National Health (IVF/GIFT Program)
Special Arrangement 2011
(PB 93 of 2011)
National Health Act 1953
I, Felicity McNeill, Acting First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under subsections 100(1) and (2) of the National Health Act 1953.
Dated 23 November 2011
FELICITY McNEILL
First Assistant Secretary (Acting)
Pharmaceutical Benefits Division
Department of Health and Ageing
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; and
(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.
Note Medicare benefit is not payable for Medicare items 13200 to 13203 where a service is provided in relation to a patient’s pregnancy or intended pregnancy that is, at the time of the service, the subject of an agreement, or arrangement, under which the patient makes provision for the transfer to another person of the guardianship of, or custodial rights to, a child born as a result of the pregnancy.
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.
Other Special Arrangement means another Special Arrangement under section 100 of the Act.
PB 26 of 2007 means National Health Act 1953 – Arrangements made under subparagraph 100(1)(b)(i) – IVF/GIFT Program made on 12 March 2007 with effect from 1 April 2007 (as amended).
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.
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 letter ‘D’ 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 letters ‘PB’ 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.
8 Transitional Arrangements
(1) An accredited IVF/GIFT clinic approved under the old Arrangement is taken to be an accredited IVF/GIFT clinic under this Special Arrangement.
(2) A medicare number that was notified to the Chief Executive Medicare under the old Arrangement is taken to have been notified under section 5 of this Special Arrangement.
(3) In this section, old Arrangement means PB 26 of 2007.
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
Choriogonadotropin Alfa
Solution for injection 250 micrograms in 0.5 mL pre-filled syringe
Injection
Ovidrel
SG
D
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
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
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
Progesterone
Pessary 100 mg
Vaginal
Orion Laboratories Pty Ltd
ON
D
Progesterone
Pessary 200 mg
Vaginal
Orion Laboratories Pty Ltd
ON
D
Schedule 2 Responsible Person Codes
(section 6)
Code
Responsible Person
Australian Business Number
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
