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. 1/2004
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 to apply to an activity, the Minister must make a Declaration.
This Declaration amends a previous declaration QAA No. 2/1999 and applies Part VC of the Act to the Australia and New Zealand Heart Valve Registry (the Registry) (Item 1). The Declaration is a disallowable instrument for the purposes of section 46A of the Acts Interpretation Act 1901.
An activity very similar to the Activity at Item 1 had previously been declared by the then Minister for Health and Ageing under Declaration QAA No. 2/1999. Both the original and the modified activities have the same title of Australia and New Zealand Heart Valve Registry. A new component has been added to the Activity.
The purpose of the original activity was to identify, locate and track patients implanted with a Bjork – Shiley Convexo -Concave heart valve (which has been well documented for its mechanical failure) through an independent registry. A class action settlement (the Pfizer-Bowling Class Action Settlement) was reached in 1992 in the USA.
The new component of the activity aims to measure, analyse and report the morbidity and mortality of patients who have had one of these valves removed from their heart.
The amendment to Declaration QAA No. 2/1999 will have the effect of revoking this earlier declaration in regards to the Australia and New Zealand Heart Valve Registry. This will be replaced, from the signing of the new declaration, by the Activity described in the Schedule to Declaration number QAA No.1/2004.
The Activity at Item 1 relates to the quality of health services that would be eligible for payment in respect of Medicare Benefits and Public Hospital Services as required by section 124W(1) of the Act.
Before the Minister can make a declaration, certain requirements must be met.
Firstly, the persons engaged in the activity must be authorised to do so. The authorisation can be by an association of health professionals, by a body that provides health care, by an educational institution or by a body established for the purposes of research [s124X(3)(a) of the Act].
The persons engaged in the Activity are authorised to do so by the Australia and New Zealand Heart Valve Registry (the Registry), Suite G06W, Carillon Avenue, Newtown, NSW 2042, an independent research body.
Secondly, in accordance with section 124X(3)(b) of the Act the Minister has to be satisfied that it is in the public interest to have Part VC of the Act apply to the Activity. In considering public interest, the Minister must have regard to criteria prescribed by the Health Insurance Regulations 1975 (the Regulations). The criteria relevant to the Activity are in Regulations 23C and 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 or the factors affecting the quality of the service, and satisfy the requirement that information is provided at times and in a manner acceptable to the Minister.
- The persons engaged in the Activity will publish non-identifying information in appropriate clinical and scientific journals. This information will also be provided to the Minister for Health and Ageing.
- As required by Regulation 23F, the Minister is satisfied that the Activity is of a kind that has been engaged in previously in Australia. The Activity was previously carried out under Item 2 of Declaration QAA No. 2/1999. A new declaration has been made (and the previous one revoked) because the activity has been expanded as described above. The application of Part VC of the Act is necessary to make the Activity effective by encouraging participation in the Activity by persons who provide health services to a greater extent than the participation, be persons who provide health services, in the previous activity.
A Regulation Impact Statement (RIS) is not necessary for this Declaration 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 13 May 2004 and comes into operation on the date of gazettal. 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. 1/2004