EXPLANATORY STATEMENT
ISSUED BY THE AUTHORITY OF
THE MINISTER FOR HEALTH AND AGEING
HEALTH INSURANCE ACT 1973
DECLARATION OF QUALITY ASSURANCE ACTIVITIES UNDER SECTION 124X
QAA No. 2/2005
Part VC of the Health Insurance Act 1973 (the Act) creates a scheme to encourage efficient quality assurance activities. The activities help to ensure the quality of health services that are funded by the government, for example, through Medicare benefits. The scheme encourages participation in such activities by protecting certain information from disclosure, and also by protecting the persons engaged in those activities, in good faith, from civil liability in respect of the activities. In order for Part VC of the Act to apply to an activity, the Minister must make a Declaration.
The Declaration is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
This Declaration applies Part VC of the Act to the Peer Review Practice Visits for obstetricians and gynaecologists in Australia (the Activity). This Activity is managed by the Royal Australian and New Zealand College of Gynaecologists and Obstetricians (RANZCOG).
As required by Section 124W(1) of the Act, the Activity relates to the quality of health services which would be eligible for payment in respect of Medicare Benefits and Public Hospital Services and to the prescribing of pharmaceutical products under the Pharmaceutical Benefits Scheme.
The purpose of the Activity is to visit, assess and evaluate the individual practice and competence of RANZCOG Fellows. The outcomes of the program are to:
- Provide the individual Fellow with recommendations to improve the quality and risk management of their practice
- Provide peer support and feedback from Fellows working in similar circumstances
- Create a core group of Fellows who have peer review skills
Before the Minister can make a declaration, certain requirements must be met.
Firstly, the organisations engaged in the Activity must be authorised to do so as described in Section 124X3(a) of the Act. This Activity meets these requirements in that the persons engaged in this Activity are authorised to do so by the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, which is an association of health professionals.
Secondly, the Minister must be satisfied that it is in the public interest to have Part VC of the Act apply to the Activity. The Minister must have regard to criteria prescribed by the regulations. The criteria relevant to this Activity are in regulations 23C and 23E of the Health Insurance Regulations 1975. The Activity meets the criteria as follows:
- As required by Regulation 23C, the Activity includes the disclosure of non-identifying information that concerns the quality of services assessed, evaluated or studied or the factors affecting the quality of the service, thereby satisfying the requirement that information is provided at times and in a manner acceptable to the Minister. This Activity will be published in RANZCOG publications such as the Australian and New Zealand Journal of Obstetrics and Gynaecology, the O&G magazine and quality in health care journals. Copies of reports will made available to the Minister for Health and Ageing throughout the course of the Activity.
- As required by Regulation 23E, the Minister is satisfied that the Activity is of a kind that has not been engaged in Australia before. The Declaration is needed to ensure that the Activity has the protections of immunity from suit and prohibitions on the disclosure of information. This will make the Activity effective by encouraging the full participation in the Activity of persons who provide health services.
Written consultation on the RANZCOG application for declaration was undertaken from June to August 2005. This included obtaining advice on the potential value of declaring each activity as a quality assurance activity for the purposes of the Act, the methodologies used to conduct the activities and whether each 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:
- independent external referees nominated by the applicant; and
- members of the Qualified Privilege Advisory Group, which includes an external clinician, a legal expert, a consumer representative and a quality manager working in the field of health care quality assurance.
Comments received during the consultation process supported the declaration of the Activity.
A Regulation Impact Statement (RIS) is not necessary for this Declaration because the declaration of the activity will not have a direct or substantial indirect effect on business.
The Declaration was signed by the Minister on 11 October 2005 and comes into operation on the day after registration with the Federal Register of Legislative Instruments. As provided by subsection 124X (4) a declaration ceases to be in force at the end of 5 years after the instrument of declaration is signed, unless revoked earlier.
QAA No. 2/2005
Overview
The Health Insurance Act 1973 was enacted to provide for the administration of a scheme of health insurance in Australia, with the overarching aim of ensuring that the scheme operates efficiently and effectively. Part VC of this Act was introduced to address the need for quality assurance activities within the health sector, particularly those that safeguard the quality of services funded by the government, such as through Medicare benefits. This part of the Act was designed to encourage participation in quality assurance activities by offering protections, such as immunity from civil liability for those participating in good faith and restrictions on the disclosure of certain information. The enacting body responsible for this legislation is the Australian Parliament. The policy objective underpinning Part VC is to foster an environment where health service providers are motivated to engage in quality assurance activities without fear of undue repercussions, thereby enhancing the overall quality of health services provided.
The explanatory statement issued by the Minister for Health and Ageing details a Declaration under section 124XA of the Health Insurance Act 1973, which applies Part VC to the Peer Review Practice Visits for obstetricians and gynaecologists in Australia. Managed by the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG), this activity aims to evaluate the practice and competence of individual Fellows. The Declaration ensures that the activity benefits from the legal protections provided by Part VC, which include immunity from suit and restrictions on information disclosure. This, in turn, encourages full participation from health service providers, ultimately aiming to improve the quality and risk management of their practices. The Declaration was made after thorough consultation with relevant stakeholders and considers it to be in the public interest.
Scope and Application
The Declaration issued under section 124X of the Health Insurance Act 1973 applies Part VC of the Act to the Peer Review Practice Visits for obstetricians and gynaecologists in Australia, an activity managed by the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG). This Act applies to the quality assurance activities related to the services that are eligible for payment under Medicare Benefits and Public Hospital Services, as well as the prescribing of pharmaceutical products under the Pharmaceutical Benefits Scheme. The Act protects certain information from disclosure and shields the persons involved in the quality assurance activities from civil liability, provided they act in good faith. The Declaration ensures that these protections apply to the specific Activity, which involves assessing and evaluating the individual practice and competence of RANZCOG Fellows, with the aim of improving the quality and risk management of their practices and creating a core group of Fellows with peer review skills. The application of the Act to this Activity is subject to the conditions set out in section 124X3(a) of the Act, which are met by the authorisation of the persons engaged in the Activity by RANZCOG. The Minister must also be satisfied that the Activity is in the public interest, a determination that is based on criteria prescribed by the regulations, which in this case are met through the disclosure of non-identifying information concerning the quality of services assessed. The protections provided by the Act are intended to encourage full participation in the Activity, which is necessary for its effectiveness. The declaration is effective for five years from the date it was signed, unless revoked earlier.
Key Provisions
The key operative sections of the Declaration of Quality Assurance Activities under Section 124XQAA No. 2/2005 are contained within Part VC of the Health Insurance Act 1973. This part of the Act establishes a scheme to support quality assurance activities in the health sector, specifically to ensure the quality of health services funded by the government, such as those under Medicare, public hospital services, and the Pharmaceutical Benefits Scheme. The purpose of this scheme is to encourage participation in quality assurance activities by offering protections, such as confidentiality of information and immunity from civil liability, to those involved in good faith. For this scheme to apply to a particular activity, the Minister must make a declaration under Section 124X, which is what QA No. 2/2005 does for the Peer Review Practice Visits for obstetricians and gynaecologists managed by RANZCOG.
The Declaration imposes several obligations and requirements on the entities involved in the quality assurance activities. Firstly, the organisations conducting these activities must be authorised, as specified in Section 124X3(a) of the Act, and in this case, RANZCOG is recognised as such an organisation. Secondly, the Minister must be satisfied that the activity is in the public interest, with specific criteria outlined in the Health Insurance Regulations 1975, including the disclosure of non-identifying information related to the quality of services. The Activity must also be of a kind that has not been previously engaged in Australia, which has been demonstrated through consultation with various stakeholders including independent external referees and the Qualified Privilege Advisory Group. The Activity must undergo a consultation process to ensure it meets the criteria for declaration and is deemed beneficial to the public interest.
Failure to comply with the provisions of the Act and the regulations can lead to various legal consequences. While the explanatory statement does not specify particular offences under this Declaration, the overarching Health Insurance Act 1973 includes provisions for both civil and criminal penalties. For example, under Section 135 of the Act, any person who wilfully makes a false statement or representation in relation to a claim for benefits can be subject to criminal penalties, including fines and imprisonment. Similarly, breaches of confidentiality or misuse of information protected under this scheme can also result in legal action, with penalties including fines and other civil remedies. The maximum penalties for such breaches can vary depending on the specific provisions of the Act and the nature of the offence.
The Declaration ensures that the Peer Review Practice Visits for obstetricians and gynaecologists are protected under the scheme for quality assurance activities. This protection includes immunity from civil liability for those participating in good faith and the confidentiality of non-identifying information related to the quality of health services. The protections are intended to encourage full and honest participation in quality assurance activities, thereby enhancing the overall quality of health services provided in Australia. The Declaration is in force for a period of five years from the date of signing, unless revoked earlier by the Minister.