Part 1—Preliminary
1 Name
(1) This instrument is the National Health (Remote Area Aboriginal Health Services Program) Special Arrangement 2017.
(2) This instrument may also be cited as PB 107 of 2017.
3 Authority
This instrument is made under section 100 of the National Health Act 1953.
5 Simplified outline of this instrument
This instrument makes a special arrangement for the supply of pharmaceutical benefits for patients of Aboriginal health services in remote areas.
To participate in the special arrangement, an Aboriginal health service must be approved by the Health Secretary under Part 2.
Part 4 provides for payments to approved pharmacists and approved hospital authorities that supply pharmaceutical benefits under this special arrangement to participating Aboriginal health services. The pharmaceutical benefits must (under Part 3) be supplied:
(a) on a bulk basis; or
(b) on presentation of a remote area Aboriginal health service prescription.
6 Definitions
Note: A number of expressions used in this instrument are defined in the Act, including Chief Executive Medicare.
In this instrument:
Act means the National Health Act 1953.
approved Aboriginal health service means an Aboriginal health service for which an approval is in force under section 9.
approved hospital authority has the meaning given by subsection 84(1) of the Act.
approved pharmacist has the meaning given by subsection 84(1) of the Act.
eligible order has the meaning given by section 11.
eligible pharmaceutical benefit means a ready‑prepared pharmaceutical benefit, other than a pharmaceutical benefit that:
(a) can only be supplied under Part VII of the Act in accordance with a special arrangement under section 100 of the Act; or
(b) can only be supplied under Part VII of the Act under the prescriber bag provisions; or
(c) is referred to in Schedule 8 to the current Poisons Standard (within the meaning of the Therapeutic Goods Act 1989).
Health Secretary means the Secretary of the Department.
medicare number has the meaning given by subsection 84(1) of the Act.
pack quantity has the meaning given by subsection 84(1) of the Act.
PBS prescriber has the meaning given by subsection 84(1) of the Act.
Note: PBS is short for pharmaceutical benefits scheme.
pharmaceutical benefit has the meaning given by subsection 84(1) of the Act.
prescriber bag provisions has the meaning given by subsection 84(1) of the Act.
ready‑prepared pharmaceutical benefit means a pharmaceutical benefit to which paragraph (d) of the definition of pharmaceutical benefit in subsection 84(1) of the Act applies.
registration number has the meaning given by section 10.
remote area Aboriginal health service prescription has the meaning given by section 12.
remote zone has the meaning given by the Rural, Remote and Metropolitan Area Classification, 1991 Census Edition, published by the Department of Primary Industries and Energy and the Department of Human Services and Health, as in force in November 1994.
under this special arrangement has the meaning given by section 13.
7 Purpose of this instrument
This instrument makes a special arrangement for providing that an adequate supply of pharmaceutical benefits will be available to persons who are living in isolated areas.
Part 2—Approval of Aboriginal health services
8 Applications for approval of Aboriginal health services
(1) An Aboriginal health service may apply to the Health Secretary to be approved for the purposes of this instrument.
(2) The application must be made:
(a) in writing; and
(b) in the form (if any) approved under subsection (3).
(3) For the purposes of subsection (2), the Health Secretary may, in writing, approve a form for applications.
9 Approval of Aboriginal health services
(1) If the Health Secretary receives an application in accordance with section 8 to approve an Aboriginal health service, the Health Secretary must, as soon as is reasonably practicable:
(a) if the Health Secretary is satisfied that the conditions in subsection (2) of this section are satisfied:
(i) approve the Aboriginal health service by notice in writing given to the Aboriginal health service; and
(ii) notify the Chief Executive Medicare in writing; or
(b) otherwise—refuse the application by notice in writing given to the Aboriginal health service.
(2) For the purposes of paragraph (1)(a), the conditions are:
(a) the Aboriginal health service has a primary function of meeting the health care needs of Aboriginal and Torres Strait Islander people; and
(b) each clinic or other health care facility operated by the Aboriginal health service and from which eligible pharmaceutical benefits are supplied to patients is in a remote zone; and
(c) the Aboriginal health service is not an approved pharmacist or an approved hospital authority; and
(d) one or more employees or contractors of the Aboriginal health service are health professionals who are qualified under the law of the relevant State or Territory to supply all eligible pharmaceutical benefits; and
(e) were the Aboriginal health service to be approved:
(i) it would maintain a stock of eligible pharmaceutical benefits supplied to the Aboriginal health service under this special arrangement; and
(ii) it would store the stock of pharmaceutical benefits in storage facilities that meet the requirements of subsection (3); and
(iii) the pharmaceutical benefits would be supplied to patients of the Aboriginal health service only by, or under the direction of, the qualified employees or contractors mentioned in paragraph (d).
(3) For the purposes of subparagraph (2)(e)(ii), the storage facilities must:
(a) prevent access by unauthorised persons; and
(b) maintain the quality (for example, chemical and biological stability and sterility) of the pharmaceutical benefits; and
(c) comply with any special conditions specified by the manufacturer of the pharmaceutical benefits.
10 Registration number
As soon as is reasonably practicable after being notified under subparagraph 9(1)(a)(ii) that the Health Secretary has approved an Aboriginal health service, the Chief Executive Medicare must, by notice in writing given to the approved Aboriginal health service, allocate a unique number (the approved Aboriginal Health service’s registration number) to the Aboriginal health service.
Part 3—Orders for supply of pharmaceutical benefits to Aboriginal health services
11 Eligible orders
(1) An eligible order is an order made:
(a) by an approved Aboriginal health service to an approved pharmacist or approved hospital authority for the supply of eligible pharmaceutical benefits to the Aboriginal health service; and
(b) in writing; and
(c) in the form (if any) approved under subsection (2).
(2) For the purposes of paragraph (1)(c), the Chief Executive Medicare may, in writing, approve a form for eligible orders.
12 Remote area Aboriginal health service prescriptions
(1) A remote area Aboriginal health service prescription for a patient of an approved Aboriginal health service is a prescription that:
(a) is for the supply of an eligible pharmaceutical benefit in relation to the treatment of the patient; and
(b) states the name, address and (if known) medicare number of the patient; and
(c) identifies the pharmaceutical benefit by such particulars as are necessary to identify the pharmaceutical benefit; and
(d) states the:
(i) quantity or number of units; and
(ii) form; and
(iii) strength;
of the pharmaceutical benefit to be supplied; and
(e) indicates the pharmaceutical benefit’s dose, frequency of administration and route of administration; and
(f) is written and signed by a person mentioned in subsection (2); and
(g) states:
(i) the name and address of the person writing the prescription; and
(ii) the name and registration number of the approved Aboriginal Health service; and
(iii) the date on which the prescription is written; and
(h) is in the form (if any) approved under subsection (3).
(2) A person is authorised to write a remote area Aboriginal health service prescription for a patient of an approved Aboriginal health service if the person is:
(a) a PBS prescriber; and
(b) an employee or contractor of the Aboriginal health service; and
(c) qualified under the law of the relevant State or Territory to supply all eligible pharmaceutical benefits.
(3) For the purposes of paragraph (1)(h), the Health Secretary may, in writing, approve a form for remote area Aboriginal health service prescriptions.
Part 4—Payments for supply of pharmaceutical benefits to Aboriginal health services
13 When a pharmaceutical benefit is supplied under this special arrangement
(1) An eligible pharmaceutical benefit is supplied to an approved Aboriginal health service under this special arrangement if it is supplied:
(a) by an approved pharmacist or an approved hospital authority; and
(b) in response to an eligible order made by the approved Aboriginal health service; and
(c) directly to the approved Aboriginal health service; and
(d) in a pack quantity; and
(e) either:
(i) as part of a bulk supply to the Aboriginal health service; or
(ii) on presentation of a remote area Aboriginal health service prescription for a patient of the approved Aboriginal health service and in accordance with subsection (2).
(2) For the purposes of subparagraph (1)(e)(ii), the pharmaceutical benefit must be prepared and labelled in accordance with the remote area Aboriginal health service prescription.
14 Payments for supply of pharmaceutical benefits to Aboriginal health services
(1) An approved pharmacist or approved hospital authority that supplies a pack quantity of a pharmaceutical benefit to an approved Aboriginal health service under this special arrangement is entitled to be paid by the Commonwealth, for the supply, the amount worked out under section 15.
(2) To avoid doubt, a reference in Part VII of the Act to payment in relation to the supply of a pharmaceutical benefit includes a reference to payment under subsection (1) of this section.
15 Amount of payments
(1) The amount to which an approved pharmacist or approved hospital authority is entitled under subsection 14(1) for the supply of a pack quantity of an eligible pharmaceutical benefit is the sum of the following amounts:
(a) the price to pharmacists for the pack quantity (worked out in accordance with the determination that is in force under paragraph 98B(1)(a) of the Act at the time of the supply of the pharmaceutical benefit);
(b) an amount equal to the administration, handling and infrastructure fee for the pack quantity (worked out in accordance with that determination);
(c) a handling fee of $3.20;
(d) if subparagraph 13(1)(e)(ii) of this instrument applies—a s100 Remote Area Aboriginal Health Service Patient Specific Medicine Supply Fee of $5.04.
Note: In 2022, the relevant determination under paragraph 98B(1)(a) of the Act was PB 62 of 2022.
(2) To avoid doubt, no additional amount is payable for the cost of transportation or cold chain maintenance.
16 Claims for payments
(1) An approved pharmacist or approved hospital authority that wants to receive payment from the Commonwealth under subsection 14(1) must make a claim for payment to the Chief Executive Medicare.
(2) The claim must be made:
(a) in writing; and
(b) in the form (if any) approved under subsection (3) of this section.
(3) For the purposes of paragraph (2)(b), the Chief Executive Medicare may, in writing, approve a form for claims.
(4) Despite subsection 14(2) of this instrument, subsections 99AAA(2), (4) and (5) of the Act do not apply in relation to a claim made under this section.
Part 5—Miscellaneous
17 No charge for supply of eligible pharmaceutical benefits by approved Aboriginal health services
An Aboriginal health service must not demand or receive a payment or other valuable consideration in respect of the supply of a pharmaceutical benefit to a patient of the Aboriginal health service by the Aboriginal health service, if the eligible pharmaceutical benefit was supplied to the Aboriginal health service under this special arrangement.
18 Conditions for approved pharmacists do not apply
The National Health (Pharmaceutical Benefits) (Conditions for approved pharmacists) Determination 2017 does not apply to the dispensing or supply of a pharmaceutical benefit if the benefit is supplied to an approved Aboriginal health service under this special arrangement.
Part 6—Transitional provisions
19 Previously registered Aboriginal health services
(1) An Aboriginal health service that, immediately before the commencement of this section, was registered for the purposes of the National Health (Remote Aboriginal Health Services Program) Special Arrangements Instrument 2010 (the old instrument) is taken, from the commencement of this section, to have been approved under paragraph 9(1)(a) of this instrument.
(2) The approval number that was allocated to the Aboriginal health service by DHS (within the meaning of the old instrument) in relation to that registration is taken, from the commencement of this section, to be a registration number allocated to the Aboriginal health service under section 10 of this instrument.
