National Health Act 1953 Arrangements made under subparagraph 100(1)(b)(i) IVF/GIFT Program (No. PB 26 of 2007) (Cth)

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Arrangements made under subparagraph 100(1)(b)(i) — IVF/GIFT Program
(No. PB 26 of 2007)

as amended

made under subparagraph 100 (1) (b) (i) of the

National Health Act 1953

This compilation was prepared on 1 February 2011
taking into account amendments up to No. PB 12 of 2011

Prepared by the Office of Legislative Drafting and Publishing,
Attorney-General’s Department, Canberra

Arrangements made under subparagraph 100 (1) (b) (i) — IVF/GIFT Program (No. PB 26 of 2007)

Commencement [see Note 1]

1.       (a)     These Arrangements commence on 1 April 2007.

(b)     The Arrangements made on 23 October 2006 with effect from 1 November 2006 (No. PB 55 of 2006) are repealed with effect from the commencement of these Arrangements.

Eligibility for special pharmaceutical products

2. Subject to paragraph 3, patients who are eligible persons within the meaning of the Health Insurance Act 1973 will be provided free of charge with the special pharmaceutical products specified in the Schedule to these Arrangements.

3.       Patients are eligible to be provided with special pharmaceutical products under these Arrangements for the following purposes only:

(a) in the case of the special pharmaceutical products specified in Part 1 of the Schedule — for patients who are receiving treatment as described in item 13200, 13201, 13202 or 13203 of the Health Insurance (General Medical Services Table) Regulations 2009 as in force from time to time; or

(b) in the case of the special pharmaceutical products specified in Part 2 of the Schedule — for luteal phase support in patients who are receiving treatment as described in item 13200 or 13201 of the Health Insurance (General Medical Services Table) Regulations 2009 as in force from time to time, where the luteal phase is defined as the time span from embryo transfer until implantation confirmed by positive beta human chorionic gonadotrophin measurement.

4.       Payment of a medicare benefit for item 13200, 13201, 13202 and 13203, as the case requires, of the Health Insurance (General Medical Services Table) Regulations 2009 as in force from time to time, will be evidence of eligibility for the supply of the special pharmaceutical products specified in the Schedule to these Arrangements.

5.       The special pharmaceutical products specified in the Schedule to these Arrangements must not be supplied for treatment rendered in conjunction with surrogacy arrangements. This is consistent with rule 81 of the Health Insurance (General Medical Services Table) Regulations 2009 as in force from time to time, which provides that medicare benefits are not payable under item 13200, 13201, 13202 or 13203  in these circumstances.

6. In order to obtain the supply of the special pharmaceutical products specified in the Schedule to these Arrangements, a provider is required to notify the Chief Executive Officer of Medicare Australia of the medicare number, within the meaning of subsection 84(1) of the National Health Act 1953, that is applicable to the patient.

THE SCHEDULE [see Note 2]

PART 1: Special pharmaceutical products for patients receiving treatment as described in items 13200, 13201, 13202 or 13203 of the Health Insurance (General Medical Services Table) Regulations 2009

Name of special pharmaceutical product

Form (strength, type, size, etc.)

Proprietary Name

Manufacturer

Cetrorelix

Powder for injection 250 micrograms (as acetate) with diluent

Cetrotide

Merck Serono Australia Pty Ltd (SG)

Choriogonadotropin Alfa

Solution for injection 250 micrograms in 0.5 mL pre-filled syringe

Ovidrel 

Merck Serono Australia Pty Ltd (SG)

Chorionic Gonadotrophin

Injection set containing 3 ampoules powder for injection 1,500 units and 3 ampoules solvent 1 mL

Pregnyl

Schering-Plough Pty Limited (SH)

Chorionic Gonadotrophin

Powder for injection 5’000 units with solvent

Pregnyl

Schering-Plough Pty Limited (SH)

Follitropin Alfa

Injection 300 I.U. in 0.5 mL multi-dose cartridge

Gonal-f Pen

Merck Serono Australia Pty Ltd (SG)

Follitropin Alfa

Injection 450 I.U. in 0.75 mL multi-dose cartridge

Gonal-f Pen

Merck Serono Australia Pty Ltd (SG)

Follitropin Alfa

Injection 900 I.U. in 1.5 mL multi-dose cartridge

Gonal-f Pen

Merck Serono Australia Pty Ltd (SG)

Follitropin Beta

Solution for injection 300 I.U. in 0.36 mL multi-dose cartridge

Puregon 300 IU/0.36 mL

Schering-Plough Pty Limited (SH)

Follitropin Beta

Solution for injection 600 I.U. in 0.72 mL multi-dose cartridge

Puregon 600 IU/0.72 mL

Schering-Plough Pty Limited (SH)

Follitropin Beta

Solution for injection 900 I.U. in 1.08 mL multi-dose cartridge

Puregon 900 IU/1.08 mL

Schering-Plough Pty Limited (SH)

Ganirelix

Injection 250 micrograms (as acetate) in 0.5mL pre-filled syringe

Orgalutran

Schering-Plough Pty Limited (SH)

PART 2: Special pharmaceutical products for luteal phase support in certain patients

Name of special pharmaceutical product Form (strength, type, size, etc.) Proprietary Name Manufacturer
Progesterone Vaginal gel (prolonged release) 90 mg in single dose pre-filled applicator Crinone 8% Merck Serono Australia Pty Ltd (SG)
Pessary 100 mg Orion Laboratories Pty Ltd (ON)
Pessary 200 mg Orion Laboratories Pty Ltd (ON)

Notes to the Arrangements made under
subparagraph 100(1)(b)(i) — IVF/GIFT Program
(No. PB 26 of 2007)

Note 1

The Arrangements made under subparagraph 100(1)(b)(i) — IVF/GIFT Program (No. PB 26 of 2007) (in force under subparagraph 100 (1) (b) (i) of the National Health Act 1953) as shown in this compilation is amended as indicated in the


Tables below.

Table of Instruments

Title

Date of FRLI
Registration

Date of
commencement

Application,
saving or
transitional
provisions

No. PB 26 of 2007 15 Mar 2007 (see F2007L00667) 1 Apr 2007
No. PB 41 of 2007 4 May 2007 (see F2007L01249) 1 June 2007
No. PB 76 of 2007 21 Sept 2007 (see F2007L03773) 1 Oct 2007
No. PB 91 of 2008 29 Aug 2008 (see F2008L03282) 1 Sept 2008
No. PB 106 of 2008 31 Oct 2008 (see F2008L04288) 1 Nov 2008
No. PB 7 of 2009 19 Jan 2009 (see F2009L00108) 1 Feb 2009
No. PB 73 of 2009 17 July 2009 (see F2009L02827) 1 Aug 2009
No. PB 3 of 2010 29 Jan 2010 (see F2010L00196) 1 Feb 2010
No. PB 24 of 2010 26 Mar 2010 (see F2010L00749) 1 Apr 2010
No. PB 52 of 2010 26 May 2010 (see F2010L01430) 1 June 2010
No. PB 78 of 2010 29 July 2010 (see F2010L02200) 1 Aug 2010
No. PB 12 of 2011 31 Jan 2011 (see F2011L00171) 1 Feb 2011

Table of Amendments

ad. = added or inserted      am. = amended      rep. = repealed      rs. = repealed and substituted

Provision affected

How affected

S. 3......................................... am. PB 91 and 106 of 2008; PB 7 of 2009; PB 3 and 78 of 2010
S. 4......................................... am. PB 91 and 106 of 2008; PB 7 of 2009; PB 3 and 78 of 2010
S. 5......................................... am. PB 91 and 106 of 2008; PB 7 of 2009; PB 3 and 78 of 2010
The Schedule
Part 1
Heading to Part 1................ am. PB 91 and 106 of 2008; PB 3 and 24 of 2010
Part 1...................................... am. PB 76 of 2007; PB 91 of 2008; PB 7 and 73 of 2009; PB 24, 52 and 78 of 2010; PB 12 of 2011
Part 2
Part 2...................................... am. PB 41 and 76 of 2007
Note 2.................................... ad. PB 3 of 2010

Note 2

Supply of the items listed in Part 1 and Part 2 of the Schedule is through an


accredited IVF/GIFT clinic. For enquiries relating to the IVF/GIFT program, medical practitioners should contact Medicare Australia on 1800 700 270.

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