National Health (Pharmaceutical Benefits) Amendment Regulations 2010 (No. 3)1
Select Legislative Instrument 2010 No. 231
I, MARIE BASHIR, Administrator of the Government of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the National Health Act 1953.
Dated 19 July 2010
MARIE BASHIR
Administrator
By Her Excellency’s Command
NICOLA ROXON
Minister for Health and Ageing
Contents
1 Name of Regulations 2
2 Commencement 2
3 Amendment of National Health (Pharmaceutical Benefits) Regulations 1960 2
Schedule 1 Amendments commencing on 1 July 2010 or the day after registration 3
Schedule 2 Amendments commencing on 1 November 2010 4
1 Name of Regulations
These Regulations are the National Health (Pharmaceutical Benefits) Amendment Regulations 2010 (No. 3).
2 Commencement
These Regulations commence as follows:
(a) regulations 1 to 3 and Schedule 1 — on the later of the following:
(i) 1 July 2010;
(ii) the day after they are registered;
(b) Schedule 2 — on 1 November 2010.
3 Amendment of National Health (Pharmaceutical Benefits) Regulations 1960
Schedules 1 and 2 amend the National Health (Pharmaceutical Benefits) Regulations 1960.
Schedule 1 Amendments commencing on 1 July 2010 or the day after registration
(regulation 3)
[1] Subregulation 5 (1), after definition of approved supplier
insert
authorised midwife has the meaning given by subsection 84 (1) of the Act.
authorised nurse practitioner has the meaning given by subsection 84 (1) of the Act.
[2] Regulation 8AA
substitute
8AA Application for approval as authorised optometrist, authorised midwife or authorised nurse practitioner
The following applications must be made in a form acceptable to the Secretary:
(a) an application for approval as an authorised optometrist under subsection 84AAB (1) of the Act;
(b) an application for approval as an authorised midwife under subsection 84AAF (1) of the Act;
(c) an application for approval as an authorised nurse practitioner under subsection 84AAJ (1) of the Act.
[3] After paragraph 8A (1) (aa)
insert
(ab) an eligible midwife under section 84AAF of the Act; or
(ac) an eligible nurse practitioner under section 84AAJ of the Act; or
Schedule 2 Amendments commencing on 1 November 2010
(regulation 3)
[1] Subregulation 13 (2)
omit
medical practitioner or an authorised optometrist (a practitioner)
insert
practitioner
[2] After subregulation 13 (7)
insert
(8) In this regulation:
practitioner means any of the following:
(a) an authorised optometrist;
(b) a medical practitioner;
(c) an authorised midwife;
(d) an authorised nurse practitioner.
[3] Part IV, heading
substitute
Part IV Supply of pharmaceutical benefits by medical practitioners, authorised midwives and authorised nurse practitioners
[4] Regulations 15 to 18
substitute
14 Meaning of practitioner
In this Part:
practitioner means any of the following:
(a) a medical practitioner;
(b) an authorised midwife;
(c) an authorised nurse practitioner.
15 Practitioners not authorised under sections 93 and 93AA of the Act
A practitioner who is practising his or her profession on a ship is not authorised to supply pharmaceutical benefits under section 93 or 93AA of the Act.
16 Obtaining benefits by practitioners under sections 93 and 93AA of the Act
(1) For sections 93 and 93AA of the Act, a practitioner who is not an approved medical practitioner may obtain a pharmaceutical benefit only if he or she lodges with an approved pharmacist:
(a) an order, in duplicate, signed by the practitioner, in accordance with a form approved in writing by the Secretary; or
(b) an order, in accordance with subregulation (1A), that is:
(i) signed by the practitioner; and
(ii) in accordance with an electronic form approved in writing by the Secretary.
(1A) For paragraph (1) (b), an order is lodged with an approved pharmacist if:
(a) it is lodged in accordance with any approved information technology requirements and by an approved electronic communication; and
(b) the practitioner, or an agent of the practitioner, who will receive the pharmaceutical benefit asks the approved pharmacist to supply the pharmaceutical benefit under the order; and
(c) the approved pharmacist consents, within the meaning of subsection 5 (1) of the Electronic Transactions Act 1999, to the order being lodged, in accordance with any approved information technology requirements and by an approved electronic communication; and
(d) the order is accessible by the approved pharmacist.
(2) A practitioner who is not an approved medical practitioner may obtain a pharmaceutical benefit under subregulation (1) only once in a calendar month.
(3) A practitioner, or an agent of a practitioner, who receives a pharmaceutical benefit under subregulation (1), must:
(a) prepare a receipt for the benefit supplied, using the part of the order form identified for that purpose, that includes the following information:
(i) the date of supply of the benefit;
(ii) if the benefit is received by an agent of the practitioner — the agent’s address; and
(b) if the order is lodged in accordance with paragraph (1) (a) — give the receipt to the approved pharmacist supplying the benefit; and
(c) if the order is lodged in accordance with paragraph (1) (b):
(i) submit the receipt, in accordance with any approved information technology requirements and by an approved electronic communication; and
(ii) ensure the receipt is accessible by the approved pharmacist supplying the benefit.
17 Supply of pharmaceutical benefits by approved pharmacists under sections 93 and 93AA of the Act
(1) An approved pharmacist commits an offence if:
(a) he or she supplies a pharmaceutical benefit on an order lodged under regulation 16; and
(b) neither of the following circumstances applies:
(i) the pharmacist knows the practitioner whose signature appears on the order;
(ii) if he or she does not know the practitioner, the pharmacist:
(A) is given the full name and address of the practitioner by the person who lodged the order; and
(B) if the practitioner is a medical practitioner — is given the medical registration number of the practitioner by the person who lodged the order; and
(C) for any other practitioner — is given the number allotted to the approval for the practitioner by the Secretary under subregulation 8A (1) by the person who lodged the order; and
(D) writes on the order form the details mentioned in sub-subparagraphs (A), (B) and (C).
Penalty: 0.4 penalty units.
(2) An offence against subregulation (1) is an offence of strict liability.
18 Payment for pharmaceutical benefits supplied under sections 93 and 93AA of the Act
An approved pharmacist who has supplied a pharmaceutical benefit to a practitioner under section 93 or 93AA of the Act on an order lodged under regulation 16 and in accordance with these Regulations is entitled to payment from the Commonwealth for the supply of the pharmaceutical benefit at the rate and subject to the conditions determined by the Minister and applicable at the time of the supply.
[5] Paragraph 19 (1) (ca)
omit
in the case of a participating dental practitioner or an authorised optometrist,
insert
for a participating dental practitioner, authorised optometrist, authorised midwife or authorised nurse practitioner —
[6] Paragraph 19 (1) (h)
omit
practitioner
insert
practitioner, authorised midwife or authorised nurse practitioner
[7] Regulation 24
omit
A
insert
(1) A
[8] Regulation 24
insert
(2) For subsection 88 (6B) of the Act, an authorised midwife or authorised nurse practitioner may, instead of directing a repeated supply, direct in a prescription the supply on 1 occasion of a quantity or number of units of the pharmaceutical benefit allowable under subsection 88 (6A) of the Act if he or she is satisfied that:
(a) the maximum quantity or number of units applicable for the pharmaceutical benefit under a determination under section 85A and subsection 88 (1D) or (1E) of the Act is insufficient for the treatment of the person for whom the prescription is written; and
(b) the person requires the pharmaceutical benefit for the treatment of a chronic illness or is residing in a place remote from the approved pharmacist nearest to the person’s place of residence; and
(c) the person could not, without great hardship, obtain the required quantity or number of units of the pharmaceutical benefit by means of repeated supplies on separate occasions.
[9] Subregulation 28 (1)
omit
medical practitioner or participating dental practitioner
insert
medical practitioner, participating dental practitioner, authorised midwife or authorised nurse practitioner
[10] Paragraph 36 (2) (c)
after
93 (2)
insert
or 93AA (2)
Note
1. All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See http://www.frli.gov.au.
