Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment (No. 1) Determination 2024

Administered by Department of Health, Disability and Ageing

Legislation au F2024L00555 Not in force Legislative Instrument

Legislation content

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

Overview

The Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment (No. 1) Determination 2024 was enacted to expand access to Medicare Benefits Schedule (MBS) pathology item 73295, which is used for the detection of germline BRCA1 or BRCA2 gene variants to determine eligibility for treatment with poly-ADP ribose polymerase inhibitors (PARP inhibitors) under the Pharmaceutical Benefits Scheme (PBS). This amendment, which comes into effect from 1 July 2024, was introduced to address the gap in access to MBS funding for pathology testing for patients with certain types of breast cancer, specifically those with triple-negative early breast cancer or hormone receptor-positive, HER2-negative early breast cancer with high-risk characteristics. The Determination was enacted by the Australian Government under the authority of the Health Insurance Act 1973, with the objective of enhancing health outcomes for eligible patients by providing them with access to necessary testing for PARP inhibitor treatment. The Amendment Determination was recommended by the Medical Services Advisory Committee (MSAC) under application 1716.1 and received support from relevant stakeholders, including Pink Hope, The Medical Oncology Group of Australia (MOGA), The Royal College of Pathologists of Australasia (RCPA), Australian Genomics (AG), and Omico. The Determination is compatible with the human rights and freedoms recognised or declared in the International Covenant on Economic, Social and Cultural Rights (ICESCR) and the International Covenant on Civil and Political Rights (ICCPR), as it 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.

Scope and Application

The Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment (No. 1) Determination 2024 applies to medical practitioners and patients within the Commonwealth of Australia, specifically in relation to the provision of pathology services under the Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits Scheme (PBS). The Amendment Determination modifies item 73295 of the MBS to expand the eligibility criteria for germline BRCA1 or BRCA2 gene variant testing, which determines eligibility for treatment with poly-ADP ribose polymerase inhibitors (PARP inhibitors) under the PBS. The changes, which take effect from 1 July 2024, allow for the inclusion of patients 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, in addition to those with advanced (FIGO III–IV) high-grade serous or high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer. The Amendment Determination is made under subsection 3C(1) of the Health Insurance Act 1973 and is a legislative instrument for the purposes of the Legislation Act 2003. The changes are based on recommendations from the Medical Services Advisory Committee and are supported by relevant stakeholders. The Amendment Determination does not explicitly state any exclusions or exemptions. However, the eligibility for the specified pathology testing remains restricted to those patients who meet the criteria of having TNBC or HR-positive, HER2-negative early breast cancer with high-risk characteristics, or advanced ovarian, fallopian tube, or primary peritoneal cancer. The application of the Amendment Determination may be further defined through subordinate instruments, although no such instruments are currently specified in the text. The instrument is compatible with human rights, particularly the rights to health, social security, and equality and non-discrimination, by expanding access to essential health services for additional patient groups.

Key Provisions

The Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment (No. 1) Determination 2024 amends the co-dependent Medicare Benefits Schedule (MBS) pathology item 73295 in the Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018. Specifically, it expands the eligibility criteria for MBS funding to include 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 (Section 4). This amendment aims to enable medical practitioners to request testing for these additional groups of patients to determine if they can access PARP inhibitors on the Pharmaceutical Benefits Scheme (PBS). It is important to note that the eligibility for patients with advanced (FIGO III–IV) high-grade serous or high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer remains unchanged. The Amendment Determination is made under subsection 3C(1) of the Health Insurance Act 1973 and commences on 1 July 2024. The Amendment Determination imposes certain obligations on medical practitioners, patients, and the Department of Health and Aged Care. Medical practitioners must ensure they adhere to the updated eligibility criteria when requesting pathology testing under item 73295. They must also provide accurate and complete information to support the request for MBS funding. Patients with the specified types of cancer must meet the new criteria to qualify for MBS-funded testing. The Department of Health and Aged Care is responsible for implementing the changes, ensuring that the updated MBS item is correctly reflected in the relevant schedules and regulations, and communicating the changes to all relevant stakeholders. Breach of the provisions in the Amendment Determination may lead to civil or administrative consequences. Medical practitioners who do not comply with the eligibility criteria when requesting pathology testing could face penalties or sanctions, including the potential denial of MBS funding for the services provided. Patients who do not meet the updated eligibility criteria may not receive the full benefits available under the MBS for their pathology testing. The Department of Health and Aged Care may also face scrutiny or legal challenges if the implementation of the Amendment Determination is deemed inadequate or non-compliant with the legislative requirements. While the Amendment Determination itself does not explicitly outline specific offences or penalties, any non-compliance with the Health Insurance Act 1973 or related regulations could result in civil penalties or legal action. For example, under the Act, penalties for providing false or misleading information to obtain benefits can amount to significant fines. Additionally, any failure to adhere to the updated MBS item criteria could lead to the recovery of any benefits improperly received by patients or practitioners. The maximum penalties for such offences would be determined by the relevant provisions of the Health Insurance Act 1973 and any related regulations or laws.

Legal classification tags

Area of Law
Health Law
Instrument
Legislative Instrument
Concepts
Commencement Provisions
Reporting & Disclosure Obligations
Regulatory Standards

Interactions

Authorises

All Versions

Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.