Health Insurance (Pharmacogenetic Testing - Epidermal Growth Factor Receptor) Revocation Determination 2014

Administered by Department of Health, Disability and Ageing

Legislation au F2014L01438 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

Issued by the Authority of the Minister for Health

 

Health Insurance Act 1973

 

Health Insurance (Pharmacogenetic Testing - Epidermal Growth Factor Receptor) Revocation 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 2014 (the Regulation), which is re-made each year.

 

The Health Insurance (Pharmacogenetic Testing - Epidermal Growth Factor Receptor) Revocation Determination 2014 revokes the Health Insurance (Pharmacogenetic Testing - Epidermal Growth Factor Receptor) Determination 2013 as item number 73337, which is currently listed in the 2013 Determination, has been added to the Regulation to commence on 1 November 2014.

 

Consultation

No consultation was undertaken in the making of this Determination as the instrument is machinery in nature and does not alter existing arrangements.

 

Details of the Determination are set out in the Attachment.

 

The Act specifies no conditions which need to be met before the power to make the Determination may be exercised.

 

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

 

This Determination commences on 1 November 2014.   


ATTACHMENT

 

DETAILS OF THE HEALTH INSURANCE (PHARMACOGENETIC TESTING - EPIDERMAL GROWTH FACTOR RECEPTOR) REVOCATION DETERMINATION 2014

 

 

Section 1  Name of Determination

 

Section 1 provides that the name of the Determination is the Health Insurance (Pharmacogenetic Testing Epidermal Growth Factor Receptor) Revocation Determination 2014.

 

Section 2  Commencement

 

Section 2 provides that the Determination commences on 1 November 2014.

 

Section 3  Revocation

 

Section 3 provides that the Determination revokes the Health Insurance (Pharmacogenetic Testing - Epidermal Growth Factor Receptor) Determination 2013.


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) Revocation 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

Medicare Benefits Schedule (MBS) item 73337 is for the payment of benefits for testing of tumour tissue from a patient with non-small cell lung cancer to determine if the patient meets the requirements relating to Epidermal Growth Factor Receptor (EGFR) gene mutation status for access to erlotinib or gefitinib under the Pharmaceutical Benefits Scheme (PBS). Medicare benefit item 73337 was included in Health Insurance (Pharmacogenetic Testing – Epidermal Growth Factor Receptor) Determination 2013 as part of the MBS. Item 73337 is now included in the Health Insurance (Pathology Services Table) Regulation 2014. There is no change to the payment of benefits for item 73337.

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 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.

 

Kirsty Faichney

Acting First Assistant Secretary

Medical Benefits Division

Department of Health

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Overview

The Health Insurance (Pharmacogenetic Testing – Epidermal Growth Factor Receptor) Revocation Determination 2014 was enacted to address the gap in the Medicare Benefits Schedule (MBS) regarding the payment of benefits for testing of tumour tissue from patients with non-small cell lung cancer to determine Epidermal Growth Factor Receptor (EGFR) gene mutation status for access to certain medications under the Pharmaceutical Benefits Scheme (PBS). This determination was introduced by the Minister for Health and revokes the previous Health Insurance (Pharmacogenetic Testing - Epidermal Growth Factor Receptor) Determination 2013 as the relevant item (73337) has been included in the Pathology Services Table. The objective of this revocation is to ensure that the payment of benefits for this specific medical service is covered under the updated Regulation, without any changes to the benefits provided. This revocation determination commenced on 1 November 2014.

Scope and Application

The Health Insurance (Pharmacogenetic Testing – Epidermal Growth Factor Receptor) Revocation Determination 2014 applies to persons covered under the Health Insurance Act 1973, specifically those who may be eligible for Medicare benefits. It concerns the revocation of a previous determination that specified the provision of certain pharmacogenetic testing services, namely the testing of tumour tissue from patients with non-small cell lung cancer to determine eligibility for access to specific medications under the Pharmaceutical Benefits Scheme. The revocation occurs because the service in question, now listed as item number 73337, has been incorporated into the Health Insurance (Pathology Services Table) Regulation 2014, which is updated annually. The Determination operates on a Commonwealth level, as it relates to Medicare, a national health scheme. There are no exclusions or thresholds specified within the Determination itself, although the underlying Act and Regulation may impose conditions on eligibility and access to benefits. The scope of the Determination is confined to the specified revocation and does not extend to other areas of health insurance or genetic testing.

Key Provisions

The Health Insurance (Pharmacogenetic Testing – Epidermal Growth Factor Receptor) Revocation Determination 2014 (sections 1-3) revokes the previous Health Insurance (Pharmacogenetic Testing – Epidermal Growth Factor Receptor) Determination 2013. This revocation occurs because the relevant Medicare benefit item, 73337, has been incorporated into the Health Insurance (Pathology Services Table) Regulation 2014, which is updated annually. The Determination commences on 1 November 2014 and does not require any specific conditions to be met before it can be exercised, as per subsection 3C(1) of the Health Insurance Act 1973. The Determination aims to ensure that the payment of benefits for item 73337, which is used for testing tumour tissue from patients with non-small cell lung cancer to determine EGFR gene mutation status for access to specific drugs under the Pharmaceutical Benefits Scheme, remains unchanged despite the revocation of the previous Determination. The Act imposes obligations on parties and entities it governs by ensuring that the revocation does not disrupt the existing arrangements for the payment of benefits under the Medicare Benefits Schedule. It mandates that the incorporation of item 73337 into the Pathology Services Table Regulation does not affect the provision of these benefits. This is achieved by ensuring that the revocation aligns with the annual updates to the Regulation, maintaining continuity in the provision of these essential healthcare services. The Act also ensures that the revocation does not limit access to these services based on discriminatory factors such as sex, age, or race, thereby upholding the principles of equality and non-discrimination. There are no specific offences, penalties, or civil/criminal consequences outlined for breach of this Determination as it primarily serves to align legislative instruments with the updated Regulation. However, any failure to adhere to the updated Regulation or the Determination could potentially lead to administrative or procedural consequences, such as the denial of Medicare benefits for the specified service. The primary focus of this Determination is to ensure a smooth transition in the provision of these healthcare services without any disruption to patients’ access to necessary medical treatments. The compatibility of this Determination with human rights is affirmed, ensuring that it advances the rights to health and social security by providing continued access to essential healthcare services.

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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.