EXPLANATORY STATEMENT
Issued by the Authority of the Minister for Health
Health Insurance Act 1973
Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination (No. 2) 2018
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 (PST) shall, in specified circumstances and for specified statutory provisions, be treated as if it were specified in the PST.
The PST is set out in the regulations made under subsection 4A(1) of the Act, and is repealed and remade each year. The table made under this subsection is referred to as the PST.
Subsection 33(3) of the Acts Interpretation Act 1901 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
The purpose of the Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination (No. 2) 2018 (the Determination) is to amend the Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018 to provide a legal basis for the payment of Medicare benefits for a test provided under new item 72814.
The new immunohistochemistry test is for the evaluation of programmed cell death ligand 1 (PD-L1) expression in patients diagnosed with metastatic non-small cell lung cancer. Patients with a positive test are then eligible to access the drug pembrolizumab under the Pharmaceutical Benefits Scheme.
The Medical Services Advisory Committee (MSAC) supported the listing of this new item.
Consultation
As part of the MSAC process, consultation is undertaken with professional bodies, consumer groups, the public and clinical experts for proposals put forward for consideration 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 Medicare Benefits Schedule (MBS). This includes the listing of new items, or amendments to existing items on the MBS.
Details of the Determination are set out in the Attachment.
The Determination commences immediately after the Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination 2018.
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 Co-Dependent Pathology Services) Amendment Determination (No. 2) 2018
Section 1 – Name
Section 1 provides for the Determination to be referred to as the Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination (No. 2) 2018.
Section 2 – Commencement
Section 2 provides that the Determination commences immediately after the Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination 2018.
Section 3 – Authority
Section 3 provides that the Determination 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 Determination is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Instrument has effect according to its terms.
Schedule 1 – Amendment
Item 1 inserts a reference to group P5 into Section 6 (Treatment of relevant services) of the Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018. Section 6 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 pathology 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 medical services prescribed under section 4A of the Health Insurance Act 1973.
Item 2 inserts the fee and item descriptor for new item 72814. Effectively, this will replace item 73288 is a PD-L1 test listed in the Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination 2018. This item will be replaced as it incorrectly categorised the item as a genetic test.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination (No. 2) 2018
This Determination 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 Co-Dependent Pathology Services) Amendment Determination (No. 2) 2018 (the Determination) is to amend the Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018 to provide a legal basis for the payment of Medicare benefits for a test provided under new item 72814.
The new immunohistochemistry test is for the evaluation of programmed cell death ligand 1 (PD-L1) expression in patients diagnosed with metastatic non-small cell lung cancer. Patients with a positive test are then eligible to access the drug pembrolizumab under the Pharmaceutical Benefits Scheme.
The Medical Services Advisory Committee (MSAC) supported the listing of this new item.
Human rights implications
This 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 advances the right to health and the right to social security by ensuring access to publicly subsidised health services which are clinically effective, safe and cost-effective.
Conclusion
This Determination 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
Department of Health