National Health (IVF Program) Special Arrangement 2015 (PB 60 of 2015)

Part 1—Preliminary

1 Name of Special Arrangement

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

(2) This Special Arrangement may also be cited as PB 60 of 2015.

4 Definitions

In this Special Arrangement:

accredited ART centre has the same meaning as the Research Involving Human Embryos Act 2002.

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 same meaning given by subsection 84(1) of the Act.

dispensed price:

(a) for the supply of a pharmaceutical benefit by a hospital authority for a public hospital—has the meaning given by section 10; and

(b) for the supply of a pharmaceutical benefit by an approved hospital authority for a private hospital or by an approved pharmacist or by an approved medical practitioner—has the meaning given by section 12.

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

Regulations mean the National Health (Pharmaceutical Benefits) Regulations 1960.

RTAC Accredited Unit Number means the number by which the Reproductive Technology Accreditation Committee of the Fertility Society of Australia identifies a person or body as being an accredited ART centre.

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 ex‑manufacturer price

• Approved pharmacist

• Approved medical practitioner

• Brand

• Pack quantity

• Pharmaceutical benefit

• Proportional ex‑manufacturer price

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.

7 Section 100 only supply

(1) If the code ‘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—Payment amounts

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

8 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 section 17.

(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 4.

(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, approved pharmacies or approved medical practitioners

9 Payments to certain suppliers of pharmaceutical benefits

(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 section 17.

(2) An approved pharmacist or an approved medical practitioner is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of a pharmaceutical benefit is greater than the amount that the approved pharmacist or approved medical practitioner was entitled to charge under section 17.

(3) The dispensed price for the supply of a pharmaceutical benefit by an approved hospital authority for a private hospital, an approved pharmacist or an approved medical practitioner is to be worked out under Division 2 of Part 4.

Part 4—Dispensed price

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

10 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 the proportional ex‑manufacturer price for each pack quantity;

(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 11;

(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 11 for the remainder of the quantity supplied that is less than a pack quantity.

11 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 10(1)(b) and subparagraph 10(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

12 The dispensed price—supply by an approved hospital authority for a private hospital, an approved pharmacist or an approved medical practitioner

(1) The dispensed price for the supply of a pharmaceutical benefit by an approved hospital authority for a private hospital, an approved pharmacist or an approved medical practitioner, 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 13, 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 14; and

(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 13, taken to the nearest cent, with one half cent being counted as 1 cent; and

(ii) the amount calculated in accordance with section 14 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.

13 Mark‑up

For subparagraphs 12(1)(a)(i) and 12(1)(c)(i) and for paragraph 14(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.

14 Where quantity is less than a pack quantity

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 12(1)(b)(i) and 12(1)(c)(ii) is to be calculated by:

(a) adding the mark‑up mentioned in section 13 to the approved ex‑manufacturer price or 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

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

15 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.

Division 3—Dispensed price—Other matters

16 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 5—Patient contributions

17 Patient contributions

(1) This section applies if an approved pharmacist, an approved medical practitioner, or an approved hospital authority for a public hospital or a private hospital supplies a pharmaceutical benefit to an eligible patient and makes a claim for payment.

(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 6—Approved Hospital Authorities

18 Modified application of section 94 approved hospital authorities

(1) Section 94 of the Act applies in a modified manner to pharmaceutical benefits supplied under this Special Arrangement.

(2) An approved hospital authority may supply pharmaceutical benefits to patients receiving treatment in or at the approved hospital or outside of the approved hospital.

Part 7—Claiming

19 Claim for payment

(1) An approved supplier who wants to receive payment from the Commonwealth for the supply of a pharmaceutical benefit under this Special Arrangement 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 following modifications:

(a) must include the RTAC Accredited Unit Number.

Schedule 1—Pharmaceutical benefits covered by this Special Arrangement and related information

(sections 5 and 7)

Listed Drug	Form	Manner of Administration	Brand	Section 100 only
Cetrorelix	Powder for injection 250 micrograms (as acetate) with diluent	Injection	Cetrotide	D(100)
Choriogonadotropin Alfa	Solution for injection 250 micrograms in 0.5 ml pre filled pen	Injection	Ovidrel	D(100)
Chorionic Gonadotrophin	Injection set containing powder for injection 1,500 units, 3 and solvent 1 mL, 3	Injection	Pregnyl	C(100)
	Powder for injection 5,000 units with solvent	Injection	Pregnyl	PB(100)
Corifollitropin Alfa	Solution for injection 100 micrograms in 0.5mL single dose pre filled syringes	Injection	Elonva	D(100)
	Solution for injection 150 micrograms in 0.5mL single dose pre filled syringes	Injection	Elonva	D(100)
Follitropin Alfa	Injection 75 I.U. in 0.125 mL pre filled pen	Injection	Bemfola	C(100)
	Injection 150 I.U. in 0.25 mL pre filled pen	Injection	Bemfola	C(100)
	Injection 225 I.U. in 0.375 mL pre filled pen	Injection	Bemfola	C(100)
	Injection 300 I.U. in 0.5 mL multi dose cartridge	Injection	Gonal f Pen	C(100)
	Injection 300 I.U. in 0.5 mL pre filled pen	Injection	Bemfola	PB(100)
	Injection 450 I.U. in 0.75 mL multi dose cartridge	Injection	Gonal f Pen	C(100)
	Injection 450 I.U. in 0.75 mL pre filled pen	Injection	Bemfola	PB(100)
	Injection 900 I.U. in 1.5 mL multi dose cartridge	Injection	Gonal f Pen	C(100)
Follitropin Alfa with Lutropin Alfa	Injection 900 I.U. ‑ 450 I.U. in 1.44 mL multi‑dose cartridge	Injection	Pergoveris	D(100)
Follitropin Beta	Solution for injection 300 I.U. in 0.36 mL multi dose cartridge	Injection	Puregon 300 IU/0.36 mL	C(100)
	Solution for injection 600 I.U. in 0.72 mL multi dose cartridge	Injection	Puregon 600 IU/0.72 mL	C(100)
	Solution for injection 900 I.U. in 1.08 mL multi dose cartridge	Injection	Puregon 900 IU/1.08 mL	C(100)
Follitropin delta	Injection 12 micrograms in 0.36 mL pre‑filled multi‑dose pen	Injection	Rekovelle	D(100)
	Injection 36 micrograms in 1.08 mL pre‑filled multi‑dose pen	Injection	Rekovelle	D(100)
	Injection 72 micrograms in 2.16 mL pre‑filled multi‑dose pen	Injection	Rekovelle	D(100)
Ganirelix	Injection 250 micrograms (as acetate) in 0.5 mL pre filled syringe	Injection	Orgalutran	D(100)
Human Menopausal Gonadotrophin	Powder for injection 600 I.U. with solvent	Injection	Menopur 600	D(100)
	Powder for injection 1,200 I.U. with solvent	Injection	Menopur 1200	D(100)
Lutropin Alfa	Powder for injection 75 I.U. with solvent	Injection	Luveris	D(100)
Nafarelin	Nasal spray (pump pack) 200 micrograms (as acetate) per dose, 60 doses	Nasal	Synarel	C(100)
Progesterone	Capsule 200 mg	Vaginal	Utrogestan	D(100)
	Pessary 100 mg	Vaginal	Oripro	D(100)
	Pessary 200 mg	Vaginal	Oripro	D(100)
	Vaginal gel (prolonged release) 90 mg in single dose pre filled applicator	Vaginal	Crinone 8%	D(100)
	Vaginal Tablet 100 mg	Vaginal	Endometrin	D(100)
Triptorelin	Injection 100 micrograms (as acetate) in 1 mL pre‑filled syringe	Injection	Decapeptyl	PB(100)

Endnotes

Endnote 1—About the endnotes

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

The following endnotes are included in every compilation:

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Abbreviation key—Endnote 2

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

Legislation history and amendment history—Endnotes 3 and 4

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

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

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

Editorial changes

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

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

Misdescribed amendments

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

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

Endnote 2—Abbreviation key

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

Endnote 3—Legislation history

Name	Registration	Commencement	Application, saving and transitional provisions
PB 60 of 2015	30 June 2015 (F2015L01004)	1 July 2015 (s 2)
PB 86 of 2015	31 Aug 2015 (F2015L01362)	1 Sept 2015 (s 2)	—
PB 58 of 2016	28 June 2016 (F2016L01093)	1 July 2016 (s 2)	—
PB 69 of 2016	28 July 2016 (F2016L01247)	1 Aug 2016 (s 2)	—
PB 86 of 2016	30 Sept 2016 (F2016L01552)	1 Oct 2016 (s 2)	—
PB 94 of 2016	31 Oct 2016 (F2016L01661)	1 Nov 2016 (s 2)	—
PB 115 of 2016	22 Dec 2016 (F2016L02028)	1 Jan 2017 (s 2)	—
PB 59 of 2017	27 July 2017 (F2017L00957)	1 Aug 2017 (s 2)	—
PB 77 of 2017	27 Sept 2017 (F2017L01282)	1 Oct 2017 (s 2)	—
PB 69 of 2018	1 Aug 2018 (F2018L01080)	1 Aug 2018 (s 2)	—
PB 23 of 2019	29 Mar 2019 (F2019L00474)	1 Apr 2019 (s 2)	—
PB 108 of 2019	23 Dec 2019 (F2019L01692)	1 Jan 2020 (s 2)	—

Endnote 4—Amendment history

Provision affected	How affected
Part 1
s 2.....................	rep LIA s 48D
s 3.....................	rep LIA s 48C
s 4.....................	am F2016L01093
Part 7
Part 7...................	rep 1 Jan 2016 (s 23)
	ad PB 58 of 2016
s 19....................	rep 1 Jan 2016 (s 23)
	ad PB 58 of 2016
s 20....................	rep 1 Jan 2016 (s 23)
s 21....................	rep 1 Jan 2016 (s 23)
s 22....................	rep 1 Jan 2016 (s 23)
s 23....................	rep 1 Jan 2016 (s 23)
Schedule 1
Schedule 1................	am PB 86 of 2015; PB 69 of 2016; PB 86 of 2016; PB 94 of 2016; PB 115 of 2016; PB 59 of 2017; PB 77 of 2017; PB 69 of 2018; PB 23 of 2019; PB 108 of 2019