telephone Authority Required procedures’ then treat as if the words used are ‘Compliance with Authority Required Procedures’.
(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
(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
(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.
Part 3—Supply
30 Entitlement to infusion or related pharmaceutical benefit
An eligible patient is entitled to receive an infusion or a related pharmaceutical benefit under this Special Arrangement without payment or other consideration, other than a charge made under Part 5.
31 Supply of infusion under this Special Arrangement
(1) An infusion may be supplied under this Special Arrangement by any of the following:
(a) an approved pharmacist;
(b) an approved medical practitioner;
(c) an approved hospital authority for a private hospital; or
(d) a public hospital authority to an eligible public hospital patient.
(2) However, a public hospital authority that is not a participating hospital authority may only supply an infusion that contains trastuzumab and that does not contain any other chemotherapy drug.
(3) However, an infusion directed to be supplied under a chemotherapy medication chart prescription cannot be supplied by:
(a) an approved medical practitioner; or
(b) a public hospital authority that is not a participating hospital authority.
32 Supply of related pharmaceutical benefits under this Special Arrangement
A related pharmaceutical benefit may be supplied under this Special Arrangement by a participating hospital authority to an eligible public hospital patient.
33 Selection of chemotherapy pharmaceutical benefits to make infusion
Form, brand and method of administering
(1) If an authorised prescriber directs the supply of a form of a chemotherapy drug in an infusion prescription or chemotherapy medication chart prescription, the supplier of the infusion may use chemotherapy pharmaceutical benefits with the same chemotherapy drug but a different form to make the infusion.
(2) If an authorised prescriber directs the supply of a listed brand of a chemotherapy drug in an infusion prescription or chemotherapy medication chart prescription, the supplier of the infusion may use chemotherapy pharmaceutical benefits with the same chemotherapy drug but a different listed brand to make the infusion.
(3) If an authorised prescriber identifies a method of administering a chemotherapy drug in an infusion prescription or chemotherapy medication chart prescription, the supply of the infusion must be consistent with the method.
(4) Subsection (3) applies regardless of whether the method identified by the authorised prescriber is also a manner of administration for one or more chemotherapy pharmaceutical benefits containing the chemotherapy drug.
Note: Authorised prescribers are required to identify each chemotherapy drug in an infusion and the dose of each drug. They are not required to identify a particular chemotherapy pharmaceutical benefit by including the form, manner of administration or brand.
Quantity and number of repeats
(5) If an authorised prescriber directs the supply of a quantity or number of units of a particular chemotherapy pharmaceutical benefit, the supplier of the infusion may disregard the direction.
(6) If an authorised prescriber directs how many times the supply of a particular chemotherapy pharmaceutical benefit is to be repeated, the supplier of the infusion may disregard the direction.
Note: Authorised prescribers are required to identify the dose of each chemotherapy drug and for an infusion prescription the number of times that supply of the infusion is to be repeated. They are not required to identify the quantity or number of units of a pharmaceutical benefit to be supplied, or the number of times supply of a pharmaceutical benefit is to be repeated.
Circumstances
(7) If an infusion prescription or chemotherapy medication chart prescription has been authorised in circumstances mentioned in Schedule 4, the supplier must only use chemotherapy pharmaceutical benefits for which the circumstances code for those circumstances is mentioned in the column in Part 1 of Schedule 1 headed ‘Circumstances’.
34 Modified application of Act and Regulations
(1) A supply of an infusion under this Special Arrangement is not an early supply of a specified pharmaceutical benefit within the meaning of subsection 84AAA(1) of the Act.
(2) Subsections 51(2) to (4) of the Regulations do not apply to the supply of an infusion under this Special Arrangement.
Note: The effect of those subregulations is to restrict how soon a repeat supply may be made. There is no restriction on how soon a repeat supply of an infusion may be made under this Special Arrangement.
(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.
(4) A reference elsewhere in the Regulations to the supply of a pharmaceutical benefit is taken to include the supply of an infusion under this Special Arrangement.
34A Modified application of paragraph 92A(1)(f) conditions of approval
a) Section 8 of the conditions of approval for approved pharmacists under paragraph 92A(1)(f) of the Act does not apply to the supply of an infusion, once prepared as a final product ready for infusion to a person, when the infusion has a physical, chemical or biological stability restricting its clinically effective shelf life to 8 hours or less.
b) For the purposes of this section, shelf life means the period of time that a medicine can be stored and still be considered safe and effective for use.
Part 4—Claims, payment and provision of under co‑payment data
Division 1—Claims for payment and provision of under co‑payment data
36 How claims to be made
(1) The following may make a claim for payment for the supply of an infusion or related pharmaceutical benefit to an eligible patient under this Special Arrangement in accordance with section 99AAA of the Act, and the rules made under subsection 99AAA(8) of the Act, as modified by this Division:
(a) an approved supplier;
(b) an HSD hospital authority.
37 Modified references for claim and provision of under co‑payment data
(1) The rules made by the Minister under subsection 99AAA(8) and subsection 98AC(4) of the Act apply to a claim or provision of under co‑payment data as follows:
(a) a reference to an approved supplier or an approved hospital authority includes a reference to an HSD hospital authority;
(ab) a reference to a medication chart prescription includes a reference to a chemotherapy medication chart prescription;
(b) a reference to a number allotted to an approval under section 16 of the Regulations includes a reference to a number allotted to an approval under section 52 of the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 for a HSD hospital authority; and
(c) the definition of under co‑payment data in section 4 of this Special Arrangement replaces the definition of under co‑payment data appearing in the rules made under subsection 98AC(4) of the Act.
39 Modified requirements for supply of infusion
For a claim or provision of under co‑payment data for supply of an infusion, the requirements in the rules made by the Minister under subsection 99AAA(8) and subsection 98AC(4) of the Act are modified as follows:
(a) a reference to a pharmaceutical benefit includes a reference to an infusion;
(b) a reference to an authority prescription in the rules includes a reference to an authority prescription within the meaning given by section 3 of this Special Arrangement;
(c) the claim or provision of under co‑payment data must include:
(i) a drug code for each chemotherapy drug in the infusion, being the code for the drug published in the Schedule of Pharmaceutical Benefits published by the Department; and
(ii) the dose of each chemotherapy drug in the infusion; and
(iii) the compounder ID of the site at which the compounder compounded the dose of a chemotherapy drug for the infusion; and
(d) the supplier is not required to include in the claim or provision of under co‑payment data:
(i) the PBS/RPBS Item Code for the supplied pharmaceutical benefit;
(ii) the brand of the supplied pharmaceutical item;
(iii) whether or not section 49 applies; or
(iv) whether or not immediate supply was necessary.
Division 2—Payment of claim
41 Payment of approved pharmacist or approved medical practitioner for supply of infusion
An approved pharmacist or approved medical practitioner who makes a claim under Division 1 for the supply of an infusion is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of the infusion is greater than the amount that the approved pharmacist or approved medical practitioner was required to charge under subsection 54(2).
42 Payment of approved hospital authority or HSD hospital authority for supply of infusion
An approved hospital authority or HSD hospital authority that makes a claim under Division 1 for the supply of an infusion is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of the infusion is greater than the amount that the approved hospital authority or HSD hospital authority was entitled to charge under subsection 55(2).
43 Payment of participating hospital authority for supply of related pharmaceutical benefit
A participating hospital authority that makes a claim under Division 1 for the supply of a related pharmaceutical benefit is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of the related pharmaceutical benefit is greater than the amount that the supplier was entitled to charge under subsection 57(2).
45 Method of working out dispensed price
Infusion
(1) The dispensed price for the supply of an infusion is the sum of:
(a) the dispensed prices of the doses of chemotherapy drugs in the infusion; and
(b) if the supply is a repeated supply—an amount equivalent to the amount that may be charged under subsection 87(2) of the Act for the supply of a pharmaceutical benefit to the eligible patient.
(2) The dispensed price for a dose of a chemotherapy drug is to be worked out under Division 3.
Related pharmaceutical benefit
(3) The dispensed price for the supply of a related pharmaceutical benefit is to be worked out under Division 4.
Rounding
(4) A dispensed price worked out under Division 3 or 4 is rounded to the nearest cent, with a half cent being rounded up.
46 No separate entitlement to payment for supply of diluent
(1) If a supplier adds a pharmaceutical benefit to an infusion supplied under this Special Arrangement as a diluent, no amount is payable under Part VII of the Act for supply of the pharmaceutical benefit.
(2) Subsection (1) applies regardless of whether the pharmaceutical benefit added as a diluent is one to which this Special Arrangement applies.
Note: For the application of this Special Arrangement to pharmaceutical benefits, see section 5.
Division 2A—Payments to TGA licensed compounders
46A Payments in relation to infusions prepared between 1 July 2015 and 30 November 2017
(1) A TGA licensed compounder may make a claim for payment for the compounding of a dose of a chemotherapy drug for an infusion prepared between 1 July 2015 and 30 November 2017.
(2) A claim under subsection (1) must:
(a) be in writing; and
(b) include a certification by the TGA licensed compounder that:
(i) each dose of a chemotherapy drug for the infusion to which the claim relates was prepared in accordance with a compounding order; and
(ii) the information provided in the claim is correct.
(3) If a claim is made under subsection (1), the Secretary may, at his or her discretion, if the Secretary is satisfied on reasonable grounds that it is appropriate to do so, pay an amount of $20 to the TGA licensed compounder for the compounding.
46B Payments in relation to infusions prepared on or after 1 December 2017
(1) If a TGA licensed compounder compounds a dose of a chemotherapy drug for an infusion prepared on or after 1 December 2017, the compounder is entitled to be paid an additional TGA licensed compounding fee by the Commonwealth.
(2) A TGA licensed compounder must not be paid more than one additional TGA licensed compounding fee for the compounding of a dose of a chemotherapy drug for a single infusion that is prepared in accordance with an infusion prescription for an individual patient.
Division 3—Dispensed price of chemotherapy drug
47 Dispensed price if drug is in infusion supplied by approved pharmacist or approved medical practitioner
(1) For a dose of a chemotherapy drug in an infusion supplied by an approved pharmacist or an approved medical practitioner to an eligible patient, the dispensed price is the sum of the following amounts:
(a) the base price for the dose worked out under subsection (2);
(b) the distribution fee;
(c) the dispensing fee;
(d) the preparation fee;
(e) the diluent fee.
(2) The base price of a dose of a chemotherapy drug is the lowest sum of reference prices for a chemotherapy pharmaceutical benefit or combination of chemotherapy pharmaceutical benefits that make up an amount of the drug equal to or greater than the dose.
Note: If there is more than one chemotherapy pharmaceutical benefit or combination of chemotherapy pharmaceutical benefits that contains enough of the drug to make up the dose, the base price is determined by the lowest priced benefit or combination of benefits.
(3) A combination of chemotherapy pharmaceutical benefits includes a quantity of 2 or more of the same chemotherapy pharmaceutical benefit.
Example: Two of the same chemotherapy pharmaceutical benefit, each of which contains 50 mg of a drug, could be used in combination to make up an amount of 100 mg of the drug. The reference price for each 50 mg would be added together to calculate the price of the combination.
Note: A chemotherapy pharmaceutical benefit is in a form mentioned in Part 1 of Schedule 1 for a listed drug—see section 5. The form establishes the amount of the drug that is in a quantity of 1 of the chemotherapy pharmaceutical benefit.
(4) In this section, the reference price of a chemotherapy pharmaceutical benefit is the sum, rounded to the nearest cent (with a half cent being rounded up), of:
(a) the ex‑manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit, rounded to the nearest cent (with a half cent being rounded up); and
(b) the mark‑up for the chemotherapy pharmaceutical benefit worked out under:
(i) if the chemotherapy pharmaceutical benefit does not have trastuzumab—section 48; or
(ii) if the chemotherapy pharmaceutical benefit has trastuzumab—section 49.
Note: The reference price and the ex‑manufacturer price for a quantity of 1 are for the form of the chemotherapy pharmaceutical benefit mentioned in Part 1 of Schedule 1, which is not necessarily the same quantity as the quantity in a manufacturer’s pack.
For example, if a chemotherapy pharmaceutical benefit has a form of ‘Injection 500 mg in 10 mL’, and a manufacturer’s pack contains 3 lots of ‘Injection 500 mg in 10 mL’, the ex‑manufacturer price of the pack would be divided by 3 to obtain the ex‑manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit.
48 Mark‑up for a chemotherapy pharmaceutical benefit that does not have trastuzumab
For subparagraph 47(4)(b)(i), the mark‑up for a chemotherapy pharmaceutical benefit that does not have trastuzumab is:
(mark‑up for maximum multiple) ÷ (maximum multiple of pharmaceutical benefit).
where:
mark‑up for maximum multiple means the administration, handling and infrastructure fee worked out under the determination made under paragraph 98B(1)(a) of the Act.
maximum multiple of pharmaceutical benefit is the whole number of multiples of the form of the chemotherapy pharmaceutical benefit required to obtain the maximum amount of the chemotherapy drug in the benefit that is permitted under section 9.
Note: The form of a chemotherapy pharmaceutical benefit is mentioned in Part 1 of Schedule 1 in the column headed ‘Form’—see section 5.
49 Mark‑up for chemotherapy pharmaceutical benefit that has trastuzumab
(1) For subparagraph 47(4)(b)(ii), the mark‑up for a chemotherapy pharmaceutical benefit that has trastuzumab is:
where:
mark‑up for maximum multiple means the amount worked out under subsection (2).
maximum multiple of pharmaceutical benefit is the whole number of multiples of the form of the chemotherapy pharmaceutical benefit required to obtain the maximum amount of trastuzumab that is permitted under section 9.
Note: The form of a chemotherapy pharmaceutical benefit is mentioned in Part 1 of Schedule 1 in the column headed ‘Form’—see section 5.
(2) The mark‑up for the maximum multiple of a chemotherapy pharmaceutical benefit with an ex‑manufacturer price mentioned in the table is the amount mentioned in the table.
Item | Ex‑manufacturer price for maximum multiple of pharmaceutical benefit | Mark‑up for maximum multiple |
1 | ≤ $40 | 10% of ex‑manufacturer price for maximum multiple of pharmaceutical benefit |
2 | > $40, ≤ $100 | $4 |
3 | > $100, ≤ $1 000 | 4% of ex‑manufacturer price for maximum multiple of pharmaceutical benefit |
4 | > $1 000 | $40 |
50 Dispensed price if drug is in infusion supplied by approved private hospital authority
(1) For a dose of a chemotherapy drug in an infusion supplied by an approved hospital authority of a private hospital to an eligible patient, the dispensed price is the sum of the following amounts:
(a) the base price for the dose worked out under subsection (2);
(b) for a drug other than trastuzumab—the distribution fee;
(c) the dispensing fee;
(d) the preparation fee;
(e) the diluent fee.
(2) The base price of a dose of a chemotherapy drug is the lowest sum of reference prices for a chemotherapy pharmaceutical benefit or combination of chemotherapy pharmaceutical benefits that make up an amount of the drug equal to or greater than the dose.
Note: If there is more than one chemotherapy pharmaceutical benefit or combination of chemotherapy pharmaceutical benefits that contains enough of the drug to make up the dose, the base price is determined by the lowest priced benefit or combination of benefits.
(3) A combination of chemotherapy pharmaceutical benefits includes a quantity of 2 or more of the same chemotherapy pharmaceutical benefit.
Example: Two of the same chemotherapy pharmaceutical benefit, each of which contains 50 mg of a drug, could be used in combination to make up an amount of 100 mg of the drug. The reference price for each 50 mg would be added together to calculate the price of the combination.
Note: A chemotherapy pharmaceutical benefit is in a form mentioned in Part 1 of Schedule 1 for a listed drug—see section 5. The form establishes the amount of the drug that is in a quantity of 1 of the chemotherapy pharmaceutical benefit.
(4) In this section, the reference price of a chemotherapy pharmaceutical benefit is the sum, rounded to the nearest cent (with a half cent being rounded up), of:
(a) the ex‑manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit, rounded to the nearest cent (with a half cent being rounded up); and
(b) 1.4% of the ex‑manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit.
Note: The reference price and the ex‑manufacturer price for a quantity of 1 are for the form of the chemotherapy pharmaceutical benefit mentioned in Part 1 of Schedule 1, which is not necessarily the same quantity as the quantity in a manufacturer’s pack.
For example, if a chemotherapy pharmaceutical benefit has a form of ‘Injection 500 mg in 10 mL’, and a manufacturer’s pack contains 3 lots of ‘Injection 500 mg in 10 mL’, the ex‑manufacturer price of the pack would be divided by 3 to obtain the ex‑manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit.
51 Dispensed price if drug is in infusion supplied by public hospital authority
(1) For a dose of a chemotherapy drug in an infusion supplied by a public hospital authority to an eligible patient, the dispensed price is the sum of the following amounts:
(a) the base price for the dose worked out under subsection (2);
(b) the preparation fee.
(2) The base price of a dose of a chemotherapy drug is the lowest sum of reference prices for a chemotherapy pharmaceutical benefit or combination of chemotherapy pharmaceutical benefits that make up an amount of the drug equal to or greater than the dose.
Note: If there is more than one chemotherapy pharmaceutical benefit or combination of chemotherapy pharmaceutical benefits that contains enough of the drug to make up the dose, the base price is determined by the lowest priced benefit or combination of benefits.
(3) A combination of chemotherapy pharmaceutical benefits includes a quantity of 2 or more of the same chemotherapy pharmaceutical benefit.
Example: Two of the same chemotherapy pharmaceutical benefit, each of which contains 50 mg of a drug, could be used in combination to make up an amount of 100 mg of the drug. The reference price for each 50 mg would be added together to calculate the price of the combination.
Note: A chemotherapy pharmaceutical benefit is in a form mentioned in Part 1 of Schedule 1 for a listed drug—see section 5. The form establishes the amount of the drug that is in a quantity of 1 of the chemotherapy pharmaceutical benefit.
(4) In this section, the reference price of a chemotherapy pharmaceutical benefit is the ex‑manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit, rounded to the nearest cent (with a half cent being rounded up).
Note: The reference price and the ex‑manufacturer price for a quantity of 1 are for the form of the chemotherapy pharmaceutical benefit mentioned in Part 1 of Schedule 1, which is not necessarily the same quantity as the quantity in a manufacturer’s pack.
For example, if a chemotherapy pharmaceutical benefit has a form of ‘Injection 500 mg in 10 mL’, and a manufacturer’s pack contains 3 lots of ‘Injection 500 mg in 10 mL’, the ex‑manufacturer price of the pack would be divided by 3 to obtain the ex‑manufacturer price for a quantity of 1 of the chemotherapy pharmaceutical benefit.
Division 4—Dispensed price of related pharmaceutical benefit
52 Dispensed price for supply of related pharmaceutical benefit
(1) For a related pharmaceutical benefit supplied by a participating hospital authority to an eligible public hospital patient, the dispensed price is as follows:
(a) if the quantity of the related pharmaceutical benefit that is ordered and supplied is equal to the quantity contained in the manufacturer’s pack—the ex‑manufacturer price for the pack;
(b) if the quantity of the related pharmaceutical benefit that is ordered and supplied is less than the quantity contained in the manufacturer’s pack—the amount worked out under section 53;
(c) if the quantity of the related pharmaceutical benefit that is ordered and supplied is more than the quantity contained in the manufacturer’s pack—the sum of:
(i) the ex‑manufacturer price for each complete pack in the quantity; and
(ii) the amount worked out under section 53 for any remainder.
(2) However, if there are 2 or more related pharmaceutical benefits that are different brands of the same pharmaceutical item, the dispensed price of those pharmaceutical benefits is to be based on the pharmaceutical benefit with the lowest ex‑manufacturer price.
53 Quantity less than manufacturer’s pack
For paragraph 52(1)(b) and subparagraph 52(1)(c)(ii), the amount for a quantity of a related pharmaceutical benefit that is less than the quantity contained in the manufacturer’s pack (a broken quantity) is worked out by:
(a) dividing the quantity or number of units in the broken quantity by the quantity or number of units in the manufacturer’s pack expressed as a percentage to 2 decimal places; and
(b) applying that percentage to the ex‑manufacturer price for the complete pack.
Part 5—Patient contributions
54 Supply of infusion by approved pharmacist or approved medical practitioner
(1) The amount that an approved pharmacist or approved medical practitioner may or must charge an eligible patient for the supply of an infusion is the total of the amounts set out in this section.
Patient co‑payment for original supply
(2) For an original supply of an infusion, the approved pharmacist or approved medical practitioner must charge the eligible patient an amount that is equivalent to the amount that is required to be charged under subsection 87(2) of the Act for the supply of a pharmaceutical benefit to the patient.
Note: This is a single amount for supply of the infusion, not a separate amount for supply of each chemotherapy pharmaceutical benefit used to make the infusion.
(3) No amount may be charged under subsection (2) for a repeat supply.
Special patient contribution for Schedule 5 pharmaceutical benefit
(4) If a chemotherapy pharmaceutical benefit the approved pharmacist or approved medical practitioner uses to make the infusion is mentioned in Schedule 5, the approved pharmacist or approved medical practitioner may charge the eligible patient an amount not exceeding the amount for the chemotherapy pharmaceutical benefit worked out under section 58.
Note: If more than one chemotherapy pharmaceutical benefit used to make an infusion is mentioned in Schedule 5, a separate amount may be charged for each one.
55 Supply of infusion by approved hospital authority or HSD hospital authority
(1) The amount that an approved hospital authority or HSD hospital authority may charge an eligible patient for the supply of an infusion is the total of the amounts set out in this section.
Patient co‑payment for original supply
(2) For an original supply of an infusion, the hospital authority may charge the eligible patient an amount not exceeding the amount that the patient could have been required to pay under subsection 87(2) of the Act if the patient had obtained a pharmaceutical benefit from an approved pharmacist.
Note: This is a single amount for supply of the infusion, not a separate amount for supply of each chemotherapy pharmaceutical benefit used to make the infusion.
(3) No amount may be charged under subsection (2) for a repeat supply.
Special patient contribution for Schedule 5 pharmaceutical benefit
(4) If a chemotherapy pharmaceutical benefit the hospital authority uses to make the infusion is mentioned in Schedule 5, the hospital authority may charge the eligible patient an amount not exceeding the amount for the chemotherapy pharmaceutical benefit worked out under section 58.
Note: If more than one chemotherapy pharmaceutical benefit used to make an infusion is mentioned in Schedule 5, a separate amount may be charged for each one.
57 Supply of related pharmaceutical benefit by participating hospital authority
(1) The amount that a participating hospital authority may charge an eligible public hospital patient for the supply of a related pharmaceutical benefit is the total of the amounts set out in this section.
Patient co‑payment
(2) The participating hospital authority may charge the eligible public hospital patient an amount not exceeding the amount that the patient could have been required to pay under subsection 87(2) of the Act if the patient had obtained the related pharmaceutical benefit from an approved pharmacist.
Special patient contribution for Schedule 5 pharmaceutical benefit
(3) If the related pharmaceutical benefit is mentioned in Schedule 5, the participating hospital authority may also charge the eligible public hospital patient an amount not exceeding the amount for the related pharmaceutical benefit worked out under section 58.
58 Special patient contribution for Schedule 5 pharmaceutical benefit
(1) The amount an eligible patient may be charged for a pharmaceutical benefit mentioned in Schedule 5 is worked out by subtracting the amount mentioned for the pharmaceutical benefit in the ‘Approved Ex‑manufacturer Price’ column in Schedule 5 from the amount mentioned for the pharmaceutical benefit in the ‘Claimed Ex‑manufacturer Price’ column in Schedule 5.
(2) However, the amounts mentioned in the ‘Approved Ex‑manufacturer price’ and ‘Claimed Ex‑manufacturer price’ columns must be adjusted proportionally if:
(a) for a chemotherapy pharmaceutical benefit—the quantity or number of units of the pharmaceutical benefit used to make the infusion is more or less than the number mentioned in the ‘Quantity or Number of Units’ column; and
(b) for a related pharmaceutical benefit—the quantity or number of units of the pharmaceutical benefit supplied is more or less than the number mentioned in the ‘Quantity or Number of Units’ column.
59 Amounts taken into account for eligibility for concession and entitlement cards
An amount charged under any of the following provisions is to be taken into account when determining a person’s eligibility for a concession card or entitlement card under section 84C of the Act:
(a) subsection 54(2);
(b) subsection 55(2);
(d) subsection 57(2).
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.
Part 6—Transitional
60 Transitional provisions for existing medication chart prescribing
(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.
