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. 3/2005
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, 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 those 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 Australian Haemophilia Centre Directors’ Organisation (AHCDO) - Australian Bleeding Disorder Registry (Item 1) and the Joint Nuclear Medicine Credentialing & Accreditation Committee of the Royal Australasian College of Physicians and the Royal Australian and New Zealand College of Radiologists - Joint Nuclear Medicine Specialist Credentialing Program (Item 2) - (the Activities).
As required by section 124W(1) of the Act, the Activities at Item 1 and Item 2 relate to the quality of health services which would be eligible for payment of Medicare Benefits and Public Hospital Services.
The purpose of the Activity at Item 1 is for the assessment and evaluation of the quality of health services through the collection of data to record the prevalence of bleeding disorders and to monitor the health and treatment outcomes of those suffering from these disorders.
The outcomes of the Activity are to:
- record the prevalence of bleeding disorders in Australia;
- improve the quality of care for people with bleeding disorders; and
- provide information to the National Blood Authority to enable good funding decisions and plan for future needs of people with bleeding disorders.
The purpose of the Activity at Item 2 is to assess providers of nuclear medicine and positron emission tomography (PET) imaging services against established professional standards, in order that they have approved credentials for their patients to be eligible to receive Medicare benefits for nuclear and PET imaging services performed by these providers. The outcome of the Activity is to ensure that nuclear medicine and PET imaging services in Australia are provided only by specialists who meet the professional standards for these services.
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 at Item 1 are authorised to do so as described in section 124X(3)(a) of the Act. This Activity meets these requirements in that the persons engaged in this Activity are authorised to do so by the Australian Haemophilia Centre Directors’ Organisation, which is established wholly or partly for the purposes of research (section 124X(3)(a)(v) refers) and is also an association of health professionals (section 124X(3)(a)(vi) refers).
The Activity at Item 2 meets the requirements of section 124X(3)(a) of the Act in that the persons engaged in this Activity are authorised to do so by the Joint Nuclear Medicine Credentialing & Accreditation Committee of the Royal Australasian College of Physicians and the Royal Australian and New Zealand College of Radiologists, 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 Activities. The Minister must have regard to criteria prescribed by the regulations. Regulation 23B of the Health Insurance Regulations 1975 (the Regulations) provides that the criteria stated in regulations 23C to 23G (inclusive) are prescribed for the purposes of section 124X(3)(b) of the Act. The criteria relevant to the Activities are in regulations 23C and 23F of the Regulations.
The Activity at Item 1 meets the criteria as follows:
- As required by regulation 23C, the Activity includes the disclosure of non-identifying information that concerns both demographic and clinical data relating to diagnosis and severity of bleeding disorder and related health concerns, including quality of service and treatment options presented. Data from this Activity will be published in academic journals such as the Medical Journal of Australia and presented in papers at national and international conferences. Six monthly reports will be provided to the National Blood Authority, and annual reports to the Department of Health and Ageing, thereby satisfying the requirement that information is provided at times and in a manner acceptable to the Minister.
- As required by Regulation 23F, the Minister is satisfied that the Activity is of a kind that has been engaged in Australia before. Item 1 is based entirely upon the National Bleeding Disorder Registry of Australia which was declared as a Quality Assurance Activity under the Act on 10 October 2000 by the then Minister for Health and Aged Care, Dr Michael Wooldridge. The National Bleeding Disorder Registry of Australia is now known as the Australian Bleeding Disorder Registry. The Declaration is needed to make the Activity effective by encouraging participation by persons who provide health services to a greater extent than the previous activity. This is achieved by encouraging physicians at each treatment centre to provide data about their treatment practices, and encourage full national participation in the Activity through the inclusion of New South Wales haemophilia centres.
The Activity at Item 2 meets the criteria as follows:
- As required by regulation 23C, the Activity includes the disclosure of non-identifying information regarding factors affecting the quality of services, including the specific credentialing criteria and their impact on the quality of nuclear medicine services as a consequence of their being assured under the Activity. Information from the Activity will be provided to the Department of Health and Ageing as well as relevant professional bodies such as the Australian and New Zealand Association of Physicians in Nuclear Medicine (ANZAPNM), Royal Australian and New Zealand College of Radiologists (RANZCR) and Royal Australasian College of Physicians (RACP), thereby satisfying the requirement that information is provided at times and in a manner acceptable to the Minister.
- As required by Regulation 23F, the Minister is satisfied that the Activity is one of a kind that has been engaged in Australia before. Item 2 is based entirely upon the Joint Nuclear Medicine Specialist Credentialling Program which was declared as a Quality Assurance Activity under the Act on 10 October 2000 by the then Minister for Health and Aged Care, Dr Michael Wooldridge. The Declaration is needed to make the Activity effective by encouraging participation by persons who provide health services to a greater extent than the previous activity. This is achieved by encouraging full participation in the Activity by those administering the Activity and those participating through their application for credentialed status.
Written consultation on the applications for declaration at Item 1 and Item 2 were 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 Activities.
A Regulation Impact Statement (RIS) is not necessary for these Declarations 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 …13/12/ 2005 and comes into operation on the day after registration with the Federal Register of Legislative Instruments. As provided by section 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. 3/2005