EXPLANATORY STATEMENT
ISSUED BY THE AUTHORITY OF
THE MINISTER FOR HEALTH
HEALTH INSURANCE ACT 1973
DECLARATION OF QUALITY ASSURANCE ACTIVITY
UNDER SECTION 124X
QAA No. 4/2015
Part VC of the Health Insurance Act 1973 (the Act) creates a scheme (known as the Commonwealth Qualified Privilege 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 of the Act 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 section 124X of the Act.
This Declaration under subsection 124X(1) applies to Part VC of the Act to the following activity:
- Improvement of surgeons’ operative outcomes and better health outcomes for patients through web-based self-audit and practice comparisons with professional peers (the Activity).
An overview of the Activity for which the Declaration pursuant to section 124X of the Act 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 Activity meets the requirements of paragraph 124X(3)(a) as the persons engaged in the Activity are authorised to do by Surgical Performance Pty Limited, under the auspice of Quality Innovation Performance (QIP) Limited, which is an association of health professionals.
- 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 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 service assessed, evaluated or studied. Results of this study will include by Surgical Performance Pty Limited annual reporting to the Department of Health, publication of papers for journals (using de-identified data) and presentation of data and outcomes at national and/or international meetings.
- Regulation 23D does not apply as the Activity will be engaged in more than one State or Territory.
- Regulation 23E applies because the Minister is satisfied that the Activity is of a kind that has not been engaged in previously in Australia. 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 for the benefit of establishing and improving quality assurance.
- Regulation 23F does not apply as the Activity has not previously been carried out in Australia.
- Regulation 23G does not apply as the Activity does not include the assessment or evaluation by a person of the services, skill or performance of a health practitioner for the purpose of determining the health care practitioner’s clinical practising rights.
Consultation
Consultations regarding the application for declaration of this Activity were undertaken in 2014 (September and December) and 2015 (January to March). This included obtaining advice on the potential value of declaring this 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 to be made, particularly the 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 this Activity will not result in any direct or substantial indirect effect on business.
The Declaration has effect from the day after registration on the Federal Register of Legislative Instruments. This Declaration ceases to be in force at the end of 5 years after it is signed.
The Declaration is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT
- IMPROVEMENT OF SURGEONS’ OPERATIVE OUTCOMES AND BETTER HEALTH OUTCOMES FOR PATIENTS THROUGH WEB-BASED SELF-AUDIT AND PRACTICE COMPARISONS WITH PROFESSIONAL PEERS
Purpose
This Activity involves web-based self audit using a software system provided by Surgical Performance Pty Ltd that provides performance feedback to health professionals, administrators and other interested parties on the outcomes of medical interventions. The software product/s allow comparison of outcomes for a health care provider with others, whether local or in the medical communities at large, with the aim of providing better health outcomes for patients.
Objective/s
The primary objective of this activity is to allow individual clinicians to compare their outcomes from treatment with the outcomes from colleagues (web-based self-audit) and to practice comparison with professional peers in a de-identifiable environment, live and online.
This activity also involves:
- promoting safe surgery and reducing surgical/obstetric adverse events;
- emphasising the importance of regular practice audit as an integral part of the quality cycle;
- achieving better patient outcomes through a reduction in surgical adverse events;
- reducing the costs for the treatment of surgical complications; and
- increasing health practitioners’ job satisfaction.
Overview
The Health Insurance Act 1973 was enacted to facilitate the administration of health insurance schemes in Australia, including Medicare and the Pharmaceutical Benefits Scheme. A gap identified in the original legislation was the need for a structured approach to quality assurance in health services funded by the government. The Commonwealth Qualified Privilege Scheme, introduced under Part VC of the Act, was designed to address this by encouraging participation in quality assurance activities while protecting relevant information from disclosure and providing some protection from civil liability to participants. The scheme was enacted by the Australian Parliament to ensure that quality assurance activities are carried out effectively and with the necessary safeguards in place. The policy objective is to improve the quality of health services provided under these schemes, ultimately leading to better health outcomes for patients.
In 2015, the Minister for Health issued a Declaration under section 124X of the Act, recognising a specific quality assurance activity as eligible for the protections and benefits of the Commonwealth Qualified Privilege Scheme. The declared activity involves improving surgeons’ operative outcomes and better health outcomes for patients through web-based self-audit and practice comparisons with professional peers. This initiative is overseen by Surgical Performance Pty Limited, under the auspices of Quality Innovation Performance (QIP) Limited, an association of health professionals. The Declaration was made after thorough consultation with relevant stakeholders, including the Qualified Privilege Advisory Group, and considers the public interest criteria set out in the Health Insurance Regulations 1975. The Declaration aims to foster full participation in the activity by providing health service providers with greater confidence and security regarding their involvement in quality assurance efforts.
Scope and Application
The Declaration of Quality Assurance Activity under Section 124X QAA No. 4/2015 of the Health Insurance Act 1973 applies to the activity involving the improvement of surgeons' operative outcomes and better health outcomes for patients through web-based self-audit and practice comparisons with professional peers. This activity is conducted by Surgical Performance Pty Limited under the auspice of Quality Innovation Performance (QIP) Limited, which is an association of health professionals. The activity is authorised and conducted in good faith, and it is deemed to be in the public interest as it encourages efficient quality assurance activities by protecting certain information from disclosure and providing some protection from civil liability to the participating persons. The activity is declared under the Commonwealth Qualified Privilege Scheme, which is established under Part VC of the Act, and it is subject to the public interest criteria set out in regulations 23C to 23G of the Health Insurance Regulations 1975. The declaration is effective for five years from the date of signing and ceases to be in force at the end of this period unless renewed.
The declaration applies to the activity conducted in more than one state or territory and involves the disclosure of non-identifying information that concerns the quality of service assessed, evaluated or studied. The activity includes the annual reporting to the Department of Health, publication of papers for journals using de-identified data, and presentation of data and outcomes at national and/or international meetings. The activity does not include the assessment or evaluation by a person of the services, skill or performance of a health practitioner for the purpose of determining the health care practitioner's clinical practising rights. The declaration does not result in any direct or substantial indirect effect on business.
Key Provisions
The main operative sections of the Health Insurance Act 1973, specifically Part VC, establish a scheme known as the Commonwealth Qualified Privilege Scheme, which is designed to promote efficient quality assurance activities in the health sector (section 124X). This scheme encourages the improvement of health services funded by the Government through mechanisms such as Medicare benefits, the Pharmaceutical Benefits Scheme, Public Hospitals, and Health Program Grants. The scheme provides protections, including immunity from disclosure of certain information and limited civil liability, for individuals or entities participating in these quality assurance activities in good faith. To qualify for these protections, the activity must be declared by the Minister as a quality assurance activity under section 124X. The current declaration pertains to the Activity of improving surgeons’ operative outcomes and patient health outcomes through web-based self-audit and practice comparisons with professional peers.
The obligations and requirements imposed by the Act on the parties or entities involved in the declared quality assurance activity include ensuring that the participants are authorised to engage in the activity (section 124X(3)(a)). The Activity is authorised by Surgical Performance Pty Limited, operating under the auspices of Quality Innovation Performance (QIP) Limited, an association of health professionals. Additionally, the Minister must be satisfied that the activity is in the public interest (section 124X(3)(b)), with this determination guided by criteria prescribed in the Health Insurance Regulations 1975. The Activity meets these criteria as it involves the disclosure of non-identifying information concerning the quality of health services, which is reported annually to the Department of Health, published in journals, and presented at national and international meetings. The Activity also meets other specified criteria such as being novel to Australia, thus encouraging participation and ensuring that the quality assurance process is effective.
The Act and associated Regulations impose penalties and consequences for breaches of the requirements set out in the Act. The specifics of these penalties are not detailed in the explanatory statement provided, but generally, breaches of legislative requirements can lead to civil or criminal consequences, including fines and imprisonment, depending on the severity and intent of the breach. The Act and Regulations provide mechanisms to enforce compliance and protect the integrity of the quality assurance activities. The declaration itself has a limited duration, being in force for up to five years from the date of signing, and ceases to be effective after this period unless renewed.
Consultation processes were undertaken with relevant stakeholders, including the Qualified Privilege Advisory Group, to gather input on the potential value and methodology of the Activity, as well as to ensure that the criteria for declaration were met. These consultations were conducted in 2014 and 2015, providing a basis for the Minister’s decision to declare the Activity as a quality assurance activity. The impact assessment noted that the declaration is not expected to have any direct or substantial indirect effects on business operations. The declaration comes into effect upon registration on the Federal Register of Legislative Instruments and will remain in force for up to five years from the date of signing.