Health Insurance (ALK Gene Testing) Determination 2015

Administered by Department of Health, Disability and Ageing

Legislation au F2015L00799 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

Health Insurance Act 1973

Health Insurance (ALK Gene Testing) Determination 2015

 

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 (ALK Gene Testing) Determination 2015 (the Determination) is to create a new Medicare pathology service, item 73341. Item 73341 is for fluorescence in situ hybridisation (FISH) testing in patients with non-small cell lung cancer (NSCLC) for identification of anaplastic lymphoma kinase (ALK) gene rearrangement to determine eligibility for treatment under the Pharmaceuticals Benefits Scheme (PBS) with crizotinib.  Crizotinib is expected to become available on the PBS from 1 July 2015. 

 

FISH testing for ALK gene rearrangement will assist in guiding the appropriate choice of chemotherapy for patients with NSCLC. Approximately 3% of patients with advanced or metastatic NSCLC which is of non-squamous histology or histology not otherwise specified and with an absence of activating mutations on the epidermal growth factor receptor gene will have an ALK gene rearrangement. While there are multiple treatments for locally advanced or metastatic NSCLC, some of which will be effective in patients with ALK gene rearrangements, crizotinib is the only treatment that specifically targets ALK tyrosine kinase activity.

 

Item 73341 must be requested by a specialist or consultant physician.

 

Consultation

A co-dependent application was resubmitted by Abbott Molecular and Pfizer Australia to the Medical Services Advisory Committee (MSAC) in March 2014 requesting reconsideration of Medicare Benefits Schedule (MBS) listing of FISH testing in patients with advanced or metastatic NSCLC for identification of ALK gene rearrangement to determine eligibility for crizotinib under the Pharmaceutical Benefits Scheme.

 

The application was considered by MSAC in October and November 2014. After considering the strength of the available evidence in relation to the safety, clinical effectiveness and cost-effectiveness of the test, MSAC advised that it supported public funding for this service through the creation of a new MBS item.  

 

The Determination commences on 1 July 2015. 

 

The 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 (ALK Gene Testing) Determination 2015

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 (ALK Gene Testing) Determination 2015 (the Determination) creates a new Medicare pathology service (item 73341) for fluorescence in situ hybridisation (FISH) testing in patients with non-small cell lung cancer for identification of anaplastic lymphoma kinase (ALK) gene rearrangement to determine eligibility for treatment under the Pharmaceutical Benefits Scheme (PBS) with crizotinib.  

 

ALK gene rearrangement testing will assist in guiding the appropriate choice of chemotherapy and determine eligibility for PBS subsidised crizotinib, which is the only treatment that specifically targets ALK tyrosine kinase activity. Approximately 3% of patients with advanced or metastatic non-small cell lung cancer which is of non-squamous histology or histology not otherwise specified and with an absence of activating mutations on the epidermal growth factor receptor gene will have an ALK gene rearrangement.

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 testing to identify ALK gene rearrangement for the purpose of access to crizotinib under the PBS. While there are a number of treatments for locally advanced or metastatic non-small cell lung cancer, crizotinib is the only treatment that specifically targets ALK tyrosine kinase activity.  This supports better health outcomes for patients.

There are no limitations on access to new item 73341 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.

 

Catherine Rule

First Assistant Secretary

Medical Benefits Division

Department of Health

Overview

The Health Insurance (ALK Gene Testing) Determination 2015 was enacted to address a specific gap in the provision of medical services under the Health Insurance Act 1973. This legislative instrument was introduced to facilitate the identification of anaplastic lymphoma kinase (ALK) gene rearrangements in patients with non-small cell lung cancer (NSCLC), thereby determining their eligibility for targeted treatment with crizotinib, which is listed under the Pharmaceutical Benefits Scheme (PBS). The creation of Medicare pathology service item 73341, which pertains to fluorescence in situ hybridisation (FISH) testing, aims to enhance the precision of chemotherapy choices for NSCLC patients and improve overall health outcomes by ensuring access to appropriate and effective treatment. Enacted by the Australian Government, the policy objective of this determination is to uphold the rights to health and social security as recognised under the International Covenant on Economic, Social and Cultural Rights, by providing financial assistance through Medicare for the necessary testing, thus enabling broader access to specialised treatments.

Scope and Application

The Health Insurance (ALK Gene Testing) Determination 2015 applies to the creation of a new Medicare pathology service, item 73341, which pertains to fluorescence in situ hybridisation (FISH) testing for patients with non-small cell lung cancer (NSCLC) to identify anaplastic lymphoma kinase (ALK) gene rearrangement. This determination specifies that this service will be treated as if it were specified in the Pathology Services Table, enabling the provision of Medicare benefits for this test to determine eligibility for treatment with crizotinib under the Pharmaceutical Benefits Scheme (PBS). The application of this Act is limited to individuals who are patients with advanced or metastatic NSCLC of non-squamous histology or histology not otherwise specified, and who lack activating mutations on the epidermal growth factor receptor gene, as these patients are most likely to benefit from the targeted treatment of crizotinib. The Determination applies nationally within the Commonwealth of Australia, as per the legislative framework set forth by the Health Insurance Act 1973. The creation of this new Medicare item is effective from 1 July 2015, and the service must be requested by a specialist or consultant physician. The Determination is a legislative instrument governed by the Legislative Instruments Act 2003, and it ensures compatibility with human rights as declared under the Human Rights (Parliamentary Scrutiny) Act 2011, particularly engaging Articles 2, 9, and 12 of the International Covenant on Economic, Social and Cultural Rights.

Key Provisions

The Health Insurance (ALK Gene Testing) Determination 2015 introduces a new Medicare pathology service, item 73341, for fluorescence in situ hybridisation (FISH) testing in patients with non-small cell lung cancer (NSCLC) to identify anaplastic lymphoma kinase (ALK) gene rearrangement (subsection 3C(1)). This testing will determine eligibility for treatment under the Pharmaceutical Benefits Scheme (PBS) with crizotinib, a treatment that specifically targets ALK tyrosine kinase activity. The new item number 73341 must be requested by a specialist or consultant physician. This Determination is effective from 1 July 2015 and is a legislative instrument under the Legislative Instruments Act 2003. The primary obligation imposed by the Determination is that it mandates the creation of a new Medicare pathology service for ALK gene rearrangement testing in NSCLC patients, which is to be requested by a specialist or consultant physician. This service is intended to aid in the appropriate selection of chemotherapy and to determine eligibility for PBS-subsidised crizotinib, a treatment specific to ALK tyrosine kinase activity. Approximately 3% of patients with advanced or metastatic NSCLC will have an ALK gene rearrangement, and crizotinib is the only treatment that specifically targets this condition. The Determination does not explicitly outline specific offences, penalties, or civil/criminal consequences for breaches of its provisions. However, any failure to comply with the Medicare Benefits Schedule (MBS) and the provisions of the Health Insurance Act 1973 could result in legal consequences, including potential fines or other penalties as stipulated in the Act. The Determination aligns with the human rights to health and social security by facilitating the payment of Commonwealth Medicare benefits to assist private patients with the financial costs associated with receiving the necessary testing.

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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.