National Health Act 1953 - Determination under subsection 84HA(1) - Pharmaceutical Benefits (25/11/2009)

Overview

The National Health Act 1953 was enacted by the Parliament of Australia to provide a framework for the regulation of health services and pharmaceutical benefits in Australia. One of the key provisions of this Act is the establishment of the Pharmaceutical Benefits Scheme (PBS) and the Repatriation Pharmaceutical Benefits Scheme (RPBS), which provide subsidised access to medications for eligible Australians, including veterans. To address the financial burden on patients who require a large number of medications, the Act includes a "safety net scheme" that offers reduced or free pharmaceutical benefits to those who reach a certain spending level on PBS or RPBS medicines. The policy objective of this scheme is to provide financial protection for patients and their families who require extensive medication use. This Determination under subsection 84HA(1) of the Act specifies the fee payable by the Commonwealth to approved pharmacists, medical practitioners, or hospital authorities for issuing safety net concession cards or pharmaceutical benefits entitlement cards, with the fee set at $8.35 and indexed annually based on the Consumer Price Index. This Determination was made in consultation with the Pharmacy Guild of Australia, as required by the Act.

Scope and Application

The National Health Act 1953, specifically under its Division 1A of Part VII, regulates the Pharmaceutical Benefits Scheme (PBS) and the Repatriation Pharmaceutical Benefits Scheme (RPBS), which provide for the supply of listed drugs and medicinal preparations as pharmaceutical benefits to eligible individuals, including veterans. The Act also establishes a "safety net scheme" designed to provide financial protection for patients and their families who require a significant number of PBS or RPBS medicines. When an individual's expenditure on PBS or RPBS medicines reaches a specified threshold, they may be eligible for a safety net concession card or a pharmaceutical benefits entitlement card. Issuance of these cards enables the individual to receive the medicines at a reduced rate or free of charge for the remainder of the calendar year. This Determination under subsection 84HA(1) of the Act sets the fee payable by the Commonwealth to an approved pharmacist, approved medical practitioner, or approved hospital authority for issuing these concession or entitlement cards, with the agreement of the Pharmacy Guild of Australia, and stipulates that the fee is indexed annually according to the Consumer Price Index. The Determination applies nationally and revokes all previous determinations, setting a fee of $8.35 for the specified card issuance activities.

Key Provisions

The main operative sections of the Determination under subsection 84HA(1) of the National Health Act 1953 establish the fee for issuing safety net concession cards, pharmaceutical benefits entitlement cards, and additional or replacement cards. This fee, determined by the Minister, is set at $8.35 and is indexed annually based on the Consumer Price Index. Section 84HA(1) mandates that this fee can only be determined with the written agreement of the Pharmacy Guild of Australia, as outlined in section 84HA(2). These provisions ensure that approved pharmacists, medical practitioners, and hospital authorities are compensated for their role in issuing these concession and entitlement cards. Additionally, the Determination revokes all previous fee determinations and specifies that the new fee will be in effect from 1 January 2010 to 31 December 2010. The Act imposes specific obligations on approved pharmacists, medical practitioners, and hospital authorities who issue these cards. Firstly, they must record the supply of PBS and RPBS medicines and the associated costs when requested by the patient. This documentation is crucial for determining eligibility for safety net concessions. Secondly, these entities must adhere to the regulations set forth in the National Health (Pharmaceutical Benefits) Regulations 1960 when issuing cards. This includes ensuring that applications for additional or replacement cards are handled appropriately, as detailed in Section 84H of the Act. Furthermore, the approved entities must comply with the terms of the Fourth Community Pharmacy Agreement, which, while not addressing fee determinations, governs other aspects of the PBS and RPBS. The Act also outlines the penalties and consequences for non-compliance. While the Act does not specify criminal penalties for breaches related to the fee determination, there are civil and administrative consequences. Failure to adhere to the regulations could result in the suspension or revocation of the entity’s approval to issue these cards. Additionally, the Act implies that any misuse of the safety net scheme, such as fraudulent applications for cards, could lead to more severe penalties, potentially including fines and legal action. The emphasis is on ensuring compliance to maintain the integrity and financial sustainability of the safety net scheme. The Determination also specifies the fee payable for issuing each safety net concession card, pharmaceutical benefits entitlement card, or additional or replacement card. This fee is $8.35 and is payable only if the card is issued by an approved pharmacist, approved medical practitioner, or approved hospital authority in accordance with the provisions of the National Health Act and the National Health (Pharmaceutical Benefits) Regulations. This financial compensation is intended to cover the administrative costs associated with processing these applications and issuing the cards. The Determination ensures that the fee is indexed annually, reflecting movements in the Consumer Price Index, thereby maintaining the relevance of the compensation in the face of inflation.