Legislation, Regulations and Guidelines
National Association of Testing Authorities
NATA provides assessment, accreditation and training services to laboratories and technical facilities throughout Australia. Approved Pathology Laboratories need to be aware of the services available from NATA which can be accessed at the following address
National Pathology Accreditation Advisory Council (NPAAC)
The National Pathology Accreditation Advisory Council (NPAAC) advises the Commonwealth, state and territory health ministers on matters relating to the accreditation of pathology laboratories. NPAAC plays a key role in ensuring the quality of Australian pathology services and is responsible for the development and maintenance of standards and guidelines for pathology practices. NPAAC is comprised of representatives from all states and territories, nominees from peak professional bodies (including Pathology Australia) and the Department of Health. Further information on NPAAC can be accessed at the following address: Department of Human Services (incorporating Medicare Australia)
Department of Human Services (DHS) has responsibility for a range of issues such as payment of claims, compliance auditing, statistical reporting etc. In addition relevant forms for ACC licences, APA, APL and APP application forms are available from the DHS Medicare website and can be accessed at the following address:
New legislation for pathology request forms
On 10 December 2010, an amendment was made to the Health Insurance Act to enable patients to choose their pathology provider. Instead of the pathology referral being made to an APP “to whom the treating practitioner has made a request for the service”, the referral is defined as applying to any APP “who received a request for the service made by the treating practitioner”. It is therefore a patient’s choice as where the referral is directed. A copy of the Amendment to the Health Insurance Act and related information is available at: http://www.health.gov.au/internet/main/publishing.nsf/Content/health-pathology-leg-index.htm
A subsequent regulation change with effect from 1 August 2012 requires any Pathology Request Form distributed by an APA to contain one of the following statements:
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.
Your treating practitioner has recommended that you use [insert name of pathology provider]. You are free to choose your own pathology provider. However, if your treating practitioner 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 treating practitioner.
New collection centre principles from 1 July 2010
These new Principles were introduced with effect from 1 July 2010. From that date, previous restrictions on the number of new Collection Centres able to be approved each year have been removed. There are now no limits on the number of new Collection Centres which can be approved.
Health Insurance Act 1973
A consolidated version of the Health Insurance Act 1973 incorporating Amendments up to October 2014 is available for inspection
In the 2017–18 Budget, the Government announced its commitment to strengthening compliance for Pathology Approved Collection Centre (ACC) rents under the prohibited practices provisions of the Health Insurance Act 1973.
Rent or other benefits may, in certain circumstances, breach the prohibited practices provisions of the Health Insurance Act 1973. Those provisions prohibit the offer or acceptance of benefits that would be reasonably likely to induce a requester of pathology services to request those services from a provider.
The Department has consulted with stakeholders and has revised the Red Book, providing guidance on the prohibited practices provisions, to ensure it meets contemporary needs.
The revised Red Book provides guidance on how the laws affect both requesters and providers of pathology and diagnostic imaging services, and outlines the Department’s compliance and enforcement strategy. This includes a timeline with examples which demonstrate the compliance activities the Department may undertake to enforce the prohibited practices provisions as they relate to ACCs.