EXPLANATORY STATEMENT

Issued by the Authority of the Minister for Health

Health Insurance Act 1973

Health Insurance (Pathologist-determinable Services) Amendment Determination 2019

Section 16A of the Health Insurance Act 1973 (the Act) specifies that certain requirements have to be met for the payment of Medicare benefits in relation to pathology services, including the requirement for a pathology service to be requested (subsection 16A(3)).  Pathologist-determinable services allow Medicare benefits to be paid for pathology services which are requested and performed by an approved pathology practitioner for their own patients, or for certain tests which are not requested, but are performed on the basis of information learned from an originally requested service.

Section 4BA of the Act provides that the Minister for Health may determine by legislative instrument, that a particular pathology service, or pathology services included in a class of pathology services, are pathologist-determinable services after consultation with Royal College of Pathologists of Australasia.

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

Item 73341 is for fluorescent in situ hybridisation testing for anaplastic lymphoma kinase immunoreactivity in patients with locally advanced or metastatic non-small cell lung cancer to determine access to crizotinib, ceritinib or alectinib under the Pharmaceutical Benefits Scheme.

In November 2017, the Medical Services Advisory Committee recommended that item 73341 be made pathologist-determinable. This would enable the service to be rendered by a pathologist, without a request, on the basis of information learned in an original requested service. This recommendation was supported by the Government.

The purpose of the Health Insurance (Pathologist-determinable Services) Amendment Determination 2019 is to amend the Health Insurance (Pathologist-determinable Services) Determination 2015 to include a reference to a new pathologist-determinable service item 73341.

Although pathology service item 73341 is not listed in the pathology services table made for the purposes of section 4A(1) of the Act, the Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018 deems it to be a pathology service specified in that table. The rendering of that service, subject to requirements being met, allows for Medicare benefits to be payable in relation to that service.

Consultation

Section 4BA of the Act requires that the Royal College of Pathologists of Australasia (RCPA) is consulted on pathology services being made pathologist-determinable services. RCPA was consulted on the inclusion of item 73341 in this legislative instrument, and supported the inclusion of item 73341 as a pathologist-determinable item.

Details of the Determination are set out in the Attachment.

The Determination commences on 1 April 2019.

The Determination is a legislative instrument for the purposes of the
Legislation Act 2003.

ATTACHMENT

Details of the Health Insurance (Pathologist-determinable Services) Amendment Determination 2019

Section 1 – Name

Section 1 provides for the instrument to be referred to as the Health Insurance (Pathologist-determinable Services) Amendment Determination 2019.

Section 2 – Commencement

Section 2 provides that the instrument commences on 1 April 2019.

Section 3 – Authority

Section 3 provides that the instrument is made under section 4BA of the Health Insurance Act 1973.

Section 4 – Schedules

Section 4 provides that each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1 – Amendment

Item 1 repeals and replaces the table under subsection 5(b)(iii) to insert new item 73341. Item 73341 is included in column 1 of row 1 of the table. This means it can be rendered as a pathologist-determinable services as a result of information learned from a service in column 2 of the table, to which a request is required. It also inserts a note at the bottom of the table to reference that items 73332, 73336, 73337, 73341, 73342 and 73344 are specified in a determination made under subsection 3C(1) of the Act.

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

Health Insurance (Pathologist-determinable Services) Amendment Determination 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

Item 73341 is for fluorescent in situ hybridisation testing for anaplastic lymphoma kinase immunoreactivity in patients with locally advanced or metastatic non-small cell lung cancer to determine access to crizotinib, ceritinib or alectinib under the Pharmaceutical Benefits Scheme.

In November 2017, the Medical Services Advisory Committee recommended that item 73341 be made pathologist-determinable. This would enable the service to be rendered by a pathologist, without a request, on the basis of information learned in an original requested service. This recommendation was supported by the Government.

The purpose of the Health Insurance (Pathologist-determinable Services) Amendment Determination 2019 is to amend the Health Insurance (Pathologist-determinable Services) Determination 2015 to include a reference to a new pathologist-determinable service item 73341.

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 advances the right to health and the right to social security by ensuring access to publicly subsidised health services which are clinically effective, safe and cost-effective.

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