National Health (IVF/GIFT Program) Special Arrangement 2011 (No. PB 93 of 2011) (Cth)

National Health (IVF/GIFT Program) Special Arrangement 2011 (PB 93 of 2011)

made under the

National Health Act 1953

Compilation No. 5

Compilation date:    1 April 2015

Includes amendments up to:            PB 32 of 2015

Registered:   2 April 2015

About this compilation

This compilation

This is a compilation of the National Health (IVF/GIFT Program) Special Arrangement 2011 (PB 93 of 2011) that shows the text of the law as amended and in force on 1 April 2015 (the compilation date).

This compilation was prepared on 1 April 2015.

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 ComLaw ( The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on ComLaw 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.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on ComLaw 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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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

1  Name of Special Arrangement.................................................................................................. 1

2  Commencement........................................................................................................................ 1

3  Revocation................................................................................................................................ 1

4  Definitions................................................................................................................................ 1

5  Eligibility for pharmaceutical benefits....................................................................................... 2

6  Responsible person.................................................................................................................. 2

7  Section 100 only supply........................................................................................................... 3

Schedule 1—Pharmaceutical benefits covered by this Special Arrangement and related information   4

Schedule 2—Responsible Person Codes   6

Schedule 3—Treatment Conditions  7

Endnotes8

Endnote 1—About the endnotes  8

Endnote 2—Abbreviation key  9

Endnote 3—Legislation history  10

Endnote 4—Amendment history  11

1  Name of Special Arrangement

(1)  This Special Arrangement is the National Health (IVF/GIFT Program) Special Arrangement 2011.

(2)  This Special Arrangement may also be cited as PB 93 of 2011.

2  Commencement

This Special Arrangement commences on 1 December 2011.

3  Revocation

  Instrument PB 26 of 2007 is revoked.

4  Definitions

  In this Special Arrangement:

ABN has the same meaning as in the A New Tax System (Australian Business Number) Act 1999.

accredited IVF/GIFT clinic means a clinic that is:

(a) an accredited ART centre within the meaning of section 8 of the Research Involving Human Embryos Act 2002; and

(b)  approved by the Human Services Department to supply pharmaceutical benefits under this Special Arrangement

Act means the National Health Act 1953.

eligible patient means a person who:

(a)  is an eligible person within the meaning of the Health Insurance Act 1973;

(b)  is receiving treatment:

(i)  mentioned in item 13200, 13201, 13202 or 13203 of the general medical services table; and

(ii)  for which Medicare benefit is payable; and

(c)  satisfies the treatment conditions, if any, mentioned in the column in Schedule 3 headed ‘Treatment Conditions’ for a pharmaceutical benefit with a drug and form mentioned for that treatment condition in Schedule 3.

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

GIFT means gamete intrafallopian transfer.

Human Services Department means the Department administered by the Human Services Minister.

IVF means in vitro fertilisation.

medication chart prescription has the meaning given in the Regulations.

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

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

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:

·     Chief Executive Medicare

·     Pharmaceutical benefit

·     Brand of pharmaceutical item

5  Eligibility for pharmaceutical benefits

(1)  An eligible patient is entitled to be supplied with a pharmaceutical benefit specified in Schedule 1, free of charge, by an accredited IVF/GIFT clinic.

(2)  Payment of a medicare benefit for item 13200, 13201, 13202 and 13203, as the case requires, of the general medical services table, will be evidence of eligibility for the supply of the pharmaceutical benefits specified in Schedule 1.

(3)  In order to obtain the supply of the pharmaceutical benefits specified in Schedule 1, an accredited IVF/GIFT clinic is required to notify the Chief Executive Medicare of the medicare number, within the meaning of subsection 84(1) of the Act, that is applicable to the eligible patient.

(4)  This Special Arrangement does not apply to a medication chart prescription.

6  Responsible person

(1)  If a code is mentioned in the column in Schedule 1 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 2 for the code, with the ABN number, if any, mentioned in Schedule 2 for the person; and

(b)  the pharmaceutical item is the listed drug mentioned in Schedule 1:

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

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

Note:          A person identified by a code in the column headed ‘Responsible Person’ in Schedule 1 has been determined by the Minister, under section 84AF of the Act, to be a responsible person for the brand of pharmaceutical item.

1. 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)’ are 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 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.

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

(sections 5, 6 and 7)

Listed Drug	Form	Manner of Administration	Brand	Responsible Person	Section 100 only
Cetrorelix	Powder for injection 250 micrograms (as acetate) with diluent	Injection	Cetrotide	SG	D(100)
Choriogonadotropin Alfa	Solution for injection 250 micrograms in 0.5ml pre-filled pen	Injection	Ovidrel	SG	D(100)
Choriogonadotropin Alfa	Solution for injection 250 micrograms in 0.5 mL pre‑filled syringe	Injection	Ovidrel	SG	D(100)
Chorionic Gonadotrophin	Injection set containing 3 ampoules powder for injection 1,500 units and 3 ampoules solvent 1 mL	Injection	Pregnyl	MK
Chorionic Gonadotrophin	Powder for injection 5’000 units with solvent	Injection	Pregnyl	MK	PB(100)
Corifollitropin Alfa	Solution for injection 100 micrograms in 0.5ml single dose pre‑filled syringes	Injection	Elonva	MK
Corifollitropin Alfa	Solution for injection 150 micrograms in 0.5ml single dose pre‑filled syringes	Injection	Elonva	MK
Follitropin Alfa	Injection 300 I.U. in 0.5 mL multi‑dose cartridge	Injection	Gonal‑f Pen	SG
Follitropin Alfa	Injection 450 I.U. in 0.75 mL multi‑dose cartridge	Injection	Gonal‑f Pen	SG
Follitropin Alfa	Injection 900 I.U. in 1.5 mL multi‑dose cartridge	Injection	Gonal‑f Pen	SG
Follitropin Beta	Solution for injection 300 I.U. in 0.36 mL multi‑dose cartridge	Injection	Puregon 300 IU/0.36 mL	MK
Follitropin Beta	Solution for injection 600 I.U. in 0.72 mL multi‑dose cartridge	Injection	Puregon 600 IU/0.72 mL	MK
Follitropin Beta	Solution for injection 900 I.U. in 1.08 mL multi‑dose cartridge	Injection	Puregon 900 IU/1.08 mL	MK
Ganirelix	Injection 250 micrograms (as acetate) in 0.5mL pre‑filled syringe	Injection	Orgalutran	MK	D(100)
Human Menopausal Gonadotrophin	Powder for injection 600IU with solvent	Injection	Menopur 600	FP	D(100)
Human Menopausal Gonadotrophin	Powder for injection 1200IU with solvent	Injection	Menopur 1200	FP	D(100)
Nafarelin	Nasal spray (pump pack) 200 micrograms (as acetate) per dose, 60 doses	Nasal	Synarel	PF
Progesterone	Vaginal gel (prolonged release) 90 mg in single dose pre‑filled applicator	Vaginal	Crinone 8%	SG	D(100)
Progesterone	Vaginal Tablet 100 mg	Vaginal	Endometrin	FP	D(100)
Progesterone	Pessary 100 mg	Vaginal	Oripro	ON	D(100)
Progesterone	Pessary 200 mg	Vaginal	Oripro	ON	D(100)

Schedule 2—Responsible Person Codes

(section 6)

Code	Responsible Person	Australian Business Number
FP	Ferring Pharmaceuticals Pty Ltd	87 003 037 170
MK	Merck Sharp & Dohme (Australia) Pty Ltd	14 000 173 508
ON	Orion Laboratories Pty Ltd	56 009 293 136
PF	Pfizer Pty Limited	50 008 422 348
SG	Merck Serono Australia Ptd Ltd	72 006 900 830

Schedule 3—Treatment Conditions

(section 4)

Treatment Condition Number	Treatment Conditions	Listed Drug in Pharmaceutical Benefit	Form
1	A patient who: (i) Has an antral follicle count of 20 or less; and (ii) Is undergoing a gonadotrophin releasing hormone antagonist cycle	Corifollitropin Alfa	Solution for injection 100 micrograms in 0.5 mL single dose pre-filled syringes
2	A patient who: (i) Has an antral follicle count of 20 or less; and (ii) Is undergoing a gonadotrophin releasing hormone antagonist cycle	Corifollitropin Alfa	Solution for injection 150 micrograms in 0.5ml single dose pre-filled syringes
3	he treatment must be for luteal phase support	Progesterone	Vaginal gel (prolonged release) 90 mg in single dose pre-filled applicator
4	The treatment must be for luteal phase support	Progesterone	Vaginal tablet  100 mg
5	The treatment must be for luteal phase support	Progesterone	Pessary 100 mg
6	The treatment must be for luteal phase support	Progesterone	Pessary 200 mg

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

Endnotes about misdescribed amendments and other matters are included in a compilation only as necessary.

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.

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 amendment is set out in the endnotes.

Endnote 2—Abbreviation key

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

Endnote 3—Legislation history

Name	FRLI registration	Commencement	Application, saving and transitional provisions
PB 93 of 2011	30 Nov 2011 (F2011L02500)	1 Dec 2011 (s 2)
PB 9 of 2012	28 Feb 2012 (F2012L00438)	1 Mar 2012 (s 2)	—
PB 78 of 2012	28 Sept 2012 (F2012L01968)	1 Oct 2012 (s 2)	—
PB 44 of 2013	31 July 2013 (F2013L01484)	1 Aug 2013 (s 2)	—
PB 58 of 2014	31 July 2014 (F2014L01061)	1 Aug 2014 (s 2)	—
PB 32 of 2015	1 Apr 2015 (F2015L00443)	1 Apr 2015 (s 2)	—

Endnote 4—Amendment history

Provision affected	How affected
s. 4.......................................	am. PB 44 of 2013; PB 32 of 2015
s 5........................................	am PB 32 of 2015
s 7........................................	am PB 78 of 2012
s 8........................................	rep PB 32 of 2015
Schedule 1
Schedule 1...........................	am. PB 9 of 2012
rs. PB 78 of 2012
am. PB 44 of 2013; PB 58 of 2014
Schedule 2
Schedule 2...........................	am. PB 78 of 2012
Schedule 3
Schedule 3...........................	ad. PB 44 of 2013; PB 58 of 2014