EXPLANATORY STATEMENT
Issued by the Authority of the Minister for Health
Health Insurance Act 1973
Health Insurance (Section 3C Pathology Services – Alport Syndrome Testing) Determination 2019
Subsection 3C(1) of the Health Insurance Act 1973 (the Act) provides that the Minister may, by legislative instrument, determine that a health service not specified in an item in the pathology services table shall, in specified circumstances and for specified statutory provisions, be treated as if it were specified in the pathology services table.
The pathology services table is set out in the regulations made under subsection 4A(1) of the Act.
Purpose
The purpose of the Health Insurance (Section 3C Pathology Services – Alport Syndrome Testing) Determination 2019 (the Determination) is to list Medicare Benefits Schedule (MBS) genetic testing services for the diagnosis of Alport syndrome from 1 May 2019.
In March 2018, the Medical Services Advisory Committee (MSAC) supported the public funding of two genetic tests to diagnosis gene mutations which cause Alport syndrome, a syndrome characterised by progressive kidney disease, significant hearing loss and eye abnormalities (MSAC assessment 1449).
Item 73298 will be listed to test patients, with a clinical or family history strongly suggestive of Alport syndrome, for gene mutations in the COL4A3, COL4A4 or COL4A5 genes. Clinical symptoms include renal disease (with no other cause), persistent glomerular haematuria, hearing loss, lenticonus, or retinopathy. A relevant family history includes a diagnosis of Alport syndrome, or the clinical assessment that the person may be carrying one of the gene mutations (for example, renal failure with no other obvious cause), in a first degree biological relative.
If a patient tests positive for a mutation in one or more of the COL4A3, COL4A4 or COL4A5 genes, that patient’s family members (first degree biological relative) will be eligible for genetic testing under new item 73299. This test will determine if the family members carry the gene mutation, and require further monitoring or treatment.
The Government agreed to this MSAC advice in the 2018-19 Mid-Year Economic and Fiscal Outlook under the Guaranteeing Medicare – strengthening primary care measure.
Consultation
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 key stakeholders, clinical experts and providers, and consumer health representatives. The Royal College of Pathologists of Australasia was consulted in relation to items 73298 and 73299 as part of the MSAC process.
Details of the Determination are set out in the Attachment.
The Determination commences on 1 May 2019.
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 – Alport Syndrome Testing) Determination 2019
Section 1 – Name
Section 1 provides for the instrument to be referred to as the Health Insurance (Section 3C Pathology Services – Alport Syndrome Testing) Determination 2019.
Section 2 – Commencement
Section 2 provides that the instrument commences on 1 May 2019.
Section 3 – Authority
Section 3 provides that the instrument is made under subsection 3C(1) of the Health Insurance Act 1973.
Section 4 – Definitions
This section defines terms used in the instrument.
Section 5 – Treatment of relevant services
Section 5 provides that a clinically relevant service provided in accordance with the instrument 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 pathology service and as if there were an item specified in the pathology services table for the service.
Schedule – Relevant services
The Schedule lists items 73298 and 73299.
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 – Alport Syndrome Testing) Determination 2019
This 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 Determination
The purpose of the Health Insurance (Section 3C Pathology Services – Alport Syndrome Testing) Determination 2019 (the Determination) is to list Medicare Benefits Schedule (MBS) genetic testing services for the diagnosis of Alport syndrome from 1 May 2019.
In March 2018, the Medical Services Advisory Committee (MSAC) supported the public funding of two genetic tests to diagnosis gene mutations which cause Alport syndrome, a syndrome characterised by progressive kidney disease, significant hearing loss and eye abnormalities.
Item 73298 will be listed to test patients, with a clinical or family history suggestive of Alport syndrome, for gene mutations in the COL4A3, COL4A4 or COL4A5 genes. Clinical symptoms include renal disease (with no other cause), persistent glomerular haematuria, hearing loss, lenticonus, or retinopathy. A relevant family history includes a diagnosis of Alport syndrome, or the clinical assessment that the person may be carrying one of the gene mutations (for example, renal failure with no other obvious cause), in a first degree biological relative.
If a patient tests positive for a mutation in one or more of the COL4A3, COL4A4 or COL4A5 genes, that patient’s family members will be eligible for genetic testing under new item 73299. This test will determine if the family members carry the gene mutation, and require further monitoring or treatment.
The Government agreed to this MSAC advice in the 2018-19 Mid-Year Economic and Fiscal Outlook under the Guaranteeing Medicare – strengthening primary care measure.
Human rights implications
This instrument 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 instrument will advance rights to health and social security by subsidising a health service which is clinically effective, safe and cost-effective. The instrument will subsidise, in the form of a Medicare benefit, at risk patients to access genetic testing services for gene mutations which cause Alport syndrome. In the case of a mutation-positive result, this instrument will provide a Medicare benefit for that patient’s family members to be tested. This will allow the appropriate management and treatment of patients with Alport syndrome.
Conclusion
This instrument is compatible with human rights as it has a positive effect on the right to health and the right to social security.
Celia Street
Assistant Secretary
Diagnostic Imaging and Pathology Branch
Medical Benefits Division
Health Financing Group
Department of Health