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Legislation relating to Pathology

Commonwealth legislation that establishes the regulatory framework for pathology services provided under Medicare.

Legislative Amendments relating to Pathology and Diagnostic Imaging

Changes to Regulations Regarding Pathology Request Forms

In the 2009-10 Budget, the Government announced that it would seek to increase patient choice by removing restrictions on pathology requesting procedures. From 11 December 2010 this restriction was removed, so that, while there is still a legislative requirement for a request for a pathology service to be made, there is no longer be a requirement that the request be made to a particular pathology practitioner. This legislative change allows patients to take a pathology request to an approved pathology practitioner or approved pathology authority of their choice, unless the requesting practitioner specified an approved pathology practitioner for clinical reasons. A late amendment to the legislation added the exception that a request will still have to be taken to a particular pathology practitioner if the requester has clinical grounds for doing so.

A copy of the amendment can be downloaded from the following link:
Health Insurance Amendment (Pathology Requests) Act 2010

Following consultation with stakeholders the next step of the process is for subordinate regulation to be amended to require that pathology request forms include a clear and obviously positioned statement advising that even if a particular provider is identified on the form, the patient is free to choose their own provider.

A letter dated 3 April 2012 providing advice on the proposed changes to the regulations regarding mandatory requirements for pathology request forms, was sent to all approved pathology authorities. Subject to the passage of regulation the proposed wording is to be on pathology forms distributed to requesting practitioners from 1 July 2012 is as follows.

Your doctor has recommended that you use [insert name of pathology provider]. You are free to choose your own pathology provider. However, if your doctor has specified a particular pathologist on clinical grounds, a Medicare rebate will only be payable if that pathologist performs the service. You should discuss this with your doctor.

A copy of the letter is provided below.
Changes to Regulations Regarding Pathology Request Forms (PDF 75 KB)

Due to circumstances beyond the Department's control, the legislative amendments outlined above are not going to commence until 1 August 2012, pending Executive Council approval. This revised commencement date will also apply to the requirement for branded diagnostic imaging request forms to include a statement that informs the patient that the request may be taken to a diagnostic imaging provider of the patient's choice. Any branded diagnostic imaging request forms supplied, or made available to, a requesting practitioner by a diagnostic imaging provider on or after 1 August 2012 will require a patient advisory statement.

Health Insurance (Accredited Pathology Laboratories - Approval) Principles

Under Section 23DNA of the Health Insurance Act 1973 (the Act), the Minister or a delegate may determine principles which outline eligibility for premises to be approved as an accredited pathology laboratory.

The current version of the principles came into effect on 1 July 2006. A copy of this document can be downloaded from the following link:
The Health Insurance (Accredited Pathology Laboratories - Approval) Principles 2002 as amended 1 July 2009
Ministerial Determination on the formal qualifications and experience needed to become an Approved Pathology Practitioner (APP) - Discussion Paper, May 2008

Health Insurance (Eligible Collection Centres) Approval Principles

Subsection 23DNBA(4) of the Health Insurance Act 1973 (the Act) requires the Minister to determine, in writing, principles that apply to the granting of approvals for eligible pathology specimen collection centres. Approved pathology specimen collection centres are known as approved collection centres (ACCs).

On 1 July 2010, new Principles came into effect that revoked and replaced the Health Insurance (Eligible Collection Centres) Approval Principles 2008 to remove the restrictions on the number of approvals of eligible collection centres that may be granted to an approved pathology authority.

Health Insurance (Eligible Collection Centres) Approval Principles 2010