Health Insurance Act 1973 - Declaration of Quality Assurance Activity under Section 124X (QAA No. 2/2006)

EXPLANATORY STATEMENT

ISSUED BY THE AUTHORITY OF

THE MINISTER FOR HEALTH AND AGEING

HEALTH INSURANCE ACT 1973

DECLARATION OF QUALITY ASSURANCE ACTIVITIES UNDER SECTION 124X

QAA No.  2/2006

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, for example, through Medicare benefits.  The scheme encourages participation in such activities by protecting certain information from disclosure, and also by protecting the persons engaged in those activities, in good faith, from civil liability in respect of those activities. 

In order for Part VC of the Act to apply to an activity, the Minister may make a Declaration pursuant to s124X of the Act, that the activity described in the Declaration is a quality assurance activity to which Part VC applies. 

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

This Declaration under s124X(1) applies Part VC of the Act to the following activities:

• the Australian Society of Plastic Surgeons – Breast Implant Registry (Item 1);
• The Melbourne Vascular Surgical Association – Melbourne Vascular Surgical Association Audit (Item 2);
• Royal Australian College of Physicians – Maintenance of Professional Standards (Item 3); and
• Australian and New Zealand Association of Physicians in Nuclear Medicine – Practice Accreditation Program (Item 4).

As required by section 124W(1) of the Act, the Activities at Item 1, 2, 3 and 4 relate to the quality of health services which would be eligible for payment of Medicare Benefits and Public Hospital Services.

An overview of the activities for which the Declaration pursuant to s124X will be made is contained in Attachment A

Written consultation on the applications for declaration at Item 1 was undertaken from September 2005 to March 2006.  Written consultations on the applications for declaration of Items 2, 3 and 4 were undertaken from January to May 2006.  This included obtaining advice on the potential value of declaring each activity as a quality assurance activity for the purposes of the Act, the methodologies used to conduct the activities and whether each application met the criteria required for declaration, in particular those criteria relating to whether it is in the public interest to declare the Activity.  Those consulted included:

• independent external referees nominated by the applicant; and
• members of the Qualified Privilege Advisory Group, which includes an external  clinician, a legal expert, a consumer representative and a quality manager working in the field of health care quality assurance.

A Regulation Impact Statement (RIS) is not necessary for these Declarations because the declaration of the activity will not have a direct or substantial indirect effect on business.

The Declaration was signed by the Minister on …15 June 2006 and comes into operation on the day after registration with the Federal Register of Legislative Instruments.

As provided by section 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. 2/2006

Attachment A

Overview of the activities

1. PURPOSE OF ACTIVITIES

The purpose of the Activity at Item 1 is to collect and analyse breast implant performance data related to the treatment of breast implant recipients which will assist in reducing the probability of adverse outcomes.  The objectives of the Activity are to:

• document the performance of breast implants; and
• provide information to practitioners on the performance of implants and techniques.

The purpose of the Activity at Item 2 is to undertake a risk-adjusted analysis of vascular surgical outcomes.  The objective of the Activity is to improve the quality of care provided to vascular surgery patients by establishing standards of practice and providing information to surgeons on their performance.

The purpose of the Activity at Item 3 is ensuring the active participation of physicians in continuing education and evaluation of the quality of their practices.  The objective of the Activity is to improve the quality of care provided by physicians by providing physicians with specific information about their own practice as well as peer feedback.

The purpose of the Activity at Item 4 is maintaining and enhancing the quality of nuclear medicine services in Australia through accreditation of participating nuclear medicine practices against standards set by the Australian and New Zealand Association of Physicians in Nuclear Medicine.

2. REQUIREMENTS TO BE MET

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 section 124X(3)(a) of the Act.

The Activity at Item 1 meets these requirements in that the persons engaged in this Activity are authorised to do so by the Australian Society of Plastic Surgeons, which is an association of health professionals (section 124X(3)(a)(vi) refers).

The Activity at Item 2 meets the requirements of section 124X(3)(a) of the Act in that the persons engaged in this Activity are authorised to do so by the Melbourne Vascular Surgical Association which is an association of health professionals.

The Activity at Item 3 meets the requirements of section 124X(3)(a) of the Act in that the persons engaged in this Activity are authorised to do so by the Royal Australasian College of Physicians (RACS) which is an association of health professionals.

The Activity at Item 4 meets the requirements of section 124X(3)(a) of the Act in that the persons engaged in this Activity are authorised to do so by the Australian and New Zealand Association of Physicians in Nuclear Medicine (ANZAPNM) which is an association of health professionals.

Secondly, Para 124X(3)(b) provides that the Minister must be satisfied that it is in the public interest to have Part VC of the Act apply to the Activities.  In doing so, the Minister must have regard to criteria prescribed by the regulations.  Regulation 23B of the Health Insurance Regulations 1975 (the Regulations) provides that the criteria stated in regulations 23C to 23G (inclusive) are prescribed for the purposes of section 124X(3)(b) of the Act.  The criteria relevant to the Activity at Item 1 are in regulations 23C and 23E of the Regulations.  The criteria relevant to the Activities at item 2 are in regulations 23C, 23F and 23G.  The criteria relevant to the Activities at Item 3 are in regulations 23C and 23F of the Regulations.

The Activity at Item 1 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 and treatment options available.  Non-identifying information will be presented, in the form of a report, to the Australian Society of Plastic Surgeons (ASPS) annual conference and then published on the ASPS web site (www.plasticsurgery.org.au).

• Regulation 23D does not apply as the activity will be engaged in more than one State or Territory.

• The requirements of Regulation 23E apply as the Minister is satisfied that the Activity is of a kind that has not been engaged in Australia before.  As required by Regulation 23E the Declaration is needed to encourage full participation in the Activity by persons who provide health services.  The Declaration will encourage plastic surgeons to provide data about the performance of each implant and insertion procedure along with details relating to the patient by reassuring participants that identifying information provided will be protected from disclosure, including to a court, in accordance with Part VC.

• Regulation 23F does not apply as the activity has not previously been engaged in Australia.  The Australian Society of Plastic Surgeons has previously operated a Breast Implant Registry; however this Activity did not include the analysis and interpretation of the quality of breast implant services and treatment options.

• 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 purposes of determining the health care practitioner’s clinical practicing rights.

The Activity at Item 2 meets the criteria as follows:

• As required by regulation 23C, the Activity includes the disclosure of non-identifying information regarding the factors affecting the quality of vascular surgical procedures.  Non-identifying information regarding compliance with the standards under the activity will be reported by the Melbourne Vascular Surgical Association as part of its annual meetings and published in peer reviewed medical journals.

• Regulation 23D does not apply as the activity will be engaged in more that one State or Territory.

• Regulation 23E does not apply as the activity has previously been engaged in Australia.

• Regulation 23F applies as the Minister is satisfied that the Activity is of a kind that has been engaged in Australia before.  Item 4 is based upon the Melbourne Vascular Surgical Association Audit which was declared as a Quality Assurance Activity under the Section 139 of the Victorian Health Services Act 1988.  The Declaration is needed to ensure that the Activity encourages participation by surgeons undertaking vascular surgery across Australia to a greater extent than previously.  Declaration of the activity under the Commonwealth legislation will encourage participation by non-Victorian vascular surgeons who were previously not covered by the State legislation. Knowing that the colleagues Australia Wide will be participating in the future will reassure Victorian surgeons who have previously been reluctant to provide data relating to private patients.  

• Regulation 23G applies as the activity does include the assessment or evaluation by a person of the services, skill or performance of a health practitioner for the purposes of determining the health care practitioner’s practicing rights and the making of findings on material questions of fact and law.  As required by Regulation 23G the Activity provides the vascular surgeon involved with reasons for the findings and allows them to appeal these findings through the Melbourne Vascular Surgical Association appeals process.  The Activity further provides for the disclosure of information about the vascular surgeon and his/her clinical practising rights to the President of the Australian and New Zealand Society of Vascular Surgeons.

The Activity at Item 3 meets the criteria as follows:

• As required by regulation 23C, the Activity includes the disclosure of non-identifying information regarding the quality of services assessed, evaluated or studied.  Non-identifying information regarding physician performance will be reported to the Royal Australasian College of Physicians Continuing Professional Development Committee each trimester and levels of participation will be reported to Fellows during the annual Royal Australasian College of Physicians conference.

• Regulation 23D does not apply as the activity will be engaged in more that one State or Territory.

• Regulation 23E does not apply as the activity has previously been engaged in Australia.

• As required by Regulation 23F, the Minister is satisfied that the Activity is of a kind that has been engaged in Australia before.  Item 4 is based entirely upon the Royal Australasian College of Physicians (RACP) Maintenance of Professional Standards Program (MOPS)  which was declared as a Quality Assurance Activity under the Act on 23 Feb 2000 by the then Minister for Health and Aged Care, Dr Michael Wooldridge. The Declaration is needed to make the Activity effective by encouraging participation by persons who provide health services to a greater extent than the previous activity.  The declaration will encourage physicians who have not yet undertaken the activity, as well as new practices opening in the future, to participate in the program by reassuring participants that individual identifying details are protected from disclosure.

• 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 purposes of determining the health care practitioner’s practicing rights.

The Activity at Item 4 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 or the factors affecting the quality of the service.  The persons engaged in the Activity will publicly disclose non-identifying information detailing the total number of applications for nuclear medicine practice site accreditation, including numbers of successful and unsuccessful applications. In addition, non-identifying information will be provided to the Royal Australasian College of Physicians and the Royal Australian and New Zealand College of Radiologists.  This information will also be provided to the Minister for Health and Ageing.

• Regulation 23D does not apply as the activity will be engaged in more that one State or Territory.

• Regulation 23E does not apply as the activity has previously been engaged in Australia.

• Regulation 23F applies as the Minister is satisfied that the Activity is of a kind that has been engaged in Australia before.  Item 3 is based entirely upon the Australian and New Zealand Association in Nuclear Medicine – Practice Accreditation Program which was declared as a Quality Assurance Activity under the Act on 6 June 2001 by the then Minister for Health and Aged Care, Dr Michael Wooldridge. The Declaration is needed to make the Activity effective by encouraging participation by persons who provide health services to a greater extent than the previous activity.  The Practice Accreditation Program is a voluntary program of quality assurance and risk management, and as such, a declaration will encourage those existing practices that have not yet applied for accreditation, as well as new practices opening in the future, to apply for accreditation by reassuring participants that individual identifying details are protected from disclosure.

• 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 purposes of determining the health care practitioner’s practicing rights.