EXPLANATORY STATEMENT

Issued by the Authority of the Minister for Health and Aged Care

Health Insurance Act 1973

Health Insurance (BRCA Gene Testing) 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.  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 (BRCA Gene testing) Determination 2017 (the Determination) is to create a new Medicare pathology service (item 73295).  Item 73295 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 (PBS).  This item is a predictive test that will identify a sub-group of patients likely to benefit from olaparib treatment.  This change was recommended by the Medical Services Advisory Committee (MSAC) at its meeting in November 2016.

Item 73295 can only be claimed once per patient.

Details of the Determination are set out in the Attachment.

This Determination commences on 1 February 2017.

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

Consultation

The listing of Medicare item 73295 in the Determination was considered and agreed to by the 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.

As part of the MSAC process, consultation was undertaken with professional bodies, consumer groups, clinical experts and the public, for proposals put forward for consideration by the Committee.

ATTACHMENT

Details of the Health Insurance (BRCA Gene Testing) Determination 2017

Section 1 – Name of Determination

This section provides for the Determination to be referred to as the Health Insurance (BRCA Gene Testing) Determination 2017.

Section 2 – Commencement

This section provides that the Determination commences on 1 February 2017.

Section 3 – Authority

This section provides that the Determination is made under subsection 3C(1) of the Health Insurance Act 1973.

Section 4 – Definitions

This section defines terms used in the Determination.

Section 5 – Treatment of relevant services

This section 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.

Schedule 1 – relevant services

This Schedule creates Medicare item 73295 for the payment of a Medicare benefit for a genetic test to determine a patient’s eligibility to access olaparib under the PBS for treatment of relapsed ovarian, fallopian tube or primary peritoneal cancer with certain clinical features.

Statement of Compatibility with Human Rights

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

Health Insurance (BRCA Gene Testing) 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 a new Medicare pathology service (item 73295).  Item 73295 provides a rebate to patients for the detection of germline BRCA1 or BRCA2 gene mutations, in a patient with platinum-sensitive relapsed ovarian, fallopian tube or primary peritoneal cancer with high grade serous features or a high grade serous component, and who has responded to subsequent platinum-based chemotherapy, requested by a specialist or consultant physician, to determine whether the eligibility criteria for olaparib under the Pharmaceutical Benefits Schedule are fulfilled.

Item 73295 can only be claimed once per patient.

The Determination takes effect from 1 February 2017.

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 providing access to a publicly subsidised health service which is clinically effective and cost-effective.

Conclusion

This Determination is compatible with the human rights recognised in the Human Rights (Parliamentary Scrutiny) Act 2011.

Michael Ryan

A/g Assistant Secretary

Medical Specialist Services Branch

Medical Benefits Division

Department of Health