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PB 93 of 2011 Arrangements as amended, taking into account amendments up to National Health (IVF/GIFT Program) Special Arrangement Amendment Instrument 2015 (PB 32 of 2015)
Administered by: Health
Registered 02 Apr 2015
Start Date 01 Apr 2015
End Date 01 Jul 2015
Date of repeal 01 Jul 2015
Repealed by National Health (IVF Program) Special Arrangement 2015
Table of contents.

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 (www.comlaw.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 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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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 3Treatment Conditions                                                   7

Endnotes                                                                                                                        8

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.

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)’ 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 1Pharmaceutical 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 2Responsible 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 3Treatment 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