Health Insurance Act 1973 - Declaration of Quality Assurance Activity under section 124X (QAA No. 3a/2005)

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.  3a/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 and New Zealand College of Anaesthetists (ANZCA) – Maintenance of Professional Standards Program (MOPS) (Item 1), The Royal Australian and New Zealand College of Radiologists’ (RANZCR) – Quality and Accreditation Program (Item 2), the Australian and New Zealand  Intensive Care Society (ANZICS) – Adult Patient Database and Research Centre for Critical Care Resources Project (Item 3), and The Medical Defence Association of Victoria (MDAV) Ltd – Practice Enhancement Programme (Item 4) - (the Activities). 

As required by section 124W(1) of the Act, the Activity at Item 1 relates to the assessment or evaluation of the quality of health services which would be eligible for payment in respect of Medicare Benefits, Public Hospital Services and the Pharmaceutical Benefits Scheme.

The Activity at Item 2 relates to the assessment or evaluation of the quality of health services which would be eligible for payment in respect of Medicare Benefits, Public Hospital Services and Health Program Grants.

The Activity at Item 3 relates to the study of the incidence or causes of conditions or circumstances that affect the quality of health services which would be eligible for payment in respect of Medicare Benefits and Public Hospital Services.

The Activity at Item 4 relates to the assessment or evaluation of the quality of health services which would be eligible for payment in respect of Medicare Benefits, Health Program Grants and the prescribing of pharmaceutical products which are eligible for payments under the Pharmaceutical Benefits Scheme.

The purpose of the Activity at Item 1 is to study the incidence or causes of conditions or circumstances that may affect the quality of anaesthetist’s clinical standards. The outcomes of the Activity are to:

• involve anaesthetists in a range of ongoing educational activities which maintain clinical standards in order to provide the highest quality of patient care; and
• review anaesthetists’ practice to ensure the best possible standard of practice is provided.

The purpose of the Activity at Item 2 is to assess or evaluate the quality of services through a documented set of practice standards for diagnostic and interventional radiology and a framework of activity to underpin the requirements of these standards.  The objectives of the Activity are to:

• establish minimum acceptable quality assurance levels for diagnostic and interventional radiology practices; and
• highlight the need for reproducible high-quality diagnostic imaging.

The purpose of the Activity at Item 3 is to support ongoing data collection of information on the quality and safety performances of Australian and New Zealand intensive care units in the delivery of patient care. The objectives of the Activity are to:

• inform policy making by intensive care funding bodies as well as health care providers and consumers;
• monitor national trends, epidemiological research and recommendations to intensive care units to support ongoing improvement in safety and quality; and
• identify patterns of intensive care practice and delineate epidemiology outcomes and factors contributing to patient outcomes.

The purpose of the Activity at Item 4 is to identify Medical Defence Association of Victoria members who need assistance in implementing effective risk management and quality assurance strategies in their practices. The Activity will assess or evaluate the quality of services provided by these medical practitioners to reduce the probability of adverse outcomes resulting from their care and to improve the health and well-being of their patients. The objectives of the Activity are to:

•                  enhance practice through clinical assessments, practice audits and counselling;
•                  to reduce the probability of adverse outcomes resulting from patient care; and
•                  to improve health and well-being of patients.

Before the Minister can make a declaration, certain requirements must be met.

Firstly, the Minister must be satisfied that the persons engaged in the Activities are authorised to do so as described in section 124X(3)(a) of the Act.  The Activity at Item 1 meets these requirements in that the persons engaged in this Activity are authorised to do so by The Australian and New Zealand College of Anaesthetists, which is established as a post graduate medical educational institution approved by the Australian Medical Council (section 124X(3)(a)(iv) 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 Royal Australian and New Zealand College of Radiologists, which is established as a medical institution providing specialist education and qualification in the fields of Diagnostic Radiology and Radiation Oncology (section 124X(3)(a)(iv) refers).

The Activity at Item 3 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 Australian and New Zealand Intensive Care Society, which is an association of health professionals (section 124X(3)(a)(vi) refers).

The Activity at Item 4 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 Medical Defence Association of Victoria Ltd, which is an association of health professionals (section 124X(3)(a)(vi) refers).

Secondly, the Minister must be satisfied that it is in the public interest to have Part VC of the Act apply to the Activities (section 124X(3)(b) refers).  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 at Item 1, Item 2 and Item 3 are in regulations 23C and 23F of the Regulations.  The criteria relevant to the Activity at Item 4 are in regulations 23C and 23E 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 the safety and quality of the health services provided by those participating in the Activity. This information will be published in an annual audit report of non-identifying information which will be forwarded to the Minister of Health and Ageing and is published in the ANZCA Bulletin, the ANZCA Annual Report and on the ANZCA website, thereby satisfying the requirement that information is provided at times and in a manner acceptable to the Minister.   

• Regulation 23F applies because 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 Maintenance of Professional Standards Program which was declared as a Quality Assurance Activity under the Act on 23 February 2000 by the then Minister for Health and Aged Care, Dr Michael Wooldridge. This Activity has been declared a Quality Assurance Activity under the Act since 7 December 1994 (QAA 5/1994) when it was declared by the then Minister for Human Services and Health, Dr Carmen Lawrence. 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 all anaesthetists to accurately provide data about their activities against each of the Quality Assurance components within the MOPS program.

The Activity at Item 2 meets the criteria as follows:

•          As required by regulation 23C, the Activity includes the disclosure of non-identifying information that details factors affecting the quality of services including participation rates, levels of quality practice identified, difficulties in meeting minimum standards and measures taken to improve quality. The information will be disseminated through aggregated annual reports, to participants, correspondence to participating practices and the RANZCR website, thereby satisfying the requirement that information is provided at times and in a manner acceptable to the Minister.

• Regulation 23F applies because the Minister is satisfied that the Activity is one of a kind that has been engaged in Australia before. Item 2 is based entirely on the RANZCR Quality and Accreditation Program which was declared as a Quality Assurance Activity under the Act on 30 May 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 providing participants with a greater degree of confidence and security that their participation is solely to the benefit of establishing and improving quality assurance.

The Activity at Item 3 meets the criteria as follows:

• As required by regulation 23C, the Activity includes the disclosure of non-identifying information detailing factors affecting the quality of delivery of intensive care in Australia and New Zealand. Non-identifying information regarding the availability and utilisation of critical care resources and their impact on the quality of services provided will also be disclosed. Information from the Activity will be widely disseminated to stakeholders in Commonwealth and State departments of health, hospitals, tertiary institutions, libraries and international intensive care societies, and will also be disseminated in the form of published reports and journals, thereby satisfying the requirement that information is provided at times and in a manner acceptable to the Minister.

• Regulation 23F applies because the Minister is satisfied that the Activity is one of a kind that has been engaged in Australia before. The Activity at Item 3 is based entirely upon the ANZICS Patient Database and Intensive Care Unit Registry which was declared as a Quality Assurance Activity under the Act on 30 May 2000 by the then Minister for Health and Aged Care, Dr Michael Wooldridge. This Activity has been declared a Quality Assurance Activity under the Act since 3 May 1994 (QAA 1/1994) when it was declared by the then Minister for Human Services and Health, Dr Carmen Lawrence. 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 in the delivery of intensive care services.

The Activity at Item 4 meets the criteria as follows:

• As required by regulation 23C, the Activity includes the disclosure of non-identifying information detailing factors affecting the quality of services, including the process and outcomes of the programme. The information will be disseminated through various newsletters and magazines distributed by MDAV to its members, as well as through occasional articles submitted to medical journals, therefore satisfying the requirement that information is provided at times and in a manner acceptable to the Minister.

• Regulation 23E applies because the Minister is satisfied that the Activity is of a kind that has not been engaged in Australia before. The Declaration is needed to make the Activity effective by encouraging full participation in the Activity by persons who provide health services by providing participants with a greater degree of confidence and security that their participation is solely to the benefit of establishing and improving quality assurance.

Written consultation on the applications for declaration at Item 1, Item 2, Item 3 and Item 4 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 applicants; 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 22/1/2006 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. 3a/2005