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