Health Insurance Regulations (Amendment)

Administered by Department of Health, Disability and Ageing

Legislation au F1996B02826 Regulations Not in force Legislative Instrument

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Health Insurance Regulations (Amendment) 1993 No. 106

EXPLANATORY STATEMENT

STATUTORY RULES 1993 No. 106

Issued by authority of the Minister for Health

Health Insurance Act 1973

Health Insurance Regulations (Amendment)

The Health Insurance (Quality Assurance Confidentiality) Amendment Act 1992 commenced operation on 21 December 1992. This Act inserted a new Part VC (sections 106J to 106R) into the Health Insurance Act 1973 ("the Act").

Section 133 of the Act provides that the Governor-General may make regulations for the purposes of the Act.

Section 106L of the Act empowers the Minister to declare a quality assurance activity to be a declared quality assurance activity. Subsection 106L(3) provides that the Minister must not make a declaration unless satisfied as to certain matters. Paragraph 106L(3)(b) requires the Minister to be satisfied that it is in the public interest "having regard to such criteria as are prescribed by the regulations" that Part VC should apply to the relevant quality assurance activity.

A "quality assurance activity" is defined in subsection 106K(1) of the Act. Broadly, it is an assessment or evaluation of the quality, or a study of the incidence or causes of conditions or circumstances that may affect the quality of certain health services. These are services which relate to payments (e.g. Medicare benefits) which have been, or may be made, under Parts II, III or IV of the Act or under Division 3 of Part VII the National Health Act 1953.

Under Part VC, declared quality assurance activities attract the operation of key provisions contained in sections 106M and 106Q of the Act. Section 106M, subject to certain exceptions, prohibits the making a record of, or the disclosure of, information becoming known solely as a result of such an activity. Section 106Q provides for immunity from suit in certain circumstances of persons engaging in good faith in a declared quality assurance activity contained in section 106Q.

The regulations amend the Health Insurance Regulations by the insertion of new regulation 23A, which will provide for applications to the Minister for declarations in respect of quality assurance activities; and the insertion of new regulations 23B-23G, which will prescribe criteria for the purposes of paragraph 106L(3)(b). Further details of the proposed regulations are provided in the Attachment.

The regulations came into effect on the date of their gazettal.

ATTACHMENT

DETAILS OF NEW REGULATIONS INSERTED BY HEALTH INSURANCE REGULATIONS (AMENDMENT) REGULATIONS

REGULATION 23A

(Application for declaration)

For a quality assurance activity to be considered for declaration, the applicant must use the form approved by the Minister. When applying on the approved form, the applicant must undertake to inform the Minister if the following occurs in the course of the quality assurance activity: if there is a change to the purposes of the activity; or if there is any significant change to the body undertaking the activity which may impact on the activity.

REGULATION 23B

(Criteria for declaring a quality assurance activity)

Provides that new regulations 23C to 23G will prescribe criteria for the purposes of paragraph 106L(3)(b) of the Act.

REGULATION 23C

(Disclosure of information)

Regulation 23C(1) provides that for the Minister to be satisfied that it is in the public interest to bring a particular quality assurance activity under the protection of the legislation, the activity must include the disclosure of information about the quality of services assessed or factors affecting the quality of the service in a form that does not allow the identification of a particular individual. This requirement does not apply if the Minister is satisfied on reasonable grounds that it is not appropriate to disclose the information at all. The timing and manner of disclosure of information must be acceptable to the Minister.

REGULATION 23D

(Activities engaged in in one State or Territory)

Regulation 23D is intended to build on the priority given by section 106R of the Act to State or Territory legislation having the same general purpose as the relevant provisions of the Act by limiting declarations of quality assurance activities engaged in in only one State or Territory to activities of broader significance. Accordingly, the Minister must be satisfied on reasonable grounds of at least one of the matters specified. These are to the following effect:

•       the State or Territory government has advised the Minister that the activity is not subject to similar State or Territory legislation and it is in the public interest that the Commonwealth legislation apply;

•       the activity includes a methodology that has not been previously used in Australia;

•       the activity is a pilot study which is investigating whether a particular methodology can be used in Australia;

•       the activity addresses new subject matter;

•       the activity potentially affects the quality of health care nationally or is a pilot study for this; or

•       the activity is of national importance.

REGULATION 23E

(Activities that have not been engaged in previously)

This regulation is intended to ensure that a declaration shall not be made in respect of an activity which would be carried out effectively in the absence of the protection of the legislation.

Regulation 23E would apply where the relevant activity has not been engaged in before in Australia.

The regulation will require the Minister to be satisfied that the application of relevant provisions of the Act is necessary to make the activity effective by encouraging the full participation of persons who provide health services and, as the case requires, the acceptance of recommendations or the participation in monitoring of the implementation of these by such persons.

REGULATION 23P

(Activities that have been engaged in previously)

This regulation will apply where the Minister is satisfied on reasonable grounds that an activity of the kind to that proposed has been engaged in previously in Australia. The intention, as with regulation 23E is to ensure that the protection of the relevant provisions of the Act is reserved to cases where their application is necessary to make the activity effective. Accordingly the regulation will provide that the Minister must be satisfied on reasonable grounds that the protection of the Act is necessary to make the activity effective by relevantly encouraging as specified the participation of health service providers to a greater extent than under the earlier activity.

REGULATION 23G

(Review procedures)

This regulation is intended to provide for procedural fairness where a quality assurance activity involves the assessment or evaluation of the services, skill or performance of a health care practitioner for the purposes of determining the practitioner's clinical practising rights and relevant findings on material questions of fact or law. The regulation defines "clinical practising rights" in terms of the practitioner's right relevantly to practise a particular profession or use particular skills or to relevantly hold himself or herself out as being certified by an association of health professionals. This assessment or evaluation is sometimes referred to as "credentialling".

The effect of the regulation will be to require the Minister to be satisfied that the purposes of this kind of activity include the giving of reasons for findings with which a health practitioner is dissatisfied; the entitlement of a practitioner to appeal against an adverse finding to another person or body; and the disclosure of information about the health care practitioner's clinical practising rights which identifies him or her.

 

Overview

The Health Insurance Regulations (Amendment) 1993 No. 106 were enacted to provide supplementary regulations under the Health Insurance Act 1973, specifically addressing quality assurance activities within the health care sector. These regulations were introduced to clarify and expand upon the provisions of the Health Insurance (Quality Assurance Confidentiality) Amendment Act 1992, which aimed to protect the confidentiality of information obtained during quality assurance activities and to ensure the integrity and effectiveness of these activities. Enacted by the Parliament of Australia, the regulations were issued by authority of the Minister for Health, ensuring that the amendments align with the broader policy objectives of maintaining high standards of health care quality and confidentiality. The key policy objective of these regulations is to provide a clear framework for the declaration and conduct of quality assurance activities, ensuring that such activities are conducted effectively and with the necessary protections in place. This includes setting out the criteria for the declaration of quality assurance activities, the conditions under which such activities can be disclosed, and the procedural fairness required in the assessment of health care practitioners. The regulations aim to strike a balance between the need for quality assurance in health services and the protection of privacy and confidentiality, thereby supporting the overall goal of improving the quality of health care in Australia.

Scope and Application

The Health Insurance Regulations (Amendment) 1993 No. 106 applies to quality assurance activities within the health services industry in Australia, which encompass assessments or evaluations of the quality of health services or studies of the incidence or causes of conditions affecting these services. These activities may involve the disclosure of information related to the quality of health services, and the regulations govern the conditions under which such information can be disclosed. The Act applies to any entity or individual conducting such activities within Australia, particularly those involving payments under the Health Insurance Act 1973 or the National Health Act 1953. The regulations introduced by this amendment provide specific criteria that the Minister for Health must consider when deciding whether a quality assurance activity should be declared, including the need for information disclosure, the geographical scope of the activity, and whether the activity has been previously undertaken in Australia. The Act extends its application through subordinate instruments, particularly the new regulations 23A to 23G, which detail the application process, criteria for declaration, and procedural fairness requirements for certain activities. The regulations came into effect on the date of their gazettal.

Key Provisions

The Health Insurance Regulations (Amendment) 1993 No. 106, issued under the authority of the Minister for Health, amends the Health Insurance Regulations to incorporate the provisions of the Health Insurance (Quality Assurance Confidentiality) Amendment Act 1992. This Act, which came into operation on 21 December 1992, introduces new sections (106J to 106R) into the Health Insurance Act 1973, establishing a framework for quality assurance activities. The primary focus of these amendments is to protect the confidentiality of information obtained during quality assurance activities, which are defined broadly as assessments or evaluations of the quality of certain health services or studies of conditions affecting the quality of such services (section 106K(1)). Section 106M of the Act, subject to exceptions, prohibits the recording or disclosure of information gained solely from a declared quality assurance activity, ensuring that such information remains confidential unless otherwise permitted. Section 106Q provides immunity from legal action for individuals engaging in good faith in a declared quality assurance activity. The new regulations, particularly regulation 23A, detail the application process for declaring a quality assurance activity, requiring the use of an approved form and notifying the Minister of any changes in the activity or the body conducting it. The new regulations also specify criteria for the Minister's consideration, including the necessity of the activity for the public interest and the protection of confidentiality (regulations 23C to 23G). The Health Insurance Regulations (Amendment) 1993 No. 106 imposes several obligations on parties involved in quality assurance activities. The Minister must be satisfied that any declared activity meets the criteria set forth in the regulations, such as the public interest and the effectiveness of the activity (regulations 23C to 23G). For instance, if a quality assurance activity involves the disclosure of information, it must be done in a way that does not identify individuals, unless the Minister is satisfied that disclosure is not appropriate (regulation 23C). Similarly, activities conducted within a single state or territory must demonstrate broader significance to warrant a declaration (regulation 23D). These requirements ensure that only activities deemed necessary and beneficial for public health are protected under the Act. The amendments also establish consequences for non-compliance with the regulations. While specific offences and penalties are not detailed in the text, the Health Insurance Act 1973 generally allows for penalties for breaches of its provisions. For example, unauthorised disclosures of confidential information could lead to civil or criminal penalties. The Health Insurance Regulations (Amendment) 1993 No. 106 ensures that the Minister’s authority to declare quality assurance activities is exercised judiciously, maintaining the confidentiality and integrity of the health services assessment processes.

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