EXPLANATORY STATEMENT
Issued by the Authority of the Minister for Health
Health Insurance Act 1973
Health Insurance (Section 3C Pathology Services – Archival Tissue Retrieval) Amendment 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The pathology services table is set out in the regulations made under subsection 4A(1) of the Act, which is repealed and re-made each year. The most recent version of the regulations is the Health Insurance (Pathology Services Table) Regulations 2019.
This instrument relies on subsection 33(3) of the Acts Interpretation Act 1901 (AIA). Subsection 33(3) of the AIA provides that where an Act confers a power to make, grant or issue any instrument of a legislative or administrative character (including rules, regulations or by-laws), the power shall be construed as including a power exercisable in the like manner and subject to the like conditions (if any) to repeal, rescind, revoke, amend, or vary any such instrument.
Purpose
Item 72860 was listed on 1 May 2019 to allow pathologists to retrieve and identify tissue blocks which are suitable for conducting genetic testing. This service enables certain patients, who require urgent genetic testing as a result of initial tissue, cytology or genetic pathology test results, to avoid another invasive biopsy. Item 72860 is prescribed in the Health Insurance (Section 3C Pathology Services – Archival Tissue Retrieval) Determination 2019 (the Principal Determination).
The Health Insurance (Section 3C Pathology Services – Archival Tissue Retrieval) Amendment Determination 2019 (the Determination) amends the Principal Determination and removes the related Approved Pathology Authority restrictions in subsection (2) and (5) of the Principal Determination. This is to clarify that the archival tissue service (item 72860) does not apply if the subsequent genetic test(s) is performed in the same laboratory as the archival service. The subsequent genetic test must be performed in a separate laboratory, but there is no limitation on the proprietor of the laboratories.
The Medical Services Advisory Committee (MSAC) supported the public funding of this archived tissue test if the sample remained valid for additional genetic testing (MSAC assessment 1331). The Determination is an administrative amendment which provides further clarity to the item.
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 the amendment to item 72860.
Details of the Determination are set out in the Attachment.
The Determination commences on 1 November 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 – Archival Tissue Retrieval) Amendment Determination 2019
Section 1 – Name
Section 1 provides for the instrument to be referred to as the Health Insurance (Section 3C Pathology Services – Archival Tissue Retrieval) Amendment Determination 2019.
Section 2 – Commencement
Section 2 provides that the instrument commences on 1 November 2019.
Section 3 – Authority
Section 3 provides that the instrument is made under subsection 3C(1) of the Health Insurance Act 1973.
Section 4 – Schedules
Section 4 provides that each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Determination has effect according to its terms.
Section 1 – Amendments
Health Insurance (Section 3C Pathology Services – Archival Tissue Retrieval) Determination 2019
Item 1 – Section 7 (below the heading)
Item 1 repeals and substitutes section 7 of the Principal Determination, which specify the limitations for services provided under item 72860.
Subsection 7(1) provides that item 72860 does not apply if it is rendered at the same ‘accredited pathology laboratory’ as the genetic test (the subsequent genetic test(s)). Accredited laboratory means premises in respect of which there is in force an approval under section 23DN of the Health Insurance Act 1973.
Subsection 7(2) specifies limitations on items which can be performed in association with item 72860. Paragraph (a) requires that 72860 does not apply if it is rendered in association with a service to which items 72858 or 72859 of the pathology services table apply. This limitation is intended to apply to the initial patient episode and the subsequent patient episode. Paragraph (b) requires that item 72860 does not apply if it is rendered in association with an item in Groups P6, P10, or P11 of the pathology services table for the subsequent patient episode.
Subsection 7(3) provides that item 72860 is applicable for one retrieval per subsequent patient episode.
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 – Archival Tissue Retrieval) Amendment 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
Item 72860 was listed on 1 May 2019 to allow pathologists to retrieve and identify tissue blocks which are suitable for conducting genetic testing. This service enables certain patients, who require urgent genetic testing as a result of initial tissue, cytology or genetic pathology test results, to avoid another invasive biopsy. Item 72860 is prescribed in the Health Insurance (Section 3C Pathology Services – Archival Tissue Retrieval) Determination 2019 (the Principal Determination).
The Health Insurance (Section 3C Pathology Services – Archival Tissue Retrieval) Amendment Determination 2019 (the Determination) amends the Principal Determination and removes the related Approved Pathology Authority restrictions in subsection (2) and (5) of the Principal Determination. This is to clarify that the archival tissue service (item 72860) does not apply if the subsequent genetic test(s) is performed in the same laboratory as the archival service. The subsequent genetic test must be performed in a separate laboratory, but there is no limitation on the proprietor of the laboratories.
The Medical Services Advisory Committee (MSAC) supported the public funding of this archived tissue test if the sample remained valid for additional genetic testing (MSAC assessment 1331). The Determination is an administrative amendment which provides further clarity to the item.
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 expand patient access rights to health and social security by ensuring that patients are able to access further testing under item 72860, if required, regardless of the location of the laboratory. This is in line with the policy intent of the service.
Conclusion
This instrument is compatible with human rights as it expands a patient access right to health and the right to social security.
Nathan Hyson
Acting Assistant Secretary
Diagnostic Imaging and Pathology Branch
Medical Benefits Division
Health Financing Group
Department of Health