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Determinations/Health as made
This instrument amends the Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018 to enable testing provided under item 73343 for patients with relapsed or refractory chronic lymphoid leukaemia or small lymphocytic lymphoma, to determine eligibility for venetoclax, in addition to ibrutinib and idelalisib, under the Pharmaceutical Benefits Scheme.
Administered by: Health
Registered 22 Feb 2019
Tabling HistoryDate
Tabled HR02-Apr-2019
Tabled Senate02-Apr-2019
Date of repeal 12 Sep 2019
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

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The PST is set out in the regulations made under subsection 4A(1) of the Act, and is repealed and remade each year.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