Health Insurance Act 1973 - Declaration of Quality Assurance Activity under section 124X (QAA No. 2/2004)

Administered by Department of Health, Disability and Ageing

Legislation au F2008B00291 Not in force Legislative Instrument

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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.  2/2004

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 to apply to an activity, the Minister must make a Declaration.

 

This Declaration applies Part VC of the Act to the Advanced Incident Monitoring System - Royal Darwin Hospital and Top End Mental Health Service (Item 1), Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) and Royal Australasian College of Physicians (RACS) perinatal mortality audit program for rural obstetricians and paediatricians (Item 2), and the Australian Safety and Efficacy Register of New Interventional Procedures – Surgical (ASERNIP-S) – audit of the endoluminal repair of abdominal aortic aneurysms (Item 3) – (the Activities).

 

The Declaration is a disallowable instrument for the purposes of section 46A of the Acts Interpretation Act 1901.

 

The Activities relate to the quality of health services which would be eligible for payment in respect of Medicare Benefits and, in some cases, public hospital services (Item 3).  

 

The Activity at Item 1 of the Schedule has the purposes of documenting, monitoring, analysing and managing potential and actual adverse patient and visitor events.  The Activity at Item 2 of has the purposes of improving the audit, investigation and peer review skills of specialists who have been involved in perinatal deaths.  The Activity at Item 3 of the Schedule has the purposes of establishing the safety of the surgical (endoluminal) procedure; establishing the efficacy of this procedure; making the results widely known; and using the information in surgical training and clinical decision making.

 

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

 

Firstly, the organisations engaged in the activities must be authorised to do so.  The authorisation can be by an association of health professionals, by a body that provides health care or by an educational institution.  The organisation engaged in the Activity under Item 1 of the Schedule is authorised to do so by the Royal Darwin Hospital and Top End Mental Health Service, bodies that provides health care. 

 

The organisation engaged in the Activity under Item 2 of the Schedule is comprised of members of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) and Royal Australasian College of Physicians (RACP) practice improvement program for rural specialist obstetricians and paediatricians which is authorised to engage in the Activity by the RANZCOG and RACP, associations of health professionals.

 

The organisation engaged in the Activity under Item 3 of the Schedule is comprised of members of The Australian Safety and Efficacy Register of New Interventional Procedures – Surgical (ASERNIP-S) which is authorised to engage in the Activity by the Royal Australasian College of Surgeons (RACS), an association of health professionals.

 

Secondly, the Minister has to 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.  The criteria relevant to the Activities are in regulations 23C, 23D and 23E or 23F of the Health Insurance Regulations.  The Activities meet those criteria as follows:

 

· as required by Regulation 23C, the Activities include the disclosure of non-identifying information that concerns the quality of service 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.  In the Activity under Item 1 of the Schedule, non-identifying information will be made available in aggregated form.  Copies of such information will be provided to the Minister for Health and Ageing.  In the Activity under Item 2 of the Schedule, the outcomes will be published in Royal Australian and New Zealand College of Obstetricians and Gynaecologists, Royal Australasian College of Physicians, and quality in health care journals. Copies of publications will be available to the Minister for Health and Ageing.  In the Activity under Item 3 of the Schedule the organisation engaged in the Activity will provide non-identifying results of the Activity to the Department of Health and Ageing and the Royal Australasian College of Surgeons.  Non-identifying information will also be published in peer reviewed and consumer journals, and presented at specialist meetings.  Copies of such information will be available to the Minister for Health and Ageing.

 

· as required by Regulation 23D, the Minister is satisfied that the Activity under Item 1 is of national importance because the data generated by the project will feed into a national incident monitoring database.  As required by Regulation 23D, the Minister is satisfied that the Activity under Item 2 comprises a pilot study for the purpose of investigating whether a methodology of a particular kind can be used in Australia.  Item 3 is exempt from Regulation 23D as its Activities are being undertaken in more than one state.

 

· as required by Regulation 23E, the Minister is satisfied that the Activities under Item 2 of the Schedule is of a kind that have not been engaged in Australia before because none has been declared and the necessary protections for those participating were not available.  The Declaration is needed to ensure that the Activity has the protections of immunity from suit and prohibitions on the disclosure of information.  These are to make the Activity effective, by encouraging the full participation in the Activity of persons who provide health services. 

 

· as required by Regulation 23F, the Minister is satisfied that the Activities under Items 1 and 3 are of a kind that have been engaged in Australia before. In respect of Item 1, a number of incident monitoring activities have previously been declared.  The application of Part VC of the Act is necessary for Item 1 to encourage participation in the Activity by persons who provide health services to a greater extent than the participation in previous activities because it will encourage the participation by persons who provide health services at the Royal Darwin Hospital and Top End Mental Health Service in addition to participation by other persons in previous activities.  In respect of Item 3, this activity has been previously declared (QAA No. 1/1999).  The application of Part VC of the Act is necessary for Item 3 to encourage greater participation by persons who provide health services to a greater extent than the participation in previous activities.

 

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 31 August 2004 and comes into operation on the date of gazettal.  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. 2/2004

Overview

The Health Insurance Act 1973, enacted to provide for a national health insurance scheme, was extended by the inclusion of Part VC, which aims to encourage efficient quality assurance activities in health services funded by the government, such as those through Medicare benefits. This part was introduced to address the need for mechanisms that protect certain information from disclosure and safeguard the individuals involved in quality assurance activities from civil liability, thereby fostering greater participation and effectiveness in these initiatives. The enacting body, the Parliament of Australia, intended the policy objective to be the enhancement of health service quality through better monitoring, analysis, and management of adverse events and clinical outcomes. The Minister for Health and Ageing, authorised to make a declaration under section 124X of the Act, issued Declaration of Quality Assurance Activities No. 2/2004, applying Part VC to specific quality assurance activities deemed to meet the criteria of national importance and public interest, thus encouraging broader participation in these essential health service improvements.

Scope and Application

The Declaration of Quality Assurance Activities under section 124XA of the Health Insurance Act 1973, made by the Minister for Health and Ageing, applies Part VC of the Act to three specific quality assurance activities aimed at improving the quality of health services funded by the government. These activities include the Advanced Incident Monitoring System at Royal Darwin Hospital and Top End Mental Health Service, the perinatal mortality audit program for rural obstetricians and paediatricians by the Royal Australian and New Zealand College of Obstetricians and Gynaecologists and the Royal Australasian College of Physicians, and the audit of the endoluminal repair of abdominal aortic aneurysms by the Australian Safety and Efficacy Register of New Interventional Procedures – Surgical. The application of Part VC is contingent upon the organisations involved being authorised by an association of health professionals, a body that provides health care, or an educational institution, and the Minister being satisfied that it is in the public interest to apply the Act to these activities. Each activity must also meet certain criteria prescribed by the regulations, such as the disclosure of non-identifying information and the importance of the activity to national health standards. The Minister must consider these criteria before making a declaration, ensuring that the activities are of a kind that have not been engaged in before or have been engaged in before but require the protections outlined in Part VC to encourage greater participation. The Declaration is a disallowable instrument and is in force for up to five years from the date of signing unless revoked earlier.

Key Provisions

The key operative sections of the Health Insurance Act 1973, as amended by the Declaration of Quality Assurance Activities under Section 124X QAA No. 2/2004, pertain to Part VC. This part of the Act aims to encourage efficient quality assurance activities by protecting certain information from disclosure and safeguarding the persons engaged in these activities from civil liability in good faith. Specifically, this declaration applies Part VC to three activities: the Advanced Incident Monitoring System at Royal Darwin Hospital and Top End Mental Health Service, the RANZCOG and RACS perinatal mortality audit program for rural obstetricians and paediatricians, and the ASERNIP-S audit of endoluminal repair of abdominal aortic aneurysms. The declaration ensures that these activities are eligible for the protections afforded by the Act, thereby promoting participation in quality assurance initiatives. The obligations imposed by the Act on the parties or entities it governs are twofold. Firstly, the organisations must be authorised to engage in quality assurance activities. For the Advanced Incident Monitoring System, authorisation comes from the Royal Darwin Hospital and Top End Mental Health Service. For the RANZCOG and RACS perinatal mortality audit program, authorisation is granted by RANZCOG and RACP. Lastly, the ASERNIP-S audit is authorised by the RACS. Secondly, the Minister must be satisfied that applying Part VC to these activities is in the public interest, taking into account specific criteria prescribed by regulations. These criteria include the provision of non-identifying information about service quality and the significance of the activities to national health standards. Failure to comply with the provisions of the Act can lead to civil or criminal consequences. However, the Act itself does not explicitly outline the penalties for breaches. It is likely that any breaches would be addressed under relevant state or federal laws concerning health service provision and information handling. The Minister’s declaration ensures that the quality assurance activities are protected from disclosure and civil liability, but any breaches of these protections or related laws would be subject to the penalties stipulated in those respective laws. The overarching aim is to encourage full participation in quality assurance activities by protecting the participants and their information. Given that the declaration of the activity does not have a direct or substantial indirect effect on business, a Regulation Impact Statement is not necessary. The declaration, signed by the Minister on 31 August 2004, comes into operation on the date of gazettal and will remain in force for five years unless revoked earlier. This timeframe ensures that the quality assurance activities can operate under the protections of the Act without undue delay or uncertainty.

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