Health Insurance (RET Gene Testing) Determination 2014

Administered by Department of Health, Disability and Ageing

Legislation au F2014L01443 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

Health Insurance Act 1973

Health Insurance (RET Gene Testing) Determination 2014

 

Subsection 3C(1) of the Health Insurance Act 1973 (the Act) provides that the Minister may determine in writing that a health service not specified in an item in the Pathology Services Table (the Table) shall, in specified circumstances and for specified statutory provisions, be treated as if it were so specified.  The Table is set out in the Health Insurance (Pathology Services Table) Regulation (the Regulation), which is re-made each year.

 

The purpose of the Health Insurance (RET Gene Testing) Determination 2014 (the Determination) is to create two new Medicare pathology services, items 73339 and 73340.  The item 73339 is for the detection of germline mutations in the RET gene in patients with a suspected clinical diagnosis of multiple endocrine neoplasia type 2 (MEN2) and item 73340 is for the detection of a known mutation in the RET gene in an asymptomatic relative of a patient with a documented pathogenic germline RET mutation.

 

RET mutation testing allows the targeted use of lifelong surveillance in patients and family members who have a definitive diagnosis of MEN2 or RET mutation, or the avoidance of this requirement in those patients and family members without a RET mutation; and appropriate treatment with prophylactic total thyroidectomy in family members with a confirmed RET mutation.  Early detection of the disease leads to lower risk of adverse events with prophylactic surgery than when patients are treated at a later disease stage.

 

These two items must be requested by a specialist or consultant physician in order to ensure adequate genetic counselling is provided.

 

Consultation

RET mutation testing, and the associated genetic counselling, of patients suspected of having multiple endocrine neoplasia type II (MEN2) and their close family members is currently standard clinical practice offered in state and territory hospitals and private facilities.  An application for public funding for RET gene test was received in October 2010.  This application was sponsored by the Royal College of Pathologists of Australasia (RCPA) and considered by the Medical Services Advisory Committee (MSAC) in August 2013.

After considering the evidence relating to the safety, effectiveness and cost-effectiveness, MSAC made a recommendation to the Australian Government to publicly fund these services.

   

The Determination commences on 1 November 2014. 

 

This Determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

 


Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

Health Insurance (RET Gene Testing) Determination 2014

This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the
Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the Legislative Instrument

The Health Insurance (RET Gene Testing) Determination 2014 (the Determination) creates two new Medicare pathology services (items 73339 and 73340) for the detection of germline mutations in the RET gene in patients with a suspected clinical diagnosis of multiple endocrine neoplasia type 2 (MEN2) or in an asymptomatic relative of a patient with a documented pathogenic germline RET mutation.

 

Human rights implications

This Determination engages Articles 2, 9 and 12 and of the International Covenant on Economic, Social and Cultural Rights (ICESCR), specifically the rights to health and social security. 

The right to health – the right to the enjoyment of the highest attainable standard of physical and mental health – is contained in article 12(1) of the ICESCR.  The UN Committee on Economic Social and Cultural Rights (the Committee) has stated that the right to health is not a right for each individual to be healthy, but is a right to a system of health protection which provides equality of opportunity for people to enjoy the highest attainable level of health. 

The Committee has also stated that the ‘highest attainable standard of health’ takes into account the country’s available resources.  The right may be understood as a right of access to a variety of public health and health care facilities, goods, services, programs and conditions necessary for the realization of the highest attainable standard of health.

The right to social security is contained in article 9 of the ICESCR.  It requires that a country must, within its maximum available resources, ensure access to a social security scheme that provides a minimum essential level of benefits to all individuals and families that will enable them to acquire at least essential health care.  Countries are obliged to demonstrate that every effort has been made to use all resources that are at their disposal in an effort to satisfy, as a matter of priority, this minimum obligation.

 

 

 

Analysis

The Determination will advance the human rights to health and social security by enabling the payment of Commonwealth Medicare benefit to assist private patients with financial costs associated with receiving these clinically relevant medical services.  There are no limitations on access to new items 73339 and 73340 based on grounds such as the sex, age or race of the patient. 

Conclusion

This Determination is compatible with the human rights recognised in the Human Rights (Parliamentary Scrutiny) Act 2011.

 

Kirsty Faichney

Acting First Assistant Secretary

Medical Benefits Division

Department of Health

 

Overview

The Health Insurance (RET Gene Testing) Determination 2014 was enacted to address the gap in Medicare coverage for RET gene testing, which is essential for diagnosing and managing multiple endocrine neoplasia type 2 (MEN2). This determination, introduced under subsection 3C(1) of the Health Insurance Act 1973, facilitates the inclusion of two new Medicare pathology services, items 73339 and 73340, to cover the detection of germline mutations in the RET gene. This was achieved following a recommendation by the Medical Services Advisory Committee (MSAC) based on evidence of the testing's safety, effectiveness, and cost-effectiveness. By ensuring these services are covered under Medicare, the Determination aims to support early detection and management of MEN2, thereby improving patient outcomes and reducing the risk of adverse events. The Determination was enacted by the Commonwealth of Australia and aligns with the human rights to health and social security as recognised in the International Covenant on Economic, Social and Cultural Rights.

Scope and Application

The Health Insurance (RET Gene Testing) Determination 2014 extends the scope of the Health Insurance Act 1973 by introducing two new Medicare pathology services, items 73339 and 73340, which pertain to the detection of germline mutations in the RET gene for patients with a suspected clinical diagnosis of multiple endocrine neoplasia type 2 (MEN2) and their asymptomatic relatives with a documented pathogenic germline RET mutation. This legislative instrument applies to individuals who require RET gene testing for MEN2 and their close family members and is intended to ensure that such critical genetic testing and the associated genetic counselling are accessible to those in need, thereby facilitating early disease detection and appropriate medical interventions. The Determination operates within the Commonwealth jurisdiction, as it is a legislative instrument under the Legislative Instruments Act 2003, and it does not exclude any specific groups based on sex, age, or race. The new items must be requested by a specialist or consultant physician to ensure that adequate genetic counselling is provided, reflecting the importance of clinical oversight in such specialised testing. This Determination is designed to enhance the rights to health and social security by enabling the provision of Medicare benefits to assist private patients with the financial costs associated with these medically necessary services.

Key Provisions

The Health Insurance (RET Gene Testing) Determination 2014 (section 3C(1) of the Health Insurance Act 1973) establishes two new Medicare pathology services: item 73339, which is for the detection of germline mutations in the RET gene in patients with a suspected clinical diagnosis of multiple endocrine neoplasia type 2 (MEN2); and item 73340, which is for the detection of a known mutation in the RET gene in an asymptomatic relative of a patient with a documented pathogenic germline RET mutation. These services aim to enable early detection of MEN2 through genetic testing, allowing for targeted lifelong surveillance or prophylactic treatment, thereby reducing the risk of adverse events. These items must be requested by a specialist or consultant physician to ensure appropriate genetic counselling is provided. The Determination imposes specific obligations on the parties involved. Firstly, the new pathology services (items 73339 and 73340) are designed to be requested by specialists or consultant physicians, ensuring that patients receive adequate genetic counselling. This requirement underscores the importance of professional oversight in managing the delivery of these services. Secondly, the Determination mandates that these services align with clinical best practices and evidence-based guidelines to ensure their safety, effectiveness, and cost-effectiveness. Failure to comply with the provisions of the Determination may result in civil or criminal consequences, depending on the nature and severity of the breach. While the Determination itself does not explicitly outline specific penalties, breaches of the Health Insurance Act 1973 generally can lead to significant penalties. For example, under section 116 of the Act, a person who contravenes the Act can be fined up to 120 penalty units for individuals and up to 600 penalty units for bodies corporate, reflecting the seriousness with which the law regards non-compliance. Additionally, the Determination's compatibility with human rights, particularly the right to health and social security under the International Covenant on Economic, Social and Cultural Rights, ensures that any failure to provide these services appropriately could be viewed as a breach of these internationally recognised rights. The Determination also ensures compatibility with human rights by providing access to these critical medical services, thereby advancing the rights to health and social security. By enabling the payment of Commonwealth Medicare benefits to assist private patients with the financial costs of these services, the Determination supports equitable access to necessary healthcare. This aligns with the broader obligations under the International Covenant on Economic, Social and Cultural Rights, ensuring that every effort is made to satisfy the minimum essential level of benefits, particularly in health care.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.