Health Insurance (Pharmacogenetic Testing) Determination 2013 (No. 1)

Administered by Department of Health, Disability and Ageing

Legislation au F2013L02018 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

Health Insurance Act 1973

Health Insurance (Pharmacogenetic Testing) Determination 2013 (No. 1)

 

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 (Pharmacogenetic Testing) Determination 2013 (No. 1) (the Determination) is to create a new Medicare pathology service, item 73336.   This item is for the test of tumour tissue from a patient with unresectable stage III or stage IV metastatic cutaneous melanoma, in order to determine if the patient meets the requirements relating to BRAF V600 gene mutation status for access under the Pharmaceutical Benefits Scheme (PBS) to the drug dabrafenib. 

 

Testing tumours in melanoma patients for a BRAF V600 mutation will assist in identifying a population for whom treatment with dabrafenib is likely to be most effective. 

 

The item descriptor for item 73336 provides it must be requested by a specialist or consultant physician. 

 

Consultation

Public consultation about the potential Medicare listing of the service described in item 73336 occurred in early 2012 as part of the Medical Services Advisory Committee review (MSAC) process.  MSAC provides advice to the Australian Government on evidence relating to the safety, effectiveness and cost-effectiveness of new medical technology and procedures.  MSAC recommended that public funding be supported for this service.   

The Determination commences on 1 December 2013. 

 

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 (Pharmacogenetic Testing) Determination 2013 (No. 1)

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 (Pharmacogenetic Testing) Determination 2013 (No. 1) (the Determination) creates a new Medicare pathology item 73336 for the test of tumour tissue from a patient with unresectable stage III or stage IV metastatic cutaneous melanoma, in order to determine if the patient meets the requirements relating to BRAF V600 gene mutation status for access under the Pharmaceutical Benefits Scheme (PBS) to the drug dabrafenib. 

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 this clinically relevant medical service.  There are no limitations on access to new item 73336 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.

 

Richard Bartlett

First Assistant Secretary

Medical Benefits Division

Department of Health

 

Overview

The Health Insurance Act 1973 was enacted to establish a national scheme for the provision of health insurance, aiming to provide Australians with affordable access to health services. The Act allows the Minister for Health to determine that certain health services, not explicitly listed in the Pathology Services Table, should be covered under Medicare. The Health Insurance (Pharmacogenetic Testing) Determination 2013 (No. 1) was introduced to address a gap in the provision of pharmacogenetic testing for patients with specific genetic mutations that can affect the effectiveness of certain medications. This determination created a new Medicare pathology service, item 73336, for testing tumour tissue in patients with unresectable stage III or stage IV metastatic cutaneous melanoma to determine their eligibility for treatment with the drug dabrafenib under the Pharmaceutical Benefits Scheme. The determination was made following recommendations from the Medical Services Advisory Committee and aims to enhance patient access to targeted therapies by ensuring that pharmacogenetic testing is available and funded under Medicare.

Scope and Application

The Health Insurance (Pharmacogenetic Testing) Determination 2013 (No. 1) applies to patients with unresectable stage III or stage IV metastatic cutaneous melanoma who require BRAF V600 gene mutation status testing to determine their eligibility for access to the drug dabrafenib under the Pharmaceutical Benefits Scheme (PBS). The Determination creates a new Medicare pathology item, 73336, for this purpose and specifies that the test must be requested by a specialist or consultant physician. This legislative instrument operates within the Commonwealth jurisdiction, governed by the Health Insurance Act 1973, and is effective from 1 December 2013. The Determination extends the application of the Act through the creation of a new item in the Pathology Services Table, which is detailed in the Health Insurance (Pathology Services Table) Regulation. There are no exclusions or exemptions specified in the Determination, but the access to the new Medicare pathology service is contingent upon the patient meeting the criteria of having unresectable stage III or stage IV metastatic cutaneous melanoma and requiring BRAF V600 gene mutation status testing.

Key Provisions

The Health Insurance (Pharmacogenetic Testing) Determination 2013 (No. 1) introduces a new Medicare pathology service, item 73336 (section 3C(1)). This item pertains to the testing of tumour tissue from patients diagnosed with unresectable stage III or stage IV metastatic cutaneous melanoma. The primary objective is to determine if these patients meet the criteria for BRAF V600 gene mutation status, which is essential for eligibility to receive the drug dabrafenib under the Pharmaceutical Benefits Scheme (PBS). This test is critical in identifying a patient population for whom treatment with dabrafenib is likely to be most effective. The service must be requested by a specialist or consultant physician (item descriptor). Public consultation on this potential Medicare listing took place in early 2012, and the Medical Services Advisory Committee (MSAC) recommended supporting public funding for this service. The Determination officially took effect on 1 December 2013. The Determination imposes specific obligations on the parties involved, primarily the requirement that the test be requested by a specialist or consultant physician. This ensures that the service is provided by appropriately qualified medical professionals who can accurately interpret and request the necessary testing. Additionally, the Determination mandates that the test be conducted under specified circumstances, ensuring it is applied correctly within the Medicare framework. The Determination also sets out the parameters for the financial benefits associated with the service, which are intended to alleviate the financial burden on patients undergoing this necessary medical procedure. There are no specific offences or penalties outlined in the Determination itself. However, any breaches of the Medicare guidelines or misrepresentations regarding the eligibility for the service could potentially lead to legal consequences under other sections of the Health Insurance Act 1973. Such breaches could result in financial penalties or other sanctions as prescribed by the relevant legislative provisions. The Determination does not specify maximum penalties but implies that adherence to the outlined procedures and requirements is crucial to avoid any negative repercussions under the broader legislative framework.

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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.