Declaration of Quality Assurance Activity under section 124X of the Health Insurance Act 1973 – QAA 6/2015

Administered by Department of Health, Disability and Ageing

Legislation au F2015L01110 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

ISSUED BY THE AUTHORITY OF

THE MINISTER FOR HEALTH

HEALTH INSURANCE ACT 1973

DECLARATION OF QUALITY ASSURANCE ACTIVITY

UNDER SECTION 124X

QAA 6/2015

 

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 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 to be declared under the section 124X.

 

This Declaration under subsection 124X(1) applies Part VC of the Act to the following activity:

 

  1. The  BreastSurgANZ Quality Audit and Outlier Process (the Activity).

 

An overview of the activity for which the Declaration pursuant to section 124X is made is contained in Attachment B.


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 Breast Surgeons of Australia and New Zealand Inc. (BreastSurgANZ), 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 regulations 23C to 23G (inclusive) of 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. Certain reports are available on the BreastSurgANZ website http://www.breastsurganz.com/BQA. Papers are also published in peer reviewed journals by BreastSurgANZ members and results presented at specialist meetings.
  • 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. This is a re-declaration of the activity previously declared as a quality assurance activity to which Part VC of the Act applies by declaration QAA 1/2010. The Minister’s re-declaration will encourage increased participation in the activity by persons who provide health services by providing participants with confidence and security that documents created solely for the purposes of the Activity or information acquired by a person solely as a result of the Activity will be afforded the relevant protections from disclosure by Part VC. 
  • 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

 

Consultations regarding the application for declaration of this Activity were undertaken in June 2015 by the Chair of the Qualified Privilege Advisory Group. 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 included the Department of Health’s Principal Medical Advisor,
Dr Andrew Singer.

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 the instrument of declaration is signed.

 

The Declaration is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

 

QAA 6/2015

ATTACHMENT A

1. The National Breast Cancer Audit and Outlier Process

Purpose

The National Breast Cancer Audit is a clinical audit that collects medical information about a patient’s early breast cancer treatment and compares the surgeon’s performance to quality thresholds (minimum standards), which have been developed using the Guidelines for the Management of Early Breast Cancer. These minimum standards are used to inform the surgeons if their practices are consistent with best practice.

Participating surgeons become part of a quality information system designed to improve performance and quality of health care.  The ‘Outlier Process’ involves identifying surgeons who do not meet the minimum thresholds and counselling them to improve their practices.

Objective/s

The objectives of the activity are to:

  • improve the surgical care and management for all people with early breast cancer in Australia and New Zealand;
  • keep up to date with changes in treatment based on available evidence and to ensure wide dissemination of this information to practitioners; and
  • inform potential changes in clinical practice to improve patient outcomes and to provide information on the uptake of evidence-based treatment practices under different circumstances.

 

 

 


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 6/2015

 

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

This Legislative Instrument declares an activity to be a quality assurance activity to which Part VC of the Health Insurance Act 1973 applies. Information produces solely for the purpose of this activity will be covered by qualified privilege.

 

Human rights implications

This Legislative Instrument does not engage any of the applicable rights or freedoms.

 

Conclusion

This Legislative Instrument is compatible with human rights as it does not raise any

human rights issues.

 

 

 

 

 

 

Prof Chris Baggoley

Chief Medical Officer

Department of Health

 

 

 

Overview

The Health Insurance Act 1973 was enacted to provide for the efficient operation of the Medicare scheme and to establish a framework for regulating health insurance in Australia. One of the key provisions introduced by the Act is Part VC, which aims to encourage efficient quality assurance activities in the health sector by providing protection from disclosure of certain information and some protection from civil liability to certain persons engaged in those activities in good faith. The Minister for Health has the authority to declare specific activities as quality assurance activities under section 124X of the Act, subject to certain criteria being met. In June 2015, the Minister made a Declaration under subsection 124X(1) of the Act that the BreastSurgANZ Quality Audit and Outlier Process is a quality assurance activity to which Part VC of the Act applies. This Declaration was made after considering the public interest criteria set out in the Health Insurance Regulations 1975 and consulting with relevant stakeholders, including the Department of Health’s Principal Medical Advisor. The policy objective of the Declaration is to encourage increased participation in quality assurance activities by providing participants with confidence and security that documents created solely for the purposes of the Activity or information acquired by a person solely as a result of the Activity will be afforded the relevant protections from disclosure by Part VC. The Declaration applies to the Activity for a period of five years and is compatible with human rights as it does not raise any human rights issues. The Activity aims to improve the surgical care and management for all people with early breast cancer in Australia and New Zealand, keep up to date with changes in treatment based on available evidence, and inform potential changes in clinical practice to improve patient outcomes.

Scope and Application

The Health Insurance Act 1973, specifically Part VC, establishes a scheme aimed at fostering efficient quality assurance activities within the health sector to ensure the quality of services funded by the government, including those under Medicare benefits, the Pharmaceutical Benefits Scheme, and Health Program Grants. This scheme protects certain information from disclosure and provides some protection from civil liability to certain persons engaged in these activities in good faith. The application of Part VC to any activity requires a Declaration by the Minister under section 124X of the Act, which was made for the BreastSurgANZ Quality Audit and Outlier Process. This activity is authorised by Breast Surgeons of Australia and New Zealand Inc., an association of health professionals, and has been deemed to be in the public interest. The Declaration, effective from the day after its registration on the Federal Register of Legislative Instruments, will remain in force for five years and is compatible with human rights as it does not engage any of the applicable rights or freedoms. The scope of the Act extends to protecting information created solely for the purposes of the declared activity from disclosure and providing protection from civil liability to participants in good faith.

Key Provisions

The key operative sections of the Health Insurance Act 1973, as declared in QAA 6/2015, pertain to the protection of information and the limitation of civil liability for certain quality assurance activities in the health sector. Specifically, section 124X (paragraphs 3(a) and 3(b)) requires that the Minister for Health be satisfied that the persons engaged in the activity are authorised to do so and that it is in the public interest for Part VC of the Act to apply to the activity (paragraphs 124X(3)(a) and 124X(3)(b)). The BreastSurgANZ Quality Audit and Outlier Process (the Activity) has been declared as a quality assurance activity under section 124X of the Act, thus making Part VC applicable. The Act provides protection from disclosure and civil liability for certain information generated by the Activity, thereby encouraging participation in quality assurance activities that aim to improve health services funded by the Government. The Act imposes several obligations and requirements on the parties involved in the declared quality assurance activity. Firstly, the persons engaged in the Activity must be authorised by Breast Surgeons of Australia and New Zealand Inc. (BreastSurgANZ). Secondly, the Minister must ensure that the Activity is in the public interest, considering the criteria prescribed by regulations 23C to 23G of the Health Insurance Regulations 1975. The Activity must include the disclosure of non-identifying information concerning the quality of service assessed, evaluated, or studied. It is also required that the Activity has been previously carried out in Australia, as evidenced by its re-declaration following the previous declaration QAA 1/2010. Furthermore, the Activity must not involve the assessment or evaluation of a health practitioner's services, skill, or performance for determining clinical practicing rights. The Act includes provisions for offences, penalties, and civil or criminal consequences for breach. However, the Explanatory Statement does not specify any particular offences, penalties, or consequences related to the declared quality assurance activity. It is important to note that the protections provided by Part VC of the Act, including the qualified privilege for information generated by the Activity, are contingent upon compliance with the criteria set out in the regulations and the Act. Any breach of these conditions could potentially lead to legal consequences, though the specifics are not detailed within the Explanatory Statement. The Declaration itself is a legislative instrument under the Legislative Instruments Act 2003 and has effect from the day after registration on the Federal Register of Legislative Instruments, ceasing to be in force at the end of five years after the instrument of declaration is signed.

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