Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination (No.2) 2019

Administered by Department of Health, Disability and Ageing

Legislation au F2019L00174 Not in force Legislative Instrument

Legislation content

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) 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 (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The PST is set out in the regulations made under subsection 4A(1) of the Act, and is repealed and remade each year.

 

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) 2019 (the Determination) is to amend the Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018 from
1 March 2019.

 

Item 73343 commenced on 1 September 2018 for 17p deletion testing by fluorescence in situ hybridisation in patients with relapsed or refractory chronic lymphoid leukaemia (CLL) or small lymphocytic lymphoma (SLL). Patients who tested positive for the 17p chromosomal deletions would be eligible for idelalisib on the Pharmaceutical Benefits Scheme (PBS). On 1 December 2018, item 73343 was amended to enable patients who tested positive for the 17p chromosomal deletions to access ibrutinib as well as idelalisib on the PBS.

 

The Determination will amend item 73343 to enable testing in patients with relapsed or refractory CLL or SLL to determine eligibility for newly PBS-subsidised venetoclax, in addition to ibrutinib and idelalisib.

 

This proposal was supported by the Medical Services Advisory Committee (MSAC) and agreed by the Pharmaceutical Benefits Advisory Committee in November 2018.

 

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 this instrument are set out in the Attachment.

 

The instrument commences on 1 March 2019.

 

The instrument 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) 2019

 

Section 1 – Name

 

Section 1 provides for the instrument to be referred to as the Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination (No.2) 2019.

 

Section 2 – Commencement

 

Section 2 provides that the instrument commences on 1 March 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 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 – Amendment

 

The instrument amends the Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018 to add venetoclax to the description of item 73343 in Schedule 1.

 

 


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) 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

The purpose of the Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination (No.2) 2019 (the Determination) is to amend the Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018 from 1 March 2019.

 

Item 73343 commenced on 1 September 2018 for 17p deletion testing by fluorescence in situ hybridisation in patients with relapsed or refractory chronic lymphoid leukaemia (CLL) or small lymphocytic lymphoma (SLL). Patients who tested positive for the 17p chromosomal deletions would be eligible for idelalisib on the Pharmaceutical Benefits Scheme (PBS). On 1 December 2018, item 73343 was amended to enable patients who tested positive for the 17p chromosomal deletions to access ibrutinib as well as idelalisib on the PBS.

 

The Determination will amend item 73343 to enable testing in patients with relapsed or refractory CLL or SLL to determine eligibility for newly PBS subsidised venetoclax, in addition to ibrutinib and idelalisib.

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 maintain or advance rights to health and social security by ensuring access to publicly subsidised health services which are clinically effective, safe and cost-effective. The instrument would enable testing in patients with relapsed or refractory CLL or SLL to determine eligibility for newly PBS subsidised venetoclax, in addition to ibrutinib and idelalisib.

Conclusion

This instrument 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

Health Financing Group

Department of Health

 

Overview

The Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination (No.2) 2019 is an amendment to the Health Insurance Act 1973, introduced to address the need for updating the pathology services table (PST) to reflect the latest clinical advancements and ensure equitable access to essential medical services. This legislative instrument, enacted by the Australian Parliament, aims to enhance the health care system by enabling the testing of patients with relapsed or refractory chronic lymphoid leukaemia (CLL) or small lymphocytic lymphoma (SLL) for the 17p chromosomal deletions, thereby determining their eligibility for newly PBS-subsidised venetoclax, in addition to ibrutinib and idelalisib. The policy objective is to ensure that patients have access to the most effective and up-to-date treatments available, improving their health outcomes and aligning with the rights to health and social security as outlined in the International Covenant on Economic, Social and Cultural Rights. The determination, which commenced on 1 March 2019, is made under the authority of subsection 3C(1) of the Health Insurance Act 1973. It was supported by the Medical Services Advisory Committee and agreed upon by the Pharmaceutical Benefits Advisory Committee in November 2018. This amendment reflects a commitment to maintaining and advancing the rights to health and social security by ensuring access to publicly subsidised health services that are clinically effective, safe, and cost-effective.

Scope and Application

The Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination (No.2) 2019 amends the Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018, effective from 1 March 2019. This instrument, made under subsection 3C(1) of the Health Insurance Act 1973, specifies that a particular health service not previously listed in the pathology services table (PST) will be treated as if it were specified in the PST under certain circumstances and for specified statutory provisions. The amendment targets item 73343, which originally allowed for 17p deletion testing by fluorescence in situ hybridisation in patients with relapsed or refractory chronic lymphoid leukaemia (CLL) or small lymphocytic lymphoma (SLL) and was updated to include access to ibrutinib and idelalisib on the Pharmaceutical Benefits Scheme (PBS) on 1 December 2018. The Determination further updates this item to also include testing for eligibility for the newly PBS-subsidised venetoclax, thereby expanding the range of treatments accessible to eligible patients. The instrument is compatible with human rights, particularly engaging Articles 9 and 12 of the International Covenant on Economic, Social and Cultural Rights, by ensuring access to a system of health protection and social security, thus advancing the rights to health and social security.

Key Provisions

The Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination (No.2) 2019 amends the Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018, effective from 1 March 2019. This amendment specifically targets item 73343, which was initially introduced on 1 September 2018 for 17p deletion testing in patients with relapsed or refractory chronic lymphoid leukaemia (CLL) or small lymphocytic lymphoma (SLL). Initially, patients who tested positive for the 17p chromosomal deletions were eligible for idelalisib under the Pharmaceutical Benefits Scheme (PBS). This item was subsequently amended on 1 December 2018 to also include ibrutinib for eligible patients. The current Determination further amends item 73343 to incorporate venetoclax, making it available for patients who test positive for the 17p chromosomal deletions, in addition to ibrutinib and idelalisib. The Determination imposes specific obligations on relevant parties, including healthcare providers, pathology services, and patients. Healthcare providers must ensure that testing for the 17p chromosomal deletion is conducted in accordance with the guidelines set out in item 73343. Pathology services must process these tests and report the results accurately to determine patient eligibility for the specified PBS-subsidised medications. Patients, in turn, must be informed about their eligibility and the availability of these treatments. The Determination also mandates that these changes be implemented from 1 March 2019, ensuring that the amendments are incorporated into the existing framework of pathology services covered under the Health Insurance Act 1973. Failure to comply with the provisions of the Determination could result in various legal consequences. While the Determination does not explicitly list specific offences or penalties, breaches of the Health Insurance Act 1973 or associated regulations can lead to civil or criminal penalties. Under the Act, unauthorised actions that contravene the provisions could result in fines or legal action. Additionally, healthcare providers who fail to adhere to the requirements for pathology services may face penalties under the relevant state or territory health legislation. The exact penalties can vary, but they may include fines, sanctions, or other corrective measures as deemed appropriate by the relevant authorities.

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