EXPLANATORY STATEMENT
Health Insurance Act 1973
Health Insurance (Section 3C Pathology –17p chromosomal deletion testing) Determination 2023
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 (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 regulations made under subsection 4A of the Act. The most recent version of the regulations is the Health Insurance (Pathology Services Table) Regulations 2020.
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
The Health Insurance (Section 3C Pathology –17p chromosomal deletion testing) Determination 2023 (the Determination) reintroduces MBS item 73343 for the detection of 17p chromosomal deletions in patients with Chronic Lymphocytic Leukaemia (CLL) or Small Lymphocytic Lymphoma (SLL) which is being repealed from the Health Insurance (Section 3C Co‑Dependent Pathology Services) Determination 2018 (the CDPS Determination).
The repeal and reintroduction of item 73343 will both commence on 1 July 2023.
The new item 73343 descriptor will:
- no longer require services to be performed as a prerequisite to accessing specific medications listed on the Pharmaceutical Benefits Scheme (PBS);
- expand the eligible patient population to all patients who suffer from CCL or SLL;
- include lymph node samples as an appropriate sample type; and
- remove the frequency restriction limiting use of the item once 12-monthly.
CCL and SLL are two closely related blood cancers. In patients diagnosed with CLL and SLL, presence of 17p deletion is an independent prognostic indicator for poor prognosis and confers a worse response to many chemotherapeutic agents.
The amendments will allow all patients with CLL and SLL to access Medicare funded testing for 17p chromosomal deletion as needed, including at initial diagnosis; disease relapse; or disease progression when initiation of, or change in therapy is anticipated. Presently, only patients who have relapsed or refractory CLL or SLL have access to item 73343, and only peripheral blood samples or bone marrow samples can be used. Lymph node samples will be an appropriate sample type.
References to specific drug names will also be removed so that the test will no longer be solely for the purpose of determining access to PBS listed drugs.
This change was recommended by the Medical Services Advisory Committee (MSAC) at its November meeting under MSAC application 1560 and MSAC application 1544. This recommendation was confirmed by MSAC Executive at its August 2022 meeting. The amendment to item 73343 was subsequently announced under the Medicare Benefits Schedule – new and amended listings measure during the May 2023-24 Budget.
Consultation
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.
Consultation on the changes described in the Determination was undertaken with peak medical bodies, including the Royal College of Pathologists of Australasia and the Haematological Society of Australia and New Zealand. The consulted stakeholders were supportive of the amendments to item 73343.
The Determination is a legislative instrument for the purposes of the Legislation Act 2003.
The Determination commences on immediately after the commencement of Schedule 3 of the Health Insurance Legislation Amendment (2023 Measures No. 2) Determination 2023.
Details of the Determination are set out in the Attachment.
Authority: Subsection 3C(1) of the
Health Insurance Act 1973
ATTACHMENT
Details of the Health Insurance (Section 3C Pathology –17p chromosomal deletion testing) Determination 2023
Section 1 – Name
Section 1 provides for the Determination to be referred to as the Health Insurance (Section 3C Pathology –17p chromosomal deletion testing) Determination 2023.
Section 2 – Commencement
Section 2 provides for the Determination to commence immediately after the commencement of Schedule 3 of the Health Insurance Legislation Amendment (2023 Measures No. 2) Determination 2023.
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 pathology service and as if there were an item specified in the pathology services table for the service.
Section 6 – Schedules
Section 6 provides that each instrument that is specified in a s Schedule to this Determination is amended or repealed as set out in the applicable items in the Schedule concerned, and any other items in a Schedule to this Determination has effect according to its terms.
Schedule – Relevant services
The Schedule specifies the service and the associated fee for item 73343 for the detection of 17p chromosomal deletions in patients with Chronic Lymphocytic Leukaemia (CLL) or Small Lymphocytic Lymphoma (SLL).
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 –17p chromosomal deletion testing) Determination 2023
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 Health Insurance (Section 3C Pathology –17p chromosomal deletion testing) Determination 2023 (the Determination) reintroduces MBS item 73343 for the detection of 17p chromosomal deletions in patients with Chronic Lymphocytic Leukaemia (CLL) or Small Lymphocytic Lymphoma (SLL) which is being repealed from the Health Insurance (Section 3C Co‑Dependent Pathology Services) Determination 2018 (the CDPS Determination).
The repeal and reintroduction of item 73343 will both commence on 1 July 2023.
The new item 73343 descriptor will:
- no longer require services to be performed as a prerequisite to accessing specific medications listed on the Pharmaceutical Benefits Scheme (PBS);
- expand the eligible patient population to all patients who suffer from CCL or SLL;
- include lymph node samples as an appropriate sample type; and
- remove the frequency restriction limiting use of the item once 12-monthly.
CCL and SLL are two closely related blood cancers. In patients diagnosed with CLL and SLL, presence of 17p deletion is an independent prognostic indicator for poor prognosis and confers a worse response to many chemotherapeutic agents.
The amendments will allow all patients with CLL and SLL to access Medicare funded testing for 17p chromosomal deletion as needed, including at initial diagnosis; disease relapse; or disease progression when initiation of, or change in therapy is anticipated. Presently, only patients who have relapsed or refractory CLL or SLL have access to item 73343, and only peripheral blood samples or bone marrow samples can be used. Lymph node samples will be an appropriate sample type.
References to specific drug names will also be removed so that the test will no longer be solely for the purpose of determining access to PBS listed drugs.
This change was recommended by the Medical Services Advisory Committee (MSAC) at its November meeting under MSAC application 1560 and MSAC application 1544. This recommendation was confirmed by MSAC Executive at its August 2022 meeting. The amendment to item 73343 was subsequently announced under the Medicare Benefits Schedule – new and amended listings measure during the May 2023-24 Budget.
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.
The right of equality and non-discrimination
The rights of equality and non-discrimination are contained in articles 2, 16 and 26 of the International Covenant on Civil and Political Rights (ICCPR). Article 26 of the ICCPR requires that all persons are equal before the law, are entitled without any discrimination to the equal protection of the law and in this respect, the law shall prohibit any discrimination and guarantee to all persons equal and effective protection against discrimination on any ground such as race, colour, sex, language, religion, political or other opinion, national or social origin, property, birth or other status.
Analysis
This instrument will reflect contemporary clinical guidelines by expanding the eligible patient population who may receive a service under item 73343 from 1 July 2023. Under the changes made in the instrument, all patients living with CLL or SLL will be able to have access to health and social security through relevant subsidised pathology services on the MBS.
Conclusion
This instrument is compatible with human rights as it advances the right to health, the right to social security and the right of equality and non-discrimination by expanding the eligible patient population who may receive a subsided service under item 73343 from 1 July 2023.
Daniel McCabe
First Assistant Secretary
Medicare Benefits and Digital Health Division
Health Resourcing Group
Department of Health and Aged Care