National Health (Pharmaceutical Benefits) Regulations (Amendment) 1996 No. 70
EXPLANATORY STATEMENT
STATUTORY RULES 1996 No. 70
Issued by Authority of the Minister for Health and Family 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.
Amendments have been made to the National Health (Pharmaceutical Benefits) Regulations (the Regulations) to remove the requirement that repeat authorisations and deferred supply authorisations for the supply of pharmaceutical benefits be prepared in duplicate, to bring up to date the processing of applications for authority to prescribe increased quantities and repeats of pharmaceutical benefits, and to make some other minor changes.
Subregulation 8(2) requires approved pharmacists, when making applications for certain types of financial assistance under Part VII of the Act, to use the relevant form approved by the Secretary. Subregulation 8(2) has been amended to take account of the change of name of "essential pharmacy allowance" to "isolated pharmacy allowance", to provide for application forms for remote pharmacy allowance and professional allowance, and to remove references to the application forms for amalgamation or closure payments, as these payments are no longer available.
Regulation 13 sets out the procedures to be followed when a medical practitioner wishes to prescribe an increased quantity or increased number of repeats of a pharmaceutical benefit for a particular patient. Regulation 13 has been amended to reflect current practice, and in particular, to provide for telephone authorisation of such prescriptions.
The medical practitioner will be required to prepare an authority prescription, either in handwriting or by computer, in accordance with the form approved by the Secretary, and then obtain authorisation from the Minister either in writing or by telephone. If authorisation is sought in writing, the complete prescription form will be forwarded to the Secretary, and, on authorisation by the Minister, returned either to the medical practitioner, or, if so requested, to the patient. If authorisation is obtained by telephone, the medical practitioner will be required to endorse the prescription with the number allotted by the Minister, and retain a copy of the prescription for one year.
A consequential amendment has also been made to the definition of "authority prescription" in subregulation 5(1).
Regulation 19 sets out the requirements to be met by medical practitioners and participating dental practitioners when preparing pharmaceutical benefit prescriptions. The regulation has been amended by restoring the requirements for the prescription to be endorsed "PBS" (or "NHS" on prescriptions printed before the commencement date of the Regulation) and for the name and address of the prescriber to be shown.
Subregulation 26(1A) sets out the requirements for the preparation of a repeat authorisation form in respect of the supply of a pharmaceutical benefit for which further supplies are allowed. The subregulation has been amended so that it is no longer necessary to prepare duplicate copies of these forms.
Similar changes have been made to sub-regulation 26A(2) in relation to the preparation of deferred supply authorisations.
Regulation 32 has been amended to cease the requirement for an approved supplier to retain duplicate copies of repeat authorisations and deferred supply authorisations prepared by the supplier, consequent on the changes made to regulations 26 and 26A. A further amendment to regulation 32 required approved hospital authorities to retain duplicate copies of prescriptions under the same conditions as apply to approved pharmacists and approved medical practitioners.
Regulation 36, which provided for payment to an approved pharmacist for supply, on a test prescription, of a pharmaceutical benefit which is found to be of appropriate standard, has been omitted as section 104 of the National Health Act 1953, which enabled an authorised person to write such a test prescription, was repealed by the Health Legislation (Powers of Investigation) Amendment Act 1994.
Regulations 44 and 45 have been amended to correct references to subregulation 40(2) in those regulations to references to subregulation 41(2).
The Regulations will commence on 1 June 1996.
Overview
The National Health (Pharmaceutical Benefits) Regulations (Amendment) 1996 No. 70, issued by authority of the Minister for Health and Family Services, was enacted to address the need for updating and streamlining the administration of pharmaceutical benefits under the National Health Act 1953. This amendment to the National Health (Pharmaceutical Benefits) Regulations primarily aimed to modernise the regulatory framework by removing the requirement for duplicate forms in certain authorisations, updating application processes for increased pharmaceutical quantities, and aligning terminology with current practices. For instance, the regulation updates forms to reflect changes such as the renaming of allowances and the discontinuation of certain payments. Additionally, the amendment introduced the option for telephone authorisation of prescriptions and adjusted the requirements for prescription endorsements and record retention. These changes were designed to enhance efficiency and responsiveness in the processing of pharmaceutical benefits while maintaining necessary controls and oversight.
Scope and Application
The National Health (Pharmaceutical Benefits) Regulations (Amendment) 1996 No. 70 pertains to the administration and processing of pharmaceutical benefits under the National Health Act 1953. This regulation applies to medical practitioners, approved pharmacists, and other healthcare professionals who prescribe or supply pharmaceutical benefits to patients. It also encompasses the entities involved in the approval and processing of these benefits, such as the Minister and the Secretary, as well as approved suppliers and hospitals that dispense these medications. The regulation's scope includes the updating of application processes for increased quantities and repeats of pharmaceutical benefits, the amendment of forms related to financial assistance for pharmacists, and modifications to the procedures for obtaining authorisation for specific prescriptions. The regulation extends to all states and territories within Australia, as it is a Commonwealth regulation. However, certain exclusions and thresholds apply, such as the removal of the requirement for duplicate copies of authorisation forms and the cessation of certain payments under specific conditions. The regulation also incorporates minor amendments to subordinate instruments, which further define and refine the application and administration of pharmaceutical benefits.
Key Provisions
The National Health (Pharmaceutical Benefits) Regulations (Amendment) 1996 No. 70 amends the National Health (Pharmaceutical Benefits) Regulations to update certain procedures and requirements regarding pharmaceutical benefits. Section 140 of the National Health Act 1953 allows the Governor-General to make regulations for the purposes of the Act. This amendment removes the requirement for duplicate copies of repeat authorisations and deferred supply authorisations for the supply of pharmaceutical benefits (Subreg. 26(1A) and Subreg. 26A(2)). It also updates the processing of applications for authority to prescribe increased quantities and repeats of pharmaceutical benefits (Reg. 13) and modifies the application forms for certain financial assistance (Subreg. 8(2)).
Obligations under the amended Regulations require medical practitioners to prepare an authority prescription in handwriting or by computer, using the approved form, and obtain authorisation from the Minister either in writing or by telephone (Reg. 13). If authorisation is sought in writing, the prescription must be forwarded to the Secretary, and if authorised by the Minister, returned to the medical practitioner or patient. In cases of telephone authorisation, the prescription must be endorsed with the allotted number and retained by the medical practitioner for one year. Approved pharmacists must use the relevant form approved by the Secretary when applying for financial assistance, such as isolated pharmacy allowance, remote pharmacy allowance, and professional allowance (Subreg. 8(2)).
The Regulations impose several requirements on medical practitioners and participating dental practitioners. Prescriptions must be endorsed "PBS" or "NHS" and must include the prescriber's name and address (Reg. 19). Approved suppliers and hospital authorities are no longer required to retain duplicate copies of repeat authorisations and deferred supply authorisations (Reg. 32). Regulation 36, which provided for payment to an approved pharmacist for supply of a pharmaceutical benefit on a test prescription, has been omitted as the enabling section 104 of the National Health Act 1953 was repealed.
There are no explicit provisions outlining offences, penalties, or consequences for breach within the explanatory statement. However, the amendments likely relate to streamlining and modernising the administrative processes, which indirectly affect compliance requirements. Failure to comply with the updated procedures and requirements could lead to delays in processing prescriptions or authorisations and potential non-compliance with regulatory standards.