(1) This Special Arrangement is the National Health (IVF Program) Special Arrangement 2015.
(2) This Special Arrangement may also be cited as PB 60 of 2015.
4 Definitions
In this Special Arrangement:
accredited ART centre has the same meaning as the Research Involving Human Embryos Act 2002.
Act means the National Health Act 1953.
approved hospital means a hospital in respect of which the hospital authority is approved under section 94 of the Act.
approved hospital authority has the same meaning given by subsection 84(1) of the Act.
CTG registered patient means a patient registered under subsection 10(2) of the CTG Special Arrangement.
CTG Special Arrangement means the National Health (Closing the Gap – PBS Co‑payment Program) Special Arrangement 2016.
CTG supplier has the same meaning as in the CTG Special Arrangement.
dispensed price:
(a) for the supply of a pharmaceutical benefit by a hospital authority for a public hospital—has the meaning given by section 10; and
(b) for the supply of a pharmaceutical benefit by an approved hospital authority for a private hospital or by an approved pharmacist or by an approved medical practitioner—has the meaning given by section 12.
other special arrangement means another Special Arrangement under section 100 of the Act.
Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.
RTAC Accredited Unit Number means the number by which the Reproductive Technology Accreditation Committee of the Fertility Society of Australia identifies a person or body as being an accredited ART centre.
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:
Note: • Approved ex‑manufacturer price
Note: • Approved pharmacist
Note: • Approved medical practitioner
Note: • Brand
Note: • Pack quantity
Note: • Pharmaceutical benefit
Note: • Proportional ex‑manufacturer price
Part 2—Pharmaceutical benefits covered by this Special Arrangement
5 Pharmaceutical benefits covered by this Special Arrangement
(1) This Special Arrangement applies to each pharmaceutical benefit mentioned in Schedule 1.
(2) Each pharmaceutical benefit is a brand of a listed drug mentioned in Schedule 1:
(a) in the form mentioned in Schedule 1 for the listed drug; and
(b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.
Note: Each listed drug mentioned in Schedule 1 has been declared by the Minister under subsection 85(2) of the Act. The form, manner of administration and brand mentioned in Schedule 1 have been determined by the Minister under subsections 85(3), (5) and (6) of the Act respectively.
6 Application of Part VII of the Act
(1) Each pharmaceutical benefit supplied in accordance with this Special Arrangement is supplied under Part VII of the Act.
(2) A provision of Part VII of the Act, or of regulations or other instruments made for Part VII of the Act, applies, subject to this Special Arrangement.
Note: See subsection 100(3) of the Act.
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)’ is 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 with 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.
(5) If the code ‘C(100)’ is mentioned in the column in Schedule 1, headed ‘Section 100 only’ for a pharmaceutical benefit, and a circumstances code is mentioned for the pharmaceutical benefit in the column headed ‘Circumstances’, the pharmaceutical benefit can only be supplied in the circumstances identified in the instrument made under section 85A of the Act and in accordance with this Special Arrangement.
(6) A pharmaceutical benefit mentioned in subsection (5) is not available for general supply on the Pharmaceutical Benefits Scheme.
Note: The Minister has declared, under paragraph 85(8)(b) of the Act, that 1 or more of the circumstances in which a prescription for the supply of the pharmaceutical benefit may be written are circumstances in which the benefit can only be supplied under a section 100 Special Arrangement.
Part 3—Payment amounts
Division 1—Payments to suppliers that are approved hospital authorities for public hospitals
8 Payments to approved hospital authorities for public hospitals
(1) An approved hospital authority for a public hospital is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for its supply of the pharmaceutical benefit is greater than the amount that the approved hospital authority was entitled to charge under section 17.
Note: However, see Part 5A in relation to the supply of a pharmaceutical benefit to a CTG registered patient by a CTG supplier.
(2) The dispensed price for the supply of a pharmaceutical benefit by an approved hospital authority for a public hospital is to be worked out under Division 1 of Part 4.
(3) No mark‑ups may be added to the cost of a pharmaceutical benefit for which payment is claimed by an approved hospital authority for a public hospital.
Division 2—Payments to suppliers that are approved hospital authorities for private hospitals, approved pharmacies or approved medical practitioners
9 Payments to certain suppliers of pharmaceutical benefits
(1) An approved hospital authority for a private hospital is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for its supply of the pharmaceutical benefit is greater than the amount that the approved hospital authority was entitled to charge under section 17.
Note: However, see Part 5A in relation to the supply of a pharmaceutical benefit to a CTG registered patient by a CTG supplier.
(2) An approved pharmacist or an approved medical practitioner is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of a pharmaceutical benefit is greater than the amount that the approved pharmacist or approved medical practitioner was entitled to charge under section 17.
(3) The dispensed price for the supply of a pharmaceutical benefit by an approved hospital authority for a private hospital, an approved pharmacist or an approved medical practitioner is to be worked out under Division 2 of Part 4.
Part 4—Dispensed price
Division 1—Dispensed price for supply of a pharmaceutical benefit by a hospital authority for a public hospital
10 The dispensed price—supply by public hospital
(1) The dispensed price for the supply of a pharmaceutical benefit by a hospital authority for a public hospital is as follows:
(a) if the quantity of the pharmaceutical benefit that is ordered and supplied is equal to a multiple of a pack quantity of the benefit—the sum of the approved ex‑manufacturer price or the proportional ex‑manufacturer price for each pack quantity;
(b) if the quantity of the pharmaceutical benefit that is ordered and supplied is less than a pack quantity of the benefit—the amount calculated in accordance with section 11;
(c) if the quantity of the pharmaceutical benefit that is ordered and supplied is more than a multiple of a pack quantity of the benefit—the sum of:
(i) the approved ex‑manufacturer price or the proportional ex‑manufacturer price for each pack quantity; and
(ii) the amount calculated in accordance with section 11 for the remainder of the quantity supplied that is less than a pack quantity.
11 Where quantity is less than a pack quantity
(1) If the quantity of a pharmaceutical benefit that is ordered and supplied is less than a pack quantity of the benefit (a broken quantity), the amount mentioned in paragraph 10(1)(b) and subparagraph 10(1)(c)(ii) is to be calculated by:
(a) dividing the quantity or number of units in the broken quantity by the pack quantity, expressed as a percentage to 2 decimal places; and
(b) applying that percentage to the approved ex‑manufacturer price or proportional ex‑manufacturer price for the pack quantity.
Division 2—Dispensed price for supply of a pharmaceutical benefit by certain suppliers
12 The dispensed price—supply by an approved hospital authority for a private hospital, an approved pharmacist or an approved medical practitioner
(1) The dispensed price for the supply of a pharmaceutical benefit by an approved hospital authority for a private hospital, an approved pharmacist or an approved medical practitioner, is as follows:
(a) if the quantity of the pharmaceutical benefit that is ordered and supplied is equal to a multiple of a pack quantity, the sum of:
(i) the approved ex‑manufacturer price or of the proportional ex‑manufacturer price for each pack quantity, plus the mark‑up mentioned in section 13, taken to the nearest cent, with one half cent being rounded up to 1 cent; and
(ii) a dispensing fee equal to the dispensing fee for the supply of a ready prepared pharmaceutical benefit, mentioned in the determination made under paragraph 98B(1)(a) of the Act, as in force at the time of the supply of the pharmaceutical benefit; or
(b) if a quantity of the pharmaceutical benefit that is ordered and supplied is less than a pack quantity, the sum of:
(i) the amount calculated in accordance with section 14; and
(ii) a dispensing fee equal to the dispensing fee for the supply of a ready prepared pharmaceutical benefit, mentioned in the determination made under paragraph 98B(1)(a) of the Act, as in force at the time of the supply of the pharmaceutical benefit; or
(c) if a quantity of the pharmaceutical benefit that is ordered and supplied is more than a multiple of a pack quantity, the sum of:
(i) for each pack quantity, the approved ex‑manufacturer price or the proportional ex‑manufacturer price for the pack quantity, plus the mark‑up mentioned in section 13, taken to the nearest cent, with one half cent being counted as 1 cent; and
(ii) the amount calculated in accordance with section 14 for the remainder of the quantity supplied that is less than a pack quantity; and
(iii) a dispensing fee equal to the dispensing fee for the supply of a ready prepared pharmaceutical benefit, mentioned in the determination made under paragraph 98B(1)(a) of the Act, as in force at the time of the supply of the pharmaceutical benefit.
13 Mark‑up
For subparagraphs 12(1)(a)(i) and 12(1)(c)(i) and for paragraph 14(a), the mark‑up for a pack quantity of a ready‑prepared pharmaceutical benefit is:
(a) if the pack quantity for which a mark‑up is to be calculated under this section is equal to a maximum quantity of the pharmaceutical benefit, the mark‑up is the amount mentioned in the table below for the approved ex‑manufacturer price (AEMP) or for the proportional ex‑manufacturer price (PEMP) for that quantity.
Table showing the ex-manufacturer price (AEMP) or for the proportional ex-manufacturer price (PEMP) for that quantity.
(b) if the pack quantity for which a mark‑up is to be calculated under this section is not equal to a maximum quantity of the pharmaceutical benefit, the mark‑up is worked out as follows:
(i) if the mark‑up that would apply to the maximum quantity is shown in the table in paragraph (a) as a monetary amount—the mark‑up for the pack quantity is that monetary amount, reduced proportionately for the relative quantities; and
(ii) if the mark‑up that would apply to the maximum quantity is shown in the table in paragraph (a) as a percentage of AEMP or PEMP—the mark‑up for the pack quantity is that percentage of the AEMP or PEMP for the pack quantity.
14 Where quantity is less than a pack quantity
If the quantity of a pharmaceutical benefit that is ordered and supplied is less than a pack quantity of the benefit (a broken quantity), the amount mentioned in subparagraphs 12(1)(b)(i) and 12(1)(c)(ii) is to be calculated by:
(a) adding the mark‑up mentioned in section 13 to the approved ex‑manufacturer price or the proportional ex‑manufacturer price for the pack quantity, taking the result to the nearest cent, with one half cent being counted as 1 cent; and
(b) dividing the quantity or number of units in the broken quantity by the pack quantity, expressed as a percentage to 2 decimal places; and
(c) applying the percentage worked out under subparagraph (b) to the amount worked out under subparagraph (a).
15 Dispensing fee
If an eligible medical practitioner, instead of directing a repeated supply of a pharmaceutical benefit, directs the supply on one occasion of a quantity or number of units of the drug, not exceeding the total quantity or number of units that could be prescribed if the eligible medical practitioner directed a repeated supply, the dispensed price for the supply of the pharmaceutical benefit will include only one dispensing fee.
Division 3—Dispensed price—Other matters
16 Rounding up of dispensed price
The dispensed price for the supply of a pharmaceutical benefit will in each case be taken to the nearest cent, one half cent being counted as one cent.
Part 5—Patient contributions
17 Patient contributions
(1) This section applies if an approved pharmacist, an approved medical practitioner, or an approved hospital authority supplies a pharmaceutical benefit to a patient and makes a claim for payment.
Note: However, see Part 5A in relation to the supply of a pharmaceutical benefit to a CTG registered patient by a CTG supplier.
(2) The approved pharmacist, approved medical practitioner or approved hospital authority may charge the patient an amount equivalent to the amount that may be charged under section 87 of the Act for the supply of a pharmaceutical benefit to the patient.
Part 5A—Supply to CTG registered patients by CTG suppliers
17A Application of this Part
This Part applies to a supply (the relevant supply) of a pharmaceutical benefit under this Special Arrangement if the relevant supply is made:
(a) to a patient who is a CTG registered patient; and
(b) by an approved pharmacist, an approved medical practitioner or an approved hospital authority who is a CTG supplier.
17B Application of the CTG Special Arrangement—co‑payment and payment etc.
(1) Despite sections 8, 9 and 17 of this Special Arrangement, subsections 11(1), (2), (3), (3E) and (4) (co‑payment reduction etc.) and section 13 (payment by Commonwealth) of the CTG Special Arrangement apply in relation to the relevant supply under this Special Arrangement with the modification set out in subsection (2) of this section.
(2) A reference in the CTG Special Arrangement to a supply of a pharmaceutical benefit under the CTG Special Arrangement is taken to be a reference to the relevant supply under this Special Arrangement.
(3) However, the notes to subsections 11(2) and (3) of the CTG Special Arrangement do not apply in relation to the relevant supply under this Special Arrangement.
Note: The notes to subsections 11(2) and (3) of the CTG Special Arrangement relate to CTG suppliers making claims for payment under the CTG Special Arrangement. Claims for payment in relation to the relevant supply under this Special Arrangement are instead dealt with under section 19 of this Special Arrangement.
Part 6—Approved Hospital Authorities
18 Modified application of section 94 approved hospital authorities
(1) Section 94 of the Act applies in a modified manner to pharmaceutical benefits supplied under this Special Arrangement.
(2) An approved hospital authority may supply pharmaceutical benefits to patients receiving treatment in or at the approved hospital or outside of the approved hospital.
Part 7—Claiming
19 Claim for payment
(1) An approved supplier who wants to receive payment from the Commonwealth for the supply of a pharmaceutical benefit under this Special Arrangement must make a claim for payment to the Chief Executive Medicare on behalf of the Secretary.
(2) The claim must be made in accordance with the rules made under subsections 98AC(4) and 99AAA(8) of the Act with the following modifications:
(a) must include the RTAC Accredited Unit Number;
(b) must include an indicator that the patient is a CTG registered patient if:
(i) the claim is made by an approved pharmacist, an approved medical practitioner or an approved hospital authority who is a CTG supplier in relation to a patient who is a CTG registered patient; and
(ii) the claim is made using the manual system referred to in section 99AAA of the Act.