EXPLANATORY STATEMENT
Issued by the Authority of the Minister for Health
Health Insurance Act 1973
Health Insurance (Pharmacogenetic Testing – Human Epidermal Growth Factor Receptor 2) Determination 2015
Subsection 3C(1) of the Health Insurance Act 1973 (the Act) provides that the Minister may, by writing, determine 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 specified in the Table. This Table is set out in the Health Insurance (Pathology Services Table) Regulation which is remade each year.
Purpose
The purpose of the Health Insurance (Pharmacogenetic Testing – Human Epidermal Growth Factor Receptor 2) Determination 2015 (the Determination) is to create a new Medicare pathology service (item 73342). The item 73342 is for an in-situ hybridisation test of tumour tissue from a patient to determine eligibility to access trastuzumab (for treatment of metastatic gastric cancer) under the Pharmaceutical Benefits Scheme (PBS).
Background
Currently, there are no items in the Medical Benefits Schedule (MBS) that provide for the payment of a Medicare benefit for an in-situ hybridisation test of tumour tissue from a patient with metastatic adenocarcinoma of the stomach or gastro-oesophageal junction, with documented evidence of human epidermal growth factor receptor 2 (HER2).
In July 2015, after considering the strength of the available evidence in relation to the safety, clinical effectiveness and cost-effectiveness of HER2 in-situ hybridisation testing to select eligible patients with metastatic gastric cancer for trastuzumab treatment, Medical Services Advisory Committee (MSAC) advised that it supported public funding. As this item is a co-dependant technology it is being listed in co-ordination with the extension of the PBS listing of trastuzumab. MSAC also recommended that this item be made a pathologist-determinable service.
Details of the Determination are set out in the Attachment.
This Determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
This Determination commences on 1 January 2016.
Consultation
Consultation was undertaken on the listing of item 73342 in the Determination. The creation of the new item was considered and agreed to by MSAC and informed by clinical experts from the Pathology Clinical Commitee.
MSAC reviews new or existing medical services or technology, and the circumstances under which public funding should be supported through listing on the MBS. This includes the listing of new items, or amendments to existing items on MBS.
As part of the MSAC process, consultation was undertaken with professional bodies, consumer groups, the public and clinical experts for proposals put forward for consideration by the Committee.
Consultation was undertaken with the Royal College of Pathologists of Australasia (RCPA) as part of the MSAC process.
ATTACHMENT
Details of the Health Insurance (Pharmacogenetic Testing – Human Epidermal Growth Factor Receptor 2) Determination 2015
Section 1 – Name of Determination
This section provides for the Determination to be referred to as the Health Insurance (Pharmacogenetic Testing – Human Epidermal Growth Factor Receptor 2) Determination 2015.
Section 2 – Commencement
This section provides for the Determination to commence on 1 January 2016.
Section 3 – Authority
This section provides that the Determination is made under the Health Insurance Act 1973.
Section 4 – Interpretation
This section defines terms used in the Determination.
Section 5 – Treatment of a relevant service
This section provides that a relevant service specified in the Schedule to the Determination shall be treated as if it were both a professional service and a medical service.
It also provides that a relevant service specified in the Schedule to the Determination is to be treated as if there were an item in Group P7 of the Table that related to the service and specified a fee in respect of that service, being the fee specified in the Schedule to the Determination in relation to the service.
Schedule – Specified Health Services
Inserts new Medicare item 73342 for the payment of a Medicare benefit for an in-situ hybridization test of tumour tissue from a patient with metastatic adenocarcinoma of the stomach or gastro-oesophageal junction, with documented evidence of human epidermal growth factor receptor 2 (HER2). This test will determine eligibility to access trastuzumab (for treatment of metastatic gastric cancer) under the Pharmaceutical Benefits Scheme.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Health Insurance (Pharmacogenetic Testing – Human Epidermal Growth Factor Receptor 2) 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 Determination creates a new Medicare pathology service (item 73342). The item 73342 is for an in-situ hybridisation test of tumour tissue from a patient to determine eligibility to access trastuzumab (for treatment of metastatic gastric cancer) under the Pharmaceutical Benefits Scheme.
Human rights implications
The regulations engage Articles 9 and 12 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 reports that the ‘highest attainable standard of health’ takes into account the country’s available resources. This 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 realisation of the highest attainable standard of health.
The Right to Social Security
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
This Determination will advance rights to health and social security by ensuring access to publicly subsidised health services which are clinically effective and cost-effective.
Conclusion
This Determination is compatible with the human rights recognised in the Human Rights (Parliamentary Scrutiny) Act 2011.
Maria Jolly
First Assistant Secretary
Medical Benefits Division
Department of Health