National Health (Pharmaceutical Benefits) Amendment Regulations 2001 (No. 1)

Administered by Department of Health, Disability and Ageing

Legislation au F2001B00127 Regulations Not in force Legislative Instrument

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National Health (Pharmaceutical Benefits) Amendment Regulations 2001 (No. 1) 2001 No. 68

EXPLANATORY STATEMENT

STATUTORY RULES 2001 No. 68

Issued by Authority of the Minister for Health and Aged Care

National Health Act 1953

National Health (Pharmaceutical Benefits) Amendment Regulations 2001 (No. 1)

Section 140 of the National Health Act 1953 ("the Act") provides that the Governor-General may make regulations, not inconsistent with the Act, prescribing all matters which by the Act are required or permitted to be prescribed, or which are necessary or convenient to be prescribed for carrying out or giving effect to the Act.

Paragraph 105(a) of the Act provides that the Regulations may prescribe the terms and conditions subject to which pharmaceutical benefits may be supplied.

The National Health (Pharmaceutical Benefits) Regulations 1960 have been amended to remove duplication of work by approved suppliers (mostly approved pharmacists). This has been achieved by providing that concessional and safety net patients' entitlement numbers need not be marked on a paper prescription if they are included in the electronic prescription information submitted by an approved supplier who is using the Claims Transmission System. Under section 99AAA of the Act and the rules made under subsection 99AAA(8) of the Act, approved suppliers (with a few exceptions provided for by sections 99AAB and 99AAC of the Act), are required to lodge claims for payment for the supply of pharmaceutical benefits by submitting information electronically to the Secretary in respect of each prescription for which payment is being claimed, in addition to submitting the paper prescriptions to the Secretary.

In addition it is not be necessary for concessional and safety net patients' entitlement numbers to be marked on repeat authorisations and deferred supply authorisations at the time of their issue.

The above changes parallel the arrangements in respect of medicare numbers that were included in the National Health Amendment (Improved Monitoring of Entitlement to Pharmaceutical Benefits) Act 2000.

The National Health (Pharmaceutical Benefits) Regulations 1960 have been also been amended to make some other minor changes, including correction of some drafting errors.

Details of the Regulations are in the Attachment.

The Regulations commenced on 12 April 2001.

ATTACHMENT

Regulation 1 of the amending regulations provides that the name of the amending regulations is the National Health (Pharmaceutical Benefits) Amendment Regulations 2001 (No. 1).

Regulation 2 of the amending regulations provides that the amending regulations will commence on 12 April 2001.

Regulation 3 of the amending regulations provides that the National Health (Pharmaceutical Benefits) Regulations 1960 will be amended as set out in Schedule 1.

Item 1 of the Schedule amends the heading to regulation 8 as a consequence of the omission of subregulation 8(2) by item 3.

Item 2 of the Schedule amends subregulation 8(1) as a consequence of the omission of subregulation 8(2) by item 3.

Item 3 of the Schedule omits subregulation 8(2), which relates to application forms for isolated pharmacy allowance, remote pharmacy allowance and professional allowance under sections 99ZA, 99ZAA and 99ZDA of the Act respectively. These sections of the Act were repealed with effect from 30 June 2000. These sections of the Act were repealed with effect from 1 July 2000 by the National Health Amendment Act (No. 1) 2000.

Item 4 of the Schedule makes a drafting amendment to the heading to regulation 19A.

Item 5 of the Schedule inserts new subregulation 19A(1A), which provides that it is will not be necessary for a concessional patient's entitlement number to be marked on the prescription where the entitlement number is included in the prescription information supplied by an approved supplier who is using the Claims Transmission System provided for by section 99AAA of the Act.

Items 6 and 7 of the Schedule correct drafting errors in punctuation in subparagraphs 25(3)(c)(iii) and 25(4)(c)(iii) respectively.

Item 8 of the Schedule amends subparagraph 26(1A)(c)(iii) as a consequence of the omission of paragraph 26(1A)(d) by item 9.

item 9 of the Schedule omits paragraph 26(1A)(d), which requires a concessional or safety net patient's entitlement number to be marked on a repeat authorisation at the time of its issue. Entitlement of all patients, including concessional and safety net patients, to pharmaceutical benefits is checked at the time of supply of the benefit.

Item 10 of the Schedule makes a drafting amendment to subregulation 26A(2) to remove gender specific language.

Item 11 of the Schedule omits paragraph 26A(2)(c), which requires a concessional or safety net patient's entitlement number to be marked on a deferred supply authorisation at the time of its issue. Entitlement of all patients, including concessional and safety net patients, to pharmaceutical benefits is checked at the time of supply of the benefit.

Item 12 of the Schedule amends subregulation 38A(2) by amending "economists" to "health economists". This amendment corrects a drafting error that has resulted in an inconsistency with paragraph 100B(1A)(b) of the Act.

 

Overview

The National Health (Pharmaceutical Benefits) Amendment Regulations 2001 (No. 1) were enacted to streamline the administration of pharmaceutical benefits under the National Health Act 1953. This set of regulations was introduced to address the inefficiencies caused by the duplication of work among approved suppliers, primarily pharmacists, by making amendments to the National Health (Pharmaceutical Benefits) Regulations 1960. The regulations were passed by the Parliament of Australia and commenced on 12 April 2001. The primary policy objective of these regulations is to improve the efficiency and accuracy of processing pharmaceutical claims by reducing the administrative burden on approved suppliers, thereby ensuring that concessional and safety net patients' entitlement numbers do not need to be marked on paper prescriptions if already included in electronic prescription information. These amendments parallel the changes made in respect of Medicare numbers through the National Health Amendment (Improved Monitoring of Entitlement to Pharmaceutical Benefits) Act 2000.

Scope and Application

The National Health (Pharmaceutical Benefits) Amendment Regulations 2001 (No. 1) applies to the supply of pharmaceutical benefits under the National Health Act 1953, specifically targeting approved suppliers, including approved pharmacists, who submit claims for payment electronically using the Claims Transmission System. The Regulations streamline the process by eliminating the requirement for concessional and safety net patients' entitlement numbers to be marked on paper prescriptions if these numbers are already included in the electronic prescription information submitted by the approved supplier. This amendment ensures efficiency in the processing of pharmaceutical benefits by reducing redundancy and aligns with the electronic claims submission framework established under section 99AAA of the Act. These Regulations are applicable nationally and were designed to simplify administrative procedures and improve the monitoring of pharmaceutical entitlements. The scope of the Regulations includes amendments to the National Health (Pharmaceutical Benefits) Regulations 1960, focusing on removing outdated requirements related to certain allowances and correcting minor drafting errors. The Regulations came into effect on 12 April 2001, and they do not introduce any new exclusions or exemptions; instead, they refine existing processes to enhance compliance and operational efficiency for approved suppliers. The Regulations are supported by subordinate instruments, which are detailed in the attached Schedule, ensuring that the legislative intent is effectively implemented and that the administrative burden on suppliers is minimised.

Key Provisions

The main operative sections of the National Health (Pharmaceutical Benefits) Amendment Regulations 2001 (No. 1) amend the National Health (Pharmaceutical Benefits) Regulations 1960 to streamline the process of supplying pharmaceutical benefits. Specifically, regulation 8 has been modified to remove the requirement for concessional and safety net patients' entitlement numbers to be marked on a paper prescription if they are already included in the electronic prescription information submitted by an approved supplier using the Claims Transmission System (Schedule 1, Item 5). This change also applies to repeat authorisations and deferred supply authorisations, where it is no longer necessary for these numbers to be marked at the time of issue (Schedule 1, Items 9 and 11). These modifications aim to reduce duplication and streamline the administrative process for approved suppliers, aligning it with the existing arrangements for medicare numbers as specified in the National Health Amendment (Improved Monitoring of Entitlement to Pharmaceutical Benefits) Act 2000. The obligations and requirements imposed by these regulations on the parties and entities they govern are primarily focused on the streamlined electronic submission of prescription information. Approved suppliers, who must lodge claims for payment for the supply of pharmaceutical benefits by submitting information electronically to the Secretary (section 99AAA of the Act), are required to ensure that the necessary entitlement information is included in their electronic submissions. This obligation ensures that the entitlement of all patients, including concessional and safety net patients, is checked at the time of supply of the benefit, thereby maintaining the integrity of the pharmaceutical benefits system. The regulations also correct several drafting errors and remove gender-specific language to enhance clarity and inclusivity. Failure to comply with these regulations may result in administrative inefficiencies and potential oversights in entitlement verification. While the regulations themselves do not explicitly outline specific offences, penalties, or consequences for breach, non-compliance with the National Health Act 1953 and its associated regulations could potentially lead to enforcement actions under the broader legislative framework. Such actions might include fines, sanctions, or other penalties as prescribed by the relevant legislation. The exact consequences would depend on the specific nature and severity of the non-compliance, and would be determined in accordance with the overarching provisions of the National Health Act and other applicable laws.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.