National Health (Claims and under co-payment data) Amendment Rules 2012 (No. 2) (No. PB 79 of 2012)

Administered by Department of Health, Disability and Ageing

Legislation au F2012L01951 Rules Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

National Health (Claims and under co-payment data) Amendment Rules 2012 (No. 2)

PB 79 of 2012

Authority

Subsections 98AC(4) and 99AAA(8) of the National Health Act 1953 (the Act) provide for the Minister to make rules related to the supply of pharmaceutical benefits and concern transmission of claims data, and transmission of data for medicines priced at or below the patient co-payment threshold.

Purpose

The purpose of this legislative instrument, made under subsections 98AC(4) and 99AAA(8) of the Act, is to amend the National Health (Claims and under co-payment data) Rules 2012 (PB 19 of 2012) (the claims rules), to make changes to the rules related to the provision of claims and under co-payment data.

The Pharmaceutical Benefits Scheme (PBS) is established under Part VII of the Act.  Under the PBS, approved suppliers provide pharmaceutical benefits to the Australian community.  In situations where a Commonwealth subsidy is payable for a pharmaceutical benefit, an approved supplier may make a claim for payment.

Subsection 99AAA(8) of the Act provides that the Minister must make rules:

  • specifying the information to be given to the Secretary by approved suppliers following their supply of pharmaceutical benefits;
  • defining the procedures to be followed by approved suppliers in making claims for payment for their supply of pharmaceutical benefits; and
  • defining the procedures to be followed by the Secretary in processing and determining claims and making payments.

Section 98AC of the Act mandates the provision of information where a pharmaceutical benefit is provided by an approved supplier but there is no Commonwealth subsidy paid because the item is priced at or below the co-payment threshold. 

The amendments made by this Instrument are consequential changes to reflect amendments made to the Act by the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2012 (the Amending Act), which commence 1 October 2012.

Schedule 3 of the Amending Act makes amendments to the Act to insert a new defined term ‘prescriber bag provisions’ and make other amendments in relation to prescriber bag supplies. The prescriber bag provisions are sections 93, 93AA and 93AB of the Act.  These sections provide for supply of certain pharmaceutical benefits to medical practitioners, authorised midwives and authorised nurse practitioners for them to supply directly to patients at no cost in emergency situations.  This Instrument makes consequential amendments to the claims rules to change references to ‘emergency drug supply form’ to ‘prescriber bag supply form’ to reflect that this form is related to supplies made under one of the prescriber bag provisions.

Item 16 of Schedule 1 of the Amending Act replaces section 85B of the Act so that subsection 85B(4) instead of subsection 85B(5) of the Act provides the power for the Minister to determine the circumstances in which the Commonwealth will pay a special patient contribution.  This Instrument makes a consequential change to the definition of ‘authority prescription’ in the claims rules to reflect the changed power for the Minister to determine the circumstances in which the Commonwealth will pay a special patient contribution. 

 Consultation

No consultation occurred regarding these amendments.  These are minor technical changes.  They are not relevant to the industry agreements, do not substantially alter existing arrangements, and have no significant impact for consumers, pharmacy, industry or other users of the PBS.

This Instrument commences on 1 October 2012.

This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

 


Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

National Health (Claims and under co-payment data) Amendment Rules 2012 (No.2)

PB 79 of 2012

This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the Legislative Instrument

The purpose of this legislative instrument, made under subsections 98AC(4) and 99AAA(8) of the Act, is to amend the National Health (Claims and under co-payment data) Rules 2012 (PB 19 of 2012) (the claims rules), to make changes to the rules related to the provision of claims and under co-payment data.

Subsection 99AAA(8) of the Act provides that the Minister must make rules defining the procedures for making a claim and the information that needs to be provided.

Section 98AC of the Act mandates the provision of information where a pharmaceutical benefit is provided by an approved supplier but there is no Commonwealth subsidy paid because the item is priced at or below the co-payment threshold. 

This Instrument makes changes to the claims rules to change references to ‘emergency drug supply form’ to ‘prescriber bag supply form’ to reflect that this form is related to supply under one of the defined prescriber bag provisions (sections 93, 93AA and 93AB of the Act). This Instrument also makes a consequential change to the definition of ‘authority prescription’ to reflect the change to the section reference in the Act for the power for the Minister to determine the circumstances in which the Commonwealth will pay a special patient contribution.

Human rights implications

This legislative instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

The Pharmaceutical Benefits Scheme (PBS) is a benefit scheme which assists with advancement of this human right by providing for subsidised access by patients to medicines.

Conclusion

This Legislative Instrument is compatible with human rights because it advances the protection of human rights.

 

Tanya Plibersek

Minister for Health

Overview

The National Health (Claims and under co-payment data) Amendment Rules 2012 (No. 2) was enacted to amend the National Health (Claims and under co-payment data) Rules 2012 and is made under the authority of the National Health Act 1953. The primary objective of these amendments is to ensure the rules are consistent with recent changes to the Act, specifically those made by the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2012. This includes updating references in the rules to reflect the introduction of 'prescriber bag provisions' and changes to the circumstances under which the Commonwealth will pay a special patient contribution. These amendments are technical in nature and aim to streamline the administration of the Pharmaceutical Benefits Scheme by aligning the rules with legislative updates. The National Health Act 1953, administered by the Australian Parliament, established the framework for the Pharmaceutical Benefits Scheme, which ensures subsidised access to medicines. The 2012 amendments to the Act introduced significant changes, including the establishment of prescriber bag provisions and modifications to patient contribution provisions. The National Health (Claims and under co-payment data) Amendment Rules 2012 (No. 2) thus serve to update the regulatory framework, ensuring that the rules governing claims and data provision remain current and aligned with legislative changes. These amendments are intended to maintain the integrity and efficiency of the PBS without impacting existing arrangements or imposing significant new burdens on industry or consumers.

Scope and Application

The National Health (Claims and under co-payment data) Amendment Rules 2012 (No. 2) amends the National Health (Claims and under co-payment data) Rules 2012, which are made under the National Health Act 1953. The rules pertain to the procedures and information requirements for approved suppliers of pharmaceutical benefits under the Pharmaceutical Benefits Scheme (PBS). The amendments are designed to reflect changes made to the Act by the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2012. The rules apply to approved suppliers of pharmaceutical benefits, which include entities such as pharmacies and suppliers who provide medicines under the PBS. These rules have a national jurisdictional reach, governing the conduct of approved suppliers across Australia in relation to claims for payments and the provision of data for pharmaceuticals. The rules are designed to ensure the effective administration of the PBS by outlining the information required and procedures to be followed in making claims and processing payments. The amendments made by this Instrument include updating terminology from 'emergency drug supply form' to 'prescriber bag supply form' and adjusting the definition of 'authority prescription' to align with changes in the Act. The changes are consequential, reflecting statutory modifications, and do not introduce new substantive requirements but rather ensure the rules remain consistent with legislative updates.

Key Provisions

The National Health (Claims and Under Co-payment Data) Amendment Rules 2012 (No. 2) (the Instrument) amends the National Health (Claims and Under Co-payment Data) Rules 2012 (the Claims Rules) to align with changes made by the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2012 (the Amending Act). The changes include modifying the reference from "emergency drug supply form" to "prescriber bag supply form" and updating the definition of "authority prescription" to reflect the amended power for the Minister to determine special patient contribution circumstances. These changes aim to ensure that the Claims Rules accurately reflect the updated legislative framework for the Pharmaceutical Benefits Scheme (PBS). Approved suppliers and the Secretary of the Department of Health are primarily affected by these amendments. Approved suppliers, who provide pharmaceutical benefits under the PBS, must now follow the updated procedures for making claims and supplying information as specified in the Claims Rules. The Secretary, who is responsible for processing and determining claims and making payments, must adhere to the revised procedures outlined in the amended Claims Rules. These obligations ensure that the PBS continues to operate efficiently and in accordance with the most recent legislative requirements. Breach of the amended Claims Rules may not explicitly outline specific offences or penalties in the Instrument itself. However, breaches of the National Health Act 1953 (the Act) generally may lead to civil or criminal penalties depending on the nature and severity of the breach. For example, under section 119 of the Act, a person who knowingly makes a false or misleading statement in connection with a claim for payment may be subject to a civil penalty of up to $22,200 for each occurrence, or a criminal penalty of up to $111,000 for each occurrence if convicted in a court. Additionally, approved suppliers who fail to comply with the requirements of the Claims Rules may face administrative penalties or have their approval to supply pharmaceutical benefits revoked. These amendments are designed to ensure that the PBS remains aligned with current legislative requirements and continues to provide effective and efficient pharmaceutical benefits to the Australian community. By updating the Claims Rules, the Instrument helps maintain the integrity and effectiveness of the PBS, ultimately supporting the right to health for all Australians.

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