Declaration of Quality Assurance Activity under section 124X of the Health Insurance Act 1973 – QAA 3/2015

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. 3/2015

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, 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 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:

1. CareTrack Kids – The appropriateness of healthcare delivered to Australian children (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 the Australian Institute of Health Innovation (AIHI) (a research body) in partnership with other bodies and State Government and with the support of the Australian Commission on Safety and Quality in Healthcare (a government authority).

• 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 AIHI annual reporting to the Department of Health and publication of information in
  peer-reviewed journals for presentation at conferences and workshops.
   
• 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.

This 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

1. CARETRACK KIDS – THE APPROPRIATENESS OF HEALTHCARE DELIVERED TO AUSTRALIAN CHILDREN

Purpose

This Activity aims to identify the appropriateness and adherence to evidence and consensus-based care delivered to children in Australia during 2012-2013 for
16 common conditions. At the same time, it will examine the frequency and type of adverse events specifically involving children in Australia in acute and primary healthcare settings and will test an intervention to improve this.

Objective/s

The primary objective of this Activity is to measure the appropriateness of healthcare delivered to children during 2012-13 in Australia based on sets of indicators for the management of 16 common conditions including diabetes and gastroenteritis.

This Activity also involves:

• measuring the appropriateness of the healthcare delivered to children in Australia in acute, primary and community healthcare settings; and
• measuring the frequencies and types of adverse events encountered in Australian paediatric care.