Health Insurance (Pharmacogenetic Testing - Epidermal Growth Factor Receptor) Determination 2013

Administered by Department of Health, Disability and Ageing

Legislation au F2013L02131 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

Health Insurance Act 1973

Health Insurance (Pharmacogenetic Testing – Epidermal Growth Factor Receptor) Determination 2013

 

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 – Epidermal Growth Factor Receptor) Determination 2013 (the Determination) is to create a new Medicare pathology service, item 73337.   This item allows for the testing of tumour tissue from a patient diagnosed with non-small lung cancer, shown to have non-squamous histology in order to determine if the patient meets the requirements relating to epidermal growth factor receptor (EGFR) gene status for access to erlotinib or gefitinib under the Pharmaceutical Benefits Scheme (PBS).

 

Testing tumours in patients for EGFR will assist in identifying a population for whom treatment with erlotinib or gefitinib is appropriate. 

 

The item descriptor for item 73337 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 73337 occurred in mid 2011as 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 January 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 (Pharmacogenetic Testing – Epidermal Growth Factor Receptor) Determination 2013

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 – Epidermal Growth Factor Receptor) Determination 2013 (the Determination) creates a new Medicare pathology item 73337 for the testing of tumour tissue from a patient diagnosed with non-small lung cancer, shown to have non-squamous histology in order to determine if the patient meets the requirements relating to epidermal growth factor receptor (EGFR) gene status for access to erlotinib or gefitinib under the Pharmaceutical Benefits Scheme (PBS).

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 73337 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 (Pharmacogenetic Testing – Epidermal Growth Factor Receptor) Determination 2013 was enacted to address a gap in the existing health services available under the Health Insurance Act 1973. The primary objective of this legislation is to introduce a new Medicare pathology service, specifically item 73337, which facilitates the testing of tumour tissue from patients diagnosed with non-small cell lung cancer, particularly those with non-squamous histology. This testing is crucial for determining the epidermal growth factor receptor (EGFR) gene status, which in turn affects eligibility for treatment with erlotinib or gefitinib under the Pharmaceutical Benefits Scheme (PBS). By creating this new Medicare item, the Determination aims to enhance patient access to targeted cancer treatments, thereby improving health outcomes. The determination was made by the Minister for Health, in accordance with subsection 3C(1) of the Health Insurance Act 1973, and it aligns with the policy objective of providing equitable access to essential medical services.

Scope and Application

The Health Insurance (Pharmacogenetic Testing – Epidermal Growth Factor Receptor) Determination 2013 applies to individuals diagnosed with non-small cell lung cancer exhibiting non-squamous histology, where there is a need to determine the epidermal growth factor receptor (EGFR) gene status to assess eligibility for treatment with erlotinib or gefitinib under the Pharmaceutical Benefits Scheme (PBS). This Determination, which came into effect on 1 January 2014, introduces a new Medicare pathology service item 73337. The service must be requested by a specialist or consultant physician, ensuring that only qualified medical professionals can order this test. The Determination operates on a national level, consistent with the provisions of the Health Insurance Act 1973, and it does not specify any exclusions or exemptions apart from the requirement that the service pertains only to patients with the specified cancer type and histological characteristics. Any further details or modifications to the application of this Determination may be established through subordinate instruments issued under the authority of the Act.

Key Provisions

The Health Insurance (Pharmacogenetic Testing – Epidermal Growth Factor Receptor) Determination 2013 (subsection 3C(1) of the Health Insurance Act 1973) introduces a new Medicare pathology service item, item 73337, for the testing of tumour tissue in patients diagnosed with non-small lung cancer and non-squamous histology. This test is essential to determine if the patient qualifies for epidermal growth factor receptor (EGFR) gene status, which is a prerequisite for access to erlotinib or gefitinib under the Pharmaceutical Benefits Scheme (PBS). The test is requested by a specialist or consultant physician, and the results help in identifying patients for whom treatment with erlotinib or gefitinib is appropriate. This Act imposes specific obligations on parties involved in the provision and use of the new pathology service. Firstly, it mandates that the test must be performed by qualified medical professionals, specifically specialists or consultant physicians. Additionally, healthcare providers must adhere to the requirements and guidelines set forth by the Medical Services Advisory Committee (MSAC) and ensure that the testing process aligns with the criteria established by the Act. Furthermore, the Act stipulates that the service must be provided in accordance with the terms and conditions outlined in the Health Insurance (Pathology Services Table) Regulation, ensuring consistency and quality in the delivery of the service. The Determination also outlines the penalties and consequences for non-compliance with the provisions of the Act. Although the specific penalties are not detailed in the provided text, it is clear that any breach of the requirements could lead to legal and financial repercussions. Given the legislative nature of the instrument, breaches may result in civil or criminal penalties, depending on the severity and intent of the violation. For instance, healthcare providers who fail to comply with the stipulated guidelines or engage in fraudulent practices could face fines, sanctions, or other legal actions. The Determination ensures that the integrity and effectiveness of the new pathology service are maintained, thereby safeguarding the interests of patients and the healthcare system as a whole. In summary, the Health Insurance (Pharmacogenetic Testing – Epidermal Growth Factor Receptor) Determination 2013 establishes a new Medicare pathology service to facilitate the testing of tumour tissue in specific patients. It imposes obligations on medical professionals to adhere to the guidelines set by MSAC and the Act, ensuring the quality and appropriateness of the service. The Determination also underscores the potential legal consequences for non-compliance, reinforcing the importance of adhering to the provisions outlined in the Act.

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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.