Medicare Australia allocates a category to an APL in accordance with the Health Insurance (Accredited Pathology Laboratories – Approval) Principles 2002 (the APL Principles). The current APL Principles, a Ministerial Determination made under section 23DNA of the Act, is provided at Attachment B.

The APL Principles define and describe five categories of APL for Medicare Benefits Scheme (MBS) billing purposes – categories GX, GY, B, S and M – including the skills and experience required to undertake clinical supervision duties within those laboratories. The categories differ in terms of the scope of services they offer and the referred patient population for whom they perform testing. The allocation of category governs the types of pathology testing for which each laboratory is accredited to bill against under the MBS.

For the laboratory categorisation process, Medicare Australia relies upon an assessment undertaken by the National Association of Testing Authorities Australia (NATA) of the laboratory’s capacity to safely undertake the range of testing for which it intends to provide services. To ensure that the laboratory will be able to meet the accreditation requirements associated with supervision of pathology testing, as set out in the APL Principles, NATA review includes an advisory visit, which includes a desktop review of the qualifications and experience of the nominated supervising pathologist. The review process occurs prior to access to MBS billing and then routinely at least every three years, according to the scheduled accreditation assessment undertaken by NATA. Laboratories are also required to inform NATA and Medicare Australia if a change to supervision arrangements is proposed, prompting an additional review of the skills and experience of the proposed supervisor.

For supervision purposes in categories GX, GY and B laboratories, where a broad and/or complex range of services may be provided, NATA and Medicare Australia currently require evidence of specialist qualifications in pathology along with the specified additional expertise and experience that are required for the purposes of supervising these categories of laboratories, as required by the National Pathology Accreditation Advisory Council (NPAAC) Requirements for Supervision of Pathology Laboratories 2007. These requirements currently state that these laboratories must be “under the direction, control and full-time supervision of a supervising pathologist, or senior scientist, who is expert in the group, or groups, concerned”. Pathologists are defined as those specialist pathologists who are recognised by Medicare Australia under the definitions and operation of the Act. Senior scientists are defined as those who have had “not less than 10 years full-time relevant laboratory experience and who possesses one of (a number of specified, relevant higher qualifications)”.

In the case of categories M and S laboratories, where the relevant pathology skills and experience are not clearly defined for supervision purposes, NATA currently undertakes a case-by-case assessment of the proposed supervising clinician’s skills and experience and usually seeks advice from the specialist professional groups relevant to the proposed scope of testing. This would normally include the Royal College of Pathologists of Australasia (RCPA) but may also include other relevant bodies such as the Royal Australian College of General Practice and the Fertility Society of Australia.