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. 4/2016
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, 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 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 the section 124X.
The Declaration is a legislative instrument for the purposes of the Legislative Instruments Act 2003. This Declaration has effect from the day after registration on the Federal Register of Legislative Instruments. Section 124X(4) of the Act prescribes that, unless sooner revoked, this determination ceases to be in force at the end of 5 years after the instrument of declaration was signed.
This declaration under subsection 124X(1) applies Part VC of the Act to the following activity:
- The colorectal surgical Society of Australia and New Zealand (CSSANZ)
BiNational Colorectal Cancer Audit (BCCA)
An overview of the activity for which the Declaration pursuant to s124X is made is contained in Attachment A.
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) in that the persons engaged in this activity are authorised to do so by the Colorectal Surgical Society of Australia and New Zealand 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 criteria relevant to the activity are in regulations 23C, 23D and 23E or 23F.
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. Information and a link to the annual audit report may be found at: https://cssanz.org/bcca-database/.
- Regulation 23D does not apply as the activity will be undertaken in more than one State or Territory.
- Regulation 23E does not apply as the activity has previously been engaged in Australia.
- Regulation 23F applies as the activity has previously been carried out in Australia. The Minister’s declaration will encourage 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.
- 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 practicing rights.
CONSULTATION
This included an assessment of the potential value of declaring the 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. Those consulted including Department of Health’s Principal Medical Advisor, Doctor Andrew Singer.
The declaration of this activity will not result in any direct or substantial indirect
effect on business.
The Declaration comes into operation on the day after registration on 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. 4/2016
ATTACHMENT A
OVERVIEW OF THE ACTIVITY
1. PURPOSE OF ACTIVITY
The BCCA is an audit of surgeons who treat patients with colorectal cancer. Patient demographics, treatment and outcome data are being collected. This allows surgeons to compare the outcomes to other surgeons throughout Australia and New Zealand in a de-identified, secure environment.
Participating surgeons become part of a quality information system designed to improve performance and quality of health care.
The objectives of the activity are:
- to facilitate clinical audit;
- participate in quality assurance activity;
- satisfy Clinical Professional Development (CPD) requirements;
- establish benchmarks;
- monitor surgical performance by peer review;
- facilitate research projects.
Overview
The Health Insurance Act 1973 was enacted to provide a comprehensive framework for health insurance in Australia, and was later amended to include provisions for quality assurance activities. The gap it was introduced to address was the need to ensure the quality of health services funded by the government through mechanisms like Medicare, the Pharmaceutical Benefits Scheme, and Public Hospitals. The enacting body was the Australian Parliament, and the policy objective was to encourage participation in quality assurance activities by providing protection from disclosure of certain information and from civil liability for those engaged in such activities in good faith. This legislative instrument, issued by the Minister for Health, is a declaration under section 124X of the Act, which applies Part VC to the colorectal surgical Society of Australia and New Zealand's BiNational Colorectal Cancer Audit. The declaration ensures that the audit activity meets public interest criteria and will encourage full participation by health service providers.
The declaration process involved consultation with relevant parties, including the Department of Health's Principal Medical Advisor, to assess the potential value of declaring the activity as a quality assurance activity, and to ensure that the methodology and application met the criteria required for declaration. The declaration will provide participants with greater confidence and security that their involvement is solely for the benefit of improving quality assurance, and will come into operation on the day after registration on the Federal Register of Legislative Instruments. The declaration will be in force for five years from the date of signing, unless revoked earlier.
Scope and Application
The Health Insurance Act 1973, through its Part VC, establishes a framework for quality assurance activities aimed at ensuring the quality of health services funded by the government via Medicare, the Pharmaceutical Benefits Scheme, Public Hospitals, and Health Program Grants. This framework provides protections, such as shielding certain information from disclosure and offering some protection from civil liability, to persons engaged in these activities in good faith. For Part VC to apply to a specific activity, the Minister for Health must declare it as a quality assurance activity under section 124X. This declaration applies to the Colorectal Surgical Society of Australia and New Zealand (CSSANZ) BiNational Colorectal Cancer Audit (BCCA), which involves the collection and analysis of non-identifying patient data to evaluate and improve surgical outcomes for colorectal cancer patients across Australia and New Zealand. The declaration ensures that participating surgeons can contribute to this audit with confidence, knowing their involvement is protected and aimed at enhancing healthcare quality. The declaration is subject to certain criteria, including the authorization of the participants and the public interest, as outlined in the Health Insurance Regulations 1975. The declaration is effective from the day after its registration on the Federal Register of Legislative Instruments and remains in force for five years unless revoked earlier.
Key Provisions
The main operative sections of the Health Insurance Act 1973 (the Act), as evidenced by the Declaration of Quality Assurance Activity under section 124X, pertain to the encouragement and regulation of quality assurance activities. Section 124X allows the Minister to declare certain activities as quality assurance activities that are protected from disclosure and provide some protection from civil liability to those engaged in these activities in good faith (Section 124X(1)). The Act’s Part VC facilitates this by ensuring that information related to these activities remains confidential and that participants are shielded from certain liabilities. Regulations 23C to 23G of the Health Insurance Regulations 1975 provide specific criteria that must be met for these activities to be eligible for declaration under section 124X. This declaration applies to the Colorectal Surgical Society of Australia and New Zealand's (CSSANZ) BiNational Colorectal Cancer Audit (BCCA), which is an audit focused on the treatment of colorectal cancer patients and the comparison of outcomes among surgeons in Australia and New Zealand.
The obligations and requirements imposed by the Act on the parties involved in the BCCA include ensuring that all persons engaged in the activity are authorised to do so, which in this case, is fulfilled by the CSSANZ, an association of health professionals (Section 124X(3)(a)). Furthermore, the Minister must be satisfied that the activity is in the public interest, which involves assessing whether the activity meets the public interest criteria prescribed by the Regulations, such as the inclusion of non-identifying information concerning the quality of service (Section 124X(3)(b); Regulation 23C). The Minister’s declaration also ensures that participants in the activity have greater confidence and security, thereby encouraging full participation aimed at improving the quality assurance of health services.
Any breach of the provisions under Part VC of the Health Insurance Act 1973 could lead to various consequences. While the explanatory statement does not explicitly detail offences or penalties, it is inferred that any misuse of the protected information or failure to adhere to the declared quality assurance activity's requirements could result in legal repercussions. The protection provided under the Act implies that unauthorised disclosure of information or misuse of the activity's protections could attract civil or criminal penalties. However, the exact penalties are not specified in the text provided but would typically be defined in relevant sections of the Act or other related legislation. The declaration itself ceases to be in force at the end of five years after the instrument of declaration is signed unless revoked earlier (Section 124X(4)).