Health Insurance (Pharmacogenetic Testing) Revocation Determination 2014

Administered by Department of Health, Disability and Ageing

Legislation au F2014L01436 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) 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) Revocation Determination 2014 revokes the Health Insurance (Pharmacogenetic Testing) Determination 2013 (No.1) as item number 73336, 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) REVOCATION DETERMINATION 2014

 

 

Section 1  Name of Determination

 

Section 1 provides that the name of the Determination is the Health Insurance (Pharmacogenetic Testing) 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) Determination 2013 (No.1).


Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

Health Insurance (Pharmacogenetic Testing) 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 73336 is for testing of tumour tissue from a patient with stage III or stage IV metastatic cutaneous melanoma to determine if the patient meets the requirements relating to relating to BRAF V600 mutation status for access to dabrafenib under Pharmaceutical Benefits Scheme (PBS). Medicare benefit item 73336 was included in Health Insurance (Pharmacogenetic Testing) Determination 2013 as part of the MBS. Item 73336 is now included in the Health Insurance (Pathology Services Table) Regulation 2014. There is no change to the payment of benefits for item 73336.

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 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.

 

Kirsty Faichney

Acting First Assistant Secretary

Medical Benefits Division

Department of Health

 

Overview

The Health Insurance (Pharmacogenetic Testing) Revocation Determination 2014 was made under subsection 3C(1) of the Health Insurance Act 1973 to revoke the Health Insurance (Pharmacogenetic Testing) Determination 2013 (No.1) because the relevant pharmacogenetic testing service had been added to the Pathology Services Table in the Health Insurance (Pathology Services Table) Regulation 2014. The Revocation Determination was made by the Minister for Health and commenced on 1 November 2014. The Determination is compatible with the human rights to health and social security recognised in the International Covenant on Economic, Social and Cultural Rights, as it will enable patients with stage III or stage IV metastatic cutaneous melanoma to access pharmacogenetic testing for BRAF V600 mutation status to determine eligibility for dabrafenib under the Pharmaceutical Benefits Scheme, thus ensuring access to essential health care services within the country's available resources.

Scope and Application

The Health Insurance (Pharmacogenetic Testing) Revocation Determination 2014 is a legislative instrument issued under the Health Insurance Act 1973, which provides the Minister for Health with the authority to determine that certain health services, not specifically listed in the Pathology Services Table, can be treated as if they were listed under specific circumstances. This particular Determination revokes the Health Insurance (Pharmacogenetic Testing) Determination 2013 (No.1) because item number 73336, pertaining to pharmacogenetic testing, has been incorporated into the Health Insurance (Pathology Services Table) Regulation 2014, effective from 1 November 2014. The revocation does not alter the existing payment arrangements for this item. The Determination applies to all entities and individuals involved in the provision and receipt of health services under the Medicare Benefits Schedule, specifically for pharmacogenetic testing services related to BRAF V600 mutation status for access to dabrafenib under the Pharmaceutical Benefits Scheme. It has a national reach, applying across Australia in accordance with the Commonwealth's legislative authority. There are no exclusions, exemptions, or thresholds specified within this Determination, which is considered machinery in nature and does not alter existing arrangements. The compatibility with human rights is affirmed, particularly engaging with Articles 2, 9, and 12 of the International Covenant on Economic, Social and Cultural Rights, ensuring the right to health and social security is upheld.

Key Provisions

The Health Insurance (Pharmacogenetic Testing) Revocation Determination 2014 (section 1) revokes the Health Insurance (Pharmacogenetic Testing) Determination 2013 (No.1) (section 3) and is effective from 1 November 2014 (section 2). This revocation arises because item number 73336, which pertains to pharmacogenetic testing for BRAF V600 mutation status in patients with stage III or IV metastatic cutaneous melanoma, has been incorporated into the Health Insurance (Pathology Services Table) Regulation 2014. This change does not alter the payment of benefits for item 73336. Under the Health Insurance Act 1973, the Minister has the authority to determine that a health service not specified in the Pathology Services Table can be treated as specified under certain conditions (subsection 3C(1)). The Revocation Determination 2014 aligns with this by revoking the previous determination and integrating the relevant item into the Regulation, ensuring continued coverage for the specified genetic testing. The Act does not impose specific conditions for exercising this power, thereby providing flexibility in updating the coverage of Medicare benefits. The obligations imposed by this Determination on the parties governed by the Health Insurance Act 1973 primarily involve the correct application and recognition of item number 73336 in the Medicare Benefits Schedule. Healthcare providers must ensure that they correctly code and bill for this service, and patients need to be aware of their eligibility for the Medicare benefit related to this specific genetic testing. The Revocation Determination facilitates a smooth transition by embedding the item into the Pathology Services Table, ensuring consistent coverage. There are no explicit offences, penalties, or civil/criminal consequences outlined in the Revocation Determination itself. However, any breaches of the Health Insurance Act 1973 or related regulations, such as improper billing or fraudulent claims, may lead to penalties under the general provisions of the Act. These could include fines, repayments of benefits, and in severe cases, criminal charges. The specific penalties would depend on the nature and severity of the breach as determined under the broader framework of the Act.

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Reporting & Disclosure Obligations
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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.