EXPLANATORY STATEMENT
Issued by the Authority of the Minister for Health
Health Insurance Act 1973
Health Insurance (Section 3C Pathology Services - BRCA Gene Testing No.2) Determination 2017
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. The Table is set out in the Health Insurance (Pathology Services Table) Regulations which is remade each year.
Purpose
The purpose of the Health Insurance (Section 3C Pathology Services - BRCA Gene Testing No.2) Determination 2017 (the Determination) is to provide a legal basis for the payment of Medicare benefits for the genetic pathology test provided under new Medicare Benefits Schedule (MBS) items 73296 and 73297.
From the commencement of this Determination, Medicare benefits will be payable under the new item 73296 to test patients with breast and/or ovarian cancer for multiple genes, including BRCA1 and BRCA2, to inform prognosis and risk of future primary cancers. Under the new item 73297, in the case of a mutation-positive result in a biological relative for certain specified genes, patients will be eligible to access testing to determine whether they also carry a mutation which predisposes them to breast and/or ovarian cancer. This testing will determine if these patients require further monitoring or treatment. Benefits are not payable to a patient for a service under item 73297 where a service under item 73296 has previously been rendered to that patient.
Item 73295, which commenced on 1 February 2017, is listed in the Determination. This item provides a rebate to patients for the detection of germline BRCA1 and BRCA2 mutation in selected patients with relapsed ovarian cancer with continued sensitivity to platinum-based chemotherapy, to inform eligibility for olaparib under the Pharmaceutical Benefits Schedule. It is currently listed in the Health Insurance (BRCA Gene Testing) Determination 2017 which will be repealed following the commencement of the Determination.
Consultation
The listing of items 73296 and 73297 in the Determination was considered and agreed to by the Medical Services Advisory Committee (MSAC) and the listing of item 73295 has previously been considered and agreed to by MSAC.
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 the MBS.
The Royal College of Pathologists Australasia were consulted in relation to items 73296 and 73297 as part of the MSAC process.
Details of the Determination are set out in the Attachment.
The Determination commences on 1 November 2017.
The Determination is a legislative instrument for the purposes of the Legislation Act 2003.
Authority: Subsection 3C(1) of the
Health Insurance Act 1973
ATTACHMENT
Details of the Health Insurance (Section 3C Pathology Services - BRCA Gene Testing No.2) Determination 2017
Section 1 – Name of Determination
Section 1 provides for the Determination to be referred to as the Health Insurance (Section 3C Pathology Services - BRCA Gene Testing No.2) Determination 2017.
Section 2 – Commencement
Section 2 provides that the Determination commences on 1 November 2017.
Section 3 – Authority
Section 3 provides that the Determination is made under subsection 3C(1) of the Health Insurance Act 1973.
Section 4 – Definitions
Section 4 defines terms used in the Determination.
Section 5 – Treatment of relevant services
Section 5 provides that a clinically relevant service provided in accordance with the Determination shall be treated, for relevant provisions of the Health Insurance Act 1973 and National Health Act 1953, and regulations made under those Acts, as if it were both a professional service and a medical service and as if there were an item specified in the pathology services table for the service. The pathology services table is a table of pathology services prescribed under section 4A of the Health Insurance Act 1973.
Section 6 – Repeal
Section 6 repeals the Health Insurance (BRCA Gene Testing) Determination 2017.
Schedule 1 – Relevant services
Schedule 1 prescribes the fee and item descriptor for items 73295, 73296 and 73297.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Health Insurance (Section 3C Pathology Services - BRCA Gene Testing No.2) Determination 2017
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 new Medicare pathology services (items 73296 and 73297) and re-lists an existing pathology service (item 73295).
Medicare benefits will be payable under the new item 73296 to test patients with breast and/or ovarian cancer for multiple genes, including BRCA1 and BRCA2, to inform prognosis and risk of future primary cancers.
Under the new item 73297, in the case of a mutation-positive result in a biological family member for certain specified genes, patients will be eligible to access testing to determine whether they also carry a mutation which predisposes them to breast and/or ovarian cancer. This testing will determine if these patients require further monitoring or treatment.
Item 73295, which commenced on 1 February 2017, will continue to be listed in the Determination. This item detects germline BRCA1 and BRCA2 mutation in selected patients with relapsed ovarian cancer with continued sensitivity to platinum-based chemotherapy, to inform eligibility for olaparib under the Pharmaceutical Benefits Schedule. It is currently listed in the Health Insurance (BRCA Gene Testing) Determination 2017 which will be repealed following the commencement of the Determination.
The Determination takes effect from 1 November 2017.
Human rights implications
The Determination engages 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.
The Committee reports that there is a strong presumption that retrogressive measures taken in relation to the right to social security are prohibited under ICESCR. In this context, a retrogressive measure would be one taken without adequate justification that had the effect of reducing existing levels of social security benefits, or of denying benefits to persons or groups previously entitled to them. However, it is legitimate for a Government to re-direct its limited resources in ways that it considers to be more effective at meeting the general health needs of all society, particularly the needs of the more disadvantaged members of society.
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 Legislative Instrument is compatible with human rights as it has a positive effect on human rights issues.
Celia Street
Assistant Secretary
Primary Care Analytics and Pathology Branch
Medical Benefits Division
Department of Health