EXPLANATORY STATEMENT
Issued by the authority of the Minister for Health and Ageing
HEALTH INSURANCE ACT 1973
DECLARATION OF QUALITY ASSURANCE ACTIVITY
UNDER SECTION 124X
QAA No. 3/2011
Part VC of the Health Insurance Act 1973 (the Act) creates a scheme to encourage efficient quality assurance activities. Those activities help to ensure the quality of health services that are funded by the Government, through Medicare benefits, the Pharmaceutical Benefits Scheme, Public Hospitals and/or Health Program Grants. The scheme encourages participation in such activities by protecting certain information from disclosure, and also by providing some protection from civil liability to certain persons engaged in those activities in good faith, in respect of those activities.
In order for Part VC to apply to an activity, the Minister must make a Declaration pursuant to Section 124X of the Act, that the activity described in the Declaration is a quality assurance activity to which Part VC applies. Regulations 23C to 23G of the Health Insurance Regulations 1975 (the Regulations) set out the public interest criteria that must be met by quality assurance activities in order to be declared under the section 124X.
This Declaration has effect from the day after registration on the Federal Register of Legislative Instruments. Section 124X(4) of the Act prescribes that, unless sooner revoked, this determination ceases to be in force at the end of 5 years after the instrument of declaration was signed.
The purpose of the Declaration is to declare nine quality assurance activities qualified privilege activities under section 124X of the Health Insurance Act 1973.
An overview of the activities for which the Declaration is made is contained in the Attachment.
Before the Minister can make a declaration, certain requirements must be met.
Firstly, the Minister must be satisfied that the persons engaged in the activity are authorised to do so as described in paragraph 124X(3)(a) of the Act.
The activities described in the Attachment meets the requirement as the persons engaged in them are authorised either by associations of health professionals or research institutions.
Secondly, paragraph 124X(3)(b) of the Act provides that the Minister must be satisfied that it is in the public interest to have Part VC of the Act apply to the activity. In doing so, the Minister must have regard to criteria prescribed by the Regulations. The criteria relevant to the activities are in regulations 23C, 23D and 23E or 23F and 23G. The activity meets the relevant criteria prescribed by the Regulations.
CONSULTATION
Consultations regarding the application for declaration were undertaken in May 2011. This included obtaining advice on the potential value of declaring the activity as a quality assurance activity for the purposes of the Act, the methodology used to conduct the activity, and whether the application met the criteria required for declaration, in particular those criteria relating to whether it is in the public interest to declare the activity.
Those consulted included members of the Qualified Privilege Advisory Group, which includes an external clinician; a legal expert; a quality manager working in the field of health care quality assurance; and a consumer representative.
The declaration of the activity will not result in any direct or substantial indirect
effect on business.
The Declaration is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT
OVERVIEW OF THE DECLARATION OF QUALITY ASSURANCE ACTIVITY UNDER SECTION 124X OF THE HEALTH INSURANCE ACT 1973 – QAA 3/2011
Breast Implant Registry
Breast Implant Registry (BIR) is a database of implant prostheses. It contains patient, surgeon and prosthesis details as well as revision information (if appropriate). It is managed by the Australian Society of Plastic Surgeons. Its main objectives are: providing a device register; document performance of breast implants and adverse outcomes; and report outcomes and findings.
Overview
The Health Insurance Act 1973 was enacted to establish a framework for the provision of health insurance in Australia, primarily through the Medicare system. This legislation was introduced to address the need for a structured approach to ensuring that health services are of high quality and efficiently managed. The Parliament of Australia established this framework to provide a comprehensive system of health insurance that could be overseen and regulated effectively. The policy objective of the Act, particularly with regards to the introduction of quality assurance activities, is to promote and maintain the highest standards of health care services funded by the Government, thereby ensuring public health and safety.
In line with this objective, the Health Insurance Act 1973 includes provisions for the Minister for Health and Ageing to declare specific quality assurance activities under Section 124X. The purpose of these declarations, as seen in the Declaration of Quality Assurance Activity under Section 124X QA 3/2011, is to identify and protect certain activities that are essential for the quality assurance of health services funded by the Government. This includes activities such as the Breast Implant Registry, which aims to document and report on the performance and outcomes of breast implant procedures. By declaring these activities, the Act provides a mechanism to protect the information gathered and to offer some protection from civil liability to those engaged in these activities in good faith.
Scope and Application
The Health Insurance Act 1973, through its Part VC, aims to encourage efficient quality assurance activities within the health sector, ensuring the quality of services funded by the Government through Medicare, the Pharmaceutical Benefits Scheme, Public Hospitals, and Health Program Grants. To facilitate this, the Act provides certain protections, such as confidentiality of information and limited liability for those involved in quality assurance activities in good faith. The Minister for Health and Ageing has the authority to declare specific activities as quality assurance activities under Section 124X of the Act, thereby extending these protections to those activities. The scope of the Act encompasses any person or entity involved in these declared quality assurance activities, provided they meet the criteria outlined in the Health Insurance Regulations 1975. The jurisdictional reach of this Act is federal, applying across Australia. However, the Act does not apply to activities not declared by the Minister, and certain exclusions may apply as specified in the Regulations. The declaration made under Section 124X of the Act extends the application of Part VC to the specified quality assurance activities for a period of five years from the date of signing, unless revoked sooner.
Key Provisions
The main operative sections of the Declaration of Quality Assurance Activity under section 124X of the Health Insurance Act 1973 (the Act) involve the declaration of certain quality assurance activities that are protected from disclosure and provide protection from civil liability to certain persons engaged in these activities in good faith. Specifically, section 124X(1) of the Act allows the Minister for Health and Ageing to declare activities as quality assurance activities, provided that certain criteria are met, as outlined in section 124X(3) of the Act. The Regulations 23C to 23G of the Health Insurance Regulations 1975 further specify the public interest criteria that must be satisfied for the declaration to be valid. In this particular case, the Minister has declared nine quality assurance activities, including the Breast Implant Registry (BIR), as qualified privilege activities under section 124X of the Act.
The Act imposes obligations on the parties and entities it governs, particularly those engaged in the declared quality assurance activities. These obligations include ensuring that the activities are conducted in good faith and in accordance with the criteria set out in the Regulations. The persons engaged in the activities must be authorised to do so, either by associations of health professionals or research institutions, as per section 124X(3)(a) of the Act. Additionally, the Minister must be satisfied that it is in the public interest to declare the activity as a quality assurance activity, taking into account the criteria prescribed by the Regulations, as per section 124X(3)(b) of the Act.
The Act also outlines potential civil and criminal consequences for breach of its provisions. While the Explanatory Statement does not provide specific details on the penalties for breach, it is clear that any unauthorised disclosure of information protected under the Act or any malicious intent in engaging in quality assurance activities could lead to legal repercussions. The specific penalties would depend on the nature and severity of the breach, but they could include fines, imprisonment, or other civil remedies as determined by the relevant courts.
In summary, the Declaration of Quality Assurance Activity under section 124X of the Health Insurance Act 1973 declares specific activities, such as the Breast Implant Registry, as qualified privilege activities, protecting them from disclosure and providing civil liability protection to those engaged in them. The Act imposes obligations on the entities and individuals involved in these activities, requiring them to adhere to the criteria set out in the Regulations and to act in good faith. Any breach of the Act's provisions could result in civil or criminal consequences, although the specific penalties are not detailed in the Explanatory Statement.