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Determinations/Health as made
This instrument determines the particulars that must be contained in an application for the Minister’s acceptance of an undertaking under subsection 23DF(1) of the Health Insurance Act 1973.
Administered by: Health
Registered 28 Sep 2018
Tabling HistoryDate
Tabled HR15-Oct-2018
Tabled Senate15-Oct-2018

EXPLANATORY STATEMENT

 

Issued by the Authority of the Minister for Health

 

Health Insurance Act 1973

 

Health Insurance (Application for Acceptance of Approved Pathology Authority Undertakings) Determination 2018

 

Section 23DF(13) of the Health Insurance Act 1973 (‘the Act’) provides for the Minister to determine the particulars that shall be contained in an application under subsection 23DF(1) of the Act.  Under subsection 23DF(2) of the Act a person who wishes to apply for acceptance of an approved pathology authority undertaking for the purposes of subsection 23DF(1) of the Act, must make an application to the Minister in writing, in accordance with the approved form. Under paragraph 23DF(2)(c) the application must also contain such particulars as are determined by the Minister under subsection 23DF(13).

Under section 16A of the Act Medicare benefits for pathology services are only payable when they are rendered by or on behalf of an approved pathology practitioner, in an accredited pathology laboratory operated by an approved pathology authority.

The approved pathology authority undertaking is set out in Schedule 2 of the Health Insurance (Approved Pathology Undertakings) Approval 2017.

Purpose of the Determination

The purpose of the Health Insurance (Application for Acceptance of Approved Pathology Authority Undertakings) Determination 2018 (“the Determination”) is to determine the particulars that must be contained in an application for the Minister’s acceptance of an undertaking under subsection 23DF(1) of the Act. As provided for under subsection 23DF(2) of the Act, the application under subsection (1) must contain such particulars as are determined by the Minister under subsection (13) for the purposes of subsection (2).

These particulars must be provided when a person applies for acceptance of an approved pathology authority undertaking by the Minister to allow them to become an approved pathology authority for the purposes of Medicare benefits in relation to pathology services.

The Determination repeals and remakes the Health Insurance (Application for Acceptance of Approved Pathology Authority Undertakings) Approval 2002 (“the Previous Determination”), which was due to be automatically repealed (sunset) on 1 October 2018 as a result of section 50 of the Legislation Act 2003. As the instrument is still required, the Determination is substantively the same as the Previous Determination, with some minor technical and machinery differences, including:

·         changes to align the instrument to current drafting standards;

·         minor updates to the particulars of an application following consultation with the Department of Human Services; and

·         other minor consequential amendments to ensure consistency with other legislation regulating the provision of pathology services.

 

Details of the legislative instrument are set out in the Attachment.


 

Consultation

The Department of Human Services, which shares responsibility for administering the approved pathology authority undertaking application process with the Department of Health, was consulted prior to making the Determination.  

Peak bodies representing pathologists, including the Royal College of Pathologists of Australasia, Australian Pathology, and Public Pathology Australia, were also notified of the decision to remake the Previous Determination in this Determination. These stakeholders did not provide any comments because the Determination is substantively the same as the Previous Determination.

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

 

The Determination commences on the day after it is registered.


 

 

ATTACHMENT

 

DETAILS OF THE HEALTH INSURANCE (APPLICATION FOR ACCEPTANCE OF APPROVED PATHOLOGY AUTHORITY UNDERTAKINGS) DETERMINATION 2018

 

1.         Name

 

Section 1 provides that the name of the instrument is the Health Insurance (Application for Acceptance of Approved Pathology Authority Undertakings) Determination 2018 (the Determination).

 

2.         Commencement

 

Section 2 provides for the Determination to commence the day after the instrument is registered on the Federal Register of Legislation.

 

3.         Authority

 

Section 3 provides the authority for the Determination under subsection 23DF(13) of the Health Insurance Act 1973 (the Act).

 

4.         Definitions

 

Section 4 provides definitions for expressions used in the Determination.

 

5.         Determination of particulars

 

Section 5 provides that for the purposes of paragraph 23DF(2)(c) of the Act, an application under subsection 23DF(1) of the Act must contain the particulars as specified in Schedule 1.

 

6.         Schedules

 

Section 6 provides that each instrument that is specified in Schedule 2 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      Particulars for Application for Acceptance of Approved Pathology Authority Undertaking

 

Schedule 1 provides the particulars for the purposes of section 5 of the Determination.

 

Schedule 2      Repeals

 

Schedule 2 specifies and repeals the Health Insurance (Application for Acceptance of Approved Pathology Authority Undertaking) Determination 2002.

Statement of Compatibility with Human Rights

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

 

Health Insurance (Application for Acceptance of Approved Pathology Undertakings) Determination 2018

This Legislative 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 Legislative Instrument

The purpose of the Health Insurance (Application for Acceptance of Approved Pathology Authority Undertakings) Determination 2018 (“the Determination”) is to determine the particulars that must be contained in an application under subsection 23DF(1) of the Act.

These particulars must be provided when a person applies for acceptance of an approved pathology authority undertaking by the Minister to allow them to become an approved pathology authority for the purposes of Medicare benefits in relation to pathology services.

The Determination repeals and remakes the Health Insurance (Application for Acceptance of Approved Pathology Authority Undertakings) Approval 2002 (“the Previous Determination”), which was due to be automatically repealed (sunset) on 1 October 2017 as a result of section 50 of the Legislation Act 2003. As the instrument is still required, the Determination is substantively identical to the Previous Determination, with a number of minor technical and machinery differences, including:

·         changes to align the instrument to current drafting standards;

·         minor updates to the particulars of an application following consultation with the Department of Human Services; and

·         other minor consequential amendments to ensure consistency with other legislation regulating the provision of pathology services.

 

Human rights implications

The Determination indirectly engages 12 of the International Covenant on Economic, Social and Cultural Rights by assisting with the progressive realisation of the right of everyone to the enjoyment of the highest attainable standard of health, including a right to a system of health protection.

If the new instrument is not made, no new persons can apply to become APAs. Additionally, given that current approvals are limited to a maximum duration of 1 year, current APAs would be prevented from being re-approved. This would have a significant impact on the Australian public’s access to Commonwealth subsidised pathology services, and therefore the right to health.

The approved form in the Determination is related to the requirement for Medicare-eligible pathology services to be rendered by an approved pathology practitioners in an accredited pathology laboratory operated by an APA. This is a reasonable measure to ensure accountability in the provision of Medicare-eligible pathology services.

 

Conclusion

The Determination promotes the right to health as it ensures individuals have access to high-quality, clinically-relevant and cost-effective pathology services by pathology laboratories operated by APAs.

This Legislative Instrument is compatible with human rights as it maintains existing arrangements and the protection of human rights.

 

David Weiss

First Assistant Secretary

Medical Benefits Division
Department of Health