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

Administered by Department of Health, Disability and Ageing

Legislation au F2007L00667 Not in force Legislative Instrument

Legislation content

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 (b) The Arrangements made on 23 October 2006 with effect from 1 November 2006 (No. PB 55 of 2006) are repealed with effect from the commencement of these Arrangements.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

 

Overview

The Arrangements made under subparagraph 100(1)(b)(i) — IVF/GIFT Program (No. PB 26 of 2007) under the National Health Act 1953 was enacted to provide free special pharmaceutical products to eligible patients undergoing in vitro fertilisation (IVF) or gamete intrafallopian transfer (GIFT) treatments. The legislation aims to address the gap in accessible fertility treatments for eligible patients by ensuring that specified pharmaceutical products necessary for IVF/GIFT treatments are provided at no cost. This legislative instrument was enacted by the Commonwealth of Australia and was prepared by the Office of Legislative Drafting and Publishing, Attorney-General’s Department. The policy objective is to ensure that eligible patients receive the necessary medical support for fertility treatments without financial burden, thus facilitating access to assisted reproductive technology.

Scope and Application

The Arrangements made under subparagraph 100(1)(b)(i) of the IVF/GIFT Program (No. PB 26 of 2007) applies to patients who are eligible under the Health Insurance Act 1973 and who are receiving in-vitro fertilisation (IVF) or gamete intrafallopian transfer (GIFT) treatment. These Arrangements provide that eligible patients will be supplied with certain special pharmaceutical products free of charge for specified treatments. The Act applies nationally, being a Commonwealth legislative instrument made under subparagraph 100(1)(b)(i) of the National Health Act 1953. The Act is amended by subordinate instruments, with amendments taking effect on dates specified in the instrument itself, with the most recent amendment being No. PB 12 of 2011. The supply of special pharmaceutical products under this Act is restricted to treatments rendered in accredited IVF/GIFT clinics and does not apply to treatments rendered in conjunction with surrogacy arrangements. For further information, medical practitioners should contact Medicare Australia.

Key Provisions

The Arrangements made under subparagraph 100(1)(b)(i) — IVF/GIFT Program (No. PB 26 of 2007) sets out the provisions for the provision of special pharmaceutical products under the National Health Act 1953. These Arrangements commenced on 1 April 2007 and replaced the previous Arrangements made on 23 October 2006. Eligible patients, as defined in the Health Insurance Act 1973, will receive the special pharmaceutical products listed in the Schedule free of charge. These products are provided for specific treatments related to infertility, as outlined in the Health Insurance (General Medical Services Table) Regulations 2009. Additionally, these products are available for luteal phase support in certain patients, and payment of a Medicare benefit for related items confirms eligibility. The Act imposes several obligations on the parties involved. Firstly, healthcare providers must notify the Chief Executive Officer of Medicare Australia of the patient's Medicare number to obtain the special pharmaceutical products. Furthermore, these products must not be supplied for treatments associated with surrogacy arrangements. The supply of these products is restricted to accredited IVF/GIFT clinics, and medical practitioners should contact Medicare Australia for any inquiries related to the IVF/GIFT program. Failure to comply with the provisions of this Act may result in civil and criminal penalties. While the Act does not explicitly state the maximum penalties, breaches of the National Health Act 1953 or related legislation may result in fines or imprisonment, depending on the severity of the offence. Additionally, supplying the special pharmaceutical products for treatments associated with surrogacy arrangements may result in the disqualification of Medicare benefits for those specific treatments.

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