Under the Health Insurance Act 1973 (the Act), with the exception of certain prescribed pathology services, a Medicare benefit is payable for a pathology service only if it is performed at an accredited pathology laboratory (APL) by or on behalf of an approved pathology practitioner (APP). The intent of this approved provider arrangement is to ensure that patients receive pathology services that are conducted by medical practitioners who have the necessary skills. All APPs are required to apply for this status annually and, as part of the application and approval process, are also required to sign a set of undertakings with Medicare Australia that sets out their responsibilities in that role. The current undertakings are at Attachment A.

In the version of the Act that was in place until 29 February 2008, although the Minister is required to consider an APP applicant’s formal qualifications and experience as well as his or her general fitness for the role (as a “fit and proper person”), the necessary qualifications and experience were not clearly defined beyond requiring an APP to be a medical practitioner. Amendments to the Act, which took effect on 1 March 2008, have given the Minister for Health and Ageing the power to determine the formal qualifications and experience that are needed to become an APP. These amendments are designed to provide the opportunity to remedy a current lack of clarity on what constitutes appropriate competencies for performance as an APP. This is intended to form one of the key assurances available to the Australian public that pathology testing will be conducted safely.

The change to the Act provides for the first time a specific mechanism for clearly defining the Government’s policy intention that APPs should hold the relevant expertise to ensure safe patient care associated with the pathology testing for which they are responsible, by specifying the formal qualifications and experience that should be held by applicants for APP status. The detail will be set out in a Ministerial Determination, which is a legislative instrument that is tabled in Parliament. This legislative instrument will provide the basis for decision-making by Medicare Australia, as the Minister’s delegate, and guidelines will be developed to support this decision-making process.

This discussion paper proposes that the formal qualifications and experience required to become an APP will vary according to the scope of testing for which each APP applicant applies. This scope of testing indicates the APP applicant’s proposed scope of practice in relation to Medicare billing for pathology services. The scope of testing would also be linked to the category of laboratory in which the applicant intends to practise, as per the existing pathology accreditation assessment framework.