Commonwealth Numbered Regulations - Explanatory Statements

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HEALTH INSURANCE REGULATIONS (AMENDMENT) 1993 NO. 106

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.