EXPLANATORY STATEMENT
Health Insurance Act 1973
Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment (No. 1) Determination 2024
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 purpose of the Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment (No. 1) Determination 2024 (the Amendment Determination) is to amend co-dependent Medicare Benefits Schedule (MBS) pathology item 73295 in the Health Insurance (Section 3C Co‑Dependent Pathology Services) Determination 2018 (the Principal Determination) from 1 July 2024.
Item 73295 is for the detection of germline BRCA1 or BRCA2 gene variants to determine eligibility for treatment with a poly-ADP ribose polymerase inhibitor (PARP inhibitor) under the Pharmaceutical Benefits Scheme (PBS) as it identifies a subgroup of patients that may benefit from, or are more likely to respond to a PARP inhibitor.
From 1 July 2024, the Amendment Determination will amend item 73295 in the Principal Determination to enable medical practitioners to request testing for additional groups of patients. More specifically those with triple-negative early breast cancer (TNBC) or hormone receptor (HR)-positive, HER2-negative early (stage 1 to 2) breast cancer with high-risk characteristics of high-grade tumour to determine if they can access PARP inhibitors on the PBS.
Prior to these amendments to qualify for MBS funding, only patients with advanced (FIGO III–IV) high-grade serous or high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer were eligible. This will remain unchanged from
1 July 2024.
The amendment to item 73295 was recommended by the Medical Services Advisory Committee (MSAC) under application 1716.1 and supported at the Pharmaceutical Benefits Advisory Committee (PBAC) meetings in November 2023.
Consultation
Consultation was undertaken with relevant stakeholders with feedback received from the following five organisations, which were supportive of the changes:
Pink Hope
The Medical Oncology Group of Australia (MOGA)
The Royal College of Pathologists of Australasia (RCPA)
Australian Genomics (AG)
Omico.
The Amendment Determination is a legislative instrument for the purposes of the Legislation Act 2003.
The Amendment Determination commences on 1 July 2024.
Details of the Amendment 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 Co-Dependent Pathology Services) Amendment (No. 1) Determination 2024
Section 1 – Name
Section 1 provides for the Amendment Determination to be referred to as the Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment (No. 1) Determination 2024.
Section 2 – Commencement
Section 2 provides for the Amendment Determination to commence on 1 July 2024.
Section 3 – Authority
Section 3 provides that the Amendment 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 Amendment 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 Determination has effect according to its terms.
Schedule 1 – Amendments to the co-dependant pathology services
Health Insurance (Section 3C Co‑Dependent Pathology Services) Determination 2018
Item 1 amends MBS item 73295 to expand access to patients with triple-negative early breast cancer (TNBC) or hormone receptor (HR)-positive, HER2-negative early breast cancer with high-risk characteristics of high-grade tumour, to determine if they can access PARP inhibitors on the PBS.
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 (No. 1) Determination 2024
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 Co-Dependent Pathology Services) Amendment (No. 1) Determination 2024 (the Amendment Determination) is to amend co-dependent Medicare Benefits Schedule (MBS) pathology item 73295 in the Health Insurance (Section 3C Co‑Dependent Pathology Services) Determination 2018 (the Principal Determination) from 1 July 2024.
Item 73295 is for the detection of germline BRCA1 or BRCA2 gene variants to determine eligibility for treatment with a poly-ADP ribose polymerase inhibitor (PARP inhibitor) under the Pharmaceutical Benefits Scheme (PBS) as it identifies a subgroup of patients that may benefit from, or are more likely to respond to a PARP inhibitor.
From 1 July 2024, the Amendment Determination will amend item 73295 in the Principal Determination to enable medical practitioners to request testing for additional groups of patients. More specifically those with triple-negative early breast cancer (TNBC) or hormone receptor (HR)-positive, HER2-negative early (stage 1 to 2) breast cancer with high-risk characteristics of high-grade tumour to determine if they can access PARP inhibitors on the PBS.
Prior to these amendments to qualify for MBS funding, only patients with advanced (FIGO III–IV) high-grade serous or high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer were eligible. This will remain unchanged from
1 July 2024.
The amendment to item 73295 was recommended by the Medical Services Advisory Committee (MSAC) under application 1716.1 and supported at the Pharmaceutical Benefits Advisory Committee (PBAC) meetings in November 2023.
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 advances the right to health, the right to social security and the right of equality and non-discrimination by providing additional patients with access to Medicare benefits for pathology testing for the detection of BRCA1 or BRCA2 pathogenic gene variants to determine the patient’s eligibility for treatment with PARP inhibitors on the PBS.
Conclusion
This instrument is compatible with human rights as it maintains the right to health and the right to social security and the right of equality and non-discrimination.
Mary Warner
Assistant Secretary
Diagnostic Imaging and Pathology Branch
Medicare Benefits and Digital Health Division
Health Resourcing Group
Department of Health and Aged Care