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