Federal Register of Legislation - Australian Government

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Determinations/Health as made
This determination prescribes categories of ‘accredited pathology laboratory’.
Administered by: Health
Registered 11 Mar 2016
Tabling HistoryDate
Tabled HR15-Mar-2016
Tabled Senate16-Mar-2016

EXPLANATORY STATEMENT

 

Health Insurance Act 1973

 

Health Insurance (Eligible Pathology Laboratories) Determination 2015

 

Subsection 23DBA of the Health Insurance Act 1973 (the Act) provides that the Minister may, by determination in writing, prescribe categories of accredited pathology laboratory for the purposes of the definition of an ‘eligible pathology laboratory’ in subsection 23DA(1) of the Act. 

 

Subsection 23DBA of the Act further provides that the Minister may do so by applying, adopting or incorporating, with or without modification, the provisions of principles determined by the Minister under section 23DNA of the Act.

 

The Act sets out no procedural requirements that must be complied with before the Minister may exercise the power under section 23DBA.

 

Purpose

 

The purpose of the Health Insurance (Eligible Pathology Laboratories) Determination 2015 (the Determination) is to prescribe categories of accredited pathology laboratory as categories of eligible pathology laboratory. 

 

Background

 

Medicare benefit is payable for a pathology service only where the pathology specimen is collected from the patient at a type of locations specified in subsection 16A(5AA) of the Act.  One of these locations is an ‘approved collection centre’, being a specimen collection centre approved by the Minister under section 23DNBA of the Act. 

 

Under section 23DNBA of the Act, the Minister may grant an approval to an approved pathology authority (APA) to operate an ‘eligible collection centre’ on premises owned, leased or otherwise occupied by the APA.  An eligible collection centre is a collection centre on premises owned, leased or sub-leased by an APA that is also the sole proprietor of at least one eligible pathology laboratory. 

 

Decisions on applications for approval of a specimen collection centre are required by the Act to be made in accordance with principles made under section 23DNBA of the Act, currently the Health Insurance Act (Eligible Collection Centres) Approval Principles 2010 (the Principles).  Section 5 of the Principles requires an application for approval of a specimen collection centre to be made by an APA:

 

     (a)        that operates and owns a laboratory allocated Category GX (General) or GY (General) in an approval by the Minister given under section 23DN of the Act; or

     (b)       that operates and owns a laboratory allocated Category S (Specialised) in an approval by the Minister given under section 23DN of the Act and that is proposing to only collect specimens within the limited range of testing performed in the laboratory; or

            (c)                          has entered into an arrangement with another APA for the use of a Category GX or GY laboratory and, immediately before the commencement of item 31 of the Health Legislation Amendment (Medical Practitioners’ Qualifications and Other Measures) Act 2001 (i.e. before 1 December 2001):

                    (i)                                  operated a collection centre that was in a rural or remote area as specified in the Rural/Remote Areas Classification document published by the Department of Human Services and Health in January 1994; and

                    (ii)                                 and was not on the premises of a ‘recognized hospital’, i.e. a hospital that was a recognized (public) hospital for the purposes of an agreement with the states relating to the provision of public hospital services or declared to be a recognized hospital in a Territory.  

 

The Determination provides that, for the definition of an eligible pathology laboratory in subsection 23DA(1) of the Act, the categories of accredited pathology laboratory are:

(a)           laboratories allocated Category GX, GY or S; and

(b)          laboratories covered by an arrangement referred to in (c) above. 

 

The category of laboratory described in (c) covers grandfathered accredited pathology laboratories operated by an approved pathology authority that, at the time of 2001 amendments to the Act to revise and strengthen requirements for specimen collection centre approvals, operated laboratories located in rural and remote areas (other than a laboratory on the premises of a public hospital), provided the approved pathology authority has an arrangement with another authority to use its Category GX or GY laboratory. Category GX and GY laboratories are laboratories which perform a full range of pathology testing.

 

As a result, the Determination will have no practical effect on who may apply for and be granted approval of a specimen collection centre, as the classes of APAs who could make valid applications under the Principles will be the same the classes of APAs who own and operate at least one eligible pathology laboratory.  The Determination will simply strengthen the basis for the criteria currently in place.  

 

Consultation

 

The Determination does not alter existing arrangements in respect of APAs that may be eligible for approval to operate an approved collection centre. No consultation has been undertaken with the pathology sector given there are no changes to existing arrangements or any associated compliance costs.  

 

This Determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

 

The Determination commences on the day after registration on the Federal Register of Legislative Instruments. 

 

 


Statement of Compatibility with Human Rights

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

 

Health Insurance (Eligible Pathology Laboratories) Determination 2015

 

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 Health Insurance (Eligible Pathology Laboratories) Determination 2015 (the Determination) prescribes categories of ‘accredited pathology laboratory’ as categories of ‘eligible pathology laboratory’. 

Under subsection 16A(5AA) of the Act, in order for Medicare benefits to be payable for pathology services rendered, pathology specimens must be collected in an ‘approved collection centre’ (ACC), or in other specified circumstances.

Under section 23DNBA of the Health Insurance Act 1973 Act, the Minister may grant an approval to an approved pathology authority (APA) to operate an ‘eligible collection centre’ on premises owned, leased or otherwise occupied by the APA.  Once approved, the eligible collection centre becomes an ACC. 

Subsection 23DA(1) of the Act provides that an eligible collection centre is a collection centre on premises owned, leased or sub-leased by an APA that is also the sole proprietor of at least one eligible pathology laboratory.  Section 23DBA of the Act empowers the Minister, by determination in writing, to prescribe categories of accredited pathology laboratory for the purposes of the definition of an eligible pathology laboratory.

The Determination provides that, for the definition of an eligible pathology laboratory in subsection 23DA(1) of the Act, the categories of accredited pathology laboratory are:

(a)           laboratories allocated Category GX, GY or S in an approval given under section 23DN of the Act; and

(b)          laboratories in respect of which the sole proprietor APA has entered into an arrangement with another APA for the use of a Category GX or GY laboratory if, immediately before the commencement of item 31 of the Health Legislation Amendment (Medical Practitioners’ Qualifications and Other Measures) Act 2001 (i.e. before 1 December 2001), the APA:

(i)         operated a collection centre that was in a rural or remote area as specified in the Rural/Remote Areas Classification document published by the Department of Human Services and Health in January 1994; and

(ii)        and was not on the premises of a ‘recognized hospital’, i.e. a hospital that was a recognized (public) hospital for the purposes of an agreement with the states relating to the provision of public hospital services or declared to be a recognized hospital in a Territory. 

 

Decisions about approvals of collection centres under section 23DNBA are currently regulated under arrangements set out in the Health Insurance (Eligible Collection Centres) Approval Principles 2010 (the Eligible Collection Centre Principles) made under that section. 

These categories of accredited pathology laboratory prescribed in the Determination replicate the restrictions on the categories of APA who may make valid applications for approval of a collection centre under section 5 of the Principles.  The Determination simply reflects these restrictions as categories of laboratory, as anticipated by section 23DBA. 

The Determination does not make any changes to the existing arrangements for the manner of applying for approval of a collection centre, or the operation of collection centres.

Human rights implications

This Legislative Instrument does not engage any of the applicable rights or freedoms. 

The proposed Determination does not impose any new requirements on APAs seeking approval of eligible collection centres. The Determination is to ensure that eligible pathology laboratories are clearly identified for the continuity in the assessment of eligible collection centres in accordance with the Act.

Patient access to Medicare rebates for pathology services is not affected by the Determination. 

Conclusion

This Legislative Instrument is compatible with the human rights as it does not engage any of the applicable rights or freedoms.

 

 

SUSSAN LEY

Minister for Health