EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 113 OF 2010
NATIONAL HEALTH ACT 1953
SUBSECTION 99AAA(8)
Amendment Rules under subsection 99AAA(8) 2010 (No.1)
Purpose
These Amendment Rules are made pursuant to subsection 99AAA(8) of the National Health Act 1953 (the Act) and amend the Rules under subsection 99AAA(8) (PB 49 of 2008) (the Rules) concerning claims for payment in relation to supply of pharmaceutical benefits.
Background
Subsection 99AAA(8) of the Act provides that the Minister must make Rules:
- defining the procedures to be followed by approved suppliers in making claims for payment in relation to the supply of pharmaceutical benefits;
- specifying the information to be given to the Secretary by approved suppliers in relation to the supply by them of pharmaceutical benefits;
- defining the procedures to be followed by approved suppliers in providing information by electronic means to the Secretary in relation to the supply by them of pharmaceutical benefits; and
- defining the procedures to be followed by the Secretary in processing and determining claims by approved suppliers relating to supply of pharmaceutical benefits and making payments.
Details of this Instrument
These Amendment Rules contain consequential changes to the definition of ‘authority prescription’ in paragraph 2(b) of the Rules due to the implementation of amendments made by the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2010 to the Act which commence on 1 December 2010. Those amendments to the Act required changes to an instrument that is cross-referenced in the definition of ‘authority prescription’ in this instrument. The updated definition for ‘authority prescription’ ensures the cross-reference to the new consolidated listing instrument made under sections 84AF, 85, 85A, 88 and 101 of the Act works correctly and that the definition is consistent with other instruments made under the Act. The amendment is consistent with the amended definition of ‘authority prescription’ in the National Health (Pharmaceutical Benefits) Amendment Regulations 1960 commencing on 1 December 2010. ‘Authority prescriptions’ are relevant to the circumstances in which pharmaceutical benefits can be prescribed, and to increases in the maximum quantity and maximum repeats in a prescription.
The Amendment Rules also contain consequential changes which replace most references to particular types of PBS prescriber with the phrase ‘PBS prescriber’.
On 1 November 2010, due to amendments to the Act made by the Health Legislation Amendment (Midwives and Nurse Practitioners) Act 2010, authorised nurse practitioners and authorised midwives joined the existing categories of ‘PBS prescriber’ (a phrase defined in subsection 84(1) of the Act). A ‘PBS prescriber’ is a medical practitioner, participating dental practitioner, authorised optometrist, authorised nurse practitioner, or authorised midwife. These amendments are needed to ensure that the Rules work appropriately when a PBS prescription is written or prepared by an authorised nurse practitioner or authorised midwife.
In addition, the Amendment Rules replace references to ‘doctor’s bag form’ (and similar) with references to ‘emergency drug supply form’. It is not necessary for the medicines supplied in this manner to be placed in a ‘bag’ and this form of supply is no longer limited to doctors – hence the replacement phrase ‘emergency drug supply form’.
The phrases ‘doctor’s bag form’ and ‘emergency drug supply form’ relate to the capacity in the Act for medical practitioners, and since 1 November 2010, authorised nurse practitioners and authorised midwives, to supply certain determined pharmaceutical benefits to patients for treatment, pursuant to section 93 (medical practitioners) and section 93AA (authorised nurse practitioners and authorised midwives). On 1 November 2010, authorised nurse practitioners had pharmaceutical benefits determined for the purpose of section 93AA.
The Amendment Rules also update cross-references appearing in the Rules to the determination made under paragraph 98B(1)(a) of the Act (Commonwealth price for pharmaceutical benefits supplied by approved pharmacists). The amendments ensure that the cross-references in the Rules to certain topics dealt with in the 98B(1)(a) determination work correctly by replacing out of date references to paragraph numbers in the 98B(1)(a) determination with current references to section numbers in the 98B(1)(a) determination. The amendments also replace one reference to ‘Standard Formulae List’ in the Rules with the phrase ‘standard formula preparation’. The phrase ‘standard formula preparation’ is not substantially different in effect, but it is preferable as it is a defined phrase in the Rules, and in the 98B(1)(a) determination.
Consultation
The amendments contained in this legislative instrument are minor and machinery in nature and do not substantially alter existing arrangements. Medicare Australia has been consulted in relation to the amendments.
General
This legislative instrument commences on 1 December 2010.
This determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003.