National Health (Botulinum Toxin Program) Special Arrangement 2015

National Health (Botulinum Toxin Program) Special Arrangement 2015

PB 87 of 2015

made under subsections 100(1) and (2) of the

National Health Act 1953

Compilation No. 5

Compilation date: 1 July 2024

Includes amendments: F2024L00803

Registered: 11 July 2024

About this compilation

This compilation

This is a compilation of the National Health (Botulinum Toxin Program) Special Arrangement 2015 that shows the text of the law as amended and in force on 1 July 2024 (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 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 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 Register for the compiled law.

Self‑repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

Contents

Part 1—Preliminary

1 Name of Special Arrangement

4 Definitions

Part 2—Pharmaceutical benefits covered by this Special Arrangement

5 Pharmaceutical benefits covered by this Special Arrangement

6 Application of Part VII of the Act

7 Section 100 only supply

Part 3—Entitlement to pharmaceutical benefits

8 Eligible persons

Part 4—Supply of pharmaceutical benefits

9 Who can supply pharmaceutical benefits

Part 5—Administration of pharmaceutical benefits

10 Requirements for administering pharmaceutical benefits under this Special Arrangement

11 Eligible medical practitioner

12 Registered practice location

Part 6—Payment amounts

Division 1—Payments to suppliers that are approved hospital authorities for public hospitals

13 Payments to approved hospital authorities for public hospitals

Division 2—Payments to suppliers that are approved hospital authorities for private hospitals

14 Payments to approved hospital authorities for private hospitals

Part 7—Dispensed price

Division 1—Dispensed price for supply of a pharmaceutical benefit by a hospital authority for a public hospital

15 The dispensed price—supply by public hospital

16 Where quantity is less than a pack quantity

Division 2—Dispensed price for supply of a pharmaceutical benefit by certain suppliers

17 The dispensed price—supply by an approved hospital authority for a private hospital

18 Mark‑up

19 Where quantity is less than a pack quantity

20 Dispensing fee

21 Rounding up of dispensed price

Part 8—Patient contributions

22 Patient contributions in relation to approved hospital authorities

Part 9—Supply to CTG registered patients by CTG suppliers

23 Application of this Part

24 Application of the CTG Special Arrangement—co‑payment and payment etc.

25 Claim for payment

Schedule 1—Pharmaceutical benefits to which this Special Arrangement applies

Endnotes

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Part 1—Preliminary

1  Name of Special Arrangement

 (1) This Special Arrangement is the National Health (Botulinum Toxin Program) Special Arrangement 2015.

 (2) This Special Arrangement may also be cited as PB 87 of 2015.

4  Definitions

  In this Special Arrangement:

Act means the National Health Act 1953.

approved hospital means a hospital in respect of which the hospital authority is approved under section 94 of the Act.

approved hospital authority has the meaning given by subsection 84(1) of the Act.

approved pharmacist has the meaning given by subsection 84(1) of the Act.

CTG registered patient means a patient registered under subsection 10(2) of the CTG Special Arrangement.

CTG Special Arrangement means the National Health (Closing the Gap – PBS Co‑payment Program) Special Arrangement 2016.

CTG supplier has the same meaning as in the CTG Special Arrangement.

eligible medical practitioner has the meaning given by section 11.

eligible patient means a person who, under subsection 8(1), is eligible to receive a pharmaceutical benefit.

medical practitioner has the same meaning as in subsection 3(1) of the Health Insurance Act 1973.

other Special Arrangement means another Special Arrangement under section 100 of the Act.

provider number has the same meaning as in section 4 of the Health Insurance Regulations 2018.

registered practice location has the meaning given by section 12.

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 Legislative Instruments Act 2003. These terms include:

 pharmaceutical benefit

 public hospital

Part 2—Pharmaceutical benefits covered by this Special Arrangement

5  Pharmaceutical benefits covered by this Special Arrangement

 (1) This Special Arrangement applies to each pharmaceutical benefit mentioned in Schedule 1.

 (2) Each pharmaceutical benefit is a brand of a listed drug mentioned in Schedule 1:

 (a) in the form mentioned in Schedule 1 for the listed drug; and

 (b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

Note: Each listed drug mentioned in Schedule 1 has been declared by the Minister under subsection 85(2) of the Act. The form, manner of administration and brand mentioned in Schedule 1 have been determined by the Minister under subsections 85(3), (5) and (6) of the Act respectively.

6  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.

  (3) If a pharmaceutical benefit is supplied in accordance with this Special Arrangement, regulations 48, 49 and 55 of the Regulations do not apply to the supply.

 (4) For the purposes of paragraph 40 of the Regulations, a pharmaceutical benefit to be supplied to a person in accordance with this Special Arrangement is taken to be the same as, or equivalent to, another pharmaceutical benefit to be supplied to that person in accordance with this Special Arrangement only if:

 (a) the prescriptions for the supply of both benefits relate to moderate to severe spasticity of the upper limb (whether or not following a stroke); or

 (b) the prescriptions for the supply of both benefits relate to urinary incontinence; or

 (c) the prescriptions for the supply of both benefits relate to spasmodic torticollis; or

 (d) the prescriptions for the supply of both benefits relate to dynamic equinus foot deformity; or

 (e) the prescriptions for the supply of both benefits relate to blepharospasm; or

 (f) the prescriptions for the supply of both benefits relate to hemifacial spasm; or

 (g) the prescriptions for the supply of both benefits relate to chronic migraine; or

 (h) the prescriptions for the supply of both benefits relate to severe primary axillary hyperhidrosis; or

 (i) the prescriptions for the supply of both benefits:

 (i) are written in circumstances, determined by the Minister under paragraph 85(7)(b) of the Act, that have the same circumstances code (within the meaning of the Minister’s determination); and

 (ii) are not prescriptions of a kind referred to in paragraphs (a) to (h) of this subsection.

7  Section 100 only supply

 (1) If the letter ‘D(100)’ is mentioned in the column in Schedule 1 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 code ‘PB(100)’ is mentioned in the column in Schedule 1, headed ‘Section 100 only’ for a pharmaceutical benefit, the pharmaceutical benefit may be supplied only in accordance with this Special Arrangement and with 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 declared, 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 code ‘C(100)’ is mentioned in the column in Schedule 1, headed ‘Section 100 only’ for a pharmaceutical benefit, and a circumstances code is mentioned for the pharmaceutical benefit in the column headed ‘Circumstances’, the pharmaceutical benefit can only be supplied in the circumstances identified in the instrument made under section 85A of the Act and in accordance with this Special Arrangement.

 (6) A pharmaceutical benefit mentioned in subsection (5) is not available for general supply on the Pharmaceutical Benefits Scheme.

Note:  The Minister has declared, under paragraph 85(8)(b) of the Act, that 1 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 3—Entitlement to pharmaceutical benefits

8  Eligible persons

 (1) A person is eligible to receive a pharmaceutical benefit under this Special Arrangement if:

 (a) the person is an eligible person within the meaning of section 86 of the Act;

 (b) the person meets the requirements specified in the circumstances code, purposes code and conditions code (if any) mentioned for the pharmaceutical benefit, as declared by the Minister under subsection 85(2) of the Act; and

 (c) either;

 (i) the person is being treated in or at a private hospital; or

 (ii) the person is being treated in or at a public hospital as a non‑admitted patient, a day‑admitted patient, or an in‑patient admitted for less than 24 hours; or

 (iii) the person is being treated at a registered practice location.

 (2) In this section:

private hospital has the same meaning as in the Health Insurance Act 1973.

Part 4—Supply of pharmaceutical benefits

9  Who can supply pharmaceutical benefits

 (1) A pharmaceutical benefit can only be supplied under this Special Arrangement by an approved hospital authority for a private hospital or public hospital:

 (a) on receipt of a valid prescription for an eligible patient; or

 (b) prior to the receipt of a valid prescription for an eligible patient, in circumstances where the eligible medical practitioner provides the prescription to the approved hospital authority within 7 days of the eligible medical practitioner treating the eligible patient with the pharmaceutical benefit.

 (2) To avoid doubt, this section modifies section 94 of the Act in that an approved hospital authority may supply pharmaceutical benefits that are subject to this Special Arrangement for an eligible patient receiving treatment in or at the hospital of which it is the governing body or proprietor, or outside of the hospital of which it is the governing body or proprietor.

 (3) To avoid doubt, an approved pharmacist or an approved medical practitioner cannot supply pharmaceutical benefits under this Special Arrangement.

 (4) Under this Special Arrangement, the supplier of a pharmaceutical benefit cannot physically supply or hand over the pharmaceutical benefit directly to an eligible patient.

Part 5—Administration of pharmaceutical benefits

10  Requirements for administering pharmaceutical benefits under this Special Arrangement

 (1) A pharmaceutical benefit to which this Special Arrangement applies may only be administered:

 (a) to an eligible patient;

 (b) by a medical practitioner who is a eligible medical practitioner under section 11;

 (c) in accordance with the eligible medical practitioner’s prescription; and

 (d) in or at a public hospital, a private hospital or a registered practice location.

11  Eligible medical practitioner

  For this Special Arrangement:

  a medical practitioner is an eligible medical practitioner for administering a pharmaceutical benefit to an eligible patient, if the medical practitioner holds the specialist qualification required in the circumstances code declared by the Minister under subsection 85(2) of the Act, for treatment of that eligible patient with that pharmaceutical benefit.

12  Registered practice location

 (1) For this Special Arrangement:

registered practice location, for an eligible medical practitioner, means a business at an address for which the eligible medical practitioner has a provider number.

 (2) An eligible medical practitioner may have more than one registered practice location.

Part 6—Payment amounts

Division 1—Payments to suppliers that are approved hospital authorities for public hospitals

13  Payments to approved hospital authorities for public hospitals

 (1) An approved hospital authority for a public hospital is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for its supply of the pharmaceutical benefit is greater than the amount that the approved hospital authority was entitled to charge under subsection 22(2).

Note: However, see Part 9 in relation to the supply of a pharmaceutical benefit to a CTG registered patient by a CTG supplier.

 (2) The dispensed price for the supply of a pharmaceutical benefit by an approved hospital authority for a public hospital is to be worked out under Division 1 of Part 7.

 (3) No mark‑ups may be added to the cost of a pharmaceutical benefit for which payment is claimed by an approved hospital authority for a public hospital.

Division 2—Payments to suppliers that are approved hospital authorities for private hospitals

14  Payments to approved hospital authorities for private hospitals

 (1) An approved hospital authority for a private hospital is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for its supply of the pharmaceutical benefit is greater than the amount that the approved hospital authority was entitled to charge under subsection 22(2).

Note: However, see Part 9 in relation to the supply of a pharmaceutical benefit to a CTG registered patient by a CTG supplier.

 (2) The dispensed price for the supply of a pharmaceutical benefit by an approved hospital authority for a private hospital is to be worked out under Division 2 of Part 7.

Part 7—Dispensed price

Division 1—Dispensed price for supply of a pharmaceutical benefit by a hospital authority for a public hospital

15  The dispensed price—supply by public hospital

 (1) The dispensed price for the supply of a pharmaceutical benefit, by a hospital authority for a public hospital, is as follows:

 (a) if the quantity of the pharmaceutical benefit that is ordered and supplied is equal to a multiple of a pack quantity of the benefit—the sum of the approved ex‑manufacturer price or of the proportional ex‑manufacturer price for each pack quantity; or

 (b) if the quantity of the pharmaceutical benefit that is ordered and supplied is less than a pack quantity of the benefit—the amount calculated in accordance with section 16; or

 (c) if the quantity of the pharmaceutical benefit that is ordered and supplied is more than a multiple of a pack quantity of the benefit—the sum of:

 (i) the approved ex‑manufacturer price or the proportional ex‑manufacturer price for each pack quantity; and

 (ii) the amount calculated in accordance with section 16 for the remainder of the quantity supplied that is less than a pack quantity.

16  Where quantity is less than a pack quantity

 (1) If the quantity of a pharmaceutical benefit that is ordered and supplied is less than a pack quantity of the benefit (a broken quantity), the amount mentioned in paragraph 15(1)(b) and subparagraph 15(1)(c)(ii) is to be calculated by:

 (a) dividing the quantity or number of units in the broken quantity by the pack quantity, expressed as a percentage to 2 decimal places; and

 (b) applying that percentage to the approved ex‑manufacturer price or proportional ex‑manufacturer price for the pack quantity.

Division 2—Dispensed price for supply of a pharmaceutical benefit by certain suppliers

17  The dispensed price—supply by an approved hospital authority for a private hospital

 (1) The dispensed price for the supply of a pharmaceutical benefit by an approved hospital authority for a private hospital is as follows:

 (a) if the quantity of the pharmaceutical benefit that is ordered and supplied is equal to a multiple of a pack quantity, the sum of:

 (i) the approved ex‑manufacturer price or of the proportional ex‑manufacturer price for each pack quantity, plus the mark‑up mentioned in section 18, taken to the nearest cent, with one half cent being rounded up to 1 cent; and

 (ii) a dispensing fee equal to the dispensing fee for the supply of a ready prepared pharmaceutical benefit, mentioned in the determination made under paragraph 98B(1)(a) of the Act, as in force at the time of the supply of the pharmaceutical benefit; or

 (b) if a quantity of the pharmaceutical benefit that is ordered and supplied is less than a pack quantity, the sum of:

 (i) the amount calculated in accordance with section 19; and

 (ii)  a dispensing fee equal to the dispensing fee for the supply of a ready prepared pharmaceutical benefit, mentioned in the determination made under paragraph 98B(1)(a) of the Act, as in force at the time of the supply of the pharmaceutical benefit; or

 (c) if a quantity of the pharmaceutical benefit that is ordered and supplied is more than a multiple of a pack quantity, the sum of:

 (i) for each pack quantity, the approved ex‑manufacturer price or the proportional ex‑manufacturer price for the pack quantity, plus the mark‑up mentioned in section 18, taken to the nearest cent, with one half cent being counted as one cent; and

 (ii) the amount calculated in accordance with section 19 for the remainder of the quantity supplied that is less than a pack quantity; and

 (iii) a dispensing fee equal to the dispensing fee for the supply of a ready prepared pharmaceutical benefit, mentioned in the determination made under paragraph 98B(1)(a) of the Act, as in force at the time of the supply of the pharmaceutical benefit.

18  Mark‑up

  For subparagraphs 17(1)(a)(i) and 17(1)(c)(i) and for paragraph 19(1)(a), the mark‑up for a pack quantity of a ready‑prepared pharmaceutical benefit is:

 (a) if the pack quantity for which a mark‑up is to be calculated under this section is equal to a maximum quantity of the pharmaceutical benefit, the mark‑up is the amount mentioned in the table below for the approved ex‑manufacturer price (AEMP) or for the proportional ex‑manufacturer price (PEMP) for that quantity.

 (b) if the pack quantity for which a mark‑up is to be calculated under this section is not equal to a maximum quantity of the pharmaceutical benefit, the mark‑up is worked out as follows:

 (i) if the mark‑up that would apply to the maximum quantity is shown in the table in paragraph (a) as a monetary amount—the mark‑up for the pack quantity is that monetary amount, reduced proportionately for the relative quantities; and

 (ii) if the mark‑up that would apply to the maximum quantity is shown in the table in paragraph (a) as a percentage of AEMP or PEMP—the mark‑up for the pack quantity is that percentage of the AEMP or PEMP for the pack quantity.

19  Where quantity is less than a pack quantity

 (1) If the quantity of a pharmaceutical benefit that is ordered and supplied is less than a pack quantity of the benefit (a broken quantity), the amount mentioned in subparagraphs 17(1)(b)(i) and 17(1)(c)(ii) is to be calculated by:

 (i) adding the mark‑up mentioned in section 18 to the approved ex‑manufacturer price or to the proportional ex‑manufacturer price for the pack quantity, taking the result to the nearest cent, with one half cent being counted as 1 cent; and

 (ii) dividing the quantity or number of units in the broken quantity by the pack quantity, expressed as a percentage to 2 decimal places; and

 (iii) applying the percentage worked out under subparagraph (b) to the amount worked out under subparagraph (a).

20  Dispensing fee

  If an eligible medical practitioner, instead of directing a repeated supply of a pharmaceutical benefit, directs the supply on one occasion of a quantity or number of units of the drug, not exceeding the total quantity or number of units that could be prescribed, if the eligible medical practitioner directed a repeated supply, the dispensed price for the supply of the pharmaceutical benefit will include only one dispensing fee.

21  Rounding up of dispensed price

  The dispensed price for the supply of a pharmaceutical benefit will in each case be taken to the nearest cent, one half cent being counted as one cent.

Part 8—Patient contributions

22  Patient contributions in relation to approved hospital authorities

 (1) This section applies to an approved hospital authority for a public hospital or to a private hospital that supplies a pharmaceutical benefit.

Note: However, see Part 9 in relation to the supply of a pharmaceutical benefit to a CTG registered patient by a CTG supplier.

 (2) The approved hospital authority may charge the patient an amount equivalent to the amount that may be charged under section 87 of the Act for the supply of a pharmaceutical benefit to the patient.

Part 9—Supply to CTG registered patients by CTG suppliers

23  Application of this Part

  This Part applies to a supply (the relevant supply) of a pharmaceutical benefit under this Special Arrangement if the relevant supply is made:

 (a) to an eligible patient who is a CTG registered patient; and

 (b) by an approved hospital authority who is a CTG supplier.

24  Application of the CTG Special Arrangement—co‑payment and payment etc.

 (1) Despite sections 13, 14 and 22 of this Special Arrangement, subsections 11(1), (2), (3) and (4) (co‑payment reduction etc.) and section 13 (payment by Commonwealth) of the CTG Special Arrangement apply in relation to the relevant supply under this Special Arrangement with the modification set out in subsection (2) of this section.

 (2) A reference in the CTG Special Arrangement to a supply of a pharmaceutical benefit under the CTG Special Arrangement is taken to be a reference to the relevant supply under this Special Arrangement.

 (3) However, the notes to subsections 11(2) and (3) of the CTG Special Arrangement do not apply in relation to the relevant supply under this Special Arrangement.

Note: The notes to subsections 11(2) and (3) of the CTG Special Arrangement relate to CTG suppliers making claims for payment under the CTG Special Arrangement. Claims for payment in relation to the relevant supply under this Special Arrangement are instead dealt with under section 25 of this Special Arrangement.

25  Claim for payment

 (1) If an approved hospital authority who is a CTG supplier wants to receive payment from the Commonwealth in relation to the relevant supply under this Special Arrangement, the approved hospital authority must make a claim for payment to the Chief Executive Medicare on behalf of the Secretary.

 (2) The claim must be made in accordance with the rules made under subsections 98AC(4) and 99AAA(8) of the Act with the modification set out in subsection (3) of this section.

 (3) A claim for payment made using the manual system referred to in section 99AAA of the Act must include an indicator that the patient is a CTG registered patient.

Schedule 1—Pharmaceutical benefits to which this Special Arrangement applies

(sections 5, and 7)

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 how an amendment is to be made. If, despite the misdescription, the amendment can be given effect as intended, then the misdescribed amendment can be incorporated through an editorial change made under section 15V of the Legislation Act 2003.

If a misdescribed amendment cannot be given effect as intended, the amendment is not incorporated and “(md not incorp)” is added to the amendment history.

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history