EXPLANATORY STATEMENT
ISSUED BY THE AUTHORITY OF THE MINISTER FOR HEALTH
HEALTH INSURANCE ACT 1973
DECLARATION OF QUALITY ASSURANCE ACTIVITY UNDER SECTION 124X OF THE HEALTH INSURANCE ACT 1973 - QAA 6/2016
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, including through Medicare benefits, the Pharmaceutical Benefits Scheme, 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 is a quality assurance activity to which Part VC applies.
The Declaration of Quality Assurance Activity under section 124X of the Health Insurance Act 1973 – QAA 6/2016 (the Declaration) has effect from the day after registration on the Federal Register of Legislation.
The Declaration applies Part VC of the Act to the following activity, to the extent it relates to health services provided in Australia:
- Australian and New Zealand Gastric and Oesophageal Surgical Association Inc (ANZGOSA): Australian and New Zealand Gastric and Oesophageal Surgical Audit ((the ANZGOSA Audit), previously declared under the name Oesophago-gastric Cancer and Gastrointestinal Stromal Tumour Audit).
An overview of the activity is contained in Attachment A.
Before making a declaration under section 124X, the Minister must be satisfied that the persons engaging in the activity are authorised to do so in one of the ways set out in paragraph 124X(3)(a) of the Act. The persons engaged in the ANZGOSA Audit are authorised to do so by ANZGOSA, which is an association of health professionals and an educational institution (see subparagraphs 124X(3)(a)(vi) and (iv)).
Secondly, paragraph 124X (3)(b) of the Act provides that the Minister must be satisfied that it is in the public interest that Part VC of the Act apply to the activity. In doing so, the Minister must have regard to criteria prescribed by regulations. The criteria are set out in regulations 23C to 23G of the Health Insurance Regulations 1975 (the Regulations).
The ANZGOSA Audit 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. In reflecting on their clinical activities, an annual report on de-identified, aggregate data is distributed to ANZGOSA surgeons at their annual conference and later readily available from the audit webpage: www.surgeons.org/anzgosa.
- 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 greater 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 will 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
The ANZGOSA Audit was previously declared to be quality assurance activity under section 124X of the Act (see Declaration of Quality Assurance Activity under section 124X of the Health Insurance Act 1973 (QAA 2/2011)). ANZGOSA applied to continue the declaration of their activity as a quality assurance activity to which Part VC applies.
An assessment of the application 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 as set out in the Regulations.
The declaration of this activity will not result in any direct or substantial indirect effect on business.
The Declaration comes into effect on the day after registration on the Federal Register of Legislation.
Subsection 124X(4) of the Act provides that, unless sooner revoked, a declaration ceases to be in force at the end of 5 years after it was signed. Accordingly, the Declaration provides that it is repealed at the end of 5 years after it is signed.
The Declaration is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT A
OVERVIEW OF THE ACTIVITY
- PURPOSE OF ACTIVITY
The ANZGOSA Audit is an ongoing quality assurance activity aiming to evaluate, improve and maintain the quality of care provided by its members. Members of the ANZGOSA collect data through a secure online system. Participants can self-assess their performance and compare against peers.
As a self-audit tool, operative outcomes are monitored by the surgeon participants of the audit. Surgeons are able to get up-to-date information on their performance against a bi-national aggregate of their peers via the online audit system.
Additionally, the data as a whole will add to the knowledge base of these cancers and be used for research into treatment practice and trends in the region. These findings will be disseminated through peer-reviewed journal articles and regular presentations at surgical meetings.
The objectives of the activity are:
- To evaluate, improve and maintain the quality of care provided to patients undergoing surgery for oesophago-gastric cancer or gastrointestinal stromal tumour in Australia and New Zealand.
- Surgeons can undertake a self-audit of their practice by comparing outcomes with peers and improve their practice.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Declaration of Quality Assurance Activity under section 124X of the
Health Insurance Act 1973 - QAA 6/2016
This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the
Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Legislative Instrument
The Declaration of Quality Assurance Activity under Section 124X of the Health Insurance Act 1973 - QAA 6/2016 (the Declaration) declares the ANZGOSA Audit to be a quality assurance activity to which Part VC of the Health Insurance Act 1973 (the Act) applies. Part VC establishes a scheme to encourage efficient quality assurance activities. Information known solely as the result of the ANZGOSA Audit, or documents created solely for the purposes of the ANZGOSA Audit, will be covered by qualified privilege.
The ANZGOSA Audit is an ongoing quality assurance activity aiming to evaluate, improve and maintain the quality of care provided by its members. Members of the Australia and New Zealand Gastric and Oesophageal Surgical Association collect data through a secure online system. Participants can self-assess their performance and compare against peers.
Human rights implications
This Declaration engages the right to health as set out in Article 12 of the International Covenant on Economic, Social and Cultural Right (ICESCR) by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.
The Qualified Privilege Scheme established by Part VC of the Act is aimed at encouraging participation in quality assurance activities that help ensure the highest possible health care standards are maintained. The quality assurance activities described in this Declaration will provide participants with a great degree of confidence and security that their participation is solely for the benefit of establishing and improving outcomes of the community health care.
- The declaration of the ANZGOSA Audit does not require any patients or doctors to participate in the activity. It merely protects against the disclosure of certain information or documents produced exclusively for the purposes of the Audit.
- While there is a requirement in r 23C that the activity must include the disclosure of information concerning the quality of the service assessed, evaluated or studied or the factors affecting the quality of the service, the requirement is for the disclosure of
de-identified information only.
Conclusion
This Declaration is compatible with human rights as it promoted the right to health.