National Health (Pharmaceutical Benefits) Regulations (Amendment) 1992 No. 226
EXPLANATORY STATEMENT
STATUTORY RULES 1992 No. 226
Issued by Authority of the Minister for Aged, Family and Health Services
National Health Act 1953
National Health (Pharmaceutical Benefits) Regulations (Amendment)
Section 140 of the National Health Act 1953 (the Act) provides that the Governor-General may make Regulations for the purposes of the Act. Certain other provisions in the Act also specifically provide for matters to be prescribed by regulation.
Subsection 84D(7) of the Act provides that a record of the supply of a pharmaceutical benefit shall include the prescribed particulars of the prescription upon which the benefit is supplied and such other particulars relating to the supply of the benefit as are prescribed.
Subsections 84DA(3) and 84E(3) of the Act provide that an application for the issue of a safety net concession card or a pharmaceutical benefits entitlement card respectively must be accompanied by such documents as are prescribed.
Subsections 84H(1) and (3) of the Act provide for the issue of an additional and replacement concession and entitlement cards in accordance with the regulations.
The Health, Housing and Community Services Legislation Amendment Act 1992 establishes a joint safety net for supplies of benefits made under the Pharmaceutical Benefits Scheme and the Repatriation Pharmaceutical Benefits Scheme and for supplies of drugs made through the out-patient departments of public hospitals. Amounts charged for drugs supplied under all of these arrangements will count towards the various thresholds for the issue of safety net concession cards and pharmaceutical benefit entitlement cards under the Act.
Regulation 5 of the National Health (Pharmaceutical Benefits) Regulations (the Regulations) is amended to include definitions of "applicable amount", "out-patient medication", "public hospital" and "public hospital authority", in each case to have the same meaning as in the National Health Act 1953. These definitions are included as they are used in several of the amending regulations.
Regulation 9A of the Regulations is amended to make the changes necessary to allow for the recording of supplies of out-patient medication on prescription record forms.
Amendments to regulations 9AA and 9B of the Regulations ensure that prescription record forms or other documents which establish the value of supplies of out-patient medication are recognised in relation to applications for safety net concession cards and pharmaceutical benefits entitlement cards respectively.
The amendments to regulations 9AB, 9AC, 9C and 9D of the Regulations enable applications to be made to the public hospital authority which issued the original card for the issue of additional or replacement concession or entitlement cards respectively.
Amendments to regulations 9AD and 9E of the Regulations provide that where a public hospital authority refuses to issue an additional or replacement concession or entitlement card, an application for the issue of the card may be made to the Secretary.
The Regulations will commence on gazettal.
Overview
The National Health (Pharmaceutical Benefits) Regulations (Amendment) 1992 No. 226 was enacted to amend the National Health (Pharmaceutical Benefits) Regulations under the authority of the Minister for Aged, Family and Health Services. This amendment responds to the introduction of a joint safety net established by the Health, Housing and Community Services Legislation Amendment Act 1992, which integrates the Pharmaceutical Benefits Scheme and the Repatriation Pharmaceutical Benefits Scheme, along with drug supplies from public hospitals. The primary objective of these amendments is to ensure consistency and streamline the processes related to the recording of supplies, applications for concession cards, and the issuance of additional or replacement cards in accordance with the newly established joint safety net provisions. The regulation amendments reflect changes necessary to align with the new legislative framework and ensure effective administration and compliance within the health sector.
Scope and Application
The National Health (Pharmaceutical Benefits) Regulations (Amendment) 1992 No. 226 amends the National Health (Pharmaceutical Benefits) Regulations to incorporate new definitions and procedures related to the recording of supplies of out-patient medication and the application processes for safety net concession cards and pharmaceutical benefits entitlement cards. These amendments are made under the authority of the National Health Act 1953, which applies to the regulation of pharmaceutical benefits within Australia. The Act applies to individuals and entities involved in the supply and administration of pharmaceutical benefits, including healthcare providers and patients who are recipients of these benefits. The Regulations extend nationally, affecting all states and territories within Australia. The scope of these amendments is to streamline the process of recording pharmaceutical supplies and applications for concession cards, ensuring that the new joint safety net provisions are accurately implemented. The amendments do not specify exclusions or exemptions but rather focus on updating the regulatory framework to accommodate the changes introduced by the Health, Housing and Community Services Legislation Amendment Act 1992.
Key Provisions
The main operative sections of the National Health (Pharmaceutical Benefits) Regulations (Amendment) 1992 No. 226 (the Amendment) are concerned with the definitions and recording of pharmaceutical benefits, as well as the application process for safety net concession cards and pharmaceutical benefits entitlement cards. Regulation 5 introduces definitions for terms such as "applicable amount", "out-patient medication", "public hospital" and "public hospital authority", which are used in several of the amending regulations (regs 5, 9A, 9AA, 9B, 9AB, 9AC, 9C, 9D, 9AD, and 9E). Regulation 9A requires the recording of supplies of out-patient medication on prescription record forms. Regulations 9AA and 9B ensure that prescription record forms or other documents that establish the value of supplies of out-patient medication are recognised in relation to applications for safety net concession cards and pharmaceutical benefits entitlement cards respectively. Regulations 9AB, 9AC, 9C and 9D enable applications to be made to the public hospital authority that issued the original card for the issue of additional or replacement concession or entitlement cards respectively. Regulations 9AD and 9E provide that where a public hospital authority refuses to issue an additional or replacement concession or entitlement card, an application for the issue of the card may be made to the Secretary.
The Amendment imposes obligations on public hospital authorities and applicants for safety net concession cards and pharmaceutical benefits entitlement cards. Public hospital authorities are required to issue additional or replacement concession or entitlement cards when applications are made in accordance with the Regulations (regs 9AB, 9AC, 9C and 9D). If a public hospital authority refuses to issue an additional or replacement card, the Regulations allow applicants to make an application to the Secretary (regs 9AD and 9E). Applicants for safety net concession cards and pharmaceutical benefits entitlement cards must ensure that their applications are accompanied by the prescribed documents, such as prescription record forms or other documents that establish the value of supplies of out-patient medication (regs 9AA and 9B).
The Amendment does not specify any offences, penalties, or civil/criminal consequences for breach. However, the National Health Act 1953 (the Act) under which the Amendment is made, does provide for offences, penalties and consequences for non-compliance with the Act and the Regulations. For example, section 123 of the Act provides for penalties for making false or misleading statements in connection with a pharmaceutical benefit. The maximum penalty for an individual is 100 penalty units ($11,000) and for a body corporate is 500 penalty units ($55,000). Other provisions of the Act and the Regulations may also provide for penalties for non-compliance, such as the imposition of fines or imprisonment. It is important for parties and entities governed by the Amendment to comply with the requirements of the Amendment and the Act to avoid any potential penalties or consequences for breach.